Drug Injury Attorney Blog

As a dangerous drug lawyer, I was pleased to see an appellate victory for a family whose daughter suffered serious birth defects from the use of a drug her mother was advised and permitted to use throughout pregnancy. In Fredericks v. Malouf, Eric and Kristine Malouf sued Kristine’s neurologist and obstetrician over injuries to their daughter, Kimberly. Kristine had been taking the drug Depakote (valproic acid) to treat seizures before her pregnancy, under the supervision of Dr. Ruth Fredericks. They discussed pregnancy with Fredericks and an obstetrician, Dr. Martin Tucker, but neither doctor took Kristine off the Depakote. The Maloufs sued Fredericks in Hinds County and added Tucker to the complaint later, whereupon the defendants moved to change venue to Rankin County. The trial court denied this, finding it had been abandoned, and the Mississippi Supreme Court agreed.

Kristine started taking Depakote in 1994 under Fredericks’s supervision, and went to Fredericks in 1995 to discuss the possibility of pregnancy with Depakote and epilepsy. Fredericks referred them to Tucker, and they conceived in mid-1996. Kristine continued taking Depakote under both doctors’ care, though Fredericks was no longer treating her after November of 1997. In March of 1997, Kristine gave birth to a seemingly healthy Kimberly. However, Kimberly was diagnosed at 22 months with a type of brain injury called periventricular leukomalaca, and at seven years with valproate syndrome, a collection of facial abnormalities. Her parents sued Fredericks in 2002, claiming Fredericks prescribed insufficient Depakote that caused Kristine to have seizures during pregnancy that caused the brain damage. When they added Tucker to the suit in 2006, they changed their case to allege that the brain damage was caused by Depakote itself.

Tucker moved to transfer the venue to Rankin County, arguing that all treatment was performed at his office there. Fredericks joined the motion. However, Tucker did not file a supplemental joint motion for the change of venue for nearly three years. The trial court thus denied the motion, finding the defendants had abandoned it by failing to pursue it for three years, during which time the deadline for pretrial motions passed and discovery continued. Defendants filed an interlocutory appeal.

On appeal, defendants argued that venue cannot be waived, pointing to a state law requiring all lawsuits against doctors to be filed in the county where the treatment took place. The Mississippi Supreme Court disagreed, noting that it has never ruled that defendants cannot waive their rights. All litigants are on notice that they may lose rights by failing to comply with the court, the high court said. Though Tucker submitted evidence that he tried to reschedule the hearing on his motion — and the trial court apparently used rules not permitted by Mississippi’s Rules of Civil Procedure — the Supreme Court found that the trial court’s nonstandard rules didn’t keep Tucker from requesting a hearing. In the time during which he failed to act, the court noted, he otherwise actively participated in the process. Thus, it upheld the lower court’s finding that the venue motion had been abandoned.

As a defective drug attorney, I’m particularly interested in the drug aspect of this case because Depakote is in pregnancy category D. That means it’s known to cause birth defects, but doctors may still prescribe it if they believe the benefits outweigh the risks. In fact, medical literature shows that the first report of harm to a fetus from a mother’s Depakote use was in 1980, sixteen years before Kristine Malouf got pregnant. Over the last three years, the FDA has issued two warnings to pregnant women taking Depakote, saying the drug can increase neural tube defects and lower IQs in their babies. As a result, doctors are now encouraged to find another epilepsy drug to prescribe as an alternative during pregnancy, or reduce dosage of Depakote and add folic acid supplements if there is no alternative. Depakote’s maker, Abbott Laboratories, is also facing allegations by ex-employees that it paid kickbacks to doctors who prescribed it for off-label use in dementia patients. As a pharmaceutical liability lawyer, I believe patients are entitled to the fullest possible information on Depakote’s safety as well as its marketing practices.

Continue reading "Mississippi Supreme Court Permits Drug Lawsuit to Continue in Original Venue – Fredericks v. Malouf" »

I write on this blog regularly about the dangers posed by the antibiotic Levaquin (levofloxacin), particularly for older patients and those taking certain other drugs. So, as a dangerous drug attorney, I was interested to see an article on the close of a trial in a Levaquin injury lawsuit. The trial in Minneapolis alleges that pharmaceutical company Johnson & Johnson, which makes Levaquin, had an inadequate warning on its label about the risk of tendon rupture. This led to two ruptured Achilles tendons for Clifford Straka, now 78, just nine days after starting a Levaquin prescription for a respiratory infection in 2006. In 2008, the Food and Drug Administration required J&J to add a warning about the risk of tendon ruptures to the label of the drug. No ruling was reported a day after the close of trial.

Straka was an active man when he was injured and had been an athlete when he was younger, even trying out for the Green Bay Packers. But after taking Levaquin for his respiratory infection, he suffered dual tendon ruptures that sidelined him. The Achilles tendon connects the heel to the calf; without it, walking is impossible or extremely painful. The risk of tendon rupture with Levaquin’s class of antibiotics has been known and reported on the label since the 1990s, but the label did not carry a warning highlighting the special risk to older patients until 2007 and again in 2008, when a “black box” warning was added. This was insufficient when Levaquin was prescribed for Straka and may still play down the risks, the lawsuit said. J&J argued that the label had always been sufficient.

Straka’s lawsuit is the third to go to trial in Minnesota and one of more than 3,700 Levaquin injury lawsuits across the United States. The first, decided in 2010, ended in a jury verdict of $1.8 million for the patient. As a Levaquin injury lawyer, I’m pleased to see more cases in the news, because each report helps raise awareness that the drug is not always safe. As this lawsuit outlines in detail, the research on the relationship between Levaquin and tendon ruptures stretches back to before the drug was approved in the United States. Watchdog group Public Citizen petitioned the FDA for any warning at all in the 1990s. Despite evidence of as much as three times the risk of tendon rupture in the elderly, it wasn’t until the early 2000s that the label was updated to mention such a connection — and even then, it subordinated age to corticosteroid use until 2007.

At Carey, Danis & Lowe, we represent clients across the United States who have suffered serious injuries because they took Levaquin or another prescription drug. Most patients believe drugs wouldn’t be sold, and doctors wouldn’t prescribe them, if they weren’t safe. Unfortunately, as Straka and many other patients across the country can testify, that’s frequently not true. Drug makers that want to protect the profits and profit potential of their drugs sometimes not only downplay the risks of their drugs, but take active steps to suppress negative information and research or even plant positive information through ghostwritten medical journal articles and company-sponsored studies. When these flawed drugs hurt or even kill someone, our pharmaceutical liability attorneys help victims hold the drug makers legally liable for their failure to make the risks clear.

Continue reading "Trial Ends in Levaquin Injury Lawsuit Filed by Patient Who Ruptured Both Achilles Tendons" »

The famous first of the Yaz bellwether trials was postponed by the presiding judge, David R. Herndon, on December 31, 2011.

According to information from a report that was posted by FiercePharma, Herndon ordered the postponement so that the lawsuits can go into mediation. While the first of the bellwether test trials was supposed to begin next week, the postponement order came down on December 31. Herndon chose Stephen Saltzburg to be the mediator. Saltzburg is a law professor at George Washington; Herndon asked him to see if he could get both sides of the litigation to agree to “settlements in this litigation.”

Currently, there are more than 10,000 lawsuits filed over the serious adverse side effects that have been linked to Yaz, Yasmin and other drospirenone-based birth control pills. A variety of side effects have been linked to Yaz, including blood clots, gallbladder disease, heart attacks, strokes and pulmonary embolisms. Yaz blood clots have been the subject of a good deal of controversy, since countless research studies have consistently shown the pills to cause women to be 75 percent more likely to develop blood clots after taking Yaz vs. any other oral contraceptive.

It was only last month that an FDA advisory panel decided that Yaz labels had to be updated to include stricter warnings against Yaz blood clots. The panel’s recommendation left a sour taste in many experts’ mouths, since many of them wanted Yaz to be recalled from the market altogether. Until the pills are recalled, consumers will continue to suffer from illnesses and death. As the plaintiffs, lawyers and defendants await the onset of the bellwether trials, it remains to be seen whether this postponement will affect the other bellwether trials that were slated for later this year.

The famous first of the Yaz bellwether trials was postponed by the presiding judge, David R. Herndon, on December 31, 2011.

According to information from a report that was posted by FiercePharma, Herndon ordered the postponement so that the lawsuits can go into mediation. While the first of the bellwether test trials was supposed to begin next week, the postponement order came down on December 31. Herndon chose Stephen Saltzburg to be the mediator. Saltzburg is a law professor at George Washington; Herndon asked him to see if he could get both sides of the litigation to agree to “settlements in this litigation.”

Currently, there are more than 10,000 lawsuits filed over the serious adverse side effects that have been linked to Yaz, Yasmin and other drospirenone-based birth control pills. A variety of side effects have been linked to Yaz, including blood clots, gallbladder disease, heart attacks, strokes and pulmonary embolisms. Yaz blood clots have been the subject of a good deal of controversy, since countless research studies have consistently shown the pills to cause women to be 75 percent more likely to develop blood clots after taking Yaz vs. any other oral contraceptive.

It was only last month that an FDA advisory panel decided that Yaz labels had to be updated to include stricter warnings against Yaz blood clots. The panel’s recommendation left a sour taste in many experts’ mouths, since many of them wanted Yaz to be recalled from the market altogether. Until the pills are recalled, consumers will continue to suffer from illnesses and death. As the plaintiffs, lawyers and defendants await the onset of the bellwether trials, it remains to be seen whether this postponement will affect the other bellwether trials that were slated for later this year.

As a defective drug attorney, I’ve written here many times about the drug Vioxx — both as a dangerous drug itself and as an example of the terrible consequences when powerful pharmaceuticals are lightly regulated. As regular observers of the pharmaceutical liability world know, Vioxx (rofecoxib) was withdrawn from the U.S. market in 2004, after scientific studies showed an increased or even doubled risk of heart attacks and strokes in users. To make matters worse, investigations showed that Merck had known about the risk for at least five years and said nothing to patients or the FDA, with some watchdogs accusing Merck of suppressing negative studies and fabricating positive ones. As a result, Merck has faced lawsuits across the world, including hundreds in Canada that the Associated Press reported Jan. 19 it would settle.

According to the article, Merck has set aside up to $36.9 million in Canadian dollars (US $36.5 million) to settle all lawsuits in Canada. The amount that will actually be paid depends on individual users’ circumstances, but attorneys for both sides expect it to be at least $21.6 million. The settlement covers Canadians who suffered a heart attack or their survivors; stroke victims will be eligible for a lesser amount of money. Canadian provinces and territories that paid for the drug will also be eligible for the money. The settlement follows Merck’s settlement of criminal and civil charges in the U.S. for a combined $950 million and an agreement to plead guilty to marketing Vioxx for off-label use with rheumatoid arthritis. A settlement of U.S. claims by 50,000 patients and their families was reached in 2007 for $4.85 billion.

Though this amount of money might seem staggeringly large to an individual, as a dangerous drug lawyer, I know it’s likely not much of a deterrent to Merck. Vioxx had sales of $2.5 billion in 2003 in the U.S. alone — experts believe up to 80 million people around the world had taken it at some point. Though it’s impossible for an outsider to calculate what kind of profit Merck made on Vioxx, it was clearly good for business for a while. And that “while” was reportedly about five years longer than it should have been. Results suggesting a link between Vioxx and cardiovascular problems began appearing even before the drug was approved by the FDA, and Merck has been criticized for failing to follow up. After approval, the pharmaceutical company allegedly withheld safety information from a medical journal that was submitted to the FDA; that agency also warned Merck for leaving cardiovascular information out of its marketing.

If you believe a dangerous or defective drug is responsible for your family’s injuries, you should call Carey, Danis & Lowe as soon as possible. Our pharmaceutical liability attorneys handle all kinds of lawsuits involving prescription and over-the-counter drugs that are tainted or unsafe to use according to the manufacturer’s directions. Patients are not medical experts; we trust our doctors to prescribe drugs that are safe and free of defects. But when manufacturers fail to warn us about serious risks, especially known risks, our trust is betrayed. Patients in this position and their families can hold the manufacturer legally liable with a defective drug lawsuit. In this kind of case, you can claim compensation for your illness or injury; personal losses; and all kinds of related costs, including lost income from not being able to work.

Continue reading "Manufacturer of Banned Painkiller Vioxx Settles Canadian Lawsuits for Up to C$37 Million" »

I’ve written here many times from my perspective as a dangerous drug attorney about the problems with atypical antipsychotic drugs. These newer drugs were originally hailed as an improvement over older antipsychotics, but their use has become controversial because they were widely prescribed for “off-label” uses until fairly recently. In fact, drug makers including Janssen, a subsidiary of Johnson & Johnson, have been accused of illegally promoting atypical antipsychotics for off-label uses, particularly dementia. That use has fallen out of favor after studies showed that antipsychotics actually increased dementia patients’ risk of death; Johnson & Johnson announced a $1 billion settlement of related charges this month. Now, according to Bloomberg News, the company is accused of paying kickbacks to a former Texas state official for giving its drugs prescribing preference.

In the lawsuit, the state of Texas accused Janssen of defrauding it paying a mental health official to give its drugs priority in prescribing. As head of the Texas Department of Mental Health and Mental Retardation, Steven Shon helped develop the Texas Medication Algorithm Project, a computer program that provided prescribing guidelines to state doctors. Shon testified that he accepted payments from Janssen to fly to other states to promote the project as a model, once or twice a month over several years. Shon also served on Janssen advisory boards and the board for a Janssen publication, and served as a continuing medical education speaker for the company. Though he testified that these trips happened on his own time, the state cited at least one instance where he stayed on the clock despite being in Arizona. He retired involuntarily in 2006.

Shon and Janssen deny the allegation that they conspired to promote drugs like Risperdal illegally. Texas is also alleging that Janssen’s illegal over-promotions overbilled the state’s Medicare program. That is one of at least 12 similar claims in state and federal lawsuits, according to the Associated Press. Jury verdicts and settlements against the drug manufacturer for its Risperdal marketing practices include a $327 million award in South Carolina in 2011 and a 2010 award of $258 in Louisiana. In addition to alleging that Janssen marketed Risperdal for dementia and, before FDA approval for this purpose, bipolar patients, states also claim that the pharmaceutical company promoted it for use in children despite no approval for that use. The FDA itself ordered Janssen at least three times, in 1994, 1999 and 2004, to stop making false marketing claims about Risperdal.

This is especially concerning to defective drug lawyers like me because Risperdal has serious side effects. In particular, it and other atypical antipsychotics have a known risk of weight gain, diabetes and related metabolic problems such as high blood pressure. In addition, studies over the past decade have revealed that they may also increase the risk of stroke and heart problems in dementia patients or other older people. Those studies that gave rise to the FDA’s decision to include a “black box” warning, the agency’s strongest, advising against their use in dementia patients. More rarely, but also more seriously, antipsychotics like Risperdal can cause life-altering neurological problems including neuroleptic malignant syndrome and tardive dyskinesia. As a pharmaceutical liability attorney, I support these lawsuits and look forward to anything else they may reveal about these apparently widespread illegal marketing practices.

Continue reading "Trial Begins in Texas Lawsuit Alleging Manufacturer Fraudulently Promoted Antipsychotics" »

I’ve written here many times before about the dangers of the birth control pills Yaz and Yasmin, in my role as a dangerous drug lawyer. Both pills contain the relatively new drug drospirenone, which is newer than other birth control and once thought safer. However, studies and patient experiences have started to pile up the evidence that drospirenone may actually be less safe than older drugs, because of a tendency to cause dangerous blood clots. These clots can cause death or emergency hospitalization due to stroke and heart problems. As a result, drug maker Bayer now faces hundreds or thousands of lawsuits over its failure to warn patients — and many have been consolidated in southern Illinois. The first case was set to go to trial in early 2012, but as FiercePharma reported Jan. 4, it’s now heading for mediation.

Judge David Herndon of the U.S. district court for the southern district of Illinois had said he’d press for settlements after the first cases — called bellwether cases because they could predict the direction of later lawsuits — were completed. The first case, Kelly Sims v. Bayer, was scheduled to start Jan. 9. But in a surprise move, Herndon delayed trial and ordered both sides to meet with a court-appointed mediator and negotiate in good faith. That mediator is Stephen Saltzburg, a law professor at George Washington University and the mediator who handled 26,000 cases alleging injuries from the antipsychotic drug Seroquel. The Dec. 31 order says Herndon believes both sides will be better served by negotiating and that the principles of a bellwether plan will not be met by going to trial. It’s unclear what might be happening in other cases.

As a defective drug attorney, I’m interested to see what happens with these negotiations. The goal in Yaz and Yasmin lawsuits is not necessarily to go to trial; it’s to get adequate compensation for plaintiffs who’ve suffered serious health consequences from taking the drugs. For that reason, I don’t believe it would be bad for plaintiffs if they were able to settle this dispute in mediation, as long as they were able to secure adequate financial compensation. However, another consequence of mediation may be to shield the proceedings from the public. This would be less good, because another point of pursuing litigation over Yasmin and Yaz is to raise public awareness that these drugs could pose an unnecessary and avoidable risk. The FDA recently voted to recommend clearer blood clot warnings on the drugs’ labels, but a high-profile win for plaintiffs in the media could do more.

If you suffered a serious illness or injury from taking a prescription drug, you should call Carey, Danis & Lowe to discuss how we can help. Based in St. Louis and southern Illinois, we represent clients across the United States who were harmed by a drug they took in order to feel better — that carried no warnings about its serious side effects. Drug manufacturers must warn patients about safety risks, just like any other consumer product manufacturer. But because of the astronomical profits that can be made from a prescription drug under patent, pharmaceutical companies often take steps to cover up a prescription drug’s risks. This exposes everyone who takes and trusts that drug to dangerous side effects. Our pharmaceutical liability lawyers help clients recover damages from companies that deceived them in this way, covering not only their past and future medical are, but compensating them for lost income, permanent disabilities and more.

Continue reading "Federal Judge Orders Mediation in Yaz Bellwether Case Set for Trial in Southern Illinois" »

As a dangerous drug attorney, I’ve written here before about a Nevada scandal in which patients were treated with infected anesthetics. Patients being treated for unrelated conditions were unwittingly exposed to serious diseases like hepatitis and HIV, and several have sued the medical centers and drug manufacturers behind the problem. One such case is Sicor et al. v. Sacks et al., in which the Nevada Supreme Court ultimately ruled that Sicor and other defendants could not move for a change of venue until a jury was selected and could be interviewed about the effects of pretrial publicity. The Clark County trial court dismissed the motion without prejudice as untimely and Sicor appealed, but the Nevada Supreme Court dismissed the appeal as not ripe because deferring the motion until jury selection did not create a final, appealable order.

Sicor and other defendants are manufacturers of propofol, which was used by non-parties to the suit in Clark County (which includes Las Vegas). About 60,000 patients received letters in 2008 warning them that they may have been exposed to infections including hepatitis B, hepatitis C and HIV. This set off a local firestorm that included criminal investigations, business and personal bankruptcies and about 200 Clark County lawsuits. This was heavily covered in the Clark County media, so Sicor moved before trial for a change of venue to Washoe County (which includes Reno, a much smaller city several hours away), arguing that it would have a better chance of a fair trial. The trial court considered arguments and jury questionnaires, and ultimately dismissed the motion without prejudice, saying the issue could be reopened if a fair jury could not be seated after voir dire. This appeal followed.

In this appeal, the Nevada Supreme Court said, the issue is whether the order was appealable at all — whether it was final enough to be appealed. The court ultimately said no. It’s true that denial of a motion for a change of venue is usually appealable — but the court noted that such orders must be final. By contrast, an order that reserves the final judgment until a later date would not normally be construed as final and appealable — but because this one had to do with change of venue, it was open to that interpretation. The Nevada high court had never considered the issue before, so it reviewed decisions from other jurisdictions, including the U.S. Supreme Court’s 2010 Skilling v. U.S. decision. Considering all these decisions and Nevada law, the Nevada Supreme Court declined to construe the trial court’s deferral of the venue change motion as a denial. Thus, it said, the order was not appealable and the appeal must be dismissed as premature.

Interestingly, this decision was issued contemporaneously with a similar appeal involving Sicor and different plaintiffs, in which Sicor waited until the jury was empaneled, but the motion for change of venue was still denied. In that case, the high court agreed with the trial court that a fair trial could be held in Clark County. As a pharmaceutical liability lawyer, I suspect this is not the last appeal Sicor will file with the Nevada high court, given that literally 60,000 Nevadans were affected by the tainted propofol. When this much money is at stake for the defendant, it often chooses to fight every issue to the appellate level, believing this is less expensive than settling. As a defective drug attorney, I fight this tendency in my own cases, attempting to minimize delays and costs for my clients — but never at the expense of justice.

Continue reading "Nevada Supreme Court Upholds Denial of Change of Venue in Anesthetic Liability Case – Sicor v. Sacks" »

The pharmaceutical company Bayer is currently facing a large number of lawsuits alleging that the birth control pills Yasmin and Yaz, both of which contain the relatively new drug drospirenone, carries an unreasonable risk of dangerous blood clots. So as a defective drug lawyer, I was disappointed but not surprised to see a report that Bayer is asking one state’s high court for a special intervention that would reduce its liability. Legal Newsline reported Dec. 12 that Bayer has asked the Pennsylvania Supreme Court to stop the lawsuits coming out of the Complex Litigation Center of the Philadelphia Court of Common Pleas. The manufacturer alleges that the CLC is encouraging lawsuits by people who don’t live in Pennsylvania and weren’t treated in Pennsylvania to be filed in Philadelphia, in order to generate more filing fees.

Attorneys for Bayer wrote to the state high court as part of an appeal of nine rejected motions to dismiss, asking it to use its power to clarify which lawsuits belong in Pennsylvania. They say 85 percent of the Yaz and Yasmin injury lawsuits in the CLC were filed by people who have no reason to litigate in Pennsylvania. This is harmful to Pennsylvanians who want to pursue injury lawsuits over Yasmin and Yaz, they wrote, and creates difficulties for Bayer by locating the lawsuit away from the forum with the evidence. Bayer Corp. has a principal place of business in Pennsylvaia, but it is a holding company for the direct manufacturer, New Jersey-based Bayer HealthCare Pharmaceuticals. Philadelphia is under fire by opponents of consumer lawsuits, having been named as the top “judicial hellhole” for 2011 by a tort reform interest group. A Pennsylvania state legislator has introduced a bill to limit forums for new lawsuits.

As a pharmaceutical injury attorney, I predict that Bayer will not succeed. If it’s true that most of the Yaz and Yasmin lawsuits in the CLC were filed by out-of-state people, these are probably not the first motions to dismiss for improper venue. Thus, whatever legal reasoning the lower court used to deny the motions is probably well-tested. Furthermore, there may be an argument that the CLC is an appropriate venue for Yasmin and Yaz lawsuits precisely because it sees a lot of these claims. Drug injury lawsuits like these are frequently complex cases involving a lot of expert testimony to explain the connection between the drug and the injury to a lay jury. And because injury cases involving popular drugs like Yaz and Yasmin tend to leave numerous people with the same complaints, consolidating all of these cases in the same place leaves the door open for a more efficient class-action lawsuit — which may be what Bayer really fears.

At Carey, Danis & Lowe, we represent clients across the United States who have been seriously injured or lost a loved one after taking a drug they thought they could trust. When doctors prescribe drugs and pharmacies offer them widely for sale, we often assume that they must be safe. Unfortunately, that’s just not a safe assumption. Because new pharmaceuticals are expensive to produce and can carry very high profits, some drug companies have been known to suppress negative information about their drugs, even important safety information, until the danger is exposed by a high rate of side effects or independent scientific research. Our dangerous drug lawyers help victims of these unsafe practices hold the drug maker legally and financially responsible for their injuries and financial damages.

Continue reading "Bayer Asks Pennsylvania Supreme Court to Intervene in Philadelphia Yaz and Yasmin Lawsuits" »

As a pharmaceutical liability attorney, I know that drug companies are not legally permitted to promote their drugs for any use the FDA has not approved. And of course, everyone knows or should know that drug makers may not withhold important safety information from consumers. That’s why I was interested to see a recent article in Bloomberg News, breaking the news of evidence that Bayer at least considered promoting the birth control pill Yaz for off-label use, and separately withheld evidence on safety risks. Yaz and its sister drug, Yasmin, are the subjects of numerous lawsuits after scientists turned up an increased risk of developing life-threatening blood clots, compared to older birth control pills. Bloomberg reports that one of those lawsuits turned up documents suggesting Bayer discussed promoting the drug for PMS.

One incriminating email came from a sales consultant for Bayer subsidiary Berlax Laboratories. The consultant cited a Woman’s Day article about Yaz, telling salespeople that it could be “a nice way of using Yaz for PMS treatment,” rather than just the narrower class of women diagnosed with premenstrual dysmorphic disorder. PMDD is a severe form of PMS. The consultant asked sales people to use the article to discuss with doctors the effects of Yaz on ordinary PMS. Yaz injury attorneys contend that this was an effort to promote the drug for off-label use. Another email discussed a contract with a gynecologist who appears on the Today show to talk about women’s health and writes a blog; it said she “definitely will mention the off-label benefits of our products.” The doctor later mentioned using Yasmin for PMS in at least two places.

Other emails cast doubt on a European safety study called the EURAS study. The lead author, Juergen Dinger, was the director of a health research center in Berlin, but had previously been a vice-president at Bayer acquisition Schering. In that role, he had overseen the development of Yaz and Yasmin. This association was not revealed when the study results were published, finding no increased risk of clots compared to other birth control pills. In emails uncovered by litigation, Schering official Maureen Cronin said she’d reached an agreement on EURAS results reporting with Dinger after a meeting. That message seemed to say Schering was structuring the report in ways that downplayed the blood clot risk. Dinger told Bloomberg the emails were out of context and that his relationship with Schering was not good.

Yasmin injury attorneys are seeking to have more emails unsealed as a result of these. As a dangerous drug lawyer, I am eager to see what might be in those new emails. The evidence that Bayer’s subsidiaries hid safety information is particularly important, because drug injury lawsuits frequently rely on claims that drug makers failed to warn patients about risks. And while any failure to warn is a basis for this kind of claim, knowingly covering up or minimizing evidence of safety risks is even more damaging. A jury may or may not agree that a company should have known enough to warn patients — but if the evidence shows that the company did know, it’s not hard to conclude that it should have shared the knowledge. This is especially true when the risk is potentially life-threatening, which certain kinds of blood clots are. As a defective drug attorney, I suspect these documents will provide a boost to the more than 10,000 Yaz and Yasmin lawsuits now pending.

Continue reading "Yaz Lawsuit Turns Up Evidence That Bayer Suggested Promoting It for Off-Label Uses" »

Most of my cases as a pharmaceutical liability attorney focus on a drug manufacturer’s failure to warn patients about a serious safety risk of its product. Unfortunately, there have been multiple cases where the pharmaceutical company not only failed to warn the public, but took active steps to cover up negative information or suppress scientific studies. This can form the basis of a failure to warn lawsuit filed by individuals or classes of individuals. In Connecticut Retirement Plans and Trust Funds v. Amgen et al., it was also the basis for a securities lawsuit alleging that a retirement investor was misled by public statements made by Amgen Inc. and four of its officers about the anemia drugs Aranesp and Epogen. The Ninth U.S. Circuit Court of Appeals joined two sister circuits in making its ruling.

In its lawsuit, CRPTF alleged that Amgen violated several provisions of the Securities Exchange Act with four public statements. It accused Amgen of downplaying the FDA’s safety concerns about its anemia products; concealing details about a clinical trial canceled because the product appeared to exacerbate tumor growth; exaggerating the safety of on-label uses; and lying about its practice of promoting off-label uses, which is illegal. These misstatements inflated the price of Amgen’s stock, CRPTF said, causing the retirement plan to lose money when the truth emerged and the stock price fell. CRPTF successfully moved to certify a class in district court, but Amgen filed an interlocutory appeal of that certification. It challenged the district court’s determination that plaintiffs need not show at the class certification stage that misrepresentations are material.

The Ninth Circuit started by dispensing with CRPTF’s motion to dismiss the appeal in light of three Ninth Circuit decisions. The court denied this motion, finding that none of the three applied closely enough to moot the issues. It then turned to Amgen’s contention that CRPTF failed to meet standards for class certification because it did not prove that the allegedly false statements by Amgen were material. This is putting the cart before the horse, the Ninth said, because materiality is an element of the merits of a securities fraud claim. Thus, it doesn’t affect class certification; a claim that cannot demonstrate materiality would be void as an individual or class action. Thus, it’s best addressed at trial or in summary judgment motions, the court said. In its holding, the Ninth joined the Seventh Circuit, which made the same ruling in 2010’s Schleicher v. Wendt, and the Third Circuit in 2011’s In re DVI Sec. Litig. This splits the three courts with three other circuits, the Ninth noted — but it agreed with the Seventh that this was based on a misreading. With similar reasoning, the Ninth rejected Amgen’s argument that it should be able to rebut the legal presumption of fraud on the market, because this is another way of debating materiality.

As a defective prescription drug lawyer, I’m pleased to see CRPTF will have a chance to prove its claim that Amgen made false public statements to protect its stock price. This is just the securities-law version of the same kind of misrepresentations made to customers, to protect sales of prescription drugs. Because prescription drugs generate millions or even billions in profits, drug companies often take steps to cover up safety information that might affect their profits. Sometimes that safety information is absolutely vital to patients — such as information that Aranesp and Epogen could exacerbate cases of cancer. As a dangerous medication attorney, I help clients hurt by this kind of deception hold drug companies legally and financially liable for their injuries.

Continue reading "Ninth Circuit Finds Amgen Made False Material Statements About Anemia Drugs – Connecticut Retirement Plans v. Amgen" »

The now-recalled painkiller Vioxx is one of the most notorious dangerous drugs from recent years. The drug had to be taken off the market after studies showed it increased users’ risk of heart attacks, and many of those users have filed lawsuits against Merck, the drug’s manufacturer, seeking compensation for their serious injuries or the wrongful death of a loved one. So I was interested, as a defective drug attorney, to see a court ruling out of Arkansas about how the proceeds of such a lawsuit might be split in an unusual family situation. In Bridges v. Shields, Curtis Bridges claimed a portion of the proceeds of a lawsuit filed by his deceased wife’s children on behalf of a previous stepfather who died after taking Vioxx. The Arkansas Supreme Court ruled that Bridges had no claim because the wife, Hazel Mae Frazier, had no claim.

Frazier had been married three times and had seven children. Her second husband, Elree Frazier, died in 2001 after taking Vioxx, leaving only her and her seven children, Elree Frazier’s stepchildren. Frazier eventually married Curtis Bridges, but died herself in 2007. After her death, one of her children, Glen Shields, filed a wrongful death claim against Merck on behalf of the estate of Elree Frazier and eventually settled for a bit under 124,000. The money was funneled into the estate of Hazel Mae Frazier for distribution to her seven children; it was the only asset. Shields successfully petitioned to be made administrator of his mother’s estate as well. Bridges then filed a claim in trial court for one-third of the money in the estate, based on his interest as her husband (curtesy interest), which Shields opposed. After much analysis, the court found for Shields, ruling that Bridges had no curtesy interest in the money because Frazier’s estate was only a conduit.

The Arkansas Supreme Court agreed. Because Frazier was not alive when the Merck lawsuit took place, she clearly did not possess the proceeds at the time of her death. Thus, the important question was whether Frazier’s right to sue Merck was a property right that became part of the estate. Under state law, the trial court found, Frazier had a chose in action — a property right to sue — when she died, but was not possessed of the proceeds of the Merck lawsuit. The high court disagreed, finding that Frazier did not have a chose in action. Arkansas law requires that a wrongful death action be brought by the administrator of the deceased’s estate — in the case of Elree Frazier, this was Glen Shields — or by all heirs together. Thus, Frazier had no individual right to bring an action, and thus no chose in action. Thus, the Supreme Court affirmed the lower court’s ruling denying Bridges any part of the Merck settlement.

As a dangerous drug lawyer, I urge other families that have lost someone to a Vioxx injury to move quickly to enforce their rights. Every state has a law called the statute of limitations, which is a deadline after which you may sue. It’s generally two to five years except under special circumstances — and drug companies will make every argument they can think of to convince a court that no exceptions should apply. Thus, the quicker you file your suit, the better your chances of recovering fair compensation. This was not an issue in this case, because the dispute was over the disposition of the settlement proceeds. But as a pharmaceutical liability attorney, I’ve seen courts turn down otherwise meritorious cases that are past the state of limitations, and I’d rather that injured people get their day in court.

Continue reading "Arkansas Supreme Court Holds Husband Not Entitled to Proceeds of Stepchildren’s Vioxx Lawsuit – Bridges v. Shields" »

As a pharmaceutical liability attorney, I frequently tell clients and potential clients to act quickly on their cases. This is not just an advertising ploy — delaying your case too long can have serious consequences. Most vitally, a delay can cause you to miss a legal deadline called the statute of limitations. If you wait until after this deadline, you are legally barred from suing, no matter how much merit your case might have. That lesson was learned in two states in Rick et al. v. Wyeth, a recent decision of the Eighth U.S. Circuit Court of Appeals. Jeanette Rick and other women sued the pharmaceutical company Wyeth, alleging that they developed breast cancer after taking its hormone-replacement drugs. Their case was dismissed as time-barred in New York, so they brought it as a federal case in Minnesota. The Eighth Circuit ultimately found that it must respect New York state law even in the federal action.

The New York state cases were filed in 2004 and 2005, asserting that hormone replacement drugs from Wyeth and other companies caused the plaintiffs’ breast cancer. After lengthy discovery, the drug companies moved for summary judgment on the basis of the statute of limitations, which is three years in New York. While this was pending, the plaintiffs filed another set of claims in Minnesota federal court, where the statute of limitations is six years. They moved to dismiss the New York cases without prejudice, but the New York court instead granted summary judgment to the drug companies, finding the cases “clearly time-barred.” The Minnesota cases were also dismissed for statute of limitations reasons. The Minnesota court found that the New York cases had been litigated enough to preclude trying the same case in other jurisdictions.

The plaintiffs appealed, arguing that the Minnesota federal court should give the New York state-court decision no weight. The Eighth Circuit disagreed. The issue was whether the state-court judgment precluded litigation of the same claims in federal court, the Eighth said, which reached issues of res judicata and the Constitution’s call for courts to give one another full faith and credit. Under a 1984 Supreme Court ruling, issues in federal court may be precluded by state-court rulings if the issue would be precluded in another court in the same state as the original ruling. Thus, the Eighth must apply New York law, it said. Fortunately, New York caselaw addresses the issue extensively, it said; and that caselaw bars New York courts from retrying claims that previously were extinguished by summary judgment. Thus, the Minnesota court was bound to do likewise, the Eighth concluded. It upheld the district court.

As a dangerous drug lawyer, I think this is a good example of the importance of statutes of limitations. This case died entirely because of concerns about the deadline. Whether the plaintiffs had a good case was not even discussed, much less tested and decided. This happens often in multi-plaintiff or class-action drug liability cases like this, because shutting it down early is more advantageous for the drug company. By stopping the case before the plaintiffs can present it to a jury, the companies substantially reduce the risk of losing and entirely eliminate the chance of a public airing of the allegations against them. To make sure you have access to justice, it’s vitally important to get in touch with a defective drug attorney as soon as you realize you’re interested in pursuing a legal case.

Continue reading "Eighth Circuit Dismisses Hormone Replacement Therapy Cases as Time Barred in New York – Rick et al. v. Wyeth" »

In the most recent Levaquin lawsuit to reach trial, a New Jersey jury has returned a verdict in favor of defendant Johnson & Johnson.

This is the third Levaquin lawsuit to reach the courtroom out of thousands that have been filed. The case began with Paul Gaffney and Robert Beare, who both alleged that the drug giant didn’t properly warn them of the risks associated with Levaquin, which they claim caused them to develop ruptured tendons.

To date, as many as 2,500 people have filed Levaquin lawsuits with similar claims. All of the plaintiffs have stated that they never would have taken the antibiotic if they knew the real risks associated with it. A great deal of research has been conducted to verify that Levaquin causes an increased risk of people suffering from tendon ruptures, which is even higher in seniors and those taking corticosteroids, but patients have been claiming for years that the manufacturers of Levaquin have been downplaying those risks. Back in July 2008, the FDA issued a black box warning against Levaquin and made Johnson & Johnson update the drug's labels to include the risk information.

With the black box warning issued and the labels updated, people who suffered from tendon started filing lawsuits. This trial is the third one to have a decision reached and it was one that many were waiting for. The jury found that the plaintiffs didn’t properly prove that Johnson & Johnson gave inadequate warnings about the risks associated with Levaquin. This case was seen as a tie-breaker case since the first two Levaquin suits resulted in a plaintiff win and a plaintiff loss. This most recent win for Johnson & Johnson just goes to show that there is no precedent to be set with drug injury lawsuits, since each individual case is unique.

As a dangerous drug attorney in St. Louis, I have followed the trials and tribulations of local pharmaceutical company KV Pharmaceutical. KV and its subsidiaries, Ethex Corp. and Ther-Rx Corp., were heavily disciplined and even shut down for major manufacturing defects that posed a risk to consumers, such as oversized pills that could create an accidental painkiller overdose. That situation led to several lawsuits, including LeFaivre v. KV Pharmaceutical et al, a proposed class action that found its way to the Eighth U.S. Circuit Court of Appeals. LeFaivre did not claim any injuries, but rather, breach of implied warranty of merchantability and violation of the Missouri Merchantability Practices Act. The companies argued that because the claims stem from federal regulatory compliance, they were federally preempted; but the Eighth Circuit ultimately disagreed.

The drug underlying the dispute is the generic metoprolol succinate ER, for treating high blood pressure. LeFaivre purchased and used it several times in his home state of Rhode Island. In 2009, KV signed a consent decree and recalled many months’ worth of drugs to settle FDA claims that it had violated manufacturing standards. LeFaivre sued KV in Missouri federal court, alleging that KV sold “unmerchantable” drugs and failed to disclose that the drug was adulterated as a matter of federal law. He sought damages for the difference between the price of drugs that were up to standards and the price of the adulterated drugs. KV moved to dismiss, arguing that because LeFaivre’s claims rested on violations of FDA law, they were essentially an attempt to privately enforce federal drug laws, a right that does not exist. The federal district court agreed and dismissed the case. LeFaivre appealed to the Eighth Circuit.

That court reversed, finding that federal preemption did not apply. Any preemption would be implied preemption, the court said, since there is no express preemption in the relevant statute. And on implied preemption, the Eighth was able to rely on the Supreme Court’s recent ruling in Wyeth v. Levine, which found express Congressional intent not to preempt state laws. The appeals court found that the federal district court was wrong when it relied on the 2001 U.S. Supreme Court ruling in Buckman Co. v. Plaintiffs’ Legal Committee. That case sought to hold a company responsible for making fraudulent representations to the FDA about another company’s products, but the Supreme Court ruled that the claims were preempted by federal law. A concurrence in that case specifically distinguished its facts, which included no FDA enforcement action, from a hypothetical case in which the FDA did take enforcement action and a plaintiff brought state-law claims on the same issues afterward. This is basically that hypothetical case, the Eighth said. Furthermore, Buckman concerned fraud on the FDA, whereas this case alleges fraud against consumers. Thus, the Eighth reversed the dismissal and sent the case back to district court.

As a defective drug lawyer, I applaud the Eighth Circuit for giving this plaintiff a chance to prove his case. As the plaintiff argued, a contrary ruling would leave people who have suffered economic injuries from dangerous drugs without a legal recourse. This may seem like a small matter compared to people who have suffered serious health consequence or even death. But as a pharmaceutical liability attorney, I know those injuries and illnesses often go hand in hand with serious financial problems. Someone who develops even a mild chronic condition can expect medical bills for a lifetime. And even those who suffered no health injury should have a remedy against a manufacturer that intentionally deceived them.

Continue reading "Eighth Circuit Allows Proposed Class Action for Drug Manufacturing Defects – LeFaivre v. KV Pharmaceutical et al. " »

With thousands of lawsuits being filed against Bayer, the makers of Yaz and Yasmin birth control pills, one question seems to pop up often in the courtroom: “Are Yaz and Yasmin the same?”

One clue that gives you an idea of what the answer to that question is can be found in the drugs' names. While Yaz and Yasmin have similar names that only vary slightly, the same can be said about the differences between the two pills. While both pills’ main medicinal ingredient is comprised of drosperinone, a synthetic progestin, it is the pills’ composition of estrogen that marks the largest difference between the two.

Yaz and Yasmin are generally referred to as “combined one-a-day birth control pills” due to the fact that they both made up of a combination of drospirenone and estrogen. Yasmin is composed of a larger dose of estrogen than Yaz, and Yasmin uses more placebo pills for each cycle (Yasmin uses 7 placebos while Yaz uses only 4). Another difference between the two pills can be found in the pills’ off-label uses. Yasmin is only used as a means of preventing pregnancy, but Yaz’s off-label uses get just as much attention as the pill’s contraceptive capabilities.

One thing that Bayer comes under fire for in recent lawsuits is its previous marketing campaign that aggressively promoted Yaz’s ability to help clear up moderate acne and severe PMS — all while downplaying the drug’s adverse side effects. It is these side effects that make both Yaz and Yasmin so dangerous to take. This is what brings us to what makes both pills so similar. Yaz and Yasmin are both comprised of the same dosage of drosperinone. It is the drosperinone that causes the severe and potentially fatal side effects such as heart attacks, strokes, pulmonary embolisms, deep vein thrombosis and gallbladder disease.

This information shows that while there are some minor differences between the both Yaz and Yasmin, the pills are identical in just how dangerous they are.

According to a new study on SSRIs (a class of medication that includes drugs like Paxil and Effexor), babies that are exposed to the drugs while still in utero appear to experience alterations to their neurobehavioral development. This is the result of a study that was published online in Neuropsychopharmacology.

The study shows that fetuses that were exposed to standard and high doses of SSRIs seemed to exhibit “disrupted emergence of quiet, non–rapid eye movement (non-REM) sleep during the third trimester, characterized by continual bodily activity and, thus, poor inhibitory motor control during this sleep state near term."

So far, it is not clear just how significant this information is; it may be able to help predict troubles in sleep patterns in children in the future according to Eduard J. Mulder, Ph.D., and colleagues from University Medical Centre, Utrecht, the Netherlands.

But another doctor doesn’t think that too much should be read into this information just yet.

Tim Oberlander, MD, FRCP, of the Child and Family Research Institute, University of British Columbia, says, "This is one step in a long series of human studies to figure out what is happening at a neurobehavioral, biologic and molecular level. At the macro level, it's important to recognize that mother's mental health is really the critical issue here and there are downstream effects of the mood disturbances themselves that need to be carefully considered.”

Oberlander wasn’t a part of this study.

When taken by pregnant women, SSRI medications like Paxil and Effexor have already proven to be dangerous for fetuses. Studies have shown that Paxil causes birth defects in children who are exposed to it while in utero. Some of those defects include oral clefts, cleft palate, PPHN, neural tube defects and heart defects. This new study just points out another potential danger to newborns exposed to the drugs, but more research needs to be conducted to verify this finding.

This year, the U.S. Supreme Court made a ruling that will set back the drug injury victims I represent as a defective drug attorney. In PLIVA v. Mensing, the court ruled that generic drug manufacturers can face no liability for the harm their products do, because state-law tort claims are preempted by federal drug laws. That ruling acknowledged the absurdity of the result, which frees generic drug makers from liability that the name-brand drug makers face, but its decision was final. That decision formed a large part of the rationale behind the Sixth U.S. Circuit Court of Appeals ruling in Morris et al. v. Wyeth et al.. In that case, a group of gastroesophageal reflux disease sufferers who had developed a rare neurological disorder sued the makers of the generic drugs they took, as well as the name-brand manufacturer. Both claims were ultimately dismissed.

Kentucky residents Lala Smith, Alice Wilson and Dennis Morris all developed tardive dyskinesia, a slow-onset disorder causing involuntary and repetitive body movements. Sufferers are disabled by a difficulty holding still, rather than an inability to move. Its main causes are psychiatric drugs and gastrointestinal drugs, and there is no cure, just a series of strategies for treating symptoms. The plaintiffs alleged that their disease was brought on by taking metoclopramide, the generic name for the drug Reglan, for GERD. They sued six generic makers whose drugs they had used for failure to warn. They also sued two companies that had previously made name-brand Reglan for fraud, negligent misrepresentation and fraudulent concealment, arguing that the two companies had played down Reglan’s risks in the Physician’s Desk Reference. The federal district court granted summary judgment to the name-brand defendants, saying they cannot make a misrepresentation claim against a manufacturer whose product was not actually used. It later granted summary judgment to generic defendants on federal preemption grounds.

The plaintiffs fought both decisions on appeal, but to no avail. The Sixth Circuit quickly affirmed the ruling about the generic manufacturers, noting that the facts are actually quite similar to those in PLIVA v. Mensing. The same result is compelled in this case, the appeals court said. It took longer to affirm the ruling on the name-brand manufacturers. Under the Kentucky Product Liability Act, it noted, plaintiffs may sue only those whose products actually caused their injuries. The plaintiffs argued that the regulatory structure surrounding name-brand drugs makes it foreseeable that doctors and patients will use name-brand labels as a guide to generic drugs. This has failed in two other federal appeals courts and a federal district court, the Sixth said; only one court, an intermediate appeals court in California, has accepted the argument. The Sixth sided with the majority. Not only did it decline to find a duty of care by name-brand drug makers to non-customers, but it found it unlikely that Kentucky state courts would do differently. Thus, it upheld the dismissal of the case.

Unfortunately, nothing here tells me, as a pharmaceutical liability attorney, that the decision was legally wrong. It is well-established that lower courts must apply Supreme Court precedent, and both common law and common sense underlie the idea that a defendant must be responsible for the plaintiff’s injuries. The problem, as I noted in July, is with the Supreme Court’s bad precedent. Under that split ruling, generic drug makers were essentially given immunity from any lawsuits, regardless of what they have done. Indeed, in this case, the courts never reached the issue of whether the drug makers knew their products could cause tardive dyskinesia. From a legal standpoint, it wouldn’t even matter whether the generic manufacturers took active steps to give patients the disorder, because they face zero responsibility for their actions. As a dangerous drug lawyer, I’m not at all sure this is the result Congress intended.

Continue reading "Allegations That GERD Drugs Caused Tardive Dyskinesia Dismissed Due to Supreme Court Rulings – Morris et al. v. Wyeth et al." »

As a Missouri defective drug lawyer, I keep an eye on drug manufacturing issues that affect us here in the Midwest. So I was interested to see an Eighth U.S. Circuit Court of Appeals decision about a man who claims he was fired for blowing the whistle on a company making impure, low-quality drugs. In Bazzi v. Tyco Healthcare Group, Ali Bazzi sued Tyco for wrongful termination that contradicted Missouri public policy. Though the stated reason for his firing had to do with his conduct toward another employee, he contended that he was actually fired either for blowing the whistle or for refusing to validate drugs he felt were not up to quality standards. The Eighth Circuit ultimately upheld the district court’s summary judgment decision in favor of Tyco.

Bazzi had been employed at Tyco for 26 years, and was an organic chemist and manager of quality assurance engineering when he was fired. His job was to oversee production and manufacturing of certain drugs; validating them means checking on their quality, purity and federal compliance. For more than a year prior to the firing, Bazzi had been verbally raising concerns about violations in the manufacturing of a drug called naltrexone hydrochloride, which is used to treat alcohol and opioid dependence. However, he had not brought them up to his supervisees, a hotline or to federal regulators. In the summer of 2007, he asked supervisee Marvin Darling to prepare a report on the last few batches of adulterated naltrexone. Darling aired those concerns at a September meeting at which Bazzi apparently did not speak. Bazzi testified that unnamed Tyco employees warned him that the memo could get Tyco in trouble with the FDA; this was struck as hearsay. In late October of that year, Bazzi was caught on videotape entering a colleague’s office, taking a pay stub from her chair and ripping a notice from her wall; he lied about it when initially confronted. This was the stated reason for letting him go.

About a year later, Bazzi sued Tyco for wrongful termination against Missouri public policy, alleging that he was really fired because he raised concerns about improper validation of naltrexone. Tyco moved for summary judgment, claiming there was no genuine issue of material fact because Bazzi failed to establish whether his belief that Tyco violated FDA rules was objectively reasonable; that he had brought his concerns to a supervisor; or that he refused outright to perform an illegal act. Bazzi appealed to the Eighth Circuit — but applying Missouri law, the appeals court affirmed the summary judgment order. In order to prove a wrongful discharge in Missouri, the court said, employees must show they were fired for refusing to violate the law or clear public policy; or for reporting serious misconduct. The Eighth started by ruling Bazzi had not established whether Tyco was breaking the law or clear public policy. In order to show this, Bazzi needed to submit evidence of what Tyco allegedly did to the naltrexone and how it violated the Food and Drug Act, possibly with expert testimony. That did not happen; the Eighth said Bazzi had offered only his unsubstantiated opinions. This was enough as a threshold issue to get warrant summary judgment, the court said. Thus, it upheld the summary judgment order in Tyco’s favor.

As a southern Illinois dangerous drug attorney, I hope for the sake of the public that Bazzi is wrong about these drugs being adulterated. In my work, I have seen ample evidence that drug manufacturers prefer to cover up mistakes rather than correct them, because correcting them costs money and can lead to a public black eye that costs even more money. That’s how KV Pharmaceutical here in St. Louis ended up in serious criminal trouble and nearly closed, and how sloppy practices at Wisconsin’s Triad Group caused bacterial contamination that allegedly injured several patients and killed a toddler in Texas. If Bazzi did blow the whistle on potentially adulterated drugs, he should be commended for his willingness to do so, not fired. As a St. Louis pharmaceutical liability attorney, I know drug companies caught knowingly selling unsafe drugs tend to pay a lot in financial damages in the end, particularly if their products hurt many people.

Continue reading "Former Employee Alleges Drug Company Fired Him for Refusing to Validate Contaminated Drugs – Bazzi v. Tyco Healthcare Group" »

As a defective drug attorney who also handles medical malpractice cases, I know the two frequently go hand in hand. After all, medical malpractice is nothing more than the legal name for very bad judgment by a medical professional, and knowingly administering a defective drug is very bad judgment. So I was interested to see the Second U.S. Circuit Court of Appeal’s ruling in Brown v. Noxubee General Hospital et al., a case that combines defective drug claims against drug maker Eli Lilly with medical malpractice claims against two hospitals in Mississippi. The claim was brought by Derrick Brown as personal representative of the estate of Dorothy Brown. He alleges Dorothy Brown died because of her use of Zyprexa (olanzapine), an atypical antipsychotic prescribed for her schizophrenia and depression with psychotic features. She also had diabetes, which Zyprexa is known to cause or worsen.

Brown was prescribed Zyprexa when she was under psychiatric care, ending in 2003. In 2005, Brown came to the emergency room at Noxubee General Hospital in Macon, Miss., with trouble breathing and high blood glucose. She was discharged the same day, but showed up the next day at Baptist Memorial Hospital in Flowood, Miss. She was discharged from Baptist the same day, but went back to Noxubee the following day, where she was again discharged. She died at home of cardiac arrest two days after the last discharge. Her estate sued two years later, alleging that Lilly failed to warn patients about the metabolic risks of Zyprexa. It also alleged that the hospitals knew or should have known Brown was unable to care for herself. After some jurisdictional squabbling, the case was ultimately removed to the Eastern District of New York, where other Zyprexa litigation was pending. That court granted summary judgment to Noxubee and eventually Baptist, saying Brown had failed to follow special Mississippi medical malpractice procedures and also, in Noxubee’s case, missed a one-year statute of limitations. It asked Brown to submit an expert witness report connecting Zyprexa with the death, but when Brown missed that deadline, it dismissed the claim against Lilly as well.

Brown appealed the dismissal of all three defendants. The Second Circuit started by noting that the appeal as to Baptist was already decided, and declined to address the issue again. The first appeal was in any case drawn partly from a non-appealable order, the court noted, and the other part was filed past a deadline. That order also dismissed the appeal as to Noxubee, because Noxubee was in the title but had no part of the orders being appealed. A separate appeal as to Noxubee was withdrawn, apparently because Brown’s attorneys believed it was too defective to survive, but this was not the case. Thus, the Second had no jurisdiction over that issue. It also dismissed Brown’s argument that federal jurisdiction was improper, since the Mississippi hospital defendants were dismissed and Lilly was from another state. Finally, it tackled the summary judgment order for Eli Lilly. Under Mississippi law, the Second said, plaintiffs in pharmaceutical liability cases must provide expert opinions connecting the drug to the death. Brown failed to do this, it noted, and even when the court threatened to dismiss the case if no report was filed, continued to not file one. Thus, dismissal was proper and the Second affirmed the lower court.

As a pharmaceutical liability lawyer, I am disappointed that Brown could not pursue his case for reasons that are mostly procedural. Though he seems to have genuinely missed deadlines and other requirements, none of this bears on the merit of the claim that Zyprexa led to Dorothy Brown’s death. Indeed, this case underscores the importance of ensuring that you get legal help as early as possible in your case, preferably as soon as you start considering a lawsuit. By contacting an experienced dangerous drug attorney right away, clients with claims against government entities, like Brown, can make sure not to miss the notoriously short deadlines for government claims. They are also more likely to understand the special procedures required in government claims and medical malpractice claims. Failing to follow these, as this case shows, can be deadly to the claim regardless of its merit.

Continue reading "Second Circuit Upholds Summary Judgment for Eli Lilly in Zyprexa Lawsuit – Brown v. Noxubee General Hospital" »

Because drug companies have a lot of resources at their disposal — far more than ordinary people dealing with prescription drug injuries — they frequently fight claims brought by pharmaceutical injury attorneys like me on procedural grounds. By claiming the lawsuit was brought too late or in the wrong state, they may be able to delay the case or drive up the costs so much that plaintiffs can’t or decide not to proceed. In Casey et al. v. Merck & Co. Inc., pharmaceutical giant Merck was fighting four lawsuits brought by families in Virginia who suffered serious injuries after a family member took the drug Fosamax (alendronate sodium) for osteoarthritis. The Second U.S. Circuit Court of Appeals ultimately decided that the Virginia Supreme Court should decide whether the families missed their deadline to sue.

All four of the plaintiffs took Fosamax for osteoarthritis and later developed osteonecrosis of the jaw, a condition in which the jawbone literally dies and creates lesions in the mouth that cause pain and sometimes infections. All four sued Merck for their injuries between May of 2007 and November of 2008. Merck moved to dismiss all the claims, arguing that plaintiffs had waited to sue past Virginia’s two-year statute of limitations, because most were injured four years before filing suit. However, a proposed class action on the same topic was filed in 2005; class certification was denied in January of 2008. The plaintiffs argued under American Pipe & Construction Company v. Utah that the statute of limitations should be tolled during the class action, regardless of whether the applicable state law permits it. The district court disagreed, ruling that American Pipe applies only if it applies under Virginia law. The Fourth Circuit, which covers Virginia, had found that the Virginia Supreme Court would not adopt cross-jurisdictional equitable tolling, so the district court declined to apply it here and dismissed the case. The plaintiffs appealed.

The Second Circuit (which covers New York, where the Merck lawsuits were filed) was not so hasty. It sided with several other circuit courts that had decided the law of the relevant state should decide whether a class action tolls a statute of limitations. In this case, the relevant state is Virginia, and the Second found that it lacked enough indications of Virginia state law on the matter. Thus, the court said it was more appropriate to certify a question to the Virginia Supreme Court rather than rely on Fourth Circuit precedent. It therefore certified two questions:
1. Does Virginia law permit equitable tolling of a state statute of limitations due to the pendency of a putative class action in another jurisdiction?
2. Does Va. Code Ann. Sec. 8.01-229(E)(1) permit tolling of a state statute of limitations due to the pendency of a putative class action in another jurisdiction?

As a pharmaceutical liability lawyer, I sympathize with the plaintiffs who were expecting a yes or no answer from the Second Circuit and instead got another delay. But I also think the Virginia Supreme Court’s answer to those questions could be very important to injured Virginians, so it’s good that the court can now choose to address them. When a class action is dismissed, as it is in this case, it doesn’t end the injured plaintiffs’ right to sue; they may still sue as individuals. However, in order to do that, they must be able to file those suits within their states’ statutes of limitations, which can be difficult if the class action was pending for two years or more. Thus, American Pipe guards the right of injured people to sue. As a defective drug attorney, I know that right can be very, very important — not only to serve justice, but also to ensure that seriously injured people have a chance to collect the money they need to support themselves and get medical care.

Continue reading "Second Circuit Punts Tolling Question in Fosamax Injury Case to Virginia Supreme Court – Casey et al. v. Merck" »

The first Levaquin trial in New Jersey is about to get underway as two plaintiffs are combining their lawsuits against the makers of the popular antibiotic. Bob Beare and Paul Gaffney both allege they were not properly warned of the side effects — specifically tendon ruptures — before taking Levaquin. So far, the total number of mass tort New Jersey Levaquin trials has reached an astounding 1,763.

The lawyers have given plaintiff fact sheets to Judge Carol E. Higbee and there have been status conferences already started with the intent of moving the chosen cases to trial. One status conference, which took place August 11, was rescheduled from its previous July 14 date; that conference was expected to address various things such as motions to prevent some evidence from expert witnesses.

As for the plaintiffs themselves, their cases are going to be tried together as a single trial. The start dates are set at late August or early September of this year. Both men are older than 60, and both of them suffered from tendon ruptures after taking Levaquin. Both of the men are from New Jersey and their cases will be tried together because they were filed under the same circumstances.

Levaquin has been the source of thousands of lawsuits because of the drug's link to tendon ruptures and other injuries. Not many of the cases have gone to trial yet; however, at least one case awarded the plaintiff almost $2 million. Still another case was lost. These Jersey cases are expected to help break the "tie." It is hoped that the next trial to reach a decision will help plaintiffs to understand what to expect as far as a verdict is concerned, even though that's nearly impossible to predict. No matter what the decision is in this case, many cases have small differences that can sway the decision for or against a plaintiff.

I’ve written here before as a dangerous drug attorney about the risk of suicidal thoughts from taking any antidepressant. That risk is why every antidepressant sold in the United States carries a “black box” warning, the strongest the FDA has, about the risk to people under 25. A murder-suicide unfortunately underlies the Tenth U.S. Circuit Court of Appeal’s decision in Rimbert v. Eli Lilly & Co., a ruling in a wrongful death lawsuit brought by Mark Rimbert. Rimbert is the adult son of Gilbert John Rimbert and Olivia Acosta Rimbert. Shortly after starting to take Prozac, Gilbert Rimbert killed Olivia Rimbert and himself. Mark Rimbert brought a wrongful death lawsuit against Eli Lilly, the maker of Prozac. In this appeal, the Tenth Circuit rules that even though Rimbert’s expert witness was properly excluded by a trial judge, that judge was wrong to grant summary judgment to Lilly.

Gilbert Rimbert took Prozac for moderate depression. He committed the murder-suicide after the initial dose was increased, and Mark Rimbert alleges that Prozac caused the violence. The first judge assigned to the case told the parties that while he did not think he needed to recuse himself, he did have personal reasons why they might be uncomfortable. Neither party asked him to recuse himself, and he subsequently denied Lilly’s motion to exclude testimony from Rimbert’s expert witness. Later, more personal issues arose and the judge again offered to recuse himself; Lilly took up the offer. When a new judge was assigned, Lilly repeated its motion to exclude the expert witness testimony, and this time, it was granted. In doing this, the new judge held no new hearing, but relied on evidence from a hearing held by the previous judge. Rimbert moved to reschedule so he could find a new witness. Lilly opposed this and moved for summary judgment, arguing that Rimbert had no case without a witness. Summary judgment was granted, and Rimbert appealed the witness ruling and the denial of a new scheduling order.

On appeal, Rimbert argued that the doctrine of the law of the case should bound the second judge to the first judge’s ruling. The court disagreed, pointing out that Tenth Circuit precedent says decisions can be revisited until a final judgment is entered. It declined to revisit issues it said it had already considered. Nor did the appeals court agree that Lilly was estopped from seeking a new ruling after the case was reassigned because it had not asked the first judge to recuse himself. Prior cases agree that parties should act promptly if they want a recusal, but in this case, the Tenth said, the second disclosure from the first judge was very different from the initial disclosure. Indeed, the second disclosure means estoppel cannot be established in this case, the Tenth said, because it represents a material change in circumstances. However, Rimbert had more luck on the scheduling order. The district court “inexplicably” made its ruling on scheduling as if the expert ruling had been entered under the previous judge, the court said. But because the case had been reassigned and then vacated by the new judge, there was no pretrial schedule for Rimbert to disrupt when he asked to delay the case. Thus, the Tenth upheld the ruling on the expert but reversed the scheduling ruling and sent the case back to trial court.

As a pharmaceutical liability attorney, I think this case is a good example of how an adverse ruling on something as small as scheduling can make a big difference to a case’s success. If the court excludes testimony from an expert and then denies the defendant a chance to find a new expert, the court has essentially decided the outcome without actually hearing the case. Without some kind of inaction or wrongdoing by the party whose expert was excluded, this could be an improper use of judicial discretion. This is especially important in defective drug cases, because they depend heavily on expert witnesses to present complex, scientific facts to the jury, who are not necessarily scientists or medical professionals. As a defective prescription drug lawyer, I am pleased that the Tenth Circuit ultimately let this plaintiff have his chance to prove his case.

Continue reading "Tenth Circuit Reverses Summary Judgment Order in Prozac Murder Suicide Lawsuit – Rimbert v. Eli Lilly" »

The drug Mirapex is prescribed for treatment of Parkinson’s disease, but it has an unusual but frightening unexpected side effect: compulsive gambling. This drug has not been getting the same kind of press attention that drugs like Avandia have, so as a defective drug attorney, I was pleased to see an Eighth U.S. Circuit Court of Appeals decision on the subject. In Gazal v. Boehringer Ingelheim Pharmaceuticals, Inc., Pfizer, Inc., Pharmacia Corporation and Pharmacia & Upjohn, LLC, Nabil Gazal sued the maker of Mirapex for breach of warranty and failure to warn after he developed a serious gambling problem he ascribed to treatment with Mirapex. Gazal, who lived in Australia and Texas, died partway through the legal process, so his widow, Maud Ledhagen Gazal, continued the appeal.

Gazal was diagnosed with Parkinson’s disease in 2002, when doctors at Baylor University prescribed him Mirapex. He began noticing increased urges to gamble shortly thereafter and started losing large amounts of money. Two studies came out in 2005 and 2008 linking Mirapex with gambling, and at least one doctor suggested to him that Mirapex was the problem.Twice, Gazal checked into the hospital for two weeks to try unsuccessfully to quit Mirapex. In early 2006, he wrote to several businesses and acquaintances requesting that they not gamble with him. Nonetheless, he continued to gamble, losing millions and creating problems with his family. His Baylor doctors renewed his prescription in 2007.

Gazal finally succeeded in quitting in May of 2009 and filed this lawsuit against the pharmaceutical corporations. His suit was transferred to Minnesota federal court as part of the Mirapex Pharmaceutical Liability Multidistrict Litigation. The pharmaceutical companies then successfully moved for summary judgment, arguing that Gazal had missed the statute of limitations because his claim started accruing in 2005, when the first study linked Mirapex and gambling. This appeal followed.

On appeal, Maud Gazal argued that the statute of limitations should properly start accruing in 2008, when a stronger study made a causal connection between Mirapex and compulsive gambling. The pharmaceutical companies maintained that 2005 was the proper start date, when the first study linked the two. The Eighth Circuit agreed. Under Texas caselaw, a claim starts accruing when symptoms become so severe or common that a reasonable person would be put on notice that there’s an injury. No scientific studies are required under that standard, the court noted. Thus, Gazal was on notice in 2005, when his symptoms were obvious and a study, a doctor and he himself were all able to connect them with Mirapex. The court also rejected arguments that the statute of limitations should have been tolled. The continuing tort and open courts doctrines both require that plaintiffs not be aware of the injury, which the court had decided Gazan was. Nor was the claim unripe, it said. Finally, it rejected Gazal’s argument that he was of unsound mind in 2005, pointing out that no doctor proposed this and that Gazal remained able to run a profitable company while he was taking Mirapex. Thus, the summary judgment order for the defendants was upheld.

For me, as a dangerous drug lawyer, this decision underscores the importance of taking action quickly. The multidistrict litigation for Mirapex suggests that many people who have similar claims are having their days in court. Gazal may have had a very strong case, but his family will never have their own day in court because the deadline was judged passed. This is why it’s vital to take action early if you plan to pursue a lawsuit, especially a complex one involving serious medical problems or a lawsuit against government agencies. Both of these can be extremely time-consuming, and claims against government agencies generally require plaintiffs to exhaust an administrative process before they can actually sue. As a pharmaceutical liability attorney, I encourage potential clients to get in touch with me as soon as they start considering a legal claim.

Continue reading "Eighth Circuit Declines to Toll Statute of Limitations in Mirapex Gambling Lawsuit – Gazal v. Boehringer Ingelheim Pharmaceuticals et al." »

I have written here before, as a pharmaceutical liability attorney, about the dangerous psychiatric side effects of the drug Chantix (varinicline). Chantix is heavily marketed, especially around the beginning of the year, as a drug that improves smokers’ chances of quitting for good. However, the drug carries a black box warning of serious psychiatric side effects, including hallucinations, depression and suicidal thoughts, and uncharacteristic aggressive behavior. Earlier this month, the Canadian Medical Association Journal published a study with another very serious concern: an increased risk of cardiovascular problems, including heart attack. On July 24, MedPage Today reported that the U.S. Food and Drug Administration has updated the label on Chantix to warn users of an increased risk of heart attack or peripheral arterial disease.

The new study was a meta-analysis of 14 studies of more than 82,00 people, most of whom had no heart problems. Of the 4,900 who took Chantix and not a placebo, nearly twice as many developed serious cardiovascular events. The study’s authors concluded that Chantix might raise the risk of heart attack and stroke by as much as 72 percent, even for people with no previous cardiovascular problems. One author noted that this is especially ironic because quitting smoking is supposed to lower the risk of heart disease. However, the FDA’s new warning is based on another study, which found a slightly increased chance of recurrent heart attack or new arterial disease in smokers who already had well-controlled heart problems.

As a dangerous drug lawyer, I hope potential Chantix patients pay close attention to these studies. The Canadian Medical Association Journal study found that the risks of Chantix outweighs its benefits, because nine out of ten Chantix users generally go back to smoking. This is better than the numbers for unassisted people, but still not a strong benefit. Quitting smoking is genuinely difficult, and for smokers who have tried before and not succeeded, a drug to make it easier might sound like a smart move. But between the cardiovascular risks — which may add to risks already present in a long-term or heavy smoker — and the risk of psychiatric side effects, potential patients face a lot of serious risks for that small benefit.

At Carey, Danis & Lowe, we focus our practice on cases of serious injury or wrongful death caused by medications that were supposed to help. Our defective drug attorneys are based in St. Louis, but we represent people around the United States, in both individual and class-action cases. Most of us trust that a drug wouldn’t be offered for sale if it weren’t safe to use, but unfortunately, that’s not true at all. Pharmaceutical companies don’t always do the necessary due diligence to determine whether their drugs are safe; in some cases, they even cover up information showing how unsafe those drugs are. By bringing a dangerous drug lawsuit, injured people can raise public awareness of the drugs’ safety problems and maybe even prevent another injury. They can also claim the money they need to make ends meet and get needed treatment after a serious injury that was no fault of their own.

Continue reading "FDA Adds Cardiovascular Risk Warning to Label of Anti Smoking Drug Chantix" »

When a family that has been harmed by a defective drug files a lawsuit, our dangerous drug attorneys usually sue in their own state because it’s most convenient. However, the drug company is rarely from the same state, and it’s also possible to sue in the company’s own home state if necessary. That choice led to a dispute in Mace v. Mylan Pharmaceuticals Inc. et al, a wrongful death lawsuit brought by Randy Mace of North Carolina against Mylan, a company headquartered in West Virginia. Mace lost his wife, Kathy W. Mace, to an overdose of the painkiller fentanyl after she wore a Mylan-made fentanyl patch for four days. He originally sued another drug maker in California, but realized that Mylan was the correct defendant after the two-year statute of limitations had passed in both North Carolina and West Virginia. Believing West Virginia would be more likely to make an exception to its deadline, he re-filed in West Virginia.

In the trial court, Mylan requested and received a dismissal on the grounds of forum non conveniens — that West Virginia is not an appropriate forum for a North Carolina injury. Under this rule, courts may send cases to another court believed more convenient if such an alternative forum exists. However, the court dismissed the case on the condition that Mylan could not oppose forum in North Carolina and would waive its statute of limitations defense. After that ruling, Mylan filed a motion to clarify, arguing that it was not required to waive any future statute of limitations defense — just ones up until that ruling. This was eventually granted, and Mace asked to reopen the case because the case would be barred in North Carolina. That motion was dismissed and he appealed.

Before the West Virginia Supreme Court, Mace argued that the trial court misinterpreted the law on forum non conveniens. Under West Virginia caselaw, he argued, the existence of an alternative forum is required for dismissal under forum non conveniens, not just consideration. He also cited caselaw in support of his argument that statutes of limitations factor into whether a forum is available. When the state legislature codified this doctrine, he said, it did not intend to change the doctrine. The Supreme Court examined the plain language of the resulting statute and found that it was ambiguous: it assumes alternative forums exist and even addressed the issue of statutes of limitations. Thus, the court chose to construe the statute according to both federal and state caselaw. It found that when the alternative forum provides no remedy or an inadequate remedy, no alternative forum “exists” under the law. Thus, it reversed the forum ruling and sent Mace’s case back to trial court for consideration of other issues.

This case decides West Virginia law, but it’s still an important decision for defective pharmaceutical lawyers. Because this decision makes it easier for out-of-state victims to sue in-state pharmaceutical companies like Mylan, it makes the state a more attractive choice for fentanyl patch lawsuits like Mace’s. Of course, we hope most people in his position act early and get good legal advice so they don’t have to worry about the statute of limitations. But if that statute expires in another state, or there’s another reason that West Virginia seems like a better forum, this decision could help keep the claim alive. Our pharmaceutical liability attorneys appreciate having more options, because each new forum increases the chance that clients who have lost a family member or suffered serious injuries will have their day in court.

Continue reading "North Carolina Man May Sue Drug Company in Its Home State When Suit Barred at Home – Mace v. Mylan Pharmaceuticals" »

As a dangerous drug attorney, I was saddened and disappointed by the Supreme Court’s late-June ruling in PLIVA Inc. et al. v. Mensing. This case consolidated two claims by people who took generic versions of Reglan (metoclopramide), and later developed a rare and permanent disability called tardive dyskinesia, which causes involuntary movements and tremors. They sued the drug makers under state-law claims for failure to warn them about the risk. In both cases, the drug makers responded that they had no duties under state law because state law was preempted by federal law and FDA rules. Those arguments were dismissed by the Fifth and Eighth U.S. Circuit Courts of Appeals, and when the manufacturers appealed to the Supreme Court, the cases were consolidated.

It is not disputed that metoclopramide can cause TD. Studies as far back as the 1990s showed the connection, and a 2004 study brought it to the FDA’s attention. However, the agency did not order a black box warning for Reglan and its generics until 2009, several years after the plaintiffs developed TD. The plaintiffs alleged that by the mid-1990s, generics manufacturers knew or should have known about the risk, which would have been adequate to press their claims under state product liability laws. However, federal law also applies, and among other things, federal law requires generics to carry the same labels as their brand-name equivalents. According to the Supreme Court’s five-justice majority, this creates a situation where it is impossible for drug makers to update their labeling independent of FDA action without violating federal law. Because federal law preempts, the court ruled against the plaintiffs.

In doing so, the majority distinguished this case from 2009’s decision in Wyeth v. Levine, which held that failure to warn lawsuits under state law were not preempted by federal regulations. In that case, the majority said, the drug was a name-brand drug, so it didn’t have the requirement that generics have to keep to the same labeling as the parent drug. Because different laws applied in Wyeth, the majority said, it was possible in that case for manufacturers to follow both sets of laws. The majority recognized that creating a split in duties between generic and name-brand manufacturers “makes little sense” — a phrase repeated by the four-justice minority in a heartfelt dissent — but felt that its job was not to overturn laws passed by Congress. The dissenters argued that generic manufacturers should be required to petition the FDA to make labeling changes, and protected from suits only when the FDA said no.

Because the majority of all prescriptions are for generic drugs, this decision worries me as a defective drug lawyer. This decision means all of those drug makers will be completely immune from litigation, even when a name-brand manufacturer who took the exact same actions would be liable. And even if every American understands the risks and wants to avoid them by requesting only brand-name drugs, it is not always financially possible to avoid generics. Not only are they less expensive than their name-brand counterparts, but some insurance plans outright refuse to cover name-brand drugs at all. Unless Congress passes legislation to fix what the Supreme Court majority sees as a gap in the law, this decision will seriously hurt people with a wide variety of injuries caused by generic drugs — and as a pharmaceutical liability attorney, I agree with the minority that Congress could not have intended that.

Continue reading "Supreme Court Rules State Drug Tort Claims Preempted by Federal Drug Regulations – PLIVA Inc. v. Mensing" »

As a dangerous drug attorney, I’ve written here before about the problems with the birth control pills Yaz and Yasmin, both of which use a newer formula than other birth control pills. So I was interested to see a decision from the Seventh U.S. Circuit Court of Appeals in a Yasmin case that put procedural issues at the forefront before anything could be decided on the merits. In Cathy M. Walton v. Bayer Corporation et al, Walton sued Bayer and other companies as well as Niemann Foods, the pharmacy where she purchased the drug.

Bayer first removed the case to federal court, arguing that Niemann was improperly included in the case so it could be in state court. The federal district judge seems to have agreed, dismissing Niemann as a defendant from the case. This allowed the case to stay in federal court. Walton then abandoned the entire case because the district judge refused to remand it to state court, failing to respond to a discovery request from the defendants. The district judge eventually dismissed the case, and Walton appealed to the Seventh Circuit.

That court scrutinized Walton’s arguments that there was no federal jurisdiction over the case. Judge Posner, writing for the majority, brushed off her principal claim that the district court should not have dismissed Niemann as a plaintiff (which allowed the case to stay in federal court). Because pharmacies are “learned intermediaries” in Illinois, and because Walton does not allege that the pharmacy knew she was especially susceptible to Yasmin’s side effects, dismissal was valid. Nor could Walton argue that all of the defendants had a common defense, it wrote, because she alleged different actions by them. Finally, the court suggested that her claim would fail in state court anyway because she would be estopped from making the opposite arguments in state court from the ones she made to the Seventh. Thus, the appeals court upheld the dismissal by the district court.

This case might look unfortunate for all Yasmin and Yaz claims, but Walton’s case made stumbles that our experienced defective drug lawyers would not make. Most importantly, Walton made failure to warn claims against the pharmacy and several Bayer-affiliated distributors, but not against the arm of Bayer that did the manufacturing. This matters because it’s manufacturers who have a legal obligation, under all states’ laws, to warn defendants about safety risks of their products. In fact, Bayer has been in trouble for failing to do this in past television advertising, and it currently faces numerous lawsuits for failure to warn individuals of the risk of blood clots from drospirenone (the active ingredient in Yaz and Yasmin). As a pharmaceutical liability attorney, I hope Walton and others who have been harmed by drospirenone can pursue their claims successfully by choosing the right courts (and counsel).

Continue reading "Seventh Circuit Upholds Dismissal of Illinois Woman’s Yasmin Lawsuit – Walton v. Bayer Corp." »

As a dangerous drug attorney, I know the newer crop of diabetes drugs has had its share of problems. So I was disappointed but not too surprised to see that the FDA has issued a new safety warning for the diabetes drug Victoza/liraglutide. Victoza is an injectable drug that is supposed to work together with diet and exercise to fight Type II diabetes, although recent research suggests it could also be used in Type I diabetes. After turning up evidence that doctors were prescribing it as a first line treatment, against recommendations, the FDA ordered manufacturer Novo Nordisk to send letters to doctors reminding them that Victoza poses an elevated risk of pancreatitis and thyroid cancer. It asked doctors to monitor Victoza patients for signs of those diseases.

Victoza was approved in early 2010, but the approval vote was split because of evidence that it increases risk of thyroid cancer in laboratory animals. The FDA allowed the drug to be approved but told doctors that it should be used only if other treatments are ineffective. Pre-approval trials found that Victoza is effective and even seemed to cause weight loss, but also increased the risk of pancreatitis and thyroid cancer over control groups. The thyroid cancer risk rose with the size of the dose and the length of treatment. The FDA did not require doctors to monitor patients for signs of thyroid problems or pancreatitis, but advised them to send patients for testing if those signs show up. Novo Nordisk was required to conduct another study and start a thyroid cancer registry.

At first glance, none of this is news — the FDA is merely reiterating its cautions. However, as a defective drug lawyer, I’m disturbed that the FDA is only reiterating those cautions after discovering that some doctors didn’t pay attention the first time. Cancer and pancreatitis are both major health problems that could kill the patient or reduce quality of life for good. Patients and doctors should be well advised about these risks before they choose Victoza over another diabetes drug. If more active patient monitoring for signs of cancer is what it takes to remind doctors of the risk, perhaps the FDA should consider ordering that monitoring. And Novo Nordisk should continue its (required) efforts to warn patients, because any attempt to hide this kind of safety information could leave it open to a defective drug lawsuit.

Continue reading "FDA Orders New Safety Information on Diabetes Drug for Cancer and Pancreatitis Risk" »

I’ve written here several times, from my perspective as a dangerous drug attorney, about the unreasonable risks posed by birth control pills containing drospirenone. The pills, whose most famous commercial names are Yaz and Yasmin, have been criticized for an alleged increased risk of life-threatening blood clots compared to older birth control methods. Now, the FDA announced May 31 that it will conduct a new safety review of birth control pills containing drospirenone, in response to two recently published studies showing a dramatic increase in that risk. Those studies, published in the online British Medical Journal, have also led European regulators to update the prescribing information for Yaz, Yasmin and their generics, and Health Canada announced that it too is reviewing the pills’ safety.

Venous thromboembolism is the scientific name for blood clots deep in the legs, which can be life-threatening if they break away and move through the body to the lungs, where they can cause sudden death through lack of blood flow, or shortness of breath, rapid heart rate and other serious symptoms. All birth control pills carry at least some risk of veinous thromboembolism, but the two studies, published in late April, found that women 15-44 were two to three times more likely to develop venous thromboembolism on drosperinone than they were with pills containing levonorgestrel, an older synthetic hormone. That was true even after the scientists controlled the data for other risk factors for blood clots.

These are not the first studies connecting drospirenone with blood clots, but they are the newest and most serious evidence. Previously, two 2009 studies made that connection, but two other studies found no increased risk compared to levonorgestrel or other synthetic hormones. The FDA added this information to its prescribing information requirements, but the new studies may spur it to add more serious warnings. The older studies also led to thousands of lawsuits against Bayer, the maker of Yaz and Yasmine, for failure to warn patients about the risks, misleading marketing and more.

As a defective prescription drug lawyer, I hope the FDA takes this new information as seriously as it warrants. Blood clots can kill, and at least some evidence suggests that they can kill people without obvious risk factors who are taking drospirenone. As I wrote last month, a New Jersey woman is suing Bayer over the death of her daughter, a college freshman who died suddenly of a fatal blood clot at the age of 18 — half the age of women considered at higher risk. The young woman had been described Yaz for acne control. Bayer maintains that the risk of blood clots is no higher with its drug than with other birth control, but the scientific evidence increasingly says otherwise. I hope the FDA places patient safety first when it decides how strong the warnings on the drugs’ labels should be.

Continue reading "FDA Announces Safety Review of Yaz and Yasmin After Studies Show Blood Clot Risk" »

Our law firm has kept an eye on reports about the diabetes drug Avandia (rosiglitazone) and its relatives for several years, since studies began connecting them to a significantly increased risk of heart attacks. So as a dangerous drug attorney, I was very pleased to see the FDA’s announcement last week that it would sharply limit patients’ access to Avandia because of its cardiovascular risks. According to a May 19 article from HealthDay News, the FDA will no longer allow retail pharmacy sale of Avandia starting in November. Instead, patients taking Avandia will have to enroll in a special program qualifying them to receive it by mail-order. Echoing a previous safety decision, the FDA will limit the pool of people eligible for a prescription and require them to acknowledge receiving information about the risks.

Avandia has been in trouble since at least 2007, when an analysis of multiple studies concluded that patients’ risk of a heart attack could be as much as 43 percent higher when taking the drug. It has also been linked to increased risk of stroke and other cardiovascular problems. To make matters worse, the drug’s maker, GlaxoSmithKline, has been accused in Congress of intentionally suppressing information about the risks. In 2010, the FDA moved to restrict Avandia’s sale to only those patients who had the risks explained to them and agreed in writing that they understood. However, the new move restricting Avandia to mail-order pharmacies is expected to make the drug very rarely prescribed. Dr. Steven Nissen, the author of the 2007 meta-study, told HealthDay that “It’s like a decade-long nightmare coming to an end” because “virtually no one will be able to get it.”

As a defective drug lawyer, I agree with Nissen that this is great news for patient safety. The results of independent studies on Avandia have not been mixed; several studies have found results similar to Nissen’s. In fact, the drug is already banned in the European Union and New Zealand for safety reasons. And the manufacturer has already settled thousands of Avandia injury lawsuits. However, I also agree with safety advocates that this action by the FDA comes too late and more slowly than it should have, given the elevated risk of death from taking Avandia. As HealthDay pointed out, the other drug in the same class, Actos (pioglitazone), doesn’t show nearly the same heart health risks, making it a safer alternative. With an alternative clearly available, it’s disappointing that the FDA is taking 14 months between deciding Avandia is unsafe and curtailing its availability.

Continue reading "FDA Dramatically Curtails Availability of Avandia After Studies Show Heart Risks" »

Our law firm has closely followed the problems associated with the birth control pills Yaz and Yasmin, both of which contain the active ingredient drospirenone. So as a dangerous drug attorney, I was not surprised to see another lawsuit filed in the United States by a family claiming Yaz caused a fatal blood clot in a young woman of 18. According to the Lehigh Valley Express-Times, Joan Cummins of Hackettstown, N.J. sued Bayer, the manufacturer of Yaz and Yasmin, May 10. Her suit follows thousands of others in North America, alleging that Bayer should have recalled the drug, has advertised it misleadingly and failed to warn doctors and patients about the risks. Many claims have been consolidated into a class-action lawsuit in Illinois.

Cummins is suing over the death of her daughter, Michelle Pfleger, who was just 18 and a college freshman at Elon University in North Carolina. Pfleger collapsed on her way to a class in September, and an autopsy report found that she had a pulmonary thromboemboli — a blood clot in her lung — that caused cardiac arrest. She had been prescribed Yaz to control acne. Cummins alleges that Bayer consciously decided not to warn patients and doctors of the risk of death and serious injury from blood clots.

All oral contraceptives carry some increased risk of blood clotting, but at least six studies have turned up an increased risk of clots for patients taking birth control containing drospirenone. As a result, Yaz and Yasmin, and their newer generics, got more safety warnings on the labels in 2010. More recently, in April, two studies published in the online version of the British Medical Journal confirmed that connection with a study of U.S. prescription data. Even after women with other risk factors for thrombosis were ruled out — which previous studies hadn’t done — the researchers still found a greater risk of blood clots compared to women taking pills with the older levonorgestrel. Bayer has also been disciplined by the FDA for advertisements that overstated the drug’s uses and played down its risks.

As a defective prescription drug lawyer, I’m pleased that this story is getting so much media attention. Cummins is far from the first person to file a Yaz/Yasmin lawsuit, but perhaps her sad and compelling story will point widespread attention toward the risks of these drugs. Despite the six studies, FDA action and thousands of lawsuits, Bayer has consistently denied that the risk from its drugs is higher than the risk from other birth control pills. But when a presumably healthy 18-year-old develops a fatal blood clot after taking Yaz, it’s worth asking whether it’s safe to use. Many individual families are fighting their way through the courts to address the issue, but I hope the FDA takes appropriate action on these studies as well.

Continue reading "Another Yaz Lawsuit Filed by Mother of College Freshman Who Died of Blood Clot" »

As a defective drug attorney, I’ve written here several times about the issue of using atypical antipsychotic drugs for off-label treatment of dementia patients. The FDA has not approved this class of drugs for dementia; they are approved for mental illness, and include name brands such as Risperdal (risperidone), Zyprexa (olanzapine) and Seroquel (quetiapine). However, despite a growing body of research showing they have dangerous side effects, particularly in the elderly, and a black box warning on the subject, they have become widely used to control the behavior of dementia patients. Now, a report from the Department of Health and Human Services has found that the vast majority of atypical antipsychotic prescriptions filled under Medicare — 88 percent — are for off-label use with dementia.

According to a May 11 story from NPR’s Shots blog, HHS’s Inspector General’s office reviewed Medicare data to reach that conclusion. The Inspector General also found that 14 percent of nursing home residents made claims for atypical antipsychotics. That’s a legal problem because a little more than half of the claims should not have been covered in the first place, wrote the Inspector General in a May 9 opinion piece. Medicare rules require that drugs be approved only for medically accepted indications and documented as actually provided to the patients. Furthermore, one in five patients received the drugs in ways that violated Medicare rules, including doses that were too high or medication courses that went on too long.

But perhaps even more important, the Inspector General noted, is the fact that atypical antipsychotics have dangerous metabolic side effects that are particularly pronounced in the elderly dementia patients who frequently get the drugs. Among other things, the drugs raise the risk of stroke, cardiovascular disease and metabolic disorders including diabetes and insulin resistance. This has led the FDA to order a black box warning stating saying atypical antipsychotics are associated with an increased risk of death in dementia patients. However, the article said, their use is still widespread, in part because manufacturers of these drugs have illegally but aggressively marketed them for off-label purposes. Multiple manufacturers have pleaded guilty or settled with the government over these charges, including one that intentionally withheld evidence that Seroquel causes diabetes.

These results concern me as a dangerous drug lawyer because they show how many dementia patients are still getting inappropriate and potentially dangerous drugs — on the federal government’s dime. Scientists have known for several years that atypical antipsychotics pose unacceptable risk of death in dementia patients, and at least one study showed prescriptions falling as a result. However, this report suggests that Medicare providers have not gotten the message, particularly those in nursing homes. Nursing homes like antipsychotics even though they’re inappropriate because they sedate dementia patients, who can be hard to control. But however convenient this is for caregivers, it poses an unacceptable risk of killing the patient.

Continue reading "Federal Audit of Medicare Use Finds Dangerous Overuse of Atypical Antipsychotics" »

As a defective prescription drug attorney, I know blood thinners can be life-saving for people who have heart problems — but they can also be dangerous when overdosed or misused. So I was disappointed to see that the FDA has recalled 1.85 million tablets of the drug Coumadin (warfarin) because of a manufacturing defect that made the drug too potent. According to a WebMD article, the recall affects one lot of 5-milligram tablets of Coumadin manufactured by Bristol-Meyers Squibb. The recall does not affect warfarin sold as a generic or under other brand names produced by other manufacturers. As of May 3, fortunately, no injuries to patients had been reported to the FDA.

Coumadin is used in people who have heart problems or circulatory problems that raise their risk of stroke or embolism. It prevents the blood from clotting as effectively as it naturally would. However, the amount necessary in each patient needs to be balanced carefully, not only for each person's metabolism and genes, but because it interacts with a variety of common medications, foods, herbs and alcohol. As a result, pills with too much of the active ingredient could cause harmful side effects like excessive bleeding, coughing up blood, blood in the urine and bruising. Patients also run the risk of unknowingly decreasing the Coumadin's effectiveness by using other drugs or foods.

I'm happy to read that no one has yet reported being harmed by the recalled pills. But as a dangerous prescription drug lawyer, I wonder whether a drug that can be thrown off balance so easily is a safe one. Patients taking Coumadin for the first time must go for weekly blood tests to establish which dosage is safe for them, because genetic and lifestyle factors make it dangerous to prescribe on the basis of body weight alone. Among the common foods and flavorings that interact with Coumadin are garlic, spinach, grapefruit, ginger and possibly cranberries. In fact, warfarin is so effective that it was originally discovered when cattle eating plants with the active ingredient began bleeding to death. That's why it's vital to make sure Coumadin supplies are manufactured exactly to specifications — and recalled promptly when there are problems.

Continue reading "FDA Recalls Name Brand Version of Blood Thinner Warfarin for Too Much Strength" »

In 2009, I wrote here as a dangerous drug attorney about the over-the-counter weight-loss drug Alli, known as orlistat to doctors and Xenical by prescription. The FDA began investigating Alli in 2009 after it received reports of liver damage from people who had taken it, and eventually required a black box warning on the drug’s packaging about the risk of severe liver damage. Now, a new study published in the Archives of Internal Medicine reports evidence that Alli has also been linked to increased risk of injury to the kidneys, according to an April 14 article from TheHeart.org. Separately, FDA watchdog group Public Citizen called on the FDA to ban Alli and Xenical. Manufacturer GlaxoSmithKline intends to sell the drug but not discontinue it.

Alli (the over-the-counter version of orlistat) and Xenical (the prescription version) work by reducing the body’s ability to absorb about a quarter of dietary fat intake. Dieters must still exercise and watch what they eat, however — especially since eating too much fat can cause fecal incontinence. The black box warning about liver damage came in 2010, after the FDA received at least 32 reports of liver damage linked to orlistat, including cases of liver failure that required transplants.

The Ontario doctors used medical records to identify users of orlistat (which is prescription-only in Canada) who had sought medical treatment for kidney problems. Out of 953 users, they found five who had suffered kidney problems before starting orlistat and 18 who suffered them after using the drug. To control the study, they also looked at incidences of gastrointestinal bleeding and found no difference in rates. Meanwhile, Public Citizen cited FDA data showing 73 cases of kidney stones and 47 cases of acute pancreatitis linked to orlistat use.

As a defective drug lawyer, I hope the FDA is taking both of these groups seriously. Most people would agree that they’d rather be overweight than suffer permanent organ damage — but unless orlisat’s problems are widely publicized, many potential users could miss the reports linking it to liver and kidney problems. Especially because Alli is available over the counter — not under the care of a well-informed doctor — the FDA has a duty to protect the public by giving us the most complete information possible. If scientists show that orlistat causes kidney damage, the FDA would also have a duty to warn users — and, potentially, pull it from the market.

Continue reading "Study Links Increase in Kidney Injuries to Diet Drug Already Known for Liver Damage" »

In the wake of all of the lawsuits against drug giant GlaxoSmithKline as well as poor sales, the company has decided to cut some jobs from its Neurosciences Division. According to a Charlotte Observer report, the jobs will be cut in North Carolina's Research Triangle Park.

A Glaxo spokeswoman, Kathy Pitman, said that the number of employees that will be cut from the company really depends on how many of them can work in other positions at the firm. So far, Glaxo has already cut 22,000 jobs all over the globe since 2007. In the U.S. alone, Glaxo has cut as many as 4,100 jobs, which brought the total from 9,500 down to 5,400. The jobs had been cut due to a drop in sales of popular drugs like Paxil and Avandia and from the company suffering financial losses in at least 2 out of the last 3 quarters. Some of those losses can be likely be attributed to settlements being made left and right over the company's harmful drugs.

The bad sales were not helped by the company losing over $2 billion dollars in lawsuits against Avandia, its popular diabetes medication, and Paxil. The various investigations and huge settlement Glaxo had to pay after the whistleblower lawsuit alone have taken their toll on the company's finances as well. Glaxo has gotten a lot of bad press over Paxil's side effects and the lawsuits haven't slowed down much, either.

As to how the company plans to correct some of its financial woes, company officials say that they are planning on selling some of their less popular brands and buying some of its stock back from investors. As for the changes in the neurosciences research department, Pitman had this to say with regards to why they are letting so many people go: "Last year we scaled back our neurosciences research so there's not as much people needed to do the late-stage trials."

As a dangerous drug attorney, I was disturbed to see a report linking a common ingredient in over-the-counter medicines to a potentially fatal condition. The U.S. Food and Drug Administration issued a safety warning April 7 about a link between benzocaine and a condition called methemoglobinemia. Patients with methemoglobinemia have reduced amounts of oxygen in their bloodstreams, causing the same symptoms they might have if they aren’t breathing at all — lightheadedness, blue or gray fingernails and lips, fatigue, rapid heart rate and shortness of breath. Benzocaine, which is found in gels and sprays for teething, canker sores and sore throats, has been linked to seven deaths and 319 bad reactions, mostly in babies and toddlers.

Methemoglobinemia is a rare condition, but it can cause death in extreme cases. Adults and children have developed the condition after using all strengths of benzocaine-containing products, after the first use or subsequent uses, and up to several hours after use. Most of those affected were children ages two and younger. The FDA’s statement advised parents not to use benzocaine in children under age two, except when supervised by a doctor. Adults are warned to follow the manufacturer’s advice when using the products and to keep them out of children’s reach. Adult patients who run an even greater risk include people who have breathing problems; heart disease; and certain genetic chemical deficiencies. Also at high risk are smokers and those who take drugs containing nitrates.

The FDA’s release notes that over-the-counter medicines containing benzocaine do not carry a warning about the risk of methemoglobinemia, and the agency says only that it will take more action if warranted. As a defective drug lawyer, I’m concerned about this lack of warnings, particularly for parents of young children. Teething children were identified as the group most vulnerable to methemoglobinemia, but an FDA press release does very little to get this information in front of their parents. Without a warning on the label, new parents — who are often too sleep-deprived to take care of their own health — may have no idea that there’s a risk of death from teething gels. The risk may be small, but it’s a risk that parents ought to have the tools to decide on for themselves. Current actions from the FDA and drug manufacturers just don’t provide those tools.

Continue reading "Ingredient in Over-the-Counter Teething Gel Linked to Deaths From Oxygen Deprivation" »

As a pharmaceutical liability attorney, I’ve written in this space before about the serious side effects of the now-defunct cold medicine Zicam. Versions of Zicam containing zinc were taken off the market in 2009 after regulators confirmed that using it could cause permanent loss of the sense of smell, also called anosima. Its manufacturer, Matrixx Initiatives, has already paid $12 million to settle lawsuits from patients, and reports say many more have been filed. But on March 23, NPR reported that the U.S. Supreme Court has allowed another class-action lawsuit to continue, this one from investors in the company. Those investors allege that Matrixx intentionally withheld information about the problems to keep its stock price high, ultimately defrauding investors when prices sank.

Under FDA regulations, Zicam was not a drug, but an “unapproved homeopathic product” with active ingredients including zinc gluconate. Zinc is believed by some to help shorten the common cold, but Zicam also constricted blood vessels in the nose, ultimately killing users’ senses of smell. After receiving reports of more than 130 people who permanently lost their ability to smell, the FDA told Matrixx to stop selling the implicated products. However, the shareholders say in their lawsuit that Matrixx executives knew about the risk as early as 1999. The stock fell dramatically in 2004, after news reports about the problem were released, and shareholders filed a class-action lawsuit.

The Supreme Court was asked to rule on whether the shareholders had standing — that is, the legal right — to sue Matrixx. In a 9-0 decision, it said they did. Writing for the majority, Justice Sotomayor said the facts suggest that Matrixx likely didn’t disclose the problems because it knew they would affect its stock prices — not because, as the company claims, it didn’t believe they were significant. Among other things, the court said, Matrixx apparently hired an outside consultant and a panel of scientists to look into the smell allegations. However, Sotomayor noted, shareholders would still be required to prove their claims in court.

I look forward to seeing them do so, because — as a dangerous drug lawyer — I know many of the shareholders’ allegations could help patients involved in highly related lawsuits against Matrixx. If the company hid negative information about its products, it broke the law in at least two ways: once by misleading shareholders, and again by deceiving patients. In the case of the patients, however, the result is permanent loss of their ability to smell, and by implication taste. Money can be repaid, but losing your sense of smell is unfortunately permanent. I suspect Matrixx settled the earlier patient lawsuits because it understands how inexcusable this will look to a jury — and how much it could pay in a jury verdict as a result

Continue reading "Supreme Court Allows Lawsuit to Continue Over Failure to Disclose Zicam Problems" »

I’ve written here many times before about the ongoing manufacturing problems at plants owned by McNeil Pharmaceuticals and Johnson & Johnson, which has led to 19 recalls of major over-the-counter drugs such as Tylenol, Motrin and Benadryl. As a dangerous drug lawyer, I was therefore disappointed but not surprised to read that McNeil has agreed to a consent decree with the U.S. Food and Drug Administration, preventing it from making and selling drugs at certain plants until it complies with the law. The consent decree also includes two McNeil executives personally, as the FDA noted. It applies to the plants in Fort Washington and Lancaster, Penn.; and Las Piedras, Puerto Rico that were the sources of the recalled drugs.

The drugs were recalled for a variety of reasons, including too-high concentrations of active ingredients in children’s medications; particles of wood and metal in the drugs; and a “musty” smell determined to come from packaging chemicals, which triggered reports of vomiting and diarrhea. FDA inspections found that the three plants had serious safety problems, including dirty equipment and poor quality control. Executives are also accused of attempting to cover the problems up, including a “secret recall” in which the company sent people to stores to buy up products. As a result, sales are down and the Fort Washington plant is closed.

Under the five-year consent decree, that plant must remain closed; the two others can stay open but must comply with good manufacturing practices or face fines of $15,000 a day. McNeil must also hire an independent expert to inspect the plants and certify them as compliant, which the FDA will follow with its own inspection. And the drug maker is required to destroy all drugs returned since December of 2009. The consent decree must be approved by a federal judge before it goes into effect.

As a dangerous medication attorney, I’m very pleased that the FDA is taking stricter regulatory action against these blatant failures by McNeil to protect its own customers. All tainted drugs pose a potential threat, but the children’s drugs were particularly worrisome because they had higher concentrations of active ingredients than they should have, making it very easy to accidentally overdose a small or slight child. In extreme cases, this could cause serious health consequences. The consent decree comes after more than two years of failed inspections at McNeil plants, so it’s clear that the company has been given plenty of chances to clean up its act independently. And a criminal investigation is reportedly ongoing, though the FDA release doesn’t mention it, suggesting that we may not have heard the last about this.

Continue reading "FDA Wins Consent Decree With McNeil Over Unsolved Tainted Drug Problems" »

A recent series of articles caught my attention as a dangerous drug attorney because it affects common over-the-counter drugs for acid reflux as well as prescription versions. The FDA announced March 2 that protein pump inhibitor drugs, including Prilosec (omeprazole), Prevacid (lansoprazole) and Zegarix (omeprazole and sodium bicarbonate), have been associated with low levels of magnesium in the blood of people taking them for three months or longer. Formally known as hypomagnesemia, the condition can cause muscle weakness, confusion, hallucinations, irregular heartbeat and seizures. The FDA recommends that patients use over-the-counter PPIs only as directed, and doctors monitor magnesium levels in patients taking prescription drugs.

Proton pump inhibitors are prescribed for acid reflux (gastroesophogal reflux disease), stomach ulcers and other digestive conditions. Reuters reported that Americans filled about 21 million prescriptions for the drugs in 2009, and weaker over-the-counter versions of some are available. The FDA’s announcement said it had received about 48 reports of low magnesium levels. Of those patients, about a quarter didn’t improve after taking magnesium supplements, and the drugs were eventually discontinued. The biggest risk of hypomagnesemia may be developing a heart arrhythmia, which can lead to a stroke in some cases. But low magnesium levels can also create high blood pressure and neurological side effects including tremors and involuntary movements, seizures, hallucinations, depression and confusion.

As a defective drug lawyer, I’m pleased that the FDA is taking early action on this drug’s potential safety risks. There are no reported incidents of people dying or sustaining permanent disabilities from proton pump inhibitors, but that’s a possibility given the risk of arrhythmia-related stroke or epileptic seizure. It’s an even stronger possibility for people who are on a PPI as well as diuretics or the heart drug digoxin, which is used to treat heart failure and atrial fibrillation, a type of heart arrhythmia. Those are not uncommon drugs, and neither are PPIs, which means millions could be at risk. With such frightening and serious conditions at stake, patients should be well armed with information when they consider starting a PPI.

Continue reading "FDA Issues Safety Warning That Stomach Acid Drugs May Cause Mineral Deficiency" »

As a defective prescription drug attorney, I’ve written before about the possible misuse of antipsychotic drugs in patients with dementia. This practice is popular because dementia patients can suffer delusions, paranoia, aggression and agitation, sometimes making them a danger to themselves and others. Starting in the early 2000s, caregivers began responding by giving patients atypical antipsychotics such as Risperdal (risperidone) and Zyprexa (olanzapine), an off-label use of the drug but a common one. However, studies increasingly began showing that these newer antipsychotics carried an increased risk of death in the elderly. In response, the FDA added a black box warning, its strongest, to the packaging of the drugs in 2005. Now, a new study shows that prescribing took a sharp downturn after that black box warning.

Difficult-to-control dementia patients demand a lot of time from caregivers, and thus a lot of money from nursing homes and other facilities. That’s why it was once more popular to prescribe atypical antipsychotics to keep dementia patients calm, even though the FDA hadn’t approved the drugs for this purpose. But after a series of studies in the early 2000s, scientists concluded that patients on those drugs were substantially more likely to die than similar patients not using the drugs – in one Canadian study, 31 to 55 percent more likely. Deaths were particularly blamed on stroke and cardiovascular causes, including diabetes.

The new study in the Archives of General Psychiatry used Veterans Affairs data to conclude that new prescriptions for all types of antipsychotics dropped from 18% of dementia patients in 1999 to 12 percent in 2007. That study found that first-generation antipsychotic use dropped throughout the study period, while atypical antipsychotic use rose until 2003 – when the medical community first reported the risk of death in the elderly. In 2003, atypical antipsychotic use began to drop – and 2005, after the black box warning, it accelerated. Another study of prescribing practices at doctors’ offices found a 50 percent reduction in antipsychotic use between 2004 and 2008.

As a dangerous prescription drug lawyer, I’m pleased to see such a strong correlation between regulatory action and changes in prescribing practices. I am particularly interested in the fact that prescriptions started dropping when the risk of death from atypical antipsychotics first became known – but dropped much faster once the FDA added a black box warning to the drug. That suggests that doctors take the FDA’s warnings seriously. That’s good in itself, and it also shows that regulatory actions likely do matter. Unfortunately, the FDA moves slowly – it frequently waits months for panels to make nonbinding decisions before taking action. Since some scientific decision-making can’t be sped up, it would be best if more doctors were willing to change their prescribing practices as soon as credible scientific evidence about a drug appeared.

Continue reading "Study Finds Drop in Use of Antipsychotics for Dementia After Black Box Warning" »

As a dangerous drug attorney, I have followed the news about the diabetes drug Avandia closely. Avandia (rosiglitazone) was once a very popular drug for treating Type II diabetes – but at least two studies showed that it actually elevated patients’ risk of heart problems and strokes. Worse, there’s evidence that Avandia’s manufacturer, GlaxoSmithKline, knew about the risks for several years before those studies, but tried to cover them up and even intimidate scientists who made negative conclusions about the drug. In September, European regulators took Avandia off the market altogether, and the FDA ordered a new, very strict warning label limiting who may take Avandia. That label has arrived, as MedPage Today reported Feb. 8, even as GlaxoSmithKline agreed to pay $250 million to settle Avandia injury and death claims.

The new warning label says Avandia may be prescribed only to two groups of patients. One is patients who are already taking it. Those patients should not stop taking it without bringing it up to their doctors. The other group is people who have not been able to control their diabetes with other drugs in the same class and have medical reasons to avoid Actos (pioglitazone). The new label also warns patients about the increased risk of heart attacks, heart failure and related conditions. GlaxoSmithKline is still working on another part of the September order, which asked it to have independent scientists analyze data from its RECORD study of Avandia, after observers raised concerns about bias in the company’s own analysis. And the company is still working on FDA-ordered measures to ensure that patients obey the warning label, which includes a requirement for patients to sign a statement that they understand the risks.

This may not be the total ban that some public health advocates wanted in the United States – but as a defective prescription drug lawyer, I believe this will go a long way toward ending unnecessary deaths, strokes and heart attacks caused by Avandia. Already, NPR reports that only about 100,000 Americans are taking Avandia, down from 600,000 in September and about 1 million in 2007. That was the year that Dr. Steven Nissen of the Cleveland Clinic performed a meta-analysis showing Avandia raised patients’ risk of heart attack by 43 percent. That’s especially troubling because diabetics are already at an increased risk of heart and circulatory problems. Just as troubling was Nissen’s allegation that GlaxoSmithKline tried to discourage him from publishing his results through deception. How many similar actions never made it into the press?

Continue reading "Avandia Manufacturer Implements FDA Requirement to Strictly Control Patient Access" »

As a pharmaceutical liability attorney, I was very interested to read that the FDA has decided not to approve a drug proposed to help obese people lose weight. The New York Times reported Feb. 1 that the agency has turned down the drug Contrave (naltrexone and bupropion) until its manufacturer, Orexigen Pharmaceuticals, can complete studies showing that it doesn’t raise a risk of heart attacks. It follows on the heels of two similar FDA decisions for obesity drugs, lorcaserin and Qnexa, both of which were turned down for approval last year. It also follows the withdrawal of the diet drug Meredia (sibutramine) from the market after evidence showed an increased risk of heart attacks and strokes but only minimal effectiveness.

Contrave is a combination of two drugs that are already approved: naltrexone and bupropion. Naltrexone inhibits the brain’s acceptance of opioids and is used to treat alcoholism and sometimes drug addition. Bupropion is sold as an antidepressant under the name Wellbutrin, but as an anti-smoking drug under the name Zyban. It also works on brain chemistry. Critics have raised safety concerns including an increased risk of stroke and psychiatric side effects like mania, psychosis and suicidal thoughts, but it’s still on the market. In small and short clinical trials, Contrave elevated blood pressure slightly, leading to concerns about cardiovascular side effects like those of Meredia. An FDA advisory committee voted in December to approve the drug before further studies of its cardiovascular effects could be conducted, but the agency chose not to follow that nonbinding vote.

The Times article includes comments from several observers who feel this decision was overly cautious. But as a dangerous drug lawyer, I believe it’s always better to be cautious when people’s lives are at risk. Obesity already raises patients’ risk of heart attacks and other cardiovascular problems. A drug that raises that risk further would be unwise to give to that population – especially since a main medical goal of losing weight is to lower the risk of heart problems. The FDA didn’t comment on why it didn’t approve Contrave, but said it might start requiring cardiovascular studies for all obesity drugs. That policy is already in place for drugs treating diabetes, which also raises cardiovascular risks. The article notes that Contrave was only mildly effective at helping people lose weight, which calls into question whether the risks are worth the benefits.

Continue reading "FDA Declines to Approve Third Diet Drug in Three Months for Safety Reasons" »

As a dangerous drug attorney, I was very pleased to see a ruling from a federal appeals court confirming Americans’ right to sue drug manufacturers who fail to warn them about known safety problems. As the San Francisco Chronicle reported Jan. 25, the Ninth U.S. Circuit Court of Appeals ruled that day that a family may sue an over-the-counter drug maker for not marking the label of its ibuprofen to let patients know that it shouldn’t be mixed with other drugs that affect the liver. In the ruling, the Ninth Circuit said over-the-counter manufacturers are subject to the same rules as prescription manufacturers requiring them to issue warnings with new safety information. The ruling applies in the western states covered by the Ninth Circuit, but may be applied as guidance in other areas.

Ibuprofen, which is a common over-the-counter painkiller, is known to have effects on the liver at high doses. In fact, the FDA considered warning patients about the problem in 2002, but decided it didn’t have enough information. In this lawsuit, the son of Margaret Gaeta underwent minor surgery when he was 10 and was given an anesthetic that can harm the liver. He was prescribed ibuprofen for post-surgical pain and took it for four days. A week after surgery, he suffered liver and kidney failure and septic shock. As a result, he needed a liver transplant and has also had some fingers and toes removed. The family alleged that Perrigo Pharmaceuticals Co. should have included a warning on the label not to mix the drug with other drugs that can cause liver failure.

The trial judge dismissed their claim, saying a 2009 Supreme Court ruling did not apply. In that case, the court said FDA approval of a prescription drug’s label didn’t shield it from failure to warn claims based on new information. The Ninth Circuit applied the same logic to over-the-counter drugs, saying it found no indication that Congress intended to keep drug costs low at the expense of safety.

As a defective prescription drug lawyer, I am very pleased with this court decision. It seems like common sense, as well as the intent of Congress, that safety should come first. That may be especially important with over-the-counter drugs, because they are not necessarily prescribed and taken under a doctor’s supervision. Unless the patient happens to be an ardent watcher of FDA safety news, he or she has no way of knowing anything that the drug’s label doesn’t disclose. To make matters worse, the list of things ibuprofen might interact with to cause liver damage includes alcohol, one of the nation’s most common drugs, as well as other common over-the-counter remedies like acetaminophen (the active ingredient in Tylenol) and naproxen sodium (the active ingredient in Aleve). Patients taking these drugs deserve tools they can use to make good decisions.

Continue reading "Appeals Court Rules Drug Makers Can Be Sued Even When Labels Meet FDA Standards" »

In early January 2011, the popular and long-running news show 60 Minutes aired a segment on the whistleblower case against drug manufacturing giant GlaxoSmithKline, the makers of problem-plagued drugs like Paxil and Avandia.

During the segment, interviewer Scott Pelley got up close and personal with whistleblower Cheryl Eckard, who was the star witness in a class action lawsuit that was filed against Glaxo. Eckard told Pelley what she saw was wrong when she conducted her survey of the facility. She mentioned that she saw that the pills were being manufactured using tainted water, that Avandia and Paxil were being mixed up in packages together and that some of the Paxil was being produced in the wrong dosages.

Eckard mentioned that when she tried to inform Glaxo officials of the problems, they ignored her and shipped the drugs anyway. She went on to say that conditions in the Cidra, Puerto Rico, plant were the worst that she had ever seen in her entire career as a quality control manager.

As a result of her survey, Eckard took part in a large class action suit that was filed against Glaxo. The suit was settled when Glaxo decided to agree to a payout that totaled almost $1 billion. Glaxo ended up paying $150 million to the federal government in fines and another $600 million in damages. The lawsuit wasn't just about the manufacturing conditions of the Cidra plant; it also alleged that Paxil caused birth defects for the babies of women that took the drug while they were pregnant.

While Glaxo officials deny accusations that they lied to the FDA about conditions at the Cidra plant, they go on to say that the drugs that were shipped from Puerto Rico were never shown to hurt anyone. As far back as October 2010, Glaxo officials issued a statement with regards to the manufacturing mistakes made at the Cidra plant that said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK's commitment to manufacturing quality."

The U.S. Food and Drug Administration recently made an order that should get attention from ordinary Americans as well as dangerous drug attorneys like me. As the Washington Post reported Jan. 13, the FDA on that day said it has asked drug makers to restrict the strength of products containing the painkiller acetaminophen. Acetaminophen is the active ingredient in Tylenol and is also used in prescription drugs such as Vicodin or Percocet, which combine it with opioid painkillers. The FDA has restricted it to no more than 325 mg per dose out of concerns about liver toxicity from overuse. That’s a reduction for many prescription painkillers, which can contain as many as 750 mg of acetaminophen.

Acetaminophen’s negative effect on the liver has been understood for years, but a 2005 study shed more light on the issue. That study found that acetaminophen was the most common cause of liver failure in the United States, with nearly half of all cases resulting from an accidental overdose. Patients can accidentally overdose if they take too many products that contain acetaminophen at once, exceed the maximum dose or combine acetaminophen with alcohol. An FDA statement issued with the safety alert noted that acetaminophen overdoses caused an estimated 450 deaths per year between 1990 and 1998. The labels of prescription drugs containing acetaminophen must also carry a “black box” warning about the potential for liver injury, and doctors were asked to advise patients to limit their doses to no more than 4,000 mg a day.

The move does not affect over-the-counter painkillers containing acetaminophen -- just their prescription-only cousins. This has raised criticism from public safety groups such as Public Citizen, and also concerns me as a defective drug lawyer. Over-the-counter drugs can contain high levels of acetaminophen too. Extra-strength Tylenol, for example, contains 500 mg per pill, which is above the 325-mg limit for prescription drugs. Patients are instructed to take two extra-strength Tylenols every four to six hours, which could mean as much as 6,000 mg in a 24-hour period. That’s over the 4,000 mg maximum dose in the instructions for doctors. And this is assuming that patients pay attention to dosing information, something that is not likely to always be true. The FDA should be commended for this move, but we hope it follows with action on OTC medicines.

Continue reading "FDA Orders Cap on Strength of Prescription Painkillers Containing Acetaminophen" »

The Supreme Court in Washington, D.C., has agreed to make the decision about whether the makers of the popular drug Reglan as well as other manufacturers can be sued over claims that they mislabeled Reglan's side effects.

According to an ABC News report, the Supreme Court is set to consider if federal law is at least partially responsible for the many lawsuits coming out against the drug, since the FDA originally approved the drug for sale in the first place. Most of the lawsuits being filed against the makers of Reglan claim that the manufacturers did not properly label the side effects on the packaging.

The manufacturers that filed the appeals case were: Teva Pharmaceutical Industries, Mylan Inc.'s UDL Laboratories and Actavis Inc. Actavis' home base is in Iceland. In that company's case, the U.S. appeals court made a ruling that Actavis could be sued by a specific woman that claimed that she was not warned properly about the risks of taking Reglan by the company. Julie Demahy is a claimant that is filing her lawsuit under a Louisiana law, and she claims that she was not properly warned about the risks involved in taking Reglan. She has suffered from a neurological disorder after taking the drug. Another of the serious side effects that occur in those patients that take Reglan is Tardive Dyskinesia. It is a disorder that causes uncontrollable facial movements.

While there is no set date as to when the Supreme Court will be hearing the case, it is bound to cause more controversy for the makers of Reglan. While the manufacturers always stand behind their products and their marketing of them, the past year has been rough on many drug makers. Countless lawsuits have been filed in 2010 alleging dishonest marketing; indeed, many drug manufacturers have been accused of not properly warning the public about the potential dangers of taking their drugs. Since 2010 was a busy time for lawsuits being filed, 2011 could see many drug companies losing billions in payouts.

As a defective drug attorney, I was displeased to see reports of death and serious illness from a prescription painkiller. As MedPage Today reported Jan. 11, the FDA has ordered new labels for an oral morphine sulfate drug sold by Roxane Laboratories. The drug had been labeled as 100 mg per mL, which apparently confused some users. That confusion led to drug overdoses with as much as 20 times the ordered amount of the drug, causing deaths and serious illnesses, the FDA said. The 100 mg/mL drug may also have been mistaken for a less concentrated version, also leading to overdose. The agency ordered a new label for the morphine sulfate distinguishing the 100 mg/mL version from less potent versions. An oral syringe will come with the drug to make correct administration easier.

Morphine was sold throughout the 20th century, but the morphine sulfate preparation sold by Roxane was approved by the FDA only in 2010, because drugmakers had never applied for FDA approval. That approval was important, because morphine is a powerful opioid painkiller with potential for both addiction and overdose. At high doses, morphine can cause breathing problems leading to death or brain damage. The 100 mg/mL morphine sulfate solution that got the label change is already a high dose. It is intended for people who are known to have an opioid tolerance, and thus need a higher dose, and for people who are receiving hospice or palliative care. The old label reportedly made that problem worse by giving the strength in mg/mL even though dosages are ordered in mg. As a result, people unfamiliar with the drug gave the doses in mL, increasing its already strong potency considerably.

The FDA’s order for a new label takes several steps to ensure that the high-potency morphine sulfate is hard to confuse for lower doses, and includes an oral syringe so that users have the tools to give the correct dose. As a pharmaceutical liability lawyer, I’m pleased that the FDA is taking these steps -- but I’m surprised it was necessary. Most Americans don’t use the metric system, so it’s not a surprise that some users were confused by the dosage instructions for this morphine. Furthermore, calculating a dosage in mg from a drug measured in mg/mL requires math that most people won’t have memorized. It’s not hard to predict that busy or distracted users could miss the distinction and simply measure out a dose. Unfortunately, with such a powerful drug, the consequences of this kind of casual mistake can be deadly.

Continue reading "FDA Orders New Label for Powerful Painkiller After Several Reports of Overdose" »

A recent FDA decision got my attention as a dangerous drug attorney, even before it became a political issue. As the Los Angeles Times reported Dec. 17, the U.S. Food and Drug Administration has started the process to revoke its approval of the drug Avastin (bevacizumab) as a treatment for breast cancer. In a safety alert issued Dec. 16, the agency said four clinical studies showed Avastin had serious side effects but didn’t seem to prolong patients’ lives or slow their diseases. The side effects cited included heart attack and heart failure; development of holes in the intestines, stomach and nose; strokes; and hemorrhage. The drug is not yet withdrawn from the market, but may be after further FDA action and an expected appeal from Genentech, its manufacturer. Avastin is still approved for colon, kidney, brain and lung cancers.

Avastin was approved in 2008 for metastatic breast cancer using the FDA’s “fast-track” approval process, which allows drug manufacturers to skip the testing and approval process if their drugs meet a need not currently being met, or have major advantages over existing treatments. Avastin’s placement in this category was controversial, because the advisory council voted against approval on the grounds that it didn’t improve patients’ survival. In July, another panel came to the same conclusion and recommended on a 12-1 vote that the drug be withdrawn. The FDA’s most recent action came after four clinical trials showed no benefit and significant risks to the drug when used in breast cancer patients. Avastin has also failed to pass muster with the British National Health Service, which found no evidence in its own trials that Avastin extended patients’ lives.

The FDA’s most recent action has become politicized, with conservatives calling it an example of “rationing” health care and breast cancer advocates calling for insurance companies to continue covering the drug off-label for patients it seems to help. As a defective drug lawyer, I sympathize with concerns that a life-prolonging drug could be taken away from patients who desperately need it. However, the scientific evidence doesn’t seem to support the idea that Avastin is a life-prolonging drug. In fact, from the very start, all of the studies on this drug have suggested the opposite -- that Avastin seems to actually hurt other parts of breast cancer patients’ health. The FDA doesn’t save money by taking drugs off the market, and it’s unclear what effect this might have on Medicare, so there’s reason to think the FDA’s action is an attempt to save money. However, Avastin costs about $100,000 per patient in the U.S. and generated $2.7 million in sales for Genentech in 2008, so it’s clear that the manufacturer and its allies have a financial incentive to keep it on the market.

Continue reading "FDA Considers Withdrawing Cancer Drug Avastin for Safety Concerns, Lack of Efficacy" »

I’ve discussed the antibiotic Levaquin and its risks frequently here, from my perspective as a pharmaceutical liability attorney. Levaquin (levofloxacin) is part of a group of antibiotics called fluoroquinolones, which have come under fire for safety reasons in the past decade. The U.S. Food and Drug Administration has added safety warnings to Levaquin’s packaging at least twice since 2004, including a 2008 warning that the drug increases the risk of tendonitis and spontaneous tendon ruptures, which are disabling and painful and take months to heal. This and other Levaquin serious side effects have led to thousands of lawsuits across the U.S. The first of these went to trial in Minnesota last week, Bloomberg News reported Dec. 8, and ended with a $1.1 million jury award to patient John Schedin.

Schedin, 82, received Levaquin for a respiratory infection in 2005. His attorneys said he was active for his age at the time, but that ended when he ruptured not one but both Achilles tendons. These are the tendons connecting the back of the foot with the calf, and they are an especially common site for a Levaquin-related tendon rupture. In his lawsuit, Schedin alleged that manufacturer Johnson & Johnson failed to adequately warn him or his doctor about the high risk of tendon ruptures, something that was fixed after the FDA ordered a black box warning three years later. This risk is higher in people over 60 and people taking steroids -- both of which described Schedin -- and people who are organ transplant recipients. The jury awarded Schedin $700,000 in actual damages, which are compensation for direct losses, and $400,000 more in punitive damages intended to penalize the manufacturer for deliberate disregard for patients’ safety.

As a Levaquin injury lawyer, I’m pleased that the jury decided this way, especially since the decision is likely to affect other Levaquin injury lawsuits. One juror said he and his colleagues talked seriously about the drug manufacturer’s responsibilities, especially responsibilities to warn doctors. Evidence shows that Johnson & Johnson knew about the tendon-related risks of Levaquin at least since 2001, and that those risks were higher in the elderly. Nonetheless, Schedin’s attorneys said the manufacturer didn’t send warning letters to doctors until it had to because of the 2008 black box warning. Meanwhile, Levaquin was prescribed millions of times around the world, for a total of 430 million prescriptions according to the article. In the first nine months of 2010 alone, the article said, its sales totaled $957 million. It’s not hard to imagine that a company might prefer to suppress negative information about a drug to preserve sales that size, but that’s not the right thing to do when people’s health is at risk.

Continue reading "First Lawsuit on Antibiotic Levaquin Ends With $1.1 Million Verdict for Injured Man" »

The first bellwether trial regarding gadolinium and causing the fatal disease nephrogenic systemic fibrosis (NSF) is scheduled for January.

Plaintiffs in the first trial are Loralei and Donald Knase. They filed suit against GE Healthcare, claiming that a serious case of NSF was triggered by the MRI contrasting agent Omniscan.

MRI and kidney failure is linked in such a way, it should be noted, that while MRI does not cause kidney failure, the use of an MRI contrast agent can have dire consequences for anyone with kidney disease, due to the inability of someone with weak or malfunctioning kidneys to clear out the contrast agent.

Kidney patients who require MRI with a contrast agent such as gadolinium are recommended to have MRI dialysis (in other words, dialysis immediately following the MRI) in an effort to expedite the eradication of gadolinium from the bloodstream.

Plaintiffs involved in hundreds of lawsuits allege that gadolinium caused them to develop NSF, which causes hardening of the skin and tissue growth along joints, eyes and internal organs.

There is no treatment or cure for NSF, and the disease can be fatal.

Lawsuits were consolidated in late 2008 in US District Court, Northern District of Ohio, after almost 400 cases were filed across the country. Trials were originally set for May of this year, but a number of the suits against Bayer, one of the defendants, settled.

US District Court Judge Dan E. Polster set the trial date for the Knase action as January 24, 2011.

On a related note, MRI health risks also exist for individuals with pacemakers. Due to the intense magnetic fields associated with MRI, patients cannot wear or be near anything metallic. That goes for an implanted pacemaker.

Earlier this year, Medtronic received European approval for its Ensura MRI SureScan pacing system. Medtronic announced in June that European patients with the new device would have access to full MRI scans without positioning restrictions in the MRI scanner.

The system is, so far, not approved in the US—thus continued MRI health risks for individuals with traditional pacemakers remain.

As a dangerous drug attorney, I’ve written multiple posts in this space about recalls of over-the-counter medicines made by McNeil Pharmaceuticals. The company, a division of Johnson & Johnson, makes major over-the-counter drug brands such as Tylenol, Motrin and Benadryl. It hit the news in 2010 because of recurring safety problems at plants in Puerto Rico and Pennsylvania, leading to recalls of hundreds of millions of bottles of medicine. The U.S. Food and Drug Administration and members of Congress are separately investigating the company. Now, the New York Times reported Nov. 27, the U.S. Food and Drug Administration has made public a report showing that at least some of the safety problems at the plant have not been corrected.

The inspection was of a Puerto Rico manufacturing plant that had also been inspected in January of this year and found to have serious safety problems. The newer inspections, which took place between September and early November, show that some of those problems have not been addressed. Among the recurring problems in the November report (PDF) were failure to thoroughly investigate problems with products and failure to detect them in the first place. The report also found inadequate equipment cleaning and controls, which could lead to contamination or confusion of drugs. Procedures intended to prevent these problems were not being followed, the inspection report said. McNeil has reportedly already responded to these inspection reports. The FDA has said it won’t issue another warning letter, suggesting that more stringent enforcement actions may be taken.

Now is the right time for more serious regulatory action, in my opinion as a defective medication lawyer. McNeil has had most of a year to respond to the inspections, and apparently has failed to take steps to solve some serious safety problems. The inadequate procedures cited in the report are important because these procedures are what stands between the public and drugs that are not safe. In fact, because McNeil has had two consumer safety recalls in the last year, the danger is not just theoretical -- failure to correct procedures stands a good chance of failing to stop unsafe drugs from hitting stores. This could put everyone who buys an over-the-counter medicine from McNeil in danger -- and that’s millions of Americans. If McNeil does not make drastic changes quickly, the FDA should step in for the safety of the public.

Consumers trust name-brand over-the-counter drugs to help them feel better when they’re sick. But when companies allow contaminated, ineffective or otherwise flawed drugs to reach the market, consumers can be made sicker by the medicine that’s supposed to help. My firm,

Continue reading "FDA Cites Tylenol Manufacturer Yet Again for Safety Failures at Puerto Rico Plant" »

Last week, I wrote about a prescription painkiller that some defective drug lawyers believe should be pulled from the market because of the risk of overdose. This week, a painkiller is in the national spotlight for even more serious problems -- a risk of fatal health complications from intended use, not overuse. As ABC News reported Nov. 19, the U.S. Food and Drug Administration has asked the maker of Darvon (propoxyphene) and Darvocet (propoxyphene plus acetominophen) to take the drugs off the U.S. market because studies have shown that they can cause serious or fatal heart rhythm abnormalities. Generic drug makers are not obligated to take their own versions off the market, although the FDA has requested this. All versions of the drug have already been withdrawn in the United Kingdom, the European Union and New Zealand, and are strictly regulated in Sweden.

Propoxyphene is a painkiller in the opioid class, which means it’s from the same family of drugs as powerful prescription painkillers as well as opium and heroin. Like many other drugs in its family, it has a high addiction potential and is sometimes illegally used as a recreational drug. However, it is considered weak compared to many other prescription painkillers. Safety groups have cited some of those facts as reasons for withdrawing propoxyphene from the market, but they have also criticized the drug as more likely to cause fatal complications than other, more effective painkillers. An FDA panel voted in January of 2009 to take propoxyphene off the market, but the agency delayed action until a clinical trial in humans showed that the drug disrupts the electrical impulses that keep the human heart beating. A review of safety studies also showed more deaths per 10,000 patients with propoxyphene than with comparable drugs tramadol and hydrocodone.

As a pharmaceutical liability attorney, I’m pleased that the FDA has taken action to protect consumers from the bad effects of this drug. As the agency itself said publicly, the heart arrhythmia problems make it clear that the benefits of the drug do not outweigh its risks. However, I am disappointed that it took the FDA so long to take action after its panel voted to take propoxyphene off the market in January of 2009. It has been nearly two years since then, and Public Citizen estimates that statistically, 1,000 to 2,000 Americans may have died from using the drug during that time. Indeed, even that vote came after some overseas regulators had already banned it. No doubt the makers of Darvon and Darvocet stood to make money during that time as well -- but the FDA is not in the business of helping drug manufacturers make a profit, particularly at the expense of public safety.

Continue reading "FDA Pulls Painkillers From Market After Tests Confirm Fatal Heart Rhythm Problems" »

As a dangerous prescription drug attorney, I know the pain medication Fentanyl (fentanil) is an ongoing safety problem for the FDA, with multiple recalls in various forms and under various names. That’s why I wasn’t surprised to see that the FDA has recalled about a million Fentanyl transdermal patches due to concerns about an overdose. Arthritis Today published an article about the recall Oct. 27, and the FDA updated its recall on Nov. 5 to include patients as well as health care providers. The recall is being blamed on a manufacturing error by Corium International, a Michigan company that makes drugs under contract for Fentanyl’s owner, Actavis Inc. The patches are believed to release the drug more quickly than intended, putting patients at risk for an overdose that could slow or stop their breathing, setting them up for brain damage and death. The FDA did not report any injuries or deaths related to the recalled patches.

Fentanyl is an opioid painkiller intended to manage severe pain when less powerful drugs do not help. The patches are supposed to release measured doses into the wearer’s bloodstream to manage pain over a long period. This is frequently used for cancer patients and patients undergoing surgery, as well as for people with certain kinds of arthritis. However, Fentanyl and Duragesic, another brand name for fentanil, have encountered repeated safety problems. Fentanil is derived from opium, making it highly addictive and very powerful. This has led to its use as a street drug and theft and misuse by hospital, clinic, nursing home and other medical employees.

That power is at the root of the safety recalls, most of which are recalls of the drug in patch form. Patches are intended to deliver the drug steadily into the patient’s bloodstream, but slight mistakes during manufacturing can make them deliver too much. Instead of merely killing the pain, an overdose can go further and depress the patient’s respiratory system. Victims can stop breathing or breathe only with difficulty, causing death. In fact, an overdose of fentanil from a legally prescribed Duragesic patch is blamed for the death of Jay Bennett, a former member of the band Wilco, in Illinois. Here in Missouri, inappropriate use of a Fentanyl patch intended for adults is blamed for the death of a six-year-old boy in Willow Springs.

As a pharmaceutical liability lawyer, I am pleased that Actavis is taking this issue seriously enough to recall the patches. But at the same time, I hope the FDA is looking seriously at whether a drug this powerful should be delivered by transdermal patch. This is not the first patch to come under fire; in fact, it’s not even the first fentanil patch to receive FDA action. Duragesic patches were blamed for deaths and other adverse events in 2005 and 2007. Two Fentanyl patch makers recalled products in 2008 because of an overdose risk from manufacturing defects. Another well-known patch safety problem had to do with Ortho Evra, a birth control patch blamed for causing blood clots by releasing too many hormones. Under these circumstances, it’s fair for drug industry observers to wonder whether patch delivery systems are right for drugs that require very careful monitoring of the dosage, which definitely includes Fentanyl.

Continue reading "FDA Recalls Powerful Fentanyl Pain Medication Patches Because of Overdose Risk" »

The last thing a parent with a teething baby wants is to cause their baby to suffer more pain. Unfortunately, according to a recent recall announced by the U.S. Food and Drug Administration, some parents may have inadvertently done just that. Hyland’s Teething Tablets, a homeopathic product containing belladonna, was recalled after the FDA received reports of serious adverse events in babies who took the product. Belladonna, also known as deadly nightshade, is one of the most well known poisonous plants in the Western hemisphere. As a defective drug lawyer, I applaud the FDA for moving quickly and hope that no more children are harmed.

According to the manufacturer, Hyland's Teething Tablets are meant to provide homeopathic relief for teething babies. The product is sold as an over-the-counter dietary supplement in grocery and drug stores. The recall notice suggests, but does not outright say, that the FDA has already identified manufacturing problems responsible for the adverse event reports it’s received. Those reports suggest that the infants who got sick suffered a toxic overdose of belladonna. The manufacturer has recalled the tablets and parents are advised to stop using them immediately, and to discard any tablets that they still have. The FDA advises consumers to contact a health care professional if their child takes the tablets and then experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation.

As a defective medication lawyer, I think this is a good reminder that patients are not well protected from “dietary supplements” marketed as medical cures. Even though the FDA does not treat homeopathic medications like Hyland's Teething Tablets as drugs, the manufacturer instructs parents to treat it as any other medication, in consultation with a licensed health care practitioner. While the manufacturer says it’s "virtually impossible" to overdose on the product, the FDA’s findings suggest otherwise. The tablets are manufactured to contain a small amount of highly toxic belladonna -- just two to five berries from the plant can kill a child. That means the amount of the belladonna should be carefully controlled -- yet FDA laboratory analysis has shown that the amount of belladonna varies widely from tablet to tablet. In addition, the containers in which the tablets are sold do not have child-proof caps, so children have been able to open the containers and consume more of the tablets than recommended.

Continue reading "Supplement for Teething Infants Recalled Due to Poisonous Herbal Ingredient" »

The iron replacement drug Feraheme (Ferumoxytol) has been associated with "life-threatening" events, including heart problems, and may get a black box warning. The U.S. Food and Drug Administration approved Feraheme last year to treat iron-deficiency anemia in adults with chronic kidney disease. Financial analysts are concerned that reports of fatal events associated with Feraheme will hurt the drug's sales. As a dangerous drug liability attorney, I am more concerned that this drug will hurt patients, and I urge patients taking this drug to educate themselves about its risks.

AMAG Pharmaceuticals, Feraheme's maker, met with the FDA in September to discuss safety concerns about the drug. Fatal and life-threatening problems including hypersensitivity and cardiac events occurred in 146 cases, out of more than 155,000 patient exposures to the drug. Some patients had adverse reactions associated with hypersensitivity, like itching, rash, hives and wheezing. Some also had hypotension, or abnormally low blood pressure, which can cause dizziness, fainting and seizures; and chronic renal failure, the progressive loss of kidney function. The FDA and AMAG are discussing label changes to alert doctors and patients to these dangers, as well as an extension of the 30-minute period for observing patients after the drug has been administered.

Feraheme's sales have declined lately, and AMAG is restructuring its business to improve its profits, cutting 24 percent of its workforce. It may be that AMAG had more employees than it needed, but the firing of trained professionals in its workforce could subject the company, and the patients who use its drugs, to more problems. When employees are spread more thinly, they can lose sight of important quality and safety issues, allowing dangerous drugs to make it through the quality control process, and patients can get hurt. I have seen enough cases in my work as a drug defect lawyer to say that making money is often a higher priority for companies than patient safety. It's good that AMAG is talking with the FDA about how to protect patients, and I hope that losing 24 percent of its workforce will not thwart whatever protections they put in place.

Continue reading "Iron Replacement Drug Feraheme May Get Black Box Warning for Fatal Cardiac Events" »

Since the European Medicines Agency (EMA) decided to remove marketing for the type 2 diabetes drug Avandia last month because of the risk it poses for heart attacks, the research group Datamonitor has conducted a survey in an effort to understand how this decision will affect consumer buying and physicians prescribing the drug.

Of course, the United States’ FDA also has issued severe restrictions on the marketing of Avandia, which is manufactured by GlaxoSmithKline. Datamonitor’s study revealed the following:

• Avandia sales will drop to zero in Europe by 2011 when marketing authorization is suspended. In the USA, Avandia sales will plummet due to safety concerns and FDA restrictions, but Datamonitor predicts a small number of patients will remain on Avandia because they cannot tolerate other therapies.

• There currently is no strategy for most doctors to change patient therapies. This, in turn, will not assist any one anti-diabetic drug to gain market share.

• Even though a lot of patients likely will want to be switched onto the less fearful drug Actos, made by Takeda, it is expected that Takeda will not be able to capitalize for long off of Glaxo's downfall because Takeda will lose its patent protection in 2011.

• More than likely, some other patients will switch to using Merck & Co’s highly-successful drug Januvia (sitagliptin). These drugs don't work as well at lowering blood sugar, but they have proven safer and offer fewer side effects.

• Byetta and Victoza probably will get themselves some patients, and this will definitely help them with their class of drugs — at least, before something else comes along that works better and for a longer time period.

• Some patients will be switched from Avandia to the more common method of just using insulin with needles. This is likely to be the case for those that could benefit from using the once-daily basal insulins like Lantus and Levemir.

• Avandia's sales restrictions will hurt GlaxoSmithKline the most from 2010 to 2012. Datamonitor is predicting the company’s losses to be more than $1.2 billion during that time.

• Regardless of Avandia's losses in 2010 to 2012, the anti-diabetics market will grow by more than $200 million because of the restrictions and patients switching drugs.

I was interested to see that the FDA has announced that it is cracking down on unapproved uses of chelation drugs. These drugs, which bind to and remove heavy metals from the body, are prescribed legitimately to treat heavy metal poisoning. But the drugs have also been marketed for unapproved uses, most famously the treatment of autism. The FDA is disciplining these drugs’ makers for this in the wake of at least two deaths attributed to misuse of chelation drugs. As a pharmaceutical liability attorney, I believe it’s important that the public be protected from drug manufacturers' attempts to market their products for dangerous, unapproved uses -- which is ultimately about increasing their profits.

Sadly, these unapproved uses have had some tragic results. A five-year-old autistic boy died of a heart attack while a Pennsylvania doctor treated him with chelation drugs, using an unproven theory that autism is caused by heavy metal poisoning. The child's parents sued the doctor and his medical license was suspended for three years. A two-year-old Texas girl also died of a heart attack attributed to chelation treatment.

Over-the-counter chelation drugs have also been marketed on the Internet to treat Alzheimer's disease, Parkinson's disease and heart disease. These drugs can cause kidney failure, dehydration and other serious health problems. A 2007 survey showed that 111,000 adults had used these treatments in the past year. The FDA sent warning letters to eight makers of these drugs notifying them that they are "unapproved drugs and devices," and that their sale is a felony. These eight sellers -- World Health Products; Hormonal Health; Evenbetternow; Maxam Nutraceutics/Maxam Laboratories; Cardio Renew; Artery Health Institute; and Dr. Rhonda Henry -- have marketed the drugs as dietary supplements. The FDA said that patients receiving legitimate chelation treatment should use only prescription drugs, under the care of a medical professional who can respond to any complications.

As a defective medication lawyer, I agree completely. Two innocent children should not have had to die from the unapproved, dangerous use of any drug, whether prescription or over-the-counter. The drug makers may have intended to make their products sound harmless when they marketed them as mere dietary supplements. But that's even more dangerous to unsuspecting consumers who are looking for medicines to help them, not make them even sicker. That kind of sneaky marketing is not just immoral, it's illegal, and I am pleased that the FDA is paying attention to it.

Drug manufacturers are required by law to warn consumers of their products' risks. If they fail to do so -- or, worse, hide their drugs' harmful effects -- the people that get hurt by using those drugs can sue. Victims of dangerous drugs can require the manufacturer to pay for their medical costs, lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused. Consumers who trust that a medication will help them should not have to bear all the consequences alone if they find that the manufacturer hid important information from them about the drug's risks.

Continue reading "FDA Cracks Down on Unapproved Uses for Chelation Drugs After Two Children Die" »

According to the Associated Press, FDA officials have issued a warning that popular bisphosphonates drugs that treat osteoporosis may actually increase the risk to thigh fractures.

Patients taking bone-strengthening drugs like Fosamax and Boniva seem to be more likely to suffer a rare fracture of the femur. This fracture occurs just under the hip joint. The injury is so rare in fact that only 1 percent of femur injuries occur in this spot.

"We know from clinical trials that these drugs do prevent the common osteoporosis fractures,” says Dr. Sandra Kweder, the FDA's deputy Director for new drugs. “The fractures we're talking about today are very unusual and rare."

More than half of the cases that are reported to the FDA say that the patients taking Boniva and Fosamax complained of pain or an aching groin just before they experienced the fractures. Right now it isn't completely clear if the drugs are directly responsible for the fractures, but as a safety precaution, the FDA is adding the potential risks to the labels of these drugs. Also, manufacturers are required to give pamphlets explaining the potential risks of taking Fosamax and Boniva to their patients.

Bisphosphonates work by helping to slow down the loss of bone cells that can lead to osteoporosis. Prescription drugs that are currently in that category include Fosamax, Boniva, Actonel, Atelvia and Reclast. The FDA has said that the fractures "may be related to the use of bisphosphonates for longer than five years." They also said that there have been some patients that have been steadily taking these drugs for over 15 years.

For now, if you are a patient that is taking any of these drugs, you should keep taking them unless you want to be weaned off of the drugs by your doctor. FDA officials have stated that they will keep investigating the drugs safety so that they can ensure the correct recommendations for their use.

As a defective medication lawyer, I wish that drug manufacturers would learn from one another's mistakes -- but as a recent report suggests, this does not seem to happen. Now that Johnson & Johnson has been thoroughly shamed for its lax adherence to safety protocols, Gilead Sciences Inc. has been warned by the FDA about problems with its contamination prevention and quality control procedures at its San Dimas, Calif., plant. A number of other drug companies have been in the news this year for lapses at their manufacturing plants, suggesting that consumers who use prescription and over-the-counter medications have reasons to be worried about their safety.

The FDA sent the Sept. 21 warning letter because Gilead had failed to respond adequately to problems found by the FDA's inspections in January and February. One of the problems the FDA identified was that Gilead wasn't taking defects in its drugs seriously enough. For example, the company changed its manufacturing process for Viread, an antiviral treatment for patients with HIV that made $668 million in sales last year. After it made the change, the company began discovering "excessive amounts of defective tablets," the FDA said, but the company concluded that the changes to its manufacturing process were blameless.

This was not the only problem the FDA turned up. Reportedly, Gilead also didn't investigate the extent of the defects in the drug. A contract manufacturer had produced the drug, and Gilead packaged it. Multiple lots of the drug failed visual inspection, but Gilead just removed the defective pills and went ahead with packaging the rest, without trying to find out what had gone wrong and how to fix it. In addition, Gilead failed to ensure that sterile products remained sterile. Certain lots of the fungal infection treatment AmBisome, which made $300 million in sales in 2009, were processed in a room that wasn't approved as an aseptic setting. That medication was released for sale in the U.S. The FDA told Gilead that its "senior management" needed to set up systems that would ensure the identification and correction of problems and "assure the identity, strength, quality, and purity of their drug products."

Gilead is known for its HIV medications. Thus, the problems the FDA identified with Gilead's manufacturing processes suggest that patients whose lives are already threatened by HIV infections may face the additional threat of contaminated medications. As a dangerous drug attorney, I worry that situations like this point to a drug manufacturer's being more interested in profits than in people's health.

Victims who have been hurt by dangerous or defective medications can require the defective product's manufacturer to pay for the harm that they caused. The law requires drug manufacturers to warn consumers about risks that they know to be linked to their products. If they fail to do so, consumers who are harmed by the defective drugs can sue for financial compensation. A victim who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by a drug can make the manufacturer pay these costs. According to the law, consumers who trusted that a medication was safe should not have to bear the consequences alone, if they find that the drug was unsafe. This is true regardless of whether the manufacturer knew about problems with the medication.

Continue reading "FDA Warns Gilead Over HIV Treatment, Other Meds Produced in Substandard Plant" »

The FDA has finally decided what to do about the serious heart risks to patients taking the diabetes drug Avandia (rosiglitazone). Given the increased danger of heart attack, stroke, and heart failure to 600,000 patients taking the drug, the FDA has severely restricted use of the drug, but it has not taken it off the market entirely. The European Union's European Medicines Agency has forbidden the sale of the drug in the EU. In my view as a pharmaceutical liability attorney, the EU's more cautious approach will probably protect more patients from serious harm. But I am glad that the FDA has at least restricted the harm that Avandia can do in the U.S.

The FDA has decided that use of Avandia can continue only for diabetics for whom other drugs have not worked. Most users will switch to different medications, and doctors will not be able to prescribe Avandia to new users without a detailed explanation of all the risks it entails. In addition, Avandia's maker, GlaxoSmithKline, is not allowed to market the drug. Avandia had been the best selling diabetes drug in the world in 2006, when its sales reached $3.2 billion, but once news of its dangers spread, they dropped to $1.2 billion in 2009.

Those billions of dollars in sales clearly were important to GlaxoSmithKline, as the company tried to suppress evidence of Avandia's problems and intimidate a cardiologist at Ohio's Cleveland Clinic who first publicized problems with the drug. Dr. Steven Nissen’s 2007 study, published in the New England Journal of Medicine, showed that taking Avandia increased a patient's heart attack risk by 64 percent, and Type 2 diabetes patients already are at high risk for heart attack. But GlaxoSmithKline insisted that Nissen was wrong, even though, as the U.S. Senate's investigation discovered, GlaxoSmithKline's own scientists privately acknowledged that Nissen's study was sound.

Nissen's research was central to Avandia's restriction by the FDA, but he says that he wishes that the FDA had acted on it more quickly. "I will sleep better tonight, but I will not sleep until I know that we've have improved how we handle these kinds of problems in the United States. We've got to fix the FDA," he said. An estimated 47,000 Avandia users suffered heart attacks, strokes, or heart failure between 1999 and 2009, a situation that Nissen described as "one of the worst drug safety tragedies in our lifetime. That's why Nissen says it's "essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future."

As a dangerous prescription medication lawyer, I'm glad that there will be fewer patients who have to suffer because of Avandia. But it would be better if no one else at all were to be harmed by this drug. Those who already have been hurt by it have strong reasons to consider seeking financial compensation from GlaxoSmithKline, as does anyone who has been hurt by a dangerous prescription or over-the-counter medication. Drug manufacturers have a legal responsibility to warn the public and the government about the harmful effects of their drugs, and from what we know of the Senate's investigation, GlaxoSmithKline may have tried to do exactly the opposite. When a patient takes a medication about which the manufacturer has withheld important safety information, that drug maker can be held legally responsible for the harmful effects of its drugs.

Continue reading "After Long Debate, FDA Severely Restricts Use of Avandia in American Diabetics" »

Recently I wrote about Dr. Frances Oldham Kelsey, whose leadership helped the FDA establish scientific standards that drug companies had to meet before they could market their drugs in the U.S. Another article about the FDA in the New York Times recently caught my attention, as a dangerous drug injury lawyer, for its discussion of how the FDA has changed in recent years to become more transparent. The FDA's new openness with the public about how it decides which drugs to approve or not approve helps it to interact with the scientific community. It also holds the FDA accountable to protect the public from drug companies focused on profits rather than patient safety, even though the agency sometimes finds it difficult to do so.

Under the Bush administration, the FDA didn't publicly discuss its deliberations about drug approvals, and staff members were expected to present a united front once decisions were made. The agency also didn't conduct deep investigations into drugs' safety and effectiveness. Under Obama, competing views and disagreements among FDA scientists have been aired publicly. The FDA presents a less united front and allows the public to how complicated the matter of drug safety can be. Dr. Joshua Sharfstein, principal deputy commissioner for the FDA, said, “I think that FDA’s credibility really depends on being able to explain its decisions well. We can’t expect people to think that FDA has decided, therefore it’s the right answer.” In my view as a dangerous prescription medication attorney, the right answer is always protection of patients' safety and well-being rather than the interests of drug makers.

Even with the agency's new openness, patients should not rely only on the FDA to protect them from drug companies that market dangerous medications. The agency seems unsure of how to handle the complexity of its decision-making sometimes, and this can result in dangerous drugs being allowed to stay on the market. Questions about FDA decision-making processes have been especially pointed in the case of Avandia, the diabetes drug that is associated with heart risks. Dr. Steven Nissen's study showing Avandia's dangerous effects, about which I have written several times, prompted doctors, patients, and legislators to wonder why the FDA had not been the one to do this study. Nissen's study was not conducted according to the FDA's procedures for scientific evaluation of medicines. However, the FDA had in fact done its own study with the same results that Nissen found. The agency just hadn't made it publicly available -- so no one knew about it until Nissen’s study.

Even though the FDA is charged with ensuring drugs' safety and effectiveness, drug manufacturers also are legally required to warn the public about risks that their products might pose. That means that even if the FDA approves a medication for sale, the drug maker can be held responsible for any failure to warn patients. If a manufacturer knows or should have known that the medication could hurt people, and doesn't make this information public, patients who are hurt by this medication can sue the drug maker to recover the costs of their medical treatment, along with compensation for pain and suffering, loss of quality of life and past and future wages.

Continue reading "Avandia Decision Underscores New Culture of Openness at Federal Drug Regulator" »

The news wires have been busy lately with reports of yet more examples of drug companies marketing their drugs illegally. St. Louis-based Forest Laboratories agreed to a settlement this month, in which it will pay over $313 million in penalties for civil and criminal complaints that it illegally marketed its antidepressant Celexa (citalopram) for uses beyond those approved by the U.S. Food and Drug Administration. Two weeks earlier, Botox (onabotulinumtoxinA) maker Allergan agreed to a settlement in which it will pay $600 million for its illegal off-label marketing. Most dismaying to me as a dangerous medication attorney, both companies were charged with trying to sell their drugs for use by children even though the drugs were only approved for use by adults. Celexa has been linked to suicide and suicidal thoughts in some children and adolescents, so marketing the drug to them illegally seems especially dangerous and unethical.

Among the charges that Forest Pharmaceuticals, a subsidiary of Forest Laboratories, settled was a charge that the company was marketing Celexa to treat depression in adolescents and children, and that it was giving doctors misleading information about the drug's effectiveness for those age groups. According to the U.S. Department of Justice, the company publicized positive results of a study of Celexa's effect in adolescents, while keeping quiet about another study that found negative results. Forest also allegedly paid doctors to prescribe Celexa and another antidepressant, Lexapro, handing out “cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services,” according to the Justice Department's civil complaint. From 1998 to 2005, Forest representatives rewarded cooperative doctors with tickets to St. Louis Cardinals and Boston Red Sox games, Broadway shows, gift certificates to expensive restaurants and deep-sea fishing trips.

The company denies the civil allegations, but admitted that its employees lied to FDA inspectors in 2003, that it misbranded Celexa as appropriate for use in children, and that it illegally distributed an unapproved thyroid drug. Thus, Forest pleaded guilty to one felony and two misdemeanors. In the case of Levothroid (levothyroxine), the thyroid pill, Forest was charged with deliberately increasing its distribution of the drug in quantities that exceeded what the FDA allowed, even after receiving an FDA warning letter. Along with the fines and forfeitures of assets, Forest has agreed to a corporate integrity agreement making its drug marketing subject to monitoring by an independent expert for the next five years.

As a pharmaceutical liability attorney, I am glad that the Justice Department is cracking down on dangerous and illegal marketing that puts children at risk. Children's bodies are not the same as adults' bodies, and it's not safe to assume that drugs that are fine for adults will work the same way for children. The dosages may not work the same way in children’s smaller bodies, and we don't know how the drugs might affect a child's developing body and mind. This is precisely why the FDA does not approve a drug once for all age groups. Suicidal thoughts are a well known problem with antidepressant use in kids and teenagers, and as noted previously, Celexa studies have linked the drug to such thoughts in kids and teens. That makes Forest’s choice to market Celexa off-label for this age group particularly irresponsible.

Drug companies know very well that the law requires them to follow established safety procedures and warn the public of any risks associated with taking the drugs they manufacture. When a drug company engages in illegal, deceptive marketing, it does the opposite. Failing to get FDA approval for an age group (or any other group) bypasses the regulatory structures that are intended to keep us safe. There's only one reason that companies do this: profit. Illegal marketing gives them an unfair advantage over their competitors who do obey the rules and get FDA approval for their medications, and that unfair advantage helps them and hurts everyone else. That's why consumers who are harmed by taking a prescription or over-the-counter medication are entitled to make the drug manufacturer pay for any costs associated with that harm. Those costs may include more than just medical bills: the victim may also sue for lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused.

Continue reading "Drugmakers Agree to Pay Huge Settlements for Illegally Marketing Drugs to Children" »

The FDA is requiring changes in label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.

The gadolinium constrast agents are sold under the brand names: (1) Ablavar (gadofosveset trisodium), (2) Eovist (gadoxetate disodium), (3) Magnevist (gadopentetate dimeglumine), (4) Multihance (gadobenate dimeglumine), (5) Omniscan (gadodiamide), (6) Optimark (gadoversetamide injection), and (7) Prohance (gadoteridol).

BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse

As a defective medication lawyer, I was interested to read that the U.S. Food and Drug Administration will convene an expert advisory panel in September to determine whether to allow Meridia (sibutramine), a weight-loss pill produced by Abbott, to remain on the market. Abbott's own company-sponsored study has shown that Meridia increases the risk of nonfatal heart attack and stroke in patients who have underlying heart disease. European drug regulators have already banned the drug, known in Europe under the brand name Reductil. Given the drug's modest-at-best effectiveness in helping patients lose weight, it hardly seems worth the increased risk to patients to keep it on the market -- except perhaps to the company who stands to profit from the drug's sales.

Meridia, an appetite suppressant, gained FDA approval 13 years ago. A monoamine reuptake inhibitor, Meridia works in a way similar to Prozac and some other anti-depressants, using the neurotransmitter serotonin to help patients feel full for a longer time after they've eaten. Before approval, the FDA was concerned that the drug significantly raised blood pressure and heart rate, and increased patients' risk for developing cardiovascular disease. But the argument for the drug was that if it helped patients to lose weight, that in itself would benefit their heart health.

As it turns out, not only does Meridia increase patients' risks of nonfatal heart attack and stroke, but studies show that it also doesn't help them lose weight. A study that followed nearly 10,000 overweight or obese people for 3.5 years found that Meridia helped patients lose an average of nine pounds, or 4.5% -- which is below the 5% threshold that the FDA considers the minimum for weight loss drugs. Worse, it increased patients' risk of heart attack by 28% and stroke by 36% compared to a sugar pill. That's why an editorial in the New England Journal of Medicine has called for the drug to be pulled from the market. Abbott has defended Meridia by saying that the drug's label advises doctors not to prescribe it to patients who have known cardiovascular disease. But this wouldn't help people who have undiagnosed cardiovascular problems. About half of all patients who die suddenly from heart attacks do not have a known history of such problems, and many overweight and obese patients do face cardiovascular health problems, whether they are aware of them or not.

Patients depend on drug manufacturers, doctors, and the FDA to ensure their safety when they take medications. We can't all have the medical training that would equip us to make our own fully informed decisions about drugs that we might take to improve our health and save our lives. That's why, as a pharmaceutical liability attorney, I think that when a medical journal as highly respected as the New England Journal of Medicine calls for Meridia's removal from the market, doctors, patients and especially the FDA should listen.

Unfortunately, sometimes the system we depend on to ensure our safety doesn't work. Even though drug manufacturers are required by law to warn consumers of risks that they know to be linked to their products, sometimes drug manufacturers fail to live up to this responsibility, and patients are harmed by defective, dangerous drugs. When that happens, patients can recover financial compensation from the drug manufacturer whose product harmed them. When consumers incur medical costs, miss work and/or are unable to work, and their quality of life suffers because of negative effects of an over-the-counter or prescription drug, they can require the drug manufacturer to pay these costs, which the manufacturer ultimately caused. Consumers who trust that a medication is safe should not have to bear all the consequences alone if they find that the medication is actually unsafe, especially if the manufacturer knew about it.

Continue reading "Meridia Weight Loss Pill Increases Patients' Risks for Heart Attacks and Strokes" »

As a dangerous prescription medication lawyer, I often see reports of drug makers seeking the U.S. Food and Drug Administration's approval to sell their medications for different illnesses than the ones the drugs were developed to treat. Recently, drug maker Eli Lilly asked the FDA to allow it to sell its antidepressant Cymbalta (duloxetine) as a treatment for chronic pain. Since I spend a lot of time helping patients who have been hurt by dangerous prescription medications, as a pharmaceutical liability attorney, I'm concerned about Cymbalta's use by more patients, since the drug has been connected with serious risks like liver damage and skin disease.

Lilly wants to market Cymbalta for use by patients with chronic pain related to arthritis and lower back pain -- a large number of Americans, as noted in the article by Dr. Bob Rappaport, the FDA's director of the Division of Anesthesia and Analgesia Products. This would clearly be a boon for Lilly's profits because it would expand the pool of potential customers. And for drugs that don't have any serious side effects, expanding their use for patients who have different illnesses can be an efficient way to help more people feel better and get well. Cymbalta's reach has already expanded to encompass not only depression but also fibromyalgia, anxiety and pain associated with diabetic neuropathy. Most Cymbalta users are being treated for depression, but 14% are being treated for pain. Prescriptions for Cymbalta nearly tripled from 2005 to 2009, from 5 million to over 14 million.

While Cymbalta is already being prescribed to treat pain, FDA reviewers are not completely convinced by Lilly's evidence that the drug is effective for that purpose. They have pointed out flaws in the design of Lilly's studies that found the drug to be effective. Further, the FDA recently scolded Lilly for making false and misleading claims about Cymbalta's effectiveness against pain, and understating the drug's risks in its marketing materials. The drug carries a number of minor side effects, but among its serious ones are Stevens-Johnson syndrome and toxic epidermal necrolysis, two forms of life-threatening skin disease that develop as a drug reaction and usually require hospitalization. The FDA is also worried about other risks that are already included in Cymbalta's labeling, such as serious liver toxicity, and suicidality in children, adolescents and young adults taking Cymbalta for depression or other psychiatric disorders.

The FDA and doctors need to be vigilant about expanding the reach of drugs that aren't as safe as we might hope. Users of Cymbalta face serious risks, which will inevitably become more widespread as more people take this medication, and new serious risks may be discovered as well. Earlier this summer, I wrote about the potential for Cymbalta to cause terrible birth defects, premature delivery, and miscarriage. If Cymbalta is to be approved for marketing to more patients for more conditions, I hope the FDA carefully considers how to make sure patients are properly warned of all the risks they face. At the same time, the FDA isn't the only one responsible for making sure patients know what they're getting into. Drug manufacturers like Lilly have a legal duty to warn consumers and the FDA about risks that their products might pose. If Lilly knows that its studies of Cymbalta's efficacy for pain are faulty and is trying to expand its markets while putting patients at risk for serious side effects, patients could be hurt. Those patients could sue Lilly to recover the costs of their medical treatment, along with compensation for pain and suffering, loss of quality of life and past and future wages.

Continue reading "Eli Lilly Seeks to Expand Cymbalta Market Despite Serious Risks to Life and Health" »

The Food and Drug Administration has issued a worrisome new warning about Lamictal, a drug used to treat seizures in children and bipolar disorder in adults. According to the FDA, Lamictal (lamotrigine) can cause aseptic meningitis, an inflammation of the brain and spinal cord that is not caused by bacterial infection, like other types of meningitis. GlaxoSmithKline, Lamictal's maker, says the risk of contracting aseptic meningitis from taking the drug is very rare, but the company agreed to change the drug's label to include a warning about it. Russell Katz, MD, director of the Division of Neurology Productsof the FDA's Center for Drug Evaluation and Research, said, "Aseptic meningitis is a rare but serious side effect of Lamictal use." As a defective medication lawyer, I think it's very important that doctors and patients be made fully aware of the risks associated with this drug so that they can make an informed decision about using it.

Patients taking Lamictal should be alert for signs of aseptic meningitis, which include headache, fever, stiff neck, nausea, vomiting, rash, and photophobia, or sensitivity to light. If they experience any of these symptoms, they should contact their health care professional right away. To diagnose the condition, doctors have to perform a spinal tap on the patient and examine a sample of spinal fluid.

Between Lamictal's FDA approval in December 1994 and the FDA's review of adverse event reports undertaken after November 2009, the FDA had received 40 reports of aseptic meningitis in both adult and pediatric patients taking Lamictal. The symptoms started within 1 to 42 days of starting the drug. Thirty-five patients had to be hospitalized, and one died, though the death was not thought to have been caused by meningitis. The 35 patients who were hospitalized recovered when they stopped taking Lamictal. Fifteen of them saw even worse symptoms return within just a few hours when they started taking the drug again. Forty-six million prescriptions for Lamictal had been dispensed during this period.

Aseptic meningitis is not the only significant but rare risk associated with this drug. A few months ago, I wrote about Lamictal users' increased risks of suicidal thoughts and suicide attempts. The drug also carries a black box warning about the drug's association with Stevens-Johnson syndrome, an often-fatal kind of rash. As GlaxoSmithKline works to increase its sales despite Lamictal going generic in 2009, pharmaceutical liability attorneys like me worry that the company and others like it will stop paying as much attention as they should to patients' safety. Drug companies are well aware that they have a responsibility to warn patients, doctors, and the FDA about risks associated with their products. But unfortunately, we regularly see drug companies fail to do so when they are more focused on money than medicine. Because the law requires them to warn the public, if they fail to do so and an unsuspecting patient is harmed by a defective drug, the drug maker can be held legally and financially accountable.

Continue reading "FDA Issues Warning for Users of Seizure Drug About Risk of Brain Inflammation Meningitis" »

As a pharmaceutical liability attorney, I was interested in a report that Astra Zeneca has settled 17,500 lawsuits at a cost of $198 million over complaints that it failed to warn patients that its drug Seroquel (quetiapine) could cause diabetes in some users. Astra Zeneca faces 26,000 lawsuits over this issue, and agreed to pay $520 million after federal investigations into its illegal marketing of Seroquel. Seroquel is the company's second-highest-selling drug, after Nexium (esomeprazole), a treatment for gastroesophageal reflux disease. When a drug is used by as many patients as Seroquel is, a large number of patients will experience the many side effects that the drug can cause, so it's especially important for drug companies to properly communicate the drug's risks to the public, the FDA, and medical professionals.

Yet Astra Zeneca seems to have been eager to push sales of Seroquel higher and higher, perhaps recklessly. Seroquel is approved by the FDA for the treatment of schizophrenia and bipolar disorder, and is prescribed off-label for other conditions like obsessive-compulsive disorder, post-traumatic stress disorder, restless legs syndrome, autism, alcoholism, depression, Tourette’s syndrome, sleep disorders and anxiety disorders. In April, government officials said that Astra Zeneca had paid illegal kickbacks to doctors to promote unapproved uses of the drug by children, the elderly, veterans and prisoners. Antipsychotics like Seroquel account for a big portion of Medicaid drug costs, and Seroquel is the fifth-best-selling drug in the world -- it brought in $4.9 billion in sales in 2009.

Clearly, Seroquel generates a lot of money for Astra Zeneca. It's unfortunate that it has done so at the expense of some patients, who allege that they developed diabetes because they were taking this medication. Diabetes isn't a side effect that goes away when a patient stops taking a drug that causes it -- it's a lifelong condition that requires constant attention and can have serious consequences if it's not treated. Diabetics must watch their diet and exercise, and take medications to control their blood sugar, or risk complications such as blindness, heart disease, kidney failure and limb amputations. This means that patients who became diabetic after taking Seroquel had to add all these concerns to their existing medical issues. And since Seroquel has been used heavily among Medicaid patients, problems with Seroquel affect many who have the fewest financial resources to deal with them.

This is why, as a defective medication lawyer, I am glad to see that patients who became diabetic from taking Seroquel have stood up for themselves and gotten financial compensation from the company that allegedly caused their illness. Patients who have been harmed by dangerous or defective medications can and should recover compensation from the drug manufacturer whose product harmed them. Drug manufacturers are required to warn consumers of their products' risks, and if they fail to do so, the law allows consumers harmed by the defective drugs to sue. The patient can require the manufacturer to pay for their medical costs, lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused. Consumers who trust that a medication is safe and that it will help them should not have to bear all the consequences alone if they find out that they were wrong -- and that the manufacturer knew about it.

Continue reading "Patients Receive $198 Million Settlement in Case Alleging Seroquel Led to Diabetes" »

The rheumatoid arthritis drug Arava (leflunomide) will now carry a black box warning, the Food and Drug Administration's most serious warning, to alert patients to the danger of fatal liver damage associated with taking the drug. The FDA received 49 adverse effect reports, including 14 deaths, between 2002 and 2009. This warning comes after the nonprofit consumer advocacy group Public Citizen asked the FDA to remove leflunomide from the market because it was too dangerous. As a dangerous drug attorney, I hope that in the future, patients will have enough information about the risks of this medication to make informed decisions about whether to take it.

Leflunomide has carried a boldface warning since 2003, explaining the risk of severe liver injury and warning women who are pregnant or may become pregnant not to use the drug. This year's review of more recent adverse effects prompted the FDA to issue a stronger warning. Besides the 14 deaths associated with taking leflunomide, adverse effects reported to the FDA included jaundice, bleeding and clotting disorders, and encephalopathy, or injury to the brain. Thirty-six of the patients reporting adverse events were hospitalized. For most of those who were harmed, the injuries occurred within the first six to 12 months of treatment, although in some cases the injuries happened after six years. Itching, yellow eyes or skin, dark urine, loss of appetite and light-colored stool are warning signs that should prompt a patient taking leflunomide to contact a health care professional.

The new black box warning states that patients with preexisting liver disease or elevated liver enzymes should not take leflunomide, and that health care professionals should use caution when prescribing it to patients who are taking other drugs that can injure the liver, such as Tylenol, Motrin, Advil, and Aleve. These categories of patients are at the greatest risk of injury from the drug. Patients who do take lefunomide should have their liver enzyme levels monitored at least once a month for three months at first, and then at least quarterly after that.

Most people suffering from rheumatoid arthritis must take medications for the illness for the rest of their lives, so the potential for injury by this medication may be great. Rheumatoid arthritis is an autoimmune disorder in which the body's immune system mistakenly attacks the body's own tissues, causing joint problems, fever, and fatigue. It affected 1.3 million people in the United States in 2005. Leflunomide was approved by the FDA in 1998 for treatment of rheumatoid arthritis under the brand name Arava, and went generic in 2005, most likely broadening its appeal because patients could get it for a lower price. That means hundreds of thousands of patients could be taking this risky medication.

From my perspective as a defective drug lawyer, it's good that the FDA is adding a more serious warning to this drug, and I hope that no more patients will be harmed by it. I've worked with many patients who have been hurt by medications that they thought would help them, and what they have to go through is heartbreaking. They incur sometimes vast medical costs as doctors try to figure out why they're sick and how to help them get better. Sometimes their injuries are permanent and cause intense pain. They miss work because they don't feel well and have to attend so many medical appointments, and their quality of life and their relationships with family and friends suffer. All of those are injuries directly caused by the harmful prescription drugs they took, and patients have the right to hold the drugs’ manufacturers legally liable for causing them, if the manufacturers failed to warn about a risk they knew or should have known about. That means patients can recover compensation for all of those costs directly from the drug manufacturer.

Continue reading "Rheumatoid Arthritis Drug Arava Blamed for 14 Patient Deaths From Liver Failure" »

Another Johnson & Johnson drug manufacturing plant operated by McNeil has received notice of problems with its manufacturing practices from the FDA. The Lancaster, Pennsylvania plant makes the heartburn and gas relief drugs Pepcid, Imodium and Mylanta. These problems, similar to those found in the company's now closed plant that made Tylenol, come after waves of recalls for defective medications and a congressional investigation into whether the company attempted to hide information from the FDA. As a defective medication lawyer, I believe this news underscores questions about how much consumers should trust medications produced by Johnson & Johnson and its McNeil division. These repeated problems could prompt concerns about any of the company’s many over-the-counter medications.

In July, the FDA issued a Form 483 to Johnson & Johnson about the Lancaster plant. A Form 483 notifies a company that the FDA has found lapses in its manufacturing practices. Of the 12 violations of good manufacturing practices that the FDA found in Lancaster -- including faulty lab work, lax hygiene and recordkeeping, and failure to follow up on consumer complaints -- five overlapped with those cited at the Tylenol plant in nearby Fort Washington, Pennsylvania. The medications from the Lancaster plant were the subject of several kinds of complaints from consumers, including "mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets" and "lack of effect" in one lot of products. In addition, the FDA report cited "unlabeled test tubes filled with product sitting out on a counter" and failure to "properly clean utensils used in the drug making process," suggesting that medications could become contaminated with foreign substances or with other medications. Staff at the manufacturing plant did not follow up to investigate and correct any of these problems, the FDA report said.

Since they did not follow up on the problems, staff at the plant would have been unable to find out whether there were serious safety concerns that consumers needed to know about. In my view as adangerous medication attorney, this is troubling from a consumer safety standpoint as well as legally, since drug manufacturers are responsible for warning consumers about any safety concerns related to their products. Consumers should continue to be wary of medications produced by Johnson & Johnson. If only one plant had these problems, we might be able to dismiss them as isolated to bad management at one site, but the problem appears to be much more widespread. Even though the medications manufactured at the Lancaster plant have not been recalled, a recall may still be coming. After all, the recalls involving the Fort Washington plant's medications were delayed in similar ways and have only gotten bigger as time has gone on.

These issues raise the question of what Johnson & Johnson has been doing instead of paying attention to its manufacturing practices. Have efforts to create new products or expand existing products' reach edged out the basic safety concerns that should be at the forefront of any medical manufacturing business's operations? Or, worse, could the company have intentionally ignored problems in order to avoid bad publicity? Ignoring safety for any reason would be dangerous, legally and morally. Consumers can be hurt by lax manufacturing practices, as KV Pharmaceutical here in St. Louis found out. And those who were hurt have the right to recover financial compensation from the defective product's manufacturer. Drug manufacturers who fail to warn consumers of risks that they know about can be liable in lawsuits filed by those consumers. This allows a consumer who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by an over-the-counter or prescription drug to require the drug manufacturer to pay these costs.

Continue reading "Another Johnson & Johnson Drug Manufacturing Plant Cited for Safety Failures" »

Doctors and patients are worried about whether the diabetes drug Avandia (rosiglitazone) is safe, as I've discussed on several occasions this year from my perspective as a dangerous prescription medication lawyer. Avandia has been associated in several studies with a marked increase in heart problems, including life-threatening heart failure. But a recent report from MedPage Today suggests that FDA seems determined not to take this drug off the market, despite those studies. An FDA advisory committee voted 20-12 in favor of keeping Avandia on the market, but 17 of the supporters wanted the drug to carry tougher warning labels. Avandia already has a black box warning, the FDA's strongest warning of a drug's risks, advising patients that it increases the risk of heart failure. So it's not clear how much good another warning label about risks of heart problems would do to prevent patients from being harmed by Avandia. As Joel Zonszein, MD, of Albert Einstein College of Medicine said, "The physician is left in limbo" by this decision.

Speaking as a href="http://www.jefflowepc.com/lawyer-attorney-1176136.html">pharmaceutical liability attorney, I believe it's good that FDA staff members and advisors are debating Avandia's risks, because that makes it more likely that they'll consider all relevant viewpoints. However, Thomas Marciniak, MD, an FDA staff reviewer, said that the debate over Avandia has turned into a turf battle between the drug's supporters and detractors, with some newcomers to the agency in the middle. Marciniak said higher-ups at the FDA reward positive assessments of drugs, while negative assessments lead to "endless meetings." Another FDA staff reviewer, David Graham, MD, pointed out that the members of the FDA advisory panel voting on Avandia's fate seemed to have been chosen to ensure a favorable outcome for Avandia. In addition, Graham alleged that higher-ups at the FDA leaked information to a popular medical blog about an Avandia study he had conducted in order to delay or prevent the study's publication.

It's unclear why the FDA wants to keep Avandia on the market, but it’s clear why GlaxoSmithKline, Avandia's maker, might be interested in doing so. We’ve already seen that the company is deeply invested in protecting Avandia. It's a profitable drug, and type 2 diabetes rates have been drastically increasing along with obesity rates. Obesity is considered a leading cause of type 2 diabetes. This means that GlaxoSmithKline stands to rake in increasing profits from Avandia as an increasing number of people need treatment for type 2 diabetes. From my perspective as a defective drug lawyer, this only adds to the questions about why the FDA seems to be protecting Avandia's place on the market.

Continue reading "FDA Dysfunction Leaves Avandia-Taking Patients to Watch Out for Their Own Safety" »

In the last few months I've kept tabs on medications recalled for quality control problems by McNeil Pharmaceuticals, as well as McNeil's parent company Johnson & Johnson's recalls of medications that were "musty-smelling." Unfortunately for consumers who thought their medicine cabinets were finally safe, the musty medications have apparently still been in production. Johnson & Johnson recalled 500,000 bottles of potentially contaminated Benadryl and Extra Strength Tylenol on June 15, and on July 9 it recalled another 2.5 million bottles of medications, including Tylenol for children and adults, Benadryl allergy tablets and Motrin (ibuprofen). As a defective medication lawyer, I'm concerned about what this growing list of recalled medicines could mean for consumers, who need to know which medications are safe for them to depend on and which ones could injure or kill them.

The latest recall involves medications that smell moldy or musty because they have been in contact with 2,4,6-tribromoanisole, or TBA, a pesticide and flame retardant chemical used in pallets for shipping and storing the medicines. According to Consumer Reports, people have reported "experiencing nausea, stomach pain, vomiting or diarrhea after taking the contaminated medications." Beyond those symptoms, the longer-term health ramifications of exposure to TBA are unclear. The medications recalled in July actually represent an expansion of the late 2009 recall; they were belatedly discovered to have been part of the same group of medications. Consumer Reports did not mention a reason for the months-long delay.

It's important to point out, from my point of view as pharmaceutical liability attorney, that there are two different kinds of problems being addressed by these recalls. That means that there's not just one thing going wrong in Johnson & Johnson's manufacturing plants, but a whole series of problems. While the November-January, June and July recalls relate to TBA contamination, the April and May recalls by McNeil relate to metal particles present in medications. There's also the serious issue of McNeil's having delayed informing the FDA of the problems until a year after the company knew about them.

The U.S. House Oversight and Government Reform Committee launched an investigation after the McNeil recalls were issued on April 30 to look into what Representative Edolphus Towns, D-NY, chairman of the oversight committee, called "wide-ranging problems at Johnson & Johnson.” This investigation might help protect consumers and get to the bottom of what caused 775 instances of "serious side effects" related to recalled McNeil drugs, including 30 deaths.

Consumers should not have to wonder whether they're better off suffering through a headache or allergies or taking an over-the-counter medication that could make them feel even worse. That's why the law requires drug manufacturers to warn consumers when their products aren't safe to use as intended. As we've seen, McNeil and Johnson & Johnson have a spotty record of complying with that requirement. But consumers don't have to just rely on the FDA to send warning letters and fix the problem from the top down. If a defective over-the-counter medication hurts someone who took it -- expecting that it would be safe -- that person can fight back against the drug manufacturer who failed to warn consumers of the drug's potential danger. The victim can sue the manufacturer for financial compensation for their injuries.

Continue reading "Johnson & Johnson, McNeil Drugs Continue to Be Investigated and Recalled for Safety" »

Diabetics should take note of two newly published studies that confirm existing evidence that the diabetes drug Avandia (rosiglitazone) increases the risk of heart attacks as well as heart failure. As a defective drug injury attorney, I've been closely following the news about Avandia this year. In February, the disturbing findings of the Senate Finance Committee that GlaxoSmithKline, Avandia's manufacturer, made claims it knew were misleading about the drug's safety. In April, the FDA considered ending a study of Avandia early because it was unethical to expose patients to a 64% greater chance that they could have a heart attack associated with the drug. Now, the Consumer Reports Insights column in the Washington Post is advising diabetics to opt for the older diabetes medicine metformin over Avandia, because two more studies have just shown that Avandia increases the risk of heart attack, stroke, heart failure and death.

Avandia already carries a black box warning, the FDA's strongest warning, that lets patients know the drug has been associated with heart failure. But in light of the two newly published studies, FDA regulators are questioning whether Avandia should be pulled off the market entirely because of its association with heart attacks. In one of the studies, published in the Archives of Internal Medicine, Dr. Steven Nissen of the Cleveland Clinic added 14 more studies to the 42 on which he performed a meta-analysis. This expanded and updated analysis confirmed his 2007 finding that taking Avandia increases the risk of heart attack. The Journal of the American Medical Association published another study, by the FDA's David Graham and others, that found that taking Avandia increased the risk of stroke, heart failure and death. Graham and his colleagues' study was based on their analysis of more than 227,000 Medicare records for patients taking Avandia or Actos (another diabetes drug).

From my perspective as a dangerous prescription drug injury lawyer, it's worrisome that so many patients' lives and health remain at risk while GlaxoSmithKline continues to deny what many studies have found. The FDA plans to consider Avandia's safety in a mid-July advisory committee meeting, and the agency has noted its concerns about the drug for several years now. It's unclear why FDA officials have not taken action against Avandia already. Internal FDA reports released by the Senate Finance Committee suggest that 500 heart attacks and 300 cases of heart failure could be prevented every month if Avandia patients took Actos instead, and some observers suspect that GlaxoSmithKline had declined to inform the public of these risks, even though the company had known of them for years.

Knowing how many things diabetics have to manage in their lives to stay alive and healthy, it's hard to imagine that a drug manufacturer would choose to put patients' lives at greater risk by withholding or denying information about a drug's safety. But that may be what is happening here -- and if so, it’s illegal as well as bad ethics. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug they thought they could trust, drug manufacturers can be held responsible for the physical, emotional and financial harm that results. Diabetes already carries an increased risk of heart and blood vessel disease, so it seems unlikely that patients and their medical caregivers would knowingly choose a drug that seriously increases their risks of heart attack and heart failure.

Continue reading "More Evidence Emerges of Increased Risk of Death and Disability From Avandia" »

A recent report by KTNV of Las Vegas brings to light some alarming effects of Lupron Depot, a hormone-altering drug known as a GnRH agonist that is widely prescribed for endometriosis and prostate cancer. Leuprolide acetate, sold as Lupron as well as under other brand names, is also used for ovarian stimulation for in-vitro fertilization treatments and a variety of other conditions. Patients have complained of serious negative effects continuing years after they stopped taking Lupron. As a dangerous prescription drugs attorney, I hope that patients are fully informed about Lupron Depot's potentially dangerous effects before they take the drugs, so that they can make an informed decision about it.

Lupron Depot is a long-acting drug that is injected into a patient's muscle tissue once a month, but its negative effects can last longer than patients want. According to the article, 21-year-old Christina Smith of Las Vegas has suffered severe anxiety, muscle pain, migraines, nausea and thyroid damage since her single injection of Lupron three years ago. She says her doctor told her only about "menopausal side effects." Several other women in the article had similar stories, which are backed up by some medical studies. The FDA is currently reviewing the safety of Lupron as a prostate cancer drug, after reports surfaced of a dramatically increased risk of heart problems, diabetes and convulsions. The prescribing information required by the FDA also warns female patients of decreased estrogen, leading to a risk of stopped menstruation, menopause symptoms and permanent loss of bone density. It also is not recommended for pregnant women because of an increased risk of birth defects.

Despite these many risks and negative experiences, manufacturers of leuprolide acetate have continued to market the drug for existing and new uses -- most notably, as a treatment for prostate cancer. But a former U.S. Food and Drug Administration medical officer has said that Lupron's manufacturer, TAP Pharmaceuticals, did not study the drug adequately before or after introducing it to the market, and he alleged that the company hid what it knew about risks of bone density loss, generalized pain, headaches, fluid retention, depression, and immune and nervous system problems, including spinal fracture, convulsions and paralysis. The company paid an $875 million settlement after the Department of Justice charged it with violations of the Prescription Drug Marketing Act and for overcharging and defrauding Medicare and Medicaid. The company had bribed doctors to prescribe the drug. A joint venture of the Japanese company Takeda Pharmaceutical and Abbott Laboratories, TAP was dissolved in 2008 and Lupron is now produced by Abbott. All of this makes me, as a defective prescription medication attorney, concerned about this drug's history.

The combination of TAP's behavior in marketing Lupron and the stories of the women hurt by Lupron should prompt the FDA to take a close look at this drug. Even if the FDA chooses not to ban or restrict the drug, patients who have been harmed by Lupron can make its manufacturer compensate them for the ill effects they have suffered. Drug manufacturers have a legal responsibility to warn the public of any potential negative effects of their products that they know about. If a drug company fails to warn the public and patients get hurt, patients can require the drug manufacturer to pay for the damage caused by its negligence. This can include medical costs, past and future lost wages, lost quality of life, damage to personal relationships, and pain and suffering. It is simply unfair and unethical to withhold information about a dangerous drug in order to protect profits, and the law recognizes that any company that does so should face the consequences of its actions.

Continue reading "Drug Used for Endometriosis and Prostate Cancer Linked With Misery for Patients" »

The birth control medication Yaz has been linked to an acute medical condition known as a pulmonary embolism. In the shortest possible terms, a pulmonary embolism results when a blood clot forms and travels through the body's blood vessels into one of the lungs. This medical condition is extremely serious and can result in death. The reason Yaz has been linked to this condition is because the hormones in the medicine can cause the blood to thicken and clot more easily.

There are a number of symptoms associated with a pulmonary embolism. If you are taking Yaz and you find yourself experiencing one or more of these symptoms, do not hesitate — go immediately to the doctor.

Symptoms include coughing up sputum (mucus or spit) that has blood in it. It can be reddish or just pink. Pains in the chest, especially those that radiate outward from the chest to a limb, are particularly indicative. Similarly present could be a rapid heartbeat or shortness of breath. Some patients of embolisms have reported an unexplained sense of anxiety, a clamminess or blue color to their skin, swelling limbs, low fever, dizziness and wheezing. Any of these symptoms could be serious, but in conjunction they should be considered an emergency.

The risk is not small. Nearly one in three women who suffer an undiagnosed embolism die from it. Even those who do not die could suffer heart damage, hypertension or even brain damage if the blood flow to the brain is interrupted. These side effects are nearly six times as common in women who take Yaz as in women who take older generation anti-pregnancy drugs, and yet it still remains one of the most popular and widely-prescribed oral contraceptives on the market today.

At the very least, any woman who has experienced this condition while taking the medication would be wise to consult a doctor, and consider all her options.

Tardive Dyskinesia is very hard to understand for someone who has not experienced the effects, whether directly or indirectly. The disorder is a known, ongoing side effect of the stomach medication Reglan and is characterized by uncontrollable movements in various body parts, ranging from facial muscles to the extremities. It is an intensely uncomfortable and frightening disorder; still, despite the medicine being subject to a black box warning from the FDA, this disorder continues to be waved away under the comforting language of "side effect."

Sometimes the best way to get a perspective on something is to have a firsthand account from a patient affected by the disorder. To that end, consider the case of Joan T. Experiencing symptoms such as stomach pains and diarrhea, she went to her doctor. Believing Joan had Irritable Bowel Syndrome, the doctor prescribed Reglan, which Joan took for just more than a year.

"At first I had no problems with it,” Joan says of the medication. “Then, all of a sudden, I had uncontrollable movements. The doctors thought it was Parkinson's disease."

Parkinson's disease is a very serious illness. There is no known cure, and it can lead to severe complications. It is not by any measure a small consideration. There is a reason Michael J. Fox has poured millions of dollars of research into the illness. Imagine being told out of nowhere that you have this condition.

In addition to this, the involuntary movements interfered with an eye surgery Joan was scheduled to have to correct cataracts. Her head was moving so much they had to physically restrain her for the procedure. Again, these movements are not small, irrelevant things that can be ignored. Tardive Dyskinesia is serious and interferes with people's lives.

Ultimately skeptical, Joan researched the diagnosis of Parkinson's and came across some information about Reglan. Realizing it had a black label warning, she ceased taking the medication and within a short while the tremors and movements stopped entirely.

"You never saw somebody so happy as I was,” she says. “I haven't had problems with the movements since then... I wouldn't recommend Reglan to my worst enemy. It's horrible, having uncontrollable movements. You can try to hide them, but you can't stop them."

One of the most difficult Effexor-related birth defects is the condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). Described briefly, PPHN results in the infant being unable to breathe properly due to a defect in the way blood interacts with the lungs.

It is not a minor matter, but rather a very serious condition requiring extensive treatments that can be difficult and expensive for a family to bear. The fact that it can result from a medicine intended to treat the mother makes this birth defect heartbreaking.

Treatment of PPHN focuses on getting more oxygen into the infant's blood. There are a number of methods used to do this, each of which create its own unique problems.

The first option is to deliver 100 percent oxygen directly to the child, using either a hood or a mask. This is a temporary solution at best, of course, because the body wasn't designed to process pure oxygen.

Sometimes assisted ventilation is the preferred technique. In this case, a tube is inserted into the child's throat to allow a machine to take over for her breathing. This procedure can be enhanced with the addition of nitric oxide, a gas that helps relax the constricted blood vessels in the lungs, allowing better blood flow and easier breathing.

A treatment of last resort is Extracorporeal Membrane Oxygenation. This treatment is a terrifying one, as it involves putting the child on a lung-bypass machine. In essence, when the child's lungs and heart prove unable to handle the problem, the infant is placed on the machine that draws their blood, cleans and oxygenates it, and then resupplies it back to the child.

Each of these options can be difficult for a parent. Worse, they aren't always guaranteed to work. The idea is to give the infant's body time to adapt to the world and heal while being given assistance, but in some cases the damage is too extensive.

PPHN is a serious condition, and needs to be discussed critically with mothers who are on Effexor while pregnant.

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Recently I wrote about the increased risk of broken bones as a danger associated with popular acid reflux drugs. Now, increased risk of bone fractures has been reported as an effect of drugs meant to prevent bone fractures. Consumer Reports has warned consumers about bisphosphonates, popular osteoporosis drugs such as alendronate (Fosamax and its generic equivalent), ibandronate (Boniva), risedronate (Actonel) and zoledronic acid (Reclast). A Canadian consumer group is planning to launch a class-action lawsuit against Merck, the maker of Fosamax for allegedly concealing the drug's harmful side effects. As a dangerous drugs attorney, I hope that the FDA will take quick action so that people will not be needlessly harmed by these drugs.

Bisphosphonates are marketed to women to prevent bone loss from osteoporosis, but doctors also prescribe them for osteopenia, or "pre-osteoporosis." According to Consumer Reports, the drugs can provide modest help with building bone and preventing fractures in vertebrae bones for patients with osteoporosis, but they aren't clearly effective for osteopenia, a condition that affects more than half of all white, pre-menopausal American women. In fact, studies show that taking bisphosphonates can lead to weak, brittle femur (thigh) bones that break spontaneously -- not from falls, but during low-energy activities such as walking down a flight of stairs. The drugs can also cause osteonecrosis, also known as Fosamax dead-jaw, in which patients suffer jaw damage after dental work.

Carey, Danis & Lowe is currently handling lawsuits related to osteonecrosis caused by bisphosphonates. Patients taking bisphosphonates also face risks including throat or chest pain, difficulty swallowing and heartburn, abnormal heart rhythm (atrial fibrillation); and incapacitating bone, joint and muscle pain. The FDA issued an alert in March about its ongoing safety review of bisphosphonates, saying there was "no clear connection" between the drugs and femur fractures, emphasizing that health care professionals needed to be aware of the risk.

One of the most important problems with bisphosphonates is that their long-term effects are unknown. They are stored in bone for up to 10 years after a patient stops taking the drugs, and during this time, the drugs may actually damage the bone's natural ability to repair and maintain itself. Over the first few years of treatment with bisphosphonates, patients appear to be doing better, but after that, it appears that their condition worsens. In 2008, bisphosphonate sales generated more than $3.5 billion, and that profit alone may be enough to prevent Merck from studying the problem -- to the detriment of thousands of women.

As a dangerous medication lawyer, I'd like to point out that placing profits ahead of people's lives and health is not just unethical, it's illegal. Drug companies have a responsibility to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug they thought they could trust, drug manufacturers can be held responsible for the resulting physical, emotional and financial harm. Patients with bones weakened because of osteoporosis or osteopenia would not take prescription drugs that they knew would cause them to fracture their thigh bones during normal activities. Patients who do suffer injuries like this can require the drug manufacturers to pay for medical expenses, lost wages, permanent injuries, pain and suffering and other damages related to the injuries that the drugs caused.

Continue reading "Consumer Reports Warns Bone-Strengthening Drugs May Actually Cause Fractures" »

A few weeks ago, I wrote about the recall of contaminated and overly concentrated children's medications produced by McNeil Pharmaceuticals, a unit of Johnson & Johnson. Since then, more information has become available about the recall, and the FDA and the House Committee on Oversight and Government Reform have launched investigations. Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, said that the FDA is even considering criminal penalties against McNeil. As a defective drug lawyer, I do not believe McNeil has demonstrated an ability or willingness to protect consumers' safety from defective or contaminated medications.

For me, the most troubling aspect of the information that has emerged since the recall began on April 30 was McNeil's apparent sloppiness in both its drug manufacturing and its communications with consumers and the FDA. This applies not just to communications from this year, but going back to at least 2008. First, the April 30 recall turns out to have left out McNeil's 1-mg grape-flavored Zyrtec, which should have been recalled. The company added this product to the recall on May 5, but as a dangerous medication lawyer, I worry that some consumers may have looked at the original recall, seen that this type of Zyrtec was not included and stopped worrying about it. Missing the new recall announcement would have exposed such families to the same serious injuries they were trying to avoid.

Second, McNeil tested some samples of its recalled infants' Tylenol and found that it contained up to 24 percent more of its active ingredient than it was supposed to. The company said that these defective medications did not reach the marketplace. However, it said, "we cannot confirm that all the individual bottles were within specification or that 24 percent would have been the maximum," according to a letter to doctors and poison control officials that was dated May 1. That date was one day after the recall of infants' and children's Benadryl, Motrin, Tylenol and Zyrtec.

Third, and most worrisome, these events look like just the latest episode in a pattern of lax quality control, including McNeil's unnecessary delay in 2008 in reporting problems with Motrin. The company had retailers remove Motrin from store shelves without informing the FDA of the drug's problems. This "paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk," said Rep. Edolphus Towns (D-N.Y.), chair of the House Committee on Oversight and Government Reform. "What we have uncovered so far is very troubling." McNeil insists that the possibility for harm caused by these defective medications is remote, but the company's sloppy handling of this situation does not inspire a lot of trust in its assessment.

The company may now have to explain itself to the FDA's office of criminal investigation and the Justice Department, since the FDA has referred the case to federal prosecutors. If consumer reports of health problems linked with the defective drugs continue -- and the FDA has already received some -- McNeil may find itself answering in civil court as well. Drug manufacturers have a responsibility to warn the public of potential negative effects their products could cause, and all signs uncovered so far by the FDA and Congress point to McNeil's not having done so. In such cases, consumers who have been harmed by defective medications can sue the drugs' manufacturers for compensation for medical costs, lost past and future wages, lost quality of life, pain and suffering. It's hard enough for parents to see their babies and children sick. When the sickness was caused by medications parents trusted to help their children feel better, the law recognizes that they should not have to bear the financial consequences as well.

Continue reading "FDA and House of Representatives Launch Investigations Into McNeil Recall" »

As a defective medication lawyer, I noticed a recent spate of reports about alarming risks posed by the third highest-selling class of drugs in the U.S. Six studies have linked the most powerful class of acid reflux drugs, known as proton pump inhibitor antacids, or PPIs, to bone fractures, especially for people who take high doses for a year or more and for people over age 50, because the drugs may disrupt the body's ability to absorb calcium. Another study suggests an increased risk of infection with C. difficile bacteria for patients using this class of drugs.

The FDA advises consumers of "possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers." The warning extends to well-known drugs such as dexlansoprazole (Dexilant), esomeprazole (Nexium), omeprazole (Prilosec and Zegerid), pantoprazole (Prevacid) and rabeprazole (Aciphex), all of which will be required to carry this information on a warning label on both prescription and non-prescription packaging. Patients whose doctors advised them to take PPIs should ask whether they should continue taking them, says the FDA. Patients are advised to use the drugs for only 14 days at a time, and for no more than three 14-day periods over the course of a year. The FDA also suggests that patients and doctors consider lower doses and shorter durations of therapy with PPIs.

PPIs work by stopping stomach acid from being produced, and they are only supposed to be taken for serious conditions like gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus. But often, people use them for less serious issues like heartburn, which could be treated with less risk of side effects by using antacids like Maalox, Rolaids, or Tums, or hydrogen receptor antagonist drugs like Axid, Pepcid, Tagamet, and Zantac. In fact, doctors write 113.4 million prescriptions for PPIs annually, and three PPIs -- Prevacid, Prilosec, and Zegerid -- are available over the counter.

As a pharmaceutical liability attorney, I wonder why doctors and consumers were in the dark about the risks of using PPIs before the FDA issued its warning. The FDA isn't the only party responsible for warning and protecting the public from risky drugs; the drug manufacturers have a legal responsibility to do this too. Surely the drug manufacturers had access to the six epidemiological studies on which the FDA based its warning. They should have let consumers know of these risks as soon as they knew, as they are legally required to do. Drug manufacturers who fail to warn consumers of risks that they know to be linked to their products violate their legal responsibility, and the law allows consumers harmed by the defective drugs to recover compensation for that harm. That means that a consumer who incurs medical costs, misses work or whose quality of life suffers because of negative effects of a dangerous drug can require the drug manufacturer to pay these costs, which the manufacturer ultimately caused.

Continue reading "FDA Says Popular Acid Reflux Drugs Pose Risks of Fractures and Infection" »

For those concerned with the potential damage caused by the proliferation of generic versions of dangerous medicines like Levaquin, there is some good news.

A U.S. Federal Court has ruled that India's fifth-largest pharma giant, Lupin, cannot market a generic formulation of Levaquin in the United States — at least not yet. The court upheld a ruling granting Ortho-McNeil's request to extend its patent protection on the medicine. This is, of course, not a final answer, as all protections do expire eventually, but it does mean that for a little longer at least there is a stop on the production of a generic version until December 2010.

Levaquin is an antibiotic used to treat infections that primarily of the prostate and for infections that don't respond well to other medications. However, it also has been linked to tendon deterioration that ultimately results in a tendon rupture, particularly in the Achilles tendons of the ankles. These conditions are often very painful, and can severely inhibit mobility. Some tendon ruptures take up to 12 months to heal when immobilized in a plaster cast.

At most, however, this is a temporary reprieve. Lupin is considered highly likely to file an appeal to a higher U.S. court. There is just too much money involved in Levaquin sales for any other decision; the drug has done $1.4 billion in sales in recent years. Even if the decision is upheld, though, the extension is only until the end of this year. At that point, it is unlikely that any further protections on the patent will be allowed, and companies such as Lupin will be permitted to make their generic offerings.

There are also other companies, such as generic manufacturer Mylan, that are eager to get in on the business. Their appeals have been denied as well, but it is unfortunately only a matter of time.

The Quincy Patriot-Ledger recently reported that the Food and Drug Administration issued a second warning to Braintree Laboratories about its manufacturing processes. Consumers had submitted 21 complaints to the FDA reporting that they found spiders, insects and insect parts in medications made by the company. Those products include multiple prescription gastrointestinal drugs. As a defective medication lawyer, I wonder what other aspects of the manufacturing process are laxer than they should be. The presence of insect and spider parts in Braintree's medications suggests that the company has not been as conscientious as their moral and legal responsibility requires them to be.

Five different products, all manufactured at the company's Holbrook, Mass., facility, were cited in the consumer complaints. The FDA had investigated the company in December and January and found significant violations of Current Good Manufacturing Practice regulations. Braintree Laboratories said that it would increase its monitoring of pest control, analyze consumer complaints more carefully, and determine the origin of the insects and spiders that consumers found. But the FDAsaid the company still couldn't say whether "facility or raw material quality problems were at the root of these complaints." The FDA is asking the company to submit its plan to find out where the contamination originated and to carefully monitor its raw materials and packaging suppliers. Braintree has 15 working days to either explain to the FDA how it is working to correct the violations or to ask for an extension. If it doesn’t respond, the FDA could seize its products, issue injunctions or withhold future product approval requests.

From my experience as a pharmaceutical liability attorney, I can say that this isn't the first time and it won't be the last time that FDA has had to prod a drug manufacturer to resolve quality issues that affect consumers. Within the last two months, I've written about three other companies whose manufacturing practices have been under FDA's scrutiny, including McNeil Pharmaceuticals, Teva Pharmaceuticals and KV Pharmaceutical. It's disturbing that adhering to FDA manufacturing standards seems to be so difficult for some pharmaceutical companies. I worry that the companies' apparently nonchalant attitude toward product contamination could be a sign that they are equally disinterested in their responsibility to warn consumers of potential negative effects of their products. Drug manufacturers have a legal responsibility to warn consumers and the FDA of any ill effects that could befall someone who uses their products -- e.g., severe side effects from the medication itself, or harm caused by contamination of the medication. When companies wait for the FDA to crack down on them before they clean up their manufacturing processes, they may not be meeting their responsibility to warn the public about the potential harm that their contaminated products could cause. That harm can be serious, up to and including a risk of death in some of the defective medications mentioned above.

Continue reading "FDA Cracks Down on Company Making Medications Contaminated With Insect Parts" »

Pharmaceutical giant Glaxo Smith Klyne (GSK) has begun a new test study of its controversial antidepressant Paxil using a group of 7-year-old Japanese children as the subjects.

GSK officials confirmed that the test has begun but have not commented on the study. The aim seems to be an attempt at casting doubt on the well-established risk of increased suicidal thoughts when young people take the potent medication.

Part of the controversy surrounding the study concerns its confusing criteria. Officially, the listed information says that this study is an efficacy test — in short, to determine whether Paxil works against a placebo as a control group. However, Paxil already is an approved drug. It has been demonstrated to help people with their depression. This is no longer an issue, so testing it again seems rather odd, unless you consider the company may be looking for some additional good press.

Notably, the study does not include a test against other antidepressant medications as a measure of suicide risk among the selected age group. Given that the drug already has been verified to work, why not test it against other drugs for the most famous problem associated with it? The only allowance the study makes for determining suicide risk is as a secondary aim. In other words, such info is "nice to know," but hardly the goal.

Further, the trial group doesn't seem to be large enough to allow for a truly representative sample. There are only about 130 children listed as participants. With approximately half in the test group and the other half in the control group, this means even small instances of unusual results can change the percentages dramatically. So in short, the study is pursuing something already known, with a sample group nowhere near large enough to provide telling results. Given the very real cases continually levied against GSK, one wonders what the point could be.

http://www.jefflowepc.com/lawyer-attorney-1176136.html

One of the most frustrating aspects of any major pharmaceutical product liability lawsuit is the sheer slowness of the process. The legal system is designed to move slowly, in order to prevent rushes to judgment that don't properly reflect the facts. On the other hand, people who have been injured by drugs such as Levaquin are suffering now, and dealing with day-to-day pain and the results of ruptured joint structure and mounting expenses while they wait.

Consider that the biggest piece of good news for Levaquin users came late last year, in Illinois.

In September 2009, 15 new lawsuits were filed against a number of companies involved in the manufacture and distribution of Levaquin. These companies include Johnson & Johnson, Ortho McNeill Pharmaceuticals, J & J's Drug Research and Development and distributor Walgreens.

A motion was filed around the same time seeking to have all the suits brought together as a mass tort matter. There is a lot of power in a mass tort suit, forcing the manufacturers to deal with the issue on a larger scale, rather than simply making small, quiet, "go away" settlements and continuing to push their product.

The evidence against Levaquin remains compelling, as it has over the entire life of the drug as a product. Even as far back as 2001, the FDA demanded the medicine carry warnings explaining the risk to tendons and muscle structures. By 2009, the warnings had increased to the FDA's most serious black-box rating, reserved for some of the most potentially harmful medicines FDA still permits to be sold.

Despite this, the manufacturers downplayed the risk of tendon injury, claiming the drug has an excellent safety rating. Hopefully the move to consolidate these actions into a single, major class action suit will force more information into the light, and result in some of the injured patients getting their costs recouped.

source: http://www.articlesbase.com/law-articles/fifteen-additional-levaquin-lawsuits-filed-in-illinois-1264133.html

As a defective medication lawyer, I have closely watched the continuing reports of problems with drugs manufactured by McNeil Pharmaceuticals. In January, I wrote about the unsettling recall of products made by McNeil Pharmaceuticals, a unit of Johnson & Johnson. That recall involved over-the-counter medications that many of us know well, such as Tylenol, Rolaids, Motrin and St. Joseph Aspirin. Now, the FDA has issued a new recall for commonly used infants' and children's medications that McNeil produces, such as Tylenol, Motrin, Zyrtec and Benadryl.

Initially, the FDA said that the products involved in the current recall could have stronger concentrations than they were supposed to, or they could contain inappropriate inactive ingredients or tiny particles. Just a few days later, we began to see more damning reports, alleging quality and security lapses at McNeil’s Fort Washington, PA, manufacturing plant. A routine FDA inspection of the plant found that raw materials for the infants' and children's medications were contaminated with Burkholderia cepacia bacteria, which is often resistant to common antibiotics. The Center for Disease Control says that the bacteria can be harmful to people with weakened immune systems or chronic lung disease. The FDA was concerned that the contaminated materials could have been used in the products that were recalled, although McNeil says that its tests of those products did not show contamination. The FDA and McNeil both say that the chance of harm from using these products is remote, but they advise customers to stop using the recalled drugs immediately.

Unfortunately, McNeil has not given consumers a lot of reasons to trust its word. The earlier McNeil recall involved medications that had a "musty" smell and that gave consumers stomach pain, nausea, vomiting and diarrhea. It was suspected that the drugs were tainted with 2,4,6-tribromoanisole (TBA), a flame retardant and pesticide used in shipping pallets. The most disturbing part was that McNeil waited at least a year, rather than the legally required three days, after receiving complaints about the medicines before it fulfilled its duty to report the problem to the FDA. In the current case, McNeil appears to be equally unable or unwilling to meet its reporting duties; the FDA has faulted it for failing to report the contamination or recall lots of tainted medicines. And infants and children have less-developed immune systems than adults, so contaminated drugs could put them at serious risk of illness. We still don't know what those "tiny particles" are that McNeil initially cited as the reason for the recall, but there have been over 40 consumer reports to the FDA about dark flecks in the medications.

Now, the House Committee on Oversight and Government Reform plans to hold hearings to investigate McNeil and the FDA. As a pharmaceutical liability attorney, I would recommend that consumers who have been harmed by these contaminated drugs ask questions too, including ones about their legal rights in situations like this. Drug manufacturers have a legal duty to warn consumers and the FDA about risks that their products might pose, such as the risk of bacterial contamination that could cause infection. If McNeil knew about problems and kept them quiet, and consumers took their contaminated medications and became sick, those consumers could sue McNeil to recover all of the costs their illnesses.

Continue reading "FDA and Congress Investigate Contamination and Other Problems at Johnson & Johnson " »

In recent news, there has been a trend for doctors in neonatal units across the United States to prescribe metoclopramide — brand name Reglan — to treat premature infants for gastrointestinal disorders. This has lead to serious concerns from consumer safety groups. Specifically of concern is the fact that Reglan has never been approved for use in infants.

Reglan was approved for very short term uses by the FDA, with terms limited to no more than three months. It was approved in 1979 for the treatment of gastric disorders. However, the FDA issued a black box warning in 2009, stating that Reglan and its generic forms had been linked to tardive dyskinesia (TD), a disorder that involves involuntary movements, especially of the lower face. A black box warning is the strongest sanction the FDA can impose on a medication. Further studies have showed Reglan is the leading cause of TD among patients who have the disorder in the USA.

Prescription of metoclopramine in neonatal units began approximately 10 years ago, when the only other medicine available was pulled for safety reasons. Those most at risk of developing TD are the elderly and women, but there are concerns about Reglan's effect on infants. There has never been a major study done on Reglan's impact on children, which makes researchers nervous.

According to one attorney, "many doctors and patients are still not aware of the significant risks associated with its use. Because Reglan has been on the market for over 30 years, many physicians assume the drug is safe and prescribe it for various off-label uses. Perhaps the most troubling of these is its use to treat premature babies whose bodies are already extremely frail."

An off-label use is any use of a drug outside its primary function, such as the use of Tramadol to treat restless leg syndrome instead of as a painkiller.

The U.S. Food and Drug Administration has issued a warning to Teva Pharmaceutical Industries Ltd.'s Parenteral Medicines unit about manufacturing problems that contaminated an anesthetic. As a dangerous drugs attorney, I am dismayed to read that another drug manufacturer has been less than scrupulous with their manufacturing processes. Last month, I wrote about the legal and financial troubles at Ethex Corp., whose parent company is KV Pharmaceuticals here in St. Louis, arising from manufacturing problems that the company admitted that it tried to cover up. Parenteral Medicines would be wise to correct the problems that the FDA points out right away, for its own sake as well as the sake of patients.

Teva Pharmaceutical is an Israeli generic drug manufacturer with a manufacturing facility in Irvine, Calif. In December, the FDA had warned Teva that it needed to correct a problem with vials of propofol injectable emulsion, a general anesthesia drug that it produced. The drug was contaminated with bacterial endotoxin. Endotoxin contamination in pharmaceuticals can be extremely dangerous to patients, as it can lead to fever, lowered blood pressure, and septic shock, a serious medical condition with an approximately 50% mortality rate. Patients who undergo general anesthesia do so for medical procedures like surgery, which already exposes them to risks of complication and infection, so it is vital that they not be exposed to additional unnecessary risks from contaminated pharmaceuticals. In late April, the FDA rebuked Teva for allegedly releasing the contaminated lot of anesthesia and failing to correct the problem. The lot of contaminated propofol was recalled, but the FDA found more problems with Teva's manufacturing practices. It said Teva hadn’t done microbiological testing of rugs or raw materials, and had insufficient cleaning and sanitizing practices.

I have seen enough cases in my work as a drug defect lawyer to believe that making money and saving time are often higher priorities for companies than making sure drugs are safe. The Ethex Corp. case that I wrote about in April was an extreme case, but other drug manufacturers have also faced FDA warnings -- as well as lawsuits from patients who were harmed by defective drugs. Drug companies do not answer only to the FDA; they also are legally responsible to the people who use their drugs expecting that they will help them, not make them sicker or kill them. Patients who have been hurt by medications that manufacturers falsely represented as safe can make the drug manufacturers bear the costs of the harm they caused. Drug makers have a legal responsibility to warn the public and the FDA if their drugs carry risks, and if they do not do so, the law holds them accountable by allowing those harmed to sue.

Continue reading "FDA Rebukes Teva Pharmaceutical for Lax Manufacturing Practices" »

In February, I wrote about the Senate's report on their investigation of the diabetes drug Avandia (rosiglitazone) and allegedly unethical behavior by the drug's manufacturer, GlaxoSmithKline. As a dangerous prescription drug lawyer, I keep a close watch when drug manufacturers face allegations of unethical behavior, as does GlaxoSmithKline, the maker of Avandia. Now, a Reuters report reveals that the FDA is considering ending a study of Avandia's safety earlier than planned because subjecting study participants to this drug's substantial risk of causing heart attack could be unethical.

A 2007 study by Dr. Steven Nissen of the Cleveland Clinic, published in the New England Journal of Medicine, showed that taking Avandia increased a patient's heart attack risk by 64%. This is a frightening risk for Type II diabetes patients already at high risk for heart attack. University of Washington researcher Bruce M. Psaty, MD, PhD, said, "There is little evidence for using this drug…. The purpose of reducing blood sugar is to prevent cardiovascular events. Now the possibility of cardiovascular benefit associated with Avandia appears remote -- indeed, it appears linked to harm." Avandia already carries a black box warning, the strongest kind of warning from the FDA, about patients' increased risk of heart failure. Two FDA drug safety reviewers recommended pulling the drug from the U.S. market in 2008, and in late March 2010, Saudi Arabia's Food and Drug Authority suspended Avandia for six months.

Meanwhile, GlaxoSmithKline maintains that the evidence does not establish that Avandia increases the risk of heart attack, citing its own long-term study, which of course may not be completely objective. The February Senate report alleged that GlaxoSmithKline also tried to quash information damaging to Avandia by intimidating doctors and downplaying evidence of its dangers. Yet the Senate investigation found that privately, GlaxoSmithKline's own scientists acknowledged that Dr. Nissen's study was sound. As a defective prescription drug attorney, I think it's important that patients be made aware of scientists' and regulators' concerns about Avandia.

By refusing to acknowledge the concerns of the FDA and the Senate, GlaxoSmithKline may be trying to protect its sales of Avandia, which reached $2.8 billion in 2006. But GlaxoSmithKline may pay a big price for doing so. Drug manufacturers can be held legally responsible for the harmful effects of their drugs if they fail to warn the public and government regulators about them. The FDA's decision to consider ending the current Avandia study because of the heart attack risk, along with the Saudia Arabian FDA's suspension of Avandia, suggests that everyone is convinced of Avandia's risks -- but GlaxoSmithKline simply won't acknowledge them until it's forced to. This is a dangerous game to play with patients' health and lives.

Continue reading "Avandia Study May End Early Due to High Risk of Patient Heart Attack" »

According to pharmaceutical industry journal PharmaLive, the U.S. Food and Drug Administration has rebuked GlaxoSmithKline for false advertising about its chronic lymphocytic leukemia (CLL) drug Arzerra (ofatumumab). In a letter to the company, the FDA says that an advertisement for Arzerra in the Journal of Clinical Oncology fails to mention any of the risks associated with the drug or the limitations on the drug's use. Because of these omissions, the FDA says that the ad implies that Arzerra is safer and more effective than evidence says it is. As a dangerous drugs attorney, I took note of this article because numerous drug companies have been discovered making similar intentional violations, exposing millions of patients to serious risks.

The FDA also upbraided GlaxoSmithKline for failing to submit its Journal of Clinical Oncology ad for the FDA’s review before publication. Because Arzerra was within 120 days of being approved by the FDA for marketing, its promotional materials were supposed to be vetted by the FDA. GlaxoSmithKline had framed the advertisement as a “disease awareness” ad, which purports to inform people about a disease without mentioning a particular drug, so no disclosure of drug side effects would have been required. But the FDA said that the ad's allusions to Arzerra were transparent, and that the ad should have described the adverse reactions to Arzerra that patients could suffer. For example, Arzerra can increase the risk of an often fatal viral infection of the brain, progressive multifocal leukoencephalopathy, which resembles a speeded-up version of multiple sclerosis. Arzerra can also be harmful to patients who have a history of hepatitis.

Drug manufacturers have a legal responsibility to warn doctors and patients of the risks associated with their drugs. As a defective prescription drug attorney, I am glad that the FDA is taking GlaxoSmithKline to task for trying to sidestep its responsibility to inform the public of all relevant safety information about Arzerra. A number of drug manufacturers have been held liable in lawsuits over false advertising of their drugs' effectiveness and safety. Patients with serious illnesses like CLL have enough to worry about without also having to research faulty claims about their medications, or worry about undisclosed safety information. Unfortunately, as the FDA's letter to GlaxoSmithKline shows, drug manufacturers often place their own financial interests ahead of patients' safety.

Continue reading "FDA Reprimands Drug Companies for Misrepresenting Drugs’ Safety" »

Patients being treated for epilepsy, depression, migraine, chronic pain, bipolar disorder, and other conditions may need to be vigilant about suicide-related side effects of their treatment. A recent report on CNN.com details the results of a study just published in the Journal of the American Medical Association (JAMA). It found that taking antiseizure drugs to treat epilepsy and other conditions roughly doubles the risk of suicidal thoughts and suicide attempts, compared with other drugs in the same class. The medications in question are the antiseizure and nerve pain relief drug gabapentin (Neurontin), the antiseizure and bipolar disorder drug lamotrigine (Lamictal), and the antiseizure drugs oxcarbazepine (Trileptal), tiagabine (Gabitril), and the seizure, bipolar disorder, and migraine treatment valproate (Depakote). I see a lot of people who have experienced unexpected negative effects from prescription drugs in my work as a defective prescription drug attorney, and I am glad that news outlets like CNN are making the public aware of these dangers.

In 2008, the U.S Food and Drug found that people who took any of eleven anticonvulsants, as these drugs are called, approximately doubled the risk of suicidal thoughts and suicide attempts. The risk is less than half of one percent -- about one in 230 patients will have suicidal behavior or thoughts. Experts say patients need to be aware of this risk, so that they'll be more likely to notice if they are that one in 230. The FDA required these drugs to carry a warning label about this risk, but did not require a “black box” warning, the most serious kind of warning.

The new study published in JAMA looked at people taking thirteen anticonvulsants over five years and tracked suicide attempts, suicides and violent deaths. It found that five of the drugs increased the risk of suicidal behavior compared with topiramate (Topamax), a widely prescribed and versatile drug in the same class. Aware that many of the anticonvulsants they looked at were used to treat mental illnesses, the authors of the study accounted for the increased risk of suicide because of mental illness as they analyzed the data. They still found that "the risk was derived from the specific drug that the patient was taking and not their underlying conditions," said Dr. Elisabetta Patorno of the Brigham and Women's Hospital in Boston, the lead author of the study. Dr. Andres Kanner of Rush Medical College in Chicago, who did not work on the study, said that patients taking anticonvulsants should tell their doctors if they or a family member have a history of mental illness. Patients should not stop taking the drugs without discussing the issue with their doctors, and they should tell their doctors if they feel depressed or have thoughts of suicide.

As a dangerous prescription drug lawyer, I am glad that patients are gaining access to better information about the drugs that they take, but I am concerned that this information is not coming from the drug manufacturers. The risk of suicide is a well known side effect of certain antidepressants, and it’s not unlikely that the manufacturers could have been aware of it before the JAMA study came out. In fact, the drugmaker Pfizer just settled a wrongful death lawsuit with the widow of a man who committed suicide while taking Neurontin. Pfizer still faces many similar lawsuits and also pleaded guilty to criminal charges in 2004 and agreed to pay $430 million because of how it promoted Neurontin. Neurontin had been one of the company's best selling drugs before it lost patent protection and generic versions became available. These circumstances suggest that some drug manufacturers might have worried that warning people about the increased risk of suicide would harm their profits.

Continue reading "Study Links Epilepsy and Depression Drugs to Suicidal Thoughts and Attempts" »

As a dangerous prescription drug attorney, I was interested in this story about a St. Louis drug manufacturer's guilty plea to two felony counts of criminal fraud. Ethex Corp, a wholly owned subsidiary of KV Pharmaceutical, admitted that it had failed to report to the FDA that it had been producing generic prescription medications that contained up to double the dose they should have had. Company leaders admit that they knew about the problem in the spring of 2008, but kept quiet about most of the drugs until an FDA order shut down production in January of 2009. They blame the problem on bad managers who have since been pushed out. Despite 15 months of no production or sales, KV faces at least 30 lawsuits, 15 of which are wrongful death claims.

In May 2008, pharmacists in California and Canada discovered that morphine sulfate tablets produced by Ethex were much larger than they should have been. Overdoses of morphine, an opiate, can cause a person to stop breathing and go into a coma. KV Pharmaceuticals recalled the defective morphine tablets the next month. However, they decided not to do anything in response to reports of similarly oversized tablets of other drugs like propafenone, a medication for irregular heartbeat, and dextroamphetamine sulfate, a component of Adderall, the attention-deficit disorder drug. Propafenone overdose can lead to coma and seizures, and dextroamphetamine sulfate overdose can, in extreme cases, lead to amphetamine psychosis, in which a person experiences hallucinations and goes for long periods of time without sleep.

Assistant U.S. Attorney Andrew Lay wrote in court papers that a KV executive knew about these problems and decided that since there was low probability that more oversize tablets would be found, the company should do nothing, even though other employees objected to this approach. This executive told employees to avoid discussing the problem in writing as much as possible, and to limit the number of people who would find out about it. In other words, the executive orchestrated a cover-up. KV employees said that they were encouraged regularly to falsify records so that the FDA would think that KV was in compliance with FDA standards on chemical tests and cleanliness of the equipment used to produce the drugs.

In the end, the company's emphasis on production over safety has already severely affected its bottom line -- industry watchers say KV could be bankrupt within the year. It is no surprise to me, as a drug defect attorney, KV is facing so many lawsuits over defects in its drugs. Over 200 more pending claims have not yet made it to court, and 26 of those involve a patient's death. CVS Pharmacies is also suing KV for $100 million for allegedly breaking a supply contract.

Continue reading "Drug Manufacturer Admits It Ignored Duty to Warn FDA of Its Defective Products" »

The FDA issued a warning to patients that Zocor (simvastatin) can cause muscle injury, or myopathy, to those who take the drug at its highest approved dose. Zocor, a statin drug, is used to control cholesterol levels and to prevent cardiovascular disease. Simvastatin is sold as on its own as Zocor or in generic form, as well as in combination with ezetimibe as Vytorin and with niacin as Simcor. Since Zocor has been a popular drug for over two decades, as a pharmaceutical liability attorney, many people could have experienced the more severe forms of myopathy that the FDA is warning us about.

The FDA's statement pointed out that "Although muscle injury ... is a known side effect with all statins, the warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug." Rhabdomyolysis, the most serious kind of myopathy, involves the breakdown of muscle fibers and release of the protein pigment myoglobin into the bloodstream. It often can result in severe kidney damage, kidney failure, and even death. People suffering from this condition can also experience weakness, fatigue, joint pain, seizures, and weight gain. The FDA advises patients not to stop taking Zocor unless their doctors advise them to, and to talk to their doctors if they have questions.

The data that the FDA considered in issuing this warning also calls into question whether Zocor is more likely than other statins to cause muscle injury. Simvastatin has been on the market since the late 1980s, so it is somewhat surprising that it has taken this long for the FDA to recognize the seriousness of the problems Zocor can cause. In fact, the statin Baycol (cerivastatin) was withdrawn from the market in 2001 precisely because it was found to carry an extremely high risk of rhabdomylosis -- up to 80% higher than other statins. Before its U.S. patent expired in 2006, Zocor was Merck's best selling drug, and the second-best selling cholesterol-lowering drug in the world, netting $4.3 billion in sales in 2005. Since then, Merck has tried hard to avoid losing its share of the Zocor market to generics, lowering the price for brand-name Zocor so that it could compete with the generics. As a drug defect lawyer, I wonder if Merck knew about these problems, but didn't want to jeopardize the huge profits Zocor brought in while it was still under patent. After all, it was the FDA that brought the muscle injury risk to the public's attention -- not Merck.

The FDA says that rhabdomyolysis is a rare adverse effect of Zocor. But those patients who do develop the condition will have to contend with not just their original heart and cholesterol problems, but painful and debilitating muscle and kidney problems as well. In extreme cases, kidney failure from rhabdomyolysis could mean death or a need for a kidney transplant. If Merck was aware before now of the problems with higher dosages of Zocor, but neglected to warn the FDA and the public, patients who have been adversely affected by the drug could hold Merck legally responsible. Drug manufacturers have a responsibility to warn doctors and patients of adverse effects that their drugs cause. When they fail to do so, the law makes them responsible for all of the injuries to patients that result. This includes all of patients’ medical costs as well as the personal cost of a new and permanent disability.

Continue reading "FDA Warns Patients That Cholesterol Drug Zocor Can Cause Muscle Damage" »

According to the popular health information Web site WebMD, the U.S. Food and Drug Administration has ordered a “black box" warning for Plavix (clopidogrel), a blood thinning drug. That is the strictest safety warning the FDA issues. The move comes after research showed that the drug’s effectiveness at normal doses is substantially reduced in people who carry certain genes. This is bad news, because Plavix is prescribed to help prevent heart attacks, strokes, blood clots in patients with stents and other serious cardiovascular problems. Plavix is the second-best-selling drug in the world, so the number of patients affected could be very large. Patients who fall into this genetic group without realizing it are at risk for any or all of these problems, and as a pharmaceutical liability attorney, I hope that Plavix-taking patients talk to their doctors about this as soon as possible.

The FDA said 2% to 14% of patients have a gene that makes it harder for their livers to metabolize the drug, which means less of it gets into their bloodstreams. That was true for about 2% of white patients, 4% of black patients, and 14% of Chinese patients, the agency said. Doctors can find out whether a patient is a poor metabolizer of Plavix by using a genetic test. This test can also show if a patient will be an "intermediate responder" or a "hyper-responder" to the drug. Unfortunately, the test costs about $500, and the amount of time it takes to get the results varies from a few hours to several weeks. For patients who are at imminent risk of having a second heart attack or stroke, waiting for several weeks to find out whether Plavix will be able to help them is "not a good idea," said the director of FDA's office of medical policy, Dr. Robert Temple. PBS' NewsHour blog The Rundown says that doctors do not typically order the genetic test before prescribing Plavix.

This is not the first time Plavix's effectiveness has come under scrutiny. In November of 2009, the Wall Street Journal reported on studies that showed Plavix's effectiveness was reduced when it was taken with some heartburn medicines. Use of heartburn medicines with Plavix is common because stomach bleeding and ulcers are common side effects of the drug. Ironically, the study found that taking a heartburn drug to treat Plavix's side effects causes it to stop working properly and raises patients' risk of heart attack and stroke by 50%. Earlier, in May of 2009, the FDA had warned patients and doctors about Plavix's poor metabolizer problem by changing information on the drug's label. The black box warning comes after the agency reviewed more data. The label asks doctors to "use the best information possible to treat their patients" and consider alternative treatments. Patients are cautioned not to stop the drug without talking to their doctors first.

As a dangerous prescription drug attorney, I am concerned that it took so long for this information to result in a serious warning. Plavix has been on the market for over a decade, and is a best-selling drug. With so many users, scientists have had a lot of opportunities to spot problems, so it would be interesting to know how much Bristol-Myers Squibb and Sanofi-Aventis, the companies that market Plavix, knew about these problems before the label changes. Would Plavix have become the second-best-selling drug in the world if patients and doctors knew they needed a $500 genetic test to find out whether it’s effective? How many people have had heart attacks or strokes while taking Plavix, thinking that they were taking the best medication available for their condition? If Bristol-Myers Squibb and Sanofi-Aventis knew of these problems and did not warn doctors and patients appropriately, they could be held responsible for harm suffered by patients who took their drug.

Continue reading "FDA Adds Black Box Warning About Effectiveness to Label of Blood Thinner Plavix" »

As a dangerous prescription drug attorney,I have paid close attention to the diabetes drug Avandia (rosiglitazone) ever since a 2007 study showed it increased risk of heart attacks substantially. That study, authored by Dr. Steven Nissen of the Cleveland Clinic and published in the New England Journal of Medicine, found that taking Avandia increased the risk of cardiac death by 64%. The study was particularly alarming because Avandia is taken by Type II diabetics, whose disease already puts them at high risk for heart problems. Among other things, this spurred a black box warning about heart failure and a Congressional investigation into allegations of unethical behavior by manufacturer GlaxoSmithKline. On Feb. 20, the Senate Finance Committee released the results of its investigation, and according to a Feb. 22 article from USA Today, the results are damning.

Most importantly, the Finance Committee found that GSK knew Avandia carried heart risks for several years before Nissen’s study. It accused GSK of trying to intimidate doctors who came to negative conclusions about the drug and minimizing or misrepresenting scientific evidence. It also said from U.S. Food and Drug Administration employees want the drug taken off the market. The FDA released a statement Monday telling patients not to quit taking Avandia without talking to their doctors, and announcing a panel meeting in July to discuss the results of a long-term, GSK-funded study of the cardiovascular risks of Avandia in Type II diabetics. The results are already in, but the agency said it needed more time to analyze them. An earlier panel voted 20-3 that Avandia does raise risk of heart attacks, but voted 22-1 to recommend keeping it on the market. It currently has sales of $1.19 billion in the United States.

Also on Feb. 22, the New York Times ran a related piece about a meeting between Nissen and GSK, just 11 days before Nissen’s study was published. Nissen legally audiotaped the meeting, concerned about intimidation by the company. He said executives made several false claims, including suggesting they had contradictory information that they could publish jointly with his study. According to the Congressional report, GSK already had the results of Nissen’s study, thanks to a journal reviewer who was also a consultant to the company. But it pretended it did not at the meeting. And even though GSK publicly criticized Nissen’s evidence and methodology, Congress found that GSK’s own scientists said Nissen’s work was sound.

We still don’t have the final results of the RECORD study, and the Times said its interim results were not conclusive. But as a pharmaceutical liability attorney, I don’t believe the public can trust a study funded by GSK. If the claims made by Congress and Nissen are true, GSK has repeatedly attempted to cover up, misrepresent or downplay scientific evidence that Avandia is dangerous, sometimes through intimidation. That behavior casts doubt on any conclusions reached by scientists on GSK’s payroll. Given that patients may risk death or lifelong heart problems from taking Avandia, the risk is just too great. If the existing evidence is not great enough to justify pulling Avandia from the market, as some regulators and safety groups want, the FDA should severely limit its use while it conducts a rigorous independent study.

Continue reading "Senate Investigation of Avandia Shows Manufacturer Knew About Risks Years Ago" »

As a dangerous drug attorney, I was interested to see a recent study adding information to the debate about antidepressants and breast cancer. A Feb. 9 article from HealthDay reports that researchers have found an increased risk of dying for breast cancer patients taking both the cancer drug tamoxifen and the antidepressant Paxil (paroxetine). The study is important because antidepressants are frequently prescribed to tamoxifen-taking patients to help reduce the menopause-like hot flashes that are a side effect of the drug. It also helps to clarify previous studies that have found mixed and uncertain results when examining the relationship between tamoxifen and antidepressants.

The study, conducted at Sunnybrook Health Sciences Center in Toronto and published in the Feb. 8 issue of the British Medical Journal, looked at the medical records of 2,430 women taking tamoxifen for breast cancer between 1993 and 2005. About thirty percent of the patients were also taking an antidepressant, with Paxil the most common antidepressant. The risk of dying from breast cancer went up significantly for the patients taking Paxil, the study found, and the risk was greater the longer patients took both drugs. Paxil, a selective serotonin reuptake inhibitor, inhibits a bodily enzyme needed to process tamoxifen, the researchers said. This was not seen with other SSRIs, like Effexor or Celexa. Lead researcher Dr. David Juurlink suggested that patients and doctors discuss transitioning to an antidepressant other than Paxil, but warned that quitting the SSRI cold turkey can cause withdrawal.

This study interests me as a defective prescription drug lawyer because it may help settle a debate in the medical community. Scientists already knew that SSRIs can interfere with the enzyme described above, but two 2009 studies conflicted about whether this lead to an increased risk of death. This study provides strong evidence that Paxil, at least, may interfere with the effectiveness of the breast cancer drug. And that means that thousands of patients may have been put at an unnecessary risk of dying. It also means that breast cancer patients may have been unnecessarily exposed to the numerous serious side effects of Paxil. Paxil already carries a warning about increased risk of suicidal thoughts and can cause reproductive and sexual problems in both men and women. As the article mentioned, it can also cause severe withdrawal symptoms.

Continue reading "Study Shows Common Antidepressant Lowers Effectiveness of Breast Cancer Drug" »

The psychiatric drug Zyprexa (olanzapine) has been at the center of several controversies interesting to defective drug attorneys like me, due to its illegal off-label marketing and its connection with major metabolic disorders like diabetes. On Jan. 29, the U.S. Food and Drug Administration struck another blow against the drug when it announced it will require more stringent warnings on the label about the risk of weight gain in teenagers. The FDA’s announcement said doctors should carefully consider the increased potential for weight gain and hyperlipidemia among teenagers, as opposed to adults, taking Zyprexa. It said this should lead doctors to consider prescribing other drugs, and reminded them that the drug should be part of a comprehensive treatment plan.

Zyprexa is an atypical antipsychotic approved for use in patients with bipolar disorder or schizophrenia. Research has connected its long-term use among adults to weight gain, high blood sugar, diabetes and pancreatitis. According to a Jan. 29 article on the Los Angeles Times blog Booster Shots, a study published in October showed an even more dramatic weight gain in teenagers taking Zyprexa -- an average of 17 pounds over 12 weeks. The teenaged participants also had more dramatic increases in triglycerides (fats in the blood) and cholesterol levels than adult patients. The FDA cited that study in its letter informing drug maker Eli Lilly about the label order. A year ago, Lilly settled a federal lawsuit claiming it put adults at unnecessary risk of these injuries by illegally marketing Zyprexa for off-label uses like dementia and anxiety. The new FDA letter also mentions Zyprexa’s greater potential for liver damage and sedation in teenagers.

I am pleased that the FDA is taking the risk of metabolic problems from Zyprexa seriously. But as a dangerous prescription medication lawyer, I’m disappointed that the label wasn’t stronger. For one thing, seventeen pounds in 12 weeks is a very dramatic weight gain -- 1.4 pounds a week. By contrast, scientists believe the average, non-dieting American adult gains half a pound to two pounds a year. With Zyprexa use, that weight gain is associated with life-altering or even life-threatening disorders like pancreatitis and diabetes. For another, the FDA’s warning entirely omitted mention of the results showing higher risks of sedation and liver damage in teenagers. Liver damage can cause permanent, lifelong disabilities, and while sedation itself may not be dangerous, it can impair judgment and motor skills, leading to dangerous situations.

Continue reading "FDA Issues Stronger Warning About Metabolic Problems for Teens Taking Zyprexa" »

As a dangerous drug attorney, I was interested to note last fall that the FDA was studying reports of increased heart attacks among patients taking diet drug Meridia (sibutramine). On Nov. 20, the FDA announced that an ongoing study showed higher-than-usual rates of heart attacks, strokes, cardiac arrest and death among people with underlying heart conditions who were taking Meridia. The study, conducted by drug maker Abbott Labs, was allowed to continue. On Jan. 21, just two months later, the FDA announced a new label warning that patients with a history of heart problems or high blood pressure should not take Meridia. In the same week, the European Medicines Agency recommended an outright ban, causing Abbott to withdraw it from the European market.

A relative of antidepressants, Meridia works by blocking brain chemicals that influence appetite. According to a Jan. 26 article on Time magazine’s Wellness blog, scientists knew more than a decade ago that it could raise blood pressure, and the American Heart Association issued a warning about it to heart patients. European regulators asked Abbott in 2002 to study the issue. It responded with the long-term SCOUT study, following 10,000 patients with a history of heart disease or diabetes. Over the six years of the study, 11.4% of participants taking sibutramine suffered death, heart attacks or strokes. By contrast, just 10% of the participants using a placebo suffered one of those events. The FDA’s new warning label saying the drug is contraindicated for patients with a history of congestive heart failure, stroke, coronary artery disease, heart arrhythmias, uncontrolled hypertension and peripheral arterial disease.

As a pharmaceutical liability attorney, I applaud the FDA’s action -- but I wonder why it didn’t follow the Europeans’ lead and consider a ban on sibutramine. The human body works the same on both continents; the difference is only how the regulatory agencies chose to respond. The safety advocacy group Public Citizen has long asked the FDA for a ban on Meridia, claiming it has caused at least 80 deaths, including 30 deaths of patients under age 50. The SCOUT study data only adds to the evidence that this drug has serious safety problems. This is particularly true considering that sibutramine’s target market, obese people, is statistically more likely than average to have a heart problem. By continuing to allow sales of sibutramine in the United States, the FDA and Abbott may be exposing patients to deadly and unnecessary risks.

Continue reading "Study Shows Anti Obesity Drug Raises Risk of Heart Attack or Stroke in Heart Patients" »

As a dangerous drug attorney, I have watched the recall of McNeil Pharmaceuticals products with interest. McNeil, a unit of Johnson & Johnson, has recalled multiple over-the-counter pain relievers because of a “musty” smell believed to be caused by a chemical used in shipping pallets, called 2,4,6-tribromoanisole (TBA). Consumers have reported stomach pain, nausea, vomiting and diarrhea after taking the tainted drugs. After finding trace amounts of TBA in Tylenol Arthritis Caplets, McNeil recalled some lots of that drug. It expanded the recall in December to include all lots, and again in early January to include multiple major OTC brands. Perhaps more importantly, the FDA sharply rebuked McNeil in a Jan. 15 warning letter for failing to fully investigate complaints about the odor or notify the FDA, despite receiving the first complaints in early 2008.

Consumers can find a list of the recalled drugs on the FDA’s Web site and learn more at mcneilproductrecall.com.

TBA is a flame retardant and pesticide. It is not well studied, but was not proven to cause harm to humans before this recall. According to a Jan. 15 Associated Press article, 70 consumers have complained to the FDA about the smell or an illness related to a TBA-tainted McNeil product. According to the warning letter, an FDA investigation of McNeil’s Puerto Rico manufacturing facility found that McNeil began receiving complaints over four months in 2008. Nonetheless, McNeil stopped its investigation after tests failed to find microbial contamination. The FDA called this decision, and the failure to look for other causes, premature and unjustified. Further complaints let to tests that fingered TBA, but the FDA said McNeil didn’t test drugs other than specific lots of Tylenol Arthritis Caplets for the chemical. Nor did it submit a report to the FDA within three working days of identifying the problem, as required by law -- instead, it waited at least a year.

The FDA’s letter raises disturbing questions for pharmaceutical liability lawyers like me. The recall currently includes more than 50 million bottles of popular over-the counter products, including Tylenol, Rolaids, Motrin and St. Joseph Aspirin. McNeil’s apparent year-long delay in addressing the problem means millions of consumers were likely exposed to TBA, possibly multiple times. It’s not clear what effect that might have on them, but the gastrointestinal reaction by some consumers, and the fact that it’s poorly studied, suggests that it’s better to stay away. If later investigations show that McNeil failed to take quick action on a serious health threat, the company could face thousands of lawsuits from sickened consumers.

Continue reading "FDA Expands McNeil OTC Drug Recall, Rebukes Manufacturer for Yearlong Delay" »

As a dangerous drug injury attorney, I was disappointed to see two new studies on the use of risky atypical antipsychotic drugs. According to a Jan. 11 article from HealthDay, a new study in the Archives of Internal Medicine found that nursing home patients are more likely to be prescribed an atypical antipsychotic than patients outside of homes. This is despite the fact that prescriptions fell sharply after a 2005 “black box” safety warning from the U.S. Food and Drug Administration, disclosing an increased risk of death in older patients with dementia.

Atypical antipsychotic drugs such as Risperdal and Abilify are used to treat mental illness. They are also widely used off-label to control the behavior of people with dementia, despite the health risks. A series of FDA actions throughout the decade warned patients that atypical antipsychotics increased their risk of strokes; metabolic problems like hyperglycemia and diabetes; and increased mortality among older people with dementia. They also carry a warning about the risk of tardive dyskinesia, involuntary repetitive movements that appear or continue even after the drug is stopped.

The study, from the University of Massachusetts Medical School in Worcester, found that almost a third of all nursing home patients were prescribed atypical antipsychotics for any reason. Of these, the study said, one-third did not have a diagnosis of schizophrenia or dementia. They also found that patients were more likely to be put on antipsychotics if they entered a nursing home where antipsychotics were already heavily used, suggesting that “organizational culture” rather than patient care was driving the decisions.

As a pharmaceutical liability attorney, I’m concerned about the continued use of these medications, particularly in patients with no mental illness or dementia to justify it. As the article notes, no medication is approved for controlling the behavior of people with dementia. One scientist said in the article that antipsychotics are the only drug known to work for this purpose -- but as another one noted, nursing home residents are a vulnerable population. In an institutional setting, without family members watching, it’s all too easy for caregivers confronted with difficult behavior to simply drug patients. But given the risk of death or permanent disability, this is a dangerous and irresponsible use of caregivers’ power over their charges.

Continue reading "Reports Find Nursing Homes Use Antipsychotics Off-Label Despite Safety Warnings" »

As a defective drug lawyer, I keep a close watch on news related to prescription antidepressants because so many have had safety issues. That’s why I was very interested in Jan. 5 articles from Dow Jones Newswires and Reuters about a new study examining the effectiveness of antidepressants. The study, published in the Journal of the American Medical Association, analyzed the results of six studies comparing prescription antidepressants to placebos. It found that antidepressants make a substantial difference for the most severely depressed. But for mildly to moderately depressed people, the study found, antidepressants had little or no effect compared to a placebo.

A total of 718 patients were in the analysis, conducted by scientists at the University of Pennsylvania. The studied compared both Paxil (paroxetine) and the 1950s-era drug imipramine to placebos over a six-week period. Patients’ depression was measured by a Hamilton score, with the most severely depressed scoring at 24 or higher and the mildly depressed scoring at 18 or below. Among the most severely depressed, those taking genuine antidepressants saw their Hamilton scores drop by 13 points, while patients on placebos saw a drop of 9 points. By contrast, people with Hamilton scores of 23 or below saw an 8-point drop for patients on antidepressants and a 7-point drop for those on placebos. In other words, it concluded that antidepressants work best for the most depressed patients, but aren’t much better than non-pharmaceutical treatment for the mildly depressed.

This is important for two reasons. Robert DeRubeis, a study author and Penn psychologist, told Reuters that most drug approval studies focus on the most severely depressed, even though most depressed Americans have only mild to moderate depression. This suggests that drug approval studies may not serve the majority of the patients. DeRubeis also noted that studies have shown that talk therapy, exercise and even self-help books have shown some effectiveness in fighting depression, without the negative side effects drugs can cause. As a pharmaceutical liability attorney familiar with the dangerous effects of Paxil, I couldn’t agree more. Paxil already carries a black box warning about the risk of suicidal thoughts, and is believed to cause birth defects as well as several other dangerous risks. If it turns out that pharmaceutical companies have exaggerated its effect for most patients, they would have exposed patients to these severe risks in exchange for next to no benefit.

Continue reading "Analysis Finds Antidepressants Have Little or No Benefit for Mild Depression" »

As a pharmaceutical injury attorney, I already knew that Type II diabetes drug Byetta (exenatide) had serious safety problems. In fact, when it was approved as a stand-alone treatment for diabetes this fall, I wrote about the labeling changes the FDA required as part of that approval, which included stronger warnings on the risk of kidney problems. Just last week, a financial analyst uncovered new information related to that approval that has major implications for Byetta’s safety. According to a Dec. 23 article from Bloomberg News, the FDA required the drug’s manufacturers to conduct more studies to determine the risk of acute pancreatitis, acute kidney failure and thyroid neoplasms.

Byetta is jointly manufactured by Eli Lily & Co. and Amylin Pharmaceuticals. In its Oct. 30 approval letter, the FDA told the manufacturers that it had post-marketing reports of the three serious diseases. They included reports of hemorrhaging or necrotic pancreatitis, both of which can be fatal; acute kidney failure leading to death or kidney transplants; and thyroid neoplasms, which can lead to thyroid cancer. Because this was new safety information not known when Byetta was approved, federal law required new studies to ensure that the drug’s benefits outweighed its risks. According to the letter, some of these studies are already in progress or even completed. But because this requirement was not mentioned in the manufacturers’ approval announcement, the new announcement before Christmas caused a drop in Amylin’s stock prices.

This is disturbing news not just for investors, but also for patients and defective drug lawyers like me. Byetta’s manufacturers almost certainly withheld the information because they didn’t want to hurt the drug’s sales or their stock prices. They may have achieved those goals -- at least until the financial analyst found the publicly available approval letter -- but they have also withheld safety information that can help patients make the best possible decisions about their own treatment. All three of the diseases that triggered the new studies are life-altering and potentially fatal. Acute pancreatitis, a sudden and serious digestive problem, can lead to the pancreatic tissue dying (necrotizing) and bleeding into the abdomen (hemorrhaging), both of which increase the chance of death significantly. Given the risk of death or disability from these diseases, patients and doctors should know about that risk so they can discuss alternatives.

Continue reading "FDA Requests Further Studies of Diabetes Drug Due to Reports of Pancreatitis " »

As a pharmaceutical liability attorney, I was disturbed to read about a new warning of serious side effects for the antidepressant Norpramin (desipramine hydrochloride). According to a Dec. 2 article from Medscape, the FDA and drug manufacturer Sanofi-Aventis have made significant changes to the warning label on Norpramin to reflect a risk of serious heart problems in patients taking the drug. The label now advises health care professionals to use extreme caution when prescribing Norpramin to patients with a family history of sudden cardiac death, arrhythmia (a heartbeat that’s too slow, too fast or not regular) or cardiac conduction disturbances.

Norpramin (sold as Pertofrane outside the U.S.) is primarily used for treating depression, but also in patients with nerve pain, cocaine withdrawal or attention deficit disorder. It is part of the tricyclic class of antidepressants, which were widely used until the introduction of the newer selective serotonin reuptake inhibitors. Along with the warning on heart problems, the FDA letter announcing the labeling changes (PDF) added a general warning to health care professionals that some patients who suffered death and cardiac arrhythmia have suffered seizures beforehand. Because an overdose of Norpramin has shown a higher risk of death than overdoses of other tricyclic antidepressants, the label also included specific instructions for doctors to treat overdose patients. Finally, the label changes deleted previous treatment advice that narrowed doctors’ options for treating an overdose.

As a dangerous drug lawyer, I hope doctors and patients take quick action on this warning. Prior to this announcement, the primary known safety problem with Norpramin (and other tricyclic antidepressants) was a heightened risk of depression, particularly in children. With this announcement, it appears that adults with a family or personal history of heart problems, a very different group, may have been lulled into a false sense of security. The FDA letter did not say how it and Sanofi-Aventis discovered the elevated cardiac risks, but as a rule, major safety changes like this are announced only after multiple reports of patient safety problems or new scientific studies. That means the chances are good that thousands of patients were unknowingly exposed to the cardiac risks of Norpramin. And because overdose of tricyclic drugs is a significant drug poisoning problem -- British and Australian studies found that 8 to 12 percent of drug overdose deaths were from tricyclic antidepressants -- the risk of death may be greater still.

Continue reading "FDA Updates Antidepressant Warning Label to Include Risk of Sudden Cardiac Death" »

The Lowe Law Firm filed a lawsuit in November alleging that a client developed a life-threatening disease after being given certain drugs in support of an MRI test. So our pharmaceutical liability attorneys were extremely pleased to see a report just a few days later that the FDA has also been investigating this class of drugs -- and that it found a greater risk with one drug our client was given. According to a Nov. 25 article from Reuters, an FDA memo released the day before Thanksgiving showed that MRI contrast agents made by GE Healthcare, Bayer AG and Covidien raise patients’ risk, even compared to other manufacturers’ versions of similar MRI imaging contrast agents made with gadolinium. The agents are injected into patients undergoing MRIs to help doctors see the resulting images better.

The entire class of imaging contrast agents already carries a black box warning disclosing that they increase risk of nephrogenic systemic fibrosis in patients with kidney problems. NSF is a disease that builds up collagen in the skin, eyes, joints and internal organs. The hardening of the skin and contracture of the joints can leave patients disabled by limited movement, physically scarred and with chronic pain. In its memo, the FDA announced that the greatest number of NSF cases were linked to use of GE Healthcare’s Omniscan -- the first contrast agent given to our own client. The FDA also found a greater risk for Bayer AG’s Magnevist and Covidien’s Optimark. Its review recommended labels on those products warning of the greater risk. At an already-scheduled meeting Dec. 8, the agency plans to ask an expert panel for advice.

As a dangerous drug lawyer, I am extremely pleased that the FDA is taking aggressive steps to limit kidney patients’ exposure to this toxic substance. In this, our government is just a short step behind the European Medicines Agency, which on Nov. 20 classified gadolinium-containing agents into low-, medium- and high-risk agents for kidney patients based on their chemical content. All three of the agents the FDA found associated with higher numbers of NSF cases are on EMEA’s high-risk list. With so much evidence against these higher-risk agents, I hope the FDA takes steps to end their use entirely, or at least require very strong warnings about the risk to people who have -- or may have -- kidney problems. Otherwise, far too many people may suffer preventable but life-altering problems similar to our client’s, which include permanent disability, disfigurement and many thousands of dollars in medical bills.

Continue reading "FDA Finds Greater Risk of Fatal Disorder From Certain MRI Drugs With Gadolinium" »

As a dangerous medication lawyer, I was gratified to read that a woman from Peoria, Ill. was awarded $6.3 million in damages after a finding that her breast cancer was caused by hormone replacement therapies. Reuters reported Nov. 20 on the largest Prempro award to date, handed down to Donna Kendall of Decatur, Ill. Kendall, 66, sued pharmaceutical company Pfizer after spending 11 years taking the hormone replacement drugs Prempro and Provera, products of Pfizer corporate units. She was diagnosed with breast cancer in 2002, the same year that new research showed dramatic increases in breast cancer and cardiovascular problems for postmenopausal women taking the drugs. In her lawsuit, Kendall said Pfizer failed to adequately warn her and other patients of these risks. The jury indicated that it planned to award punitive damages as well, suggesting that it felt there was evidence of serious wrongdoing.

Prempro was once widely recommended for post-menopausal women, to treat symptoms of life after menopause. However, that changed after the 2002 study from the Women’s Health Initiative at the National Institutes of Health. That long-term study showed a substantially increased risk of breast cancer, heart attacks and strokes among users of Prempro, Provera and Premarin. In fact, that study was ended early because of concerns for the participants’ health. Later studies confirmed the link and suggested that Prempro may also raise women’s risk of blood clots and dementia. Perhaps most damningly of all, later evidence showed that Wyeth, a unit of Pfizer, paid medical ghostwriters to plant articles in medical journals under doctors’ names. At least some of the articles denied the breast cancer link altogether, triggering multiple lawsuits and a Congressional investigation.

As a pharmaceutical liability attorney, I am pleased to see the justice system doing its job with these drugs. By now, most observers agree that the FDA approval process, while important, is not enough to ensure that drugs are safe. Too many drugs have slipped through the cracks in recent years, including drugs that have since been linked to life-threatening diseases. In a few cases, pharmaceutical companies have also been caught misleading the public, as with Prempro, using deceptive advertising, biased medical studies and unethical corporate policies. In addition to causing unnecessary deaths and lowered quality of life to patients and their families, these drugs can also trigger six or even seven figures in bills for medical care that patients would never have otherwise needed. As the FDA itself once acknowledged, lawsuits like this one help incentivize drug companies to stay honest by generating severe financial costs and negative publicity when the issues are publicly and fully aired.

Continue reading "Jury in Prempro Trial Awards Illinois Woman $6.3 Million for Link to Breast Cancer" »

As a St. Louis defective drug attorney, I was disturbed to read about a new Food and Drug Administration warning of potential irreversible cartilage damage from certain anesthetics and medical devices. According to a Nov. 17 article from the Wall Street Journal, the FDA has called for stronger warnings on the labels of pain pumps and certain anesthetics after 35 reports that they caused permanent cartilage damage (chondrolysis) in patients who received continuous infusions after surgery. In more than half the cases, patients needed additional surgery, including joint replacements for otherwise healthy young adults. The FDA required pain pump and anesthetic makers to update their labels within 30 days to include warnings about the destruction of cartilage.

The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.

Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.

The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them -- and doctors continued to prescribe pain pumps full of anesthesia.

Continue reading "FDA Calls for New Labeling for Anesthetics Used in Post-Surgery Pain Pumps" »

As a defective prescription drug attorney, I am familiar with at least one older study linking a class of anemia drugs to potentially life-threatening blood clots. On Nov. 10, a study to be published in the Dec. 2 Journal of the National Cancer Institute confirmed that link. According to a Nov. 10 article from HealthDay, the study found that a class of drugs called erithropoiesis-stimulating agents (ESAs) doubled the risk of blood clots in cancer patients receiving the drugs during chemotherapy. Of those patients, 14.3% developed thromboembolism (blood clots big enough to block blood flow), while 9.8% of those not receiving an ESA developed it.

ESAs are typically prescribed to people undergoing chemotherapy -- of which anemia can be a side effect -- or people with chronic kidney disease. Common brand names for these drugs include Procrit, Epogen (both epoetin alfa) and Aranesp (darbepoetin alfa). They were approved in the late 1990s to reduce the need among chemotherapy patients for blood transfusions and are now widely prescribed. According to the article, U.S. ESA sales were $10 billion in 2006, and Medicare spent more on ESAs than on any other drug. However, the new study found no difference in number of transfusions between patients receiving ESAs during chemotherapy and chemotherapy patients not taking the drugs. Survival rates were also similar.

However, patients taking ESAs had an higher risk of developing veinous thromboembolism -- blood clots in veins big enough to block at least some blood flow. Specifically, they had a higher rate of pulmonary embolism and deep vein thrombosis, both of which can cause life-threatening complications. When a blood clot passes into the lungs in a pulmonary embolism, it can cause breathing problems, heart palpitations, abnormally low blood pressure, collapse and sometimes death. Deep vein thrombosis that doesn’t result in a pulmonary embolism can still cause swelling, pain and skin problems. Because of the risk of death, both are considered medical emergencies.

As a dangerous medication lawyer, I’m not sure whether it’s more disturbing that these drugs can cause sudden death from pulmonary embolism -- or that they don’t appear to do what they were approved to do. The study’s lead author, Dr. Dawn Hershman of the Herbert Irving Comprehensive Cancer Center in New York, said her results raise questions about the approval process and post-marketing research for ESAs. After the first studies connecting ESAs with blood clots, the Food and Drug Administration added a black box warning to their labels -- the most serious warning available -- disclosing the risk of blood clots and death and suggesting limitations on which patients should receive them. With this new study, I hope doctors and regulators seriously consider whether chemotherapy patients truly need an ESA before prescribing one.

Continue reading "Study Confirms Serious Blood Clot Threat From Anemia Drugs for Cancer Patients" »

As a pharmaceutical liability attorney, I have noticed several reports of serious safety problems with the newest drugs intended for treatment of Type II diabetes. So I was disappointed, but not entirely surprised, to see a safety alert issued by the Food and Drug Administration Nov. 2 about problems with the diabetes drug Byetta (exenatide). According to a report from U.S. News and World Report, the FDA received 78 reports of kidney function problems in 4.5 years from people taking Byetta. In response, the agency announced major labeling changes for Byetta, including the addition of information on the kidney risks as well as advice to physicians to monitor patients for kidney problems.

Byetta, made by Amylin Pharmaceuticals Inc. of San Diego, is used to control blood sugar levels in Type II diabetes patients already using diet, exercise and some other diabetes medications. The FDA said its reports of problems with Byetta included 62 cases of acute kidney failure as well as 16 cases of renal insufficiency. Some, but not all, of the cases were in patients who already had kidney problems or were at risk for kidney problems. In addition to adding information on those cases to the label, the FDA said it would add information on kidney dysfunction to the prescription information for Byetta, so that patients can identify problems more quickly. It also asked health care professionals not to use the drug in patients with severe kidney problems and to use caution with patients with moderate kidney problems.

This is the second post-marketing report of serious side effects for Byetta. In 2007, the FDA issued a safety alert after receiving reports of acute pancreatitis in patients taking the drug. In 2008, the agency received at least four reports of death from pancreatitis, a sudden and painful inflammation of the pancreas. It can also reduce blood sugar to dangerously low levels (hypoglycemia).

As a dangerous drug lawyer, I am pleased to see the FDA take reasonably quick action on these reports of kidney problems. Renal failure is a type of organ failure with very serious implications for the patient. When the kidneys stop working, patients suffer pain and serious illness, as well as high risk of complications like anemia. Severely affected patients must depend on daily dialysis or hope for a transplant in order to stay healthy. And U.S. News and World Report said there were seven million prescriptions for the drug written during the 4.5-year period the FDA examined, which means millions of Americans are likely exposed to this side effect. When the risk is this serious, patients and their doctors have the right to know as much as possible about it.

Continue reading "Diabetes Drug Prescribing Information Revised to Reflect Reports of Kidney Problems" »

Back in April, I wrote on this blog about the withdrawal of the drug Raptiva (efalizumab) from the market for safety reasons. That medication, intended for treating psoriasis, was implicated for weakening the immune system and allowing users to contract a rare brain infection called progressive multifocal leukoencephalopathy. Now, PML is back in the news in connection with two other drugs -- Tysabri (natalizumab), a treatment for multiple sclerosis, and Rituxan (rituximab), which is for treatment of arthritis. The FDA is already watching both drugs for cases of PML. Now, the FDA has announced a new and slightly different case of PML in a patient taking Rituxan, and the European Medicines Agency, the EU’s FDA, is reviewing whether additional measures are necessary to make Tysabri safe.

The Tysabri review comes after 23 cases of PML were reported -- about twice as many as were thought to exist before. The U.S. manufacturer, Boston’s Biogen Idec, said it was already considering a labeling change that would tell consumers that their risk of PML increases the longer they take Tysabri. Ironically, PML resembles a much faster form of multiple sclerosis, a degenerative disease that attacks patients’ movement, vision, speech and cognition. In MS, the body attacks myelin sheaths that protect nerve cells, but the sheaths can be replaced, causing the disease to progress slowly over a number of years. In PML, the cells that make the myelin are destroyed. As a result, PML progresses quickly, often killing its patients within a year of diagnosis.

While the effects of PML may be confused with the effects of MS in patients taking Tysabri, the problem is substantially less likely for patients taking Rituxan, which is indicated for rheumatoid arthritis. The FDA announced Oct. 23 that it had received a report of a new case of PML related to Rituxan, its third reported case. In this case, a 73-year-old woman received one course of treatment with the drug, then developed symptoms of PML within four to six months. This case is different from the previous two, the FDA said, because the woman had not previously been treated with a type of cancer drug called a TNF inhibitor. The FDA said “information to date suggests that patients with [rheumatoid arthritis] who receive Rituxan have an increased risk of PML.”

As a drug injury attorney, I hope that doctors are seriously reconsidering writing new prescriptions for Rituxan and Tysabri. Rheumatoid arthritis and MS are both serious, life-altering diseases, but this is a case where the cure may be even worse. Aside from AIDS patients, who can fight PML with newer drugs that restore their immune functions, patients diagnosed with PML are statistically likely to die within a year of diagnosis. Those who survive may live with severe neurological disabilities. This is a terrible fate and a terrible thing to watch a loved one go through. If the manufacturers originally understated this risk-- or they negligently failed to examine it thoroughly -- they could be legally liable in multiple pharmaceutical injury lawsuits from around the U.S. and the world.

Continue reading "European Regulators Review Arthritis Drug Safety as FDA Announces New Case of Brain Infection" »

Nearly seven months after the drug Phenergan was the center of a controversial U.S. Supreme Court ruling, the Food and Drug Administration has required a black box warning for the label of its generic version, promethazine. According to the Associated Press, the agency made the labeling change to warn patients about the possibility of gangrene if the drug is administered improperly -- the same issue at the center of the Supreme Court case.

Promethazine, an anti-nausea, anti-vomiting and sedative drug, is administered as an injection deep into muscle tissue. However, if it’s administered to an artery or under the skin instead, it can damage tissues so badly that the cells die, sometimes causing gangrene and amputation of the affected area. According to the FDA’s press release, the new label moves the warning about the possibility of gangrene from the package insert onto the outside of the package itself. It will also caution health care professionals to inject the drug deep into the patient’s muscle, and to give the injection slowly and at low concentrations to prevent promethazine from leaking from the veins into the surrounding tissue, where it can do damage.

The lack of strong warnings on the drug was the center of the Supreme Court case, Wyeth v. Levine. Patient Janet Levine sued drug company Wyeth after an injection of Phenergan caused the amputation of her right arm. She alleged that Wyeth failed to provide sufficient warning about the risk of gangrene. Wyeth argued that its labeling was sufficient because it had been approved by the FDA. The federal law allowing the FDA to regulate drug labeling preempts state law, the drug manufacturer argued, meaning that state juries like the one in Levine’s case should not be able to find that its labels are insufficient. This would have effectively ended nearly all lawsuits against drug manufacturers over this issue. However, the Supreme Court ruled 6-3 for Levine, saying Congress did not intend to preempt state juries when it established the FDA.

As a dangerous prescription drug attorney, I am pleased that the FDA took the next logical step after the Wyeth ruling -- confirming the need for a labeling change by ordering the strongest warning available. Tissue death, gangrene and resulting amputation are not common reactions to promethazine -- but when they happen, they change the lives of the victims forever. Losing an arm requires victims to relearn how to do nearly everything in life, from eating to dressing to driving. It also takes away careers and livelihoods; Levine, the plaintiff in the Supreme Court case, was a guitarist and pianist before she lost her arm. If it can prevent others from suffering from an irreversible, lifelong disability, this labeling change is worthwhile.

Continue reading "FDA Orders Black Box Warning for Injected Sedative at Center of Supreme Court Case" »

Pharmaceutical company GlaxoSmithKline discussed burying studies linking antidepressant Paxil (paroxetine) to birth defects, Bloomberg News reported Sept. 15. The revelation came in the opening phases of a lawsuit against GlaxoSmithKline by Michelle David and her three-year-old son, Lyam Kilker, who claim Paxil is responsible for Kilker’s life-threatening heart defects. The plaintiffs and their dangerous prescription drug attorney claim GlaxoSmithKline knew Paxil could cause birth defects and intentionally withheld that information in order to protect the drug’s sales, estimated at $942 million in 2008. According to Bloomberg, the case is the first of more than 600 claiming that GlaxoSmithKline knew Paxil causes birth defects, but continued selling it anyway without notifying consumers, doctors or regulators.

The memo in question was written in 1997 by GlaxoSmithKline executive Bonnie Rossello, about the possibility of doing animal studies on the drug. “If neg[ative], results can bury,” Rossello wrote. The plaintiffs also claim the manufacturer knew when it bought the drug’s patent in 1980 that the previous owner had found evidence that Paxil caused birth defects in rats. Nonetheless, they said, GlaxoSmithKline resisted doing a study on its drug for almost 20 years to see why the young rats in that study died. In 1998, the plaintiffs said, GlaxoSmithKline reviewed its reports of Paxil side effects and found a high number of birth defects -- then deleted the relevant parts of the report and never notified the U.S. Food and Drug Administration. And in 2001, an internal report said birth defects in a patient’s fetus were “almost certainly” caused by Paxil use.

After a 2003 order from the FDA for more safety tests, the company acknowledged that Paxil increased the risk of birth defects. Nonetheless, a lawyer for the drug maker said at trial that it had not received reports of the specific defect Kilker has before he was born in 2005. Since 2003, several studies have shown that Paxil use during pregnancy increases the risk of heart defects in babies by 1.5 to 1.7 times. A study in the British medical journal The Lancet also found that babies born to mothers using Paxil had withdrawal symptoms, including convulsions. The drug’s labeling now warns of this risk, and the American College of Obstetricians and Gynecologists has recommended that pregnant women and women trying to become pregnant avoid Paxil.

As a defective prescription drug attorney, I will watch this and other Paxil cases closely. Heart defects in newborn infants are frightening and potentially life-threatening. Children with severe defects may need surgery or multiple-drug regimens to be well enough to live normal lives. This is a terrible challenge for any family to face -- and juries will likely sympathize with children who are ill through no fault of their own. That may be particularly true if plaintiffs can prove that GlaxoSmithKline knew or should reasonably have known about the link between Paxil and infant heart defects earlier. If these plaintiffs can prove the claims outlined in the article, I think they have a strong chance.

Continue reading "Memo Introduced at Paxil Trial Suggests Drug Company May Have Buried Negative Studies" »

Researchers who study the effectiveness and safety of asthma drugs are questioning the results of a new study, Reuters reported Aug. 19. The new study examines the safety of a class of inhaled asthma drugs called long-acting beta agonists, which include Serevent (salmeterol) and Foradil (formoterol); and, in combination with inhaled corticosteroids, Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide). The study was conducted by researchers including Dr. David Lang of the Cleveland Clinic Foundation -- but it was funded with an unrestricted grant from GlaxoSmithKline, the maker of Serevent and Advair. As a result, say independent researchers, the study’s conclusion -- that these drugs don’t increase asthma-related illnesses -- is not reliable.

For several years, scientists have suspected that long-acting beta agonists actually increase the chances of serious complications from asthma. In fact, one 2003 study showed that the chance of death was actually higher for asthma patients using the drug than it was for those taking only a placebo. Another study found that the risk is even greater for African-Americans, although it was not clear why that might be. The FDA updated the drugs’ warning labels to reflect that risk three times, in 2003, 2005 and 2006, and recommended in 2008 that long-acting beta agonists be banned as asthma medication.

The study by Lang and his colleagues examined that risk. They examined hospitalizations for asthma in Philadelphia between 1995 and 1999, then checked them against prescription rates for both short-acting and long-acting beta agonists. According to the findings, hospitalizations rose with short-acting beta agonist prescriptions, but fell with more prescriptions for the long-acting drugs. The researchers concluded that the study showed no evidence that long-acting beta agonists increase asthma-related illnesses.

Asthma drug researcher Dr. Christopher Cates of the University of London disagreed. He said the study design was unreliable, at least in part because researchers didn’t determine whether the drugs were prescribed for asthma. (As a dangerous drug attorney, I can add that correlation between two events does not necessarily mean that one caused the other, although dishonest people may try to imply otherwise.) Another independent scientist, Dr. Shelly Salpeter of Stanford University, said the association between long-acting beta agonists and asthma complications is clear from multiple studies. In fact, both doctors said, the medical community has moved on to examining whether these drugs are safe in combination with corticosteroids; recent evidence suggests that they are not.

As a pharmaceutical injury lawyer, I am not surprised that a study funded entirely by GlaxoSmithKline would draw conclusions favorable to GlaxoSmithKline’s drugs. There are 300 million people around the world who suffer from asthma, and Advair alone has $3.8 billion in annual sales. All of those profits and more would be lost to the drug maker if it is forced to remove Advair and Serevent from the market because of safety concerns. Nonetheless, evidence is growing that these drugs may actually raise the risk of a serious asthma-related illness, up to and including fatal illnesses. Under those circumstances, it is, at the least, highly irresponsible to sponsor studies that deceptively claim otherwise. If even a fraction of those 300 million people fall seriously ill because they were misled into believing long-acting beta agonists were safe, the drug maker could be responsible for thousands of deaths and catastrophic illnesses.

Continue reading "Scientists Question Findings in Study of Asthma Drugs Funded by Drug Manufacturer" »

Barr Laboratories is recalling one lot of its generic Adderall due to a serious manufacturing defect, the Los Angeles Times reported Aug. 14. The laboratory is recalling lot number 311756 of the 20-mg, 110-count bottles of Adderall, a mixture of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. The manufacturer started the recall after finding that some of the pills in the lot were oversized, which can lead to an overdose causing heart arrhythmia, heart palpitations, high blood pressure, anxiety, insomnia and other side effects. Patients who have this lot of the drug are advised to stop taking it and return it immediately to their pharmacy, or call Barr Laboratories for more information at 1-888-742-5578.

Adderall is a drug used in children and adults with attention deficit hyperactivity disorder (ADHD). It is a mixture of several salts from the amphetamine family of drugs, which also contains the street drug methamphetamine. Like methamphetamine, Adderall is a stimulant that can cause severe adverse effects in an overdose, including mental health problems as well as potentially serious effects on the heart and cardiovascular system. Barr Laboratories’ press release lists potential physical effects of an overdose such as increased heart rate, high blood pressure, heart palpitations, tremors, dizziness, insomnia and nausea. Possible psychological side effects of the oversized pills include anxiety, euphoria, mania and agitation.

Fortunately, the manufacturer and the FDA did not report hearing of any dangerous side effects from the oversized, defective pills. But as a dangerous prescription drug lawyer, I know ADHD drugs and stimulants generally have a troubled history when it comes to safety. Adderall and other stimulants are not prescribed to people with a history of heart problems, seizures or drug abuse because they can be dangerous or even fatal for all of those groups. Furthermore, studies have shown that they can cause changes in vision and stunt children’s growth, at least temporarily. And in 2006, an FDA advisory panel voted to put a black box warning on the drug’s label about potential cardiovascular and mental health side effects in children -- a recommendation the FDA ignored.

The current recall should not be a cause for alarm for all patients taking Adderall; only one lot is affected. But because an overdose of amphetamines can be very serious, patients who purchased the oversized pills are at risk of health- or life-threatening side effects. Like all drug manufacturers, Barr Laboratories is strictly liable for the damage its products cause if they have a manufacturing defect -- even if they didn’t know about the problem ahead of time. Any patients who are seriously harmed by the oversized pills would have the right to hold the manufacturer legally responsible with a defective prescription medication lawsuit.

Continue reading "Manufacturer Recalls Generic Adderall Because of Oversized Pills Posing Risk of Heart Problems" »

The FDA is studying data from ongoing safety tests of the asthma medication Xolair, the agency’s August 2009 MedWatch Safety Alert said. Xolair (omalizumab) is an injected medication that controls asthma in patients with year-round allergies who don’t respond well to inhaled treatments. The alert said the FDA has data showing that Xolair increases patients’ chance of developing cardiovascular problems, including potentially fatal heart attacks and strokes. The agency has not yet made a decision and suggests that patients continue taking the medication, but talk to their doctors about its risks and benefits and the ongoing study.

That study, named EXCELS, compares 5,000 patients taking Xolair to a control group not taking the drug. Preliminary results suggest that the group taking Xolair had a disproportionate rate of adverse events involving the heart and brain compared to the control group. Those adverse events included ischemic heart disease, heart arrhythmia, heart failure, high blood pressure, blood clots and strokes. Xolair already has a black box warning, the strongest available, warning patients about the risk of a life-threatening allergic reaction called anaphylaxis. That threat, while rare, led to a requirement that doctors administer the drug -- which was previously self-administered by patients -- and observe patients for two hours after.

As a defective prescription drug attorney, I suspect that another black box warning may be ordered if the study turns up strong evidence of a link between Xolair and cardiovascular problems. The FDA has already signaled that it plans to pursue safety issues more thoroughly than it did under the last presidency, and the problems the study allegedly turned up include potentially life-threatening and disabling health problems. A stroke can not only kill, but leave patients partially paralyzed or with permanent, lifelong problems with speech and memory. (That’s on top of the known risk of anaphylaxis, which can kill very quickly if the patient does not get treatment.) The drug is not used widely, but with side effects this serious, Xolair maker Genentech and distributor Novartis could face huge liability from patients who are killed or permanently disabled by what they thought was a life-saving allergy medication.

Continue reading "FDA Reviewing Data Suggesting Asthma Medication May Cause Heart Problems and Strokes" »

The U.S. Food and Drug Administration has ordered the strongest safety warning possible for a class of prescription drugs called TNF blockers, HealthDay reported Aug. 4. The FDA ordered the warning for children and teenagers using these anti-inflammatory drugs after an analysis of current users showed that the drug increased their risk of cancer, including fatal cancer. The FDA said it was working with manufacturers to better understand the cancer risk of these drugs. It also included information in the black box warning about reports of psoriasis associated with TNF blockers.

The affected patients are children and teens using TNF blockers to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease and other chronic inflammatory diseases. Common drugs that will get the new safety warning include Remicade (infliximab), Humira (adalimumab), Enbrel (etancercept), Cimzia (certolizumab pegol) and Simponi (golimumab). All of these drugs are tumor necrosis factor-alpha blockers or inhibitors, which means they stop the action of a body chemical that promotes inflammation of tissues. Too much of that chemical is believed to be responsible for the inflammation and tissue damage involved in conditions like rheumatoid arthritis, which can be crippling.

The FDA’s study found that children and teens using these prescription drugs had an increased risk of cancer, though they did not specify how much greater the risk was. The cancers began an average of 30 months after treatment, and about half of the cancers were lymphomas, a type of immune system cancer. Some of the cases were fatal. This study was launched in June of 2008, a month before the New England Journal of Medicine published the case of an adult woman who developed lung cancer after taking TNF blockers for Crohn’s disease. When she stopped the drug, her cancer vanished. A doctor with the Arthritis Foundation told HealthDay that patients should weigh the risks of taking TNF blockers against the benefits, which include preventing disability and deformation in children with juvenile rheumatoid arthritis.

The same doctor mentioned that patients with inflammatory illnesses are already at an increased risk of cancer. Given that fact, adding an even greater risk of cancer by using TNF blockers sends up red flags for me, as a dangerous prescription drug attorney. Current and future patients can talk to their doctors about risks versus benefits -- but for children and teens who have already developed cancer because of taking TNF blockers, it’s too late to make an informed decision. These kids may already have developed life-threatening lymphomas or other cancers, and their families may have racked up many thousands of dollars in medical bills to fight the cancer.

Continue reading "Black Box Safety Warning Ordered for Certain Children’s Drugs That Raise Risk of Cancer" »

The U.S. Food and Drug Administration has ordered makers of a drug for digestive problems to add the strongest warning possible to its label, WebMD reported earlier this year. The “black box” warning will caution patients about the risk of developing a serious and potentially incurable muscle disorder called tardive dyskinesia after taking Reglan (metoclopramide). Patients with tardive dyskinesia have involuntary, repetitive muscle spasms, including pursing and smacking of the lips, grimacing, sticking out the tongue and rapid blinking. Patients taking Reglan who have noticed these effects are encouraged to contact the FDA to report any problems with the medication.

According to the FDA press release, two million Americans take some form of Reglan. It is used primarily to treat nausea and vomiting due to certain kinds of cancer treatments, infection, drug side effects and pregnancy, as well as for diabetics with digestion problems. Tardive dyskinesia is a known side effect of Reglan, which is why the FDA recommends that patients use the drug for no more than three months at a time. However, the agency ordered the more stringent warning after recent analyses found that Reglan is the most common cause of drug-induced movement disorders. The agency had also received continuing and spontaneous reports of patients developing tardive dyskinesia after using Reglan. Reglan was also the subject of a defective drug lawsuit in California, in which drug maker Wyeth was held liable for its failure to warn patients about the risk of tardive dyskinesia.

Tardive dyskinesia is a side effect of prolonged or high-dose use of dopamine antagonist medications, including antipsychotics and neurological drugs as well as Reglan and other gastrointestinal drugs. The condition may be mistaken for Parkinson’s disease, but while Parkinson’s patients have trouble moving, tardive dyskinesia patients have trouble not moving. These patients experience involuntary, rapid and repetitive movements, especially movement in the face, fingers and extremities. The movements may or may not disappear after the drug is stopped, and they may take years to subside. There is no known cure for tardive dyskinesia, which is why medical professionals focus on preventing it by limiting the use and dosage of the drugs that cause it.

As a dangerous drug injury attorney, I noticed that Reglan is part of a class of drugs normally used to manipulate the brain chemistry of patients with menal illness or neurological disorders. That’s one reason why Reglan’s side effects include tardive dyskinesia and other neurological symptoms, from drowsiness and dizziness to neuroleptic malignant syndrome. This is too high a price to pay for relief from nausea and vomiting. As the FDA said, this black box warning on Reglan should help patients and doctors make an informed decision about whether the risks are worth the benefits. But for the millions who have already taken Reglan, it may be too late. If an investigation shows that Wyeth and others failed to adequately warn patients of the risk of tardive dyskinesia before the labeling change, patients who develop this terrible, incurable disability have the right to sue the drug makers.

Continue reading "FDA Requires Black Box Warning for Label of Gastrointestinal Drug Reglan" »

The U.S. Food and Drug Administration has required the strongest warning label a drug can have for two painkillers, the Washington Post reported July 8. Darvon (propoxyphene) and Darvocet (propoxyphene with acetaminophen) got the increased warning, the agency said, to reduce the risk of fatal overdoses. The new label will warn patients about the risk of an overdose, and accompanying packaging will include a medication guide emphasizing the risks of not using the drug as directed. In addition, the FDA has ordered a new study of the effects of a propoxyphene overdose on the heart.

The agency’s action came a few weeks after the European Union’s drug regulator voted to phase out Darvon and Darvocet for safety reasons. In the U.S., the activist group Public Citizen petitioned in 2006 to take propoxyphene off the market, saying it is a relatively weak painkiller with too many side effects. In fact, an advisory panel for the FDA voted in 14 to 12 January that the drug should be withdrawn from the U.S. marketplace. The FDA decided not to follow its panel’s advice (which it is free to do) saying the benefits of the drugs outweighed the risks.

According to the Post, the problem with propoxyphene is its effect on the heart. Propoxyphene can decrease the patient’s heart rate and raises the risk of a potentially fatal heart arrhythmia, which has led to fatal overdoses. Because it is also a weak opioid painkiller with potential for addiction, watchdogs may be concerned about its potential for overdoses among drug abusers. The FDA has recorded 91 cases of fatal overdose since 1969, but overdoses are widely thought to be underreported. In the form of Darvocet, which combines propoxyphene with acetaminophen, overdose also carries the risk of fatal liver poisoning.

Darvon has been on the U.S. market since 1957 -- and that’s what concerns me, as a dangerous prescription drug attorney. Though it’s not nearly as popular as prescription painkillers like Vicodin, propoxyphene is prescribed about 22 million times a year. Even if only a tiny fraction of patients overdose each year, that’s a huge number of people over the decades who may have been killed by a drug they trusted to help them. That means the pharmaceutical companies that make and sell Darvon and Darvocet could face thousands of pharmaceutical injury lawsuits from the families of people who were wrongfully killed.

Continue reading "FDA Adds Black Box Warning to Painkillers Darvon and Darvocet Because of Risk of Fatal Overdose" »

The U.S. Food and Drug Administration announced July 1 that it would require the strongest safety warning possible on the labels of prescription smoking cessation drugs Chantix (varenicline) and Zyban (bupropion, also sold as Wellbutrin), the Washington Post’s The Checkup blog said July 1. Both are sold to people who are trying to quit smoking, but have come under fire as users and scientists began to discover serious psychiatric side effects. The black box warning will tell patients that the drugs carry an increased risk of depression, hostility, mood changes and suicidal thoughts. Manufacturers Pfizer (Chantix) and GlaxoSmithKline (Zyban) are also required to run new clinical trials examining how often these mental health problems occur in users.

The move came after multiple reports of depression, increased depression and other behavioral changes that started shortly after taking the drug and stopped shortly after discontinuing use. An FDA newsletter said it received 153 reports of suicidal “adverse events” for Chantix and 75 for Zyban since their approval for use as anti-smoking drugs. This was true at the recommended dose, for people both with and without a previous history of depression. However, the FDA noted that some of these side effects may also be associated with nicotine withdrawal. It also told users not to stop the drugs cold turkey, since this can cause side effects and smoking is a serious health risk -- just to be aware of the risk and talk to their doctors about problems.

I’m sorry to say that this is not the first report of mental health side effects I’ve seen as a dangerous drug attorney. Chantix in particular (called Champix overseas) has been under investigation since 2007, shortly after its fast-tracked approval the year before. In addition to depression and suicidal thoughts, Chantix users have reported agitation, aggression, homicidal thoughts, bizarre dreams and psychosis. Zyban users have reported similar problems, including hallucinations -- and when it is sold as Wellbutrin, bupropion already carries a black box warning about suicide.

The FDA’s action doesn’t take these drugs off the market, but the black box requirement is a powerful warning to consumers that they should be use caution. As a defective drug lawyer, I have seen several accounts of people who suffered serious psychiatric changes after starting one of these quit-smoking drugs, most recently a Pennsylvania man who said taking Chantix might have something to do with his attack on his wife. Like all manufacturers, drug makers have a legal responsibility to offer us products that are safe and free of defects. When they fail, consumers who are hurt can hold them legally and financially responsible for the results. If it becomes clear that Pfizer and GlaxoSmithKline were selling drugs without a clearly necessary warning -- or even knew of the side effects ahead of time -- they could be hit with multiple pharmaceutical injury lawsuits.

Continue reading "Anti-Smoking Drugs Chantix and Zyban Get Black Box Warning About Risk of Suicide and Mental Illness" »

On Thursday, by order of the U.S. Food and Drug Administration, U.S. Marshals raided generic drug company Caraco's factories and seized more than 30 of the 40-odd medications it markets. The seizure was ordered after the FDA found manufacturing problems at all three of the company’s plants in Detroit, Michigan.

Caraco is no stranger to FDA-related controversy. Indeed, it has had several high-profile recalls of its medications just in the past year, all of which exposed it to multiple dangerous drug lawsuits. These recalls included the popular diabetes drug metformin (generic for Glucophage), and the heart drug digoxin, the latter of which allows Caraco to hold a fifth of the U.S. market. Both products were recalled due to concerns about accidental variations in the pills' sizes.

Despite the FDA's drastic measures, the director of its drug division's office of compliance has said that patients taking generic drugs made by Caraco should continue to take them, because all of the defective drugs had been recalled or seized. This seems an interesting instruction, considering how great the damage could be if she is wrong. Digoxin, a derivative of the poisonous plant foxglove, is known to be toxic and has a narrow margin between beneficial and lethal amounts. Improperly sized digoxin tablets can cause heart instability and even death, particularly in patients with kidney failure. Last year, a different generic drug company, Actavis Group, recalled its generic digoxin medication due to concerns that some of the tablets had been manufactured twice as thick as the company intended. According to the FDA, "several reports of illness and injuries" were linked to Activis pills last year.

Caraco's products also include a generic form of epilepsy drug Tegretol, a pain reliever called tramadol/APAP, and many others. A full list of the company's defective products can be found on the FDA's website. Generic defective drugs can be even more dangerous than their brand-name counterparts, as the manufacturer's name does not call attention to itself. However, it should always be listed, so please check the labels of all your generic medications. If you or someone you love has experienced serious ill effects or untimely death after taking a Caraco-manufactured product, please contact a St. Louis pharmaceutical liability lawyer to learn more about your rights and your potential legal claim. Innocent consumers who fall victim to mistakes by Caraco or any other drug company should be heard -- and, if appropriate, compensated for their physical, emotional and financial losses.

Based in St. Louis, Missouri, The Lowe Law Firm's pharmaceutical injury lawyers represent clients in Missouri, southern Illinois and across the country who have been hurt by defective prescription and over-the-counter medications. If you or someone you care about has been harmed by a dangerous drug, and you would like to learn more about your rights and options, please contact the Lowe Law Firm online, or call us toll-free at 1-877-678-3400 for a free, confidential consultation.

On Tuesday, the FDA shocked thousands of consumers with an advisement to stop using Zicam cold remedies. The announcement cited links between three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids' Size -- with the loss of sense of smell. The culprit ingredient in these so-called "natural" Zicam Products is zinc, a mineral that scientists say has been known since 1938 to damage nerves in the nose needed for smell. According to the Washington Post, zinc also has apparently been used to destroy sense of smell in laboratory animals.

Also called anosmia, the loss of sense of smell can be permanent. This amounts to the loss of one of your five basic senses. Without sense of smell, not only are you unable to experience full quality of life by smelling pleasant scents, but your ability to detect dangerous fumes or smoke is also greatly impaired -- in other words, a properly functioning nose could save your life. Your sense of taste is also greatly diminished when you can't smell, making you much more likely to ingest spoiled food, or food tainted with harmful substances.

The advisement came after more than 130 reports had been submitted to the FDA about a loss of sense of smell in patients who used one of the three Zicam products. Some reports came after several doses of Zicam, but many of these people said their anosmia occurred suddenly, after just one dose. In response to this alarming body of evidence, the FDA sent Matrixx Initiatives, manufacturer of Zicam products, a letter of warning stating that the products could no longer be marketed without FDA approval.

The FDA has stated that Zicam Cold Remedy was never formally approved because it is part of a group of remedies called homeopathic products, formulations that typically use small doses of "natural" active ingredients including herbs, minerals and flowers. This may be the FDA's policy, but as a southern Illinois product liability lawyer I would like to point out that this is no excuse for laxity in product testing. "Natural" is a far cry from "harmless."

The letter also stated that the products were not properly labeled to reflect the risk of anosmia that has been associated with them. You might think this was all news to Matrixx, or that they thought that 130 cases somehow weren't enough to merit labeling their product with a safety advisement. The fact is that they have already settled more than 400 lawsuits about this very thing, including a giant $12 million lawsuit in 2006. The company also has received more than 800 anosmia complaints, which the FDA recently asked them to surrender. The company did not comply.Speaking as a St. Louis pharmaceutical liability attorney and as a human being, a company neglecting to account for that many injuries in the name of profit is positively appalling.

The FDA says it is especially concerned about intranasal zinc use in children, since children might lose sense of smell but be less likely to communicate the condition to an adult. Fortunately, the Kids' Size Cold Remedy Swabs had already been discontinued prior to the FDA's announcement. Matrixx has said it will withdraw its dangerous products from stores, but extensive damage has already been done. With Zicam sales in the millions, the chances are good that someone close to you has used this product, or considered using it, at least once. Worse, reports are now surfacing that Zicam products are not the only "homeopathic" products out there that are causing serious side effects. These problems could affect millions of Americans -- all of whom would have a legal claim against the products’ manufacturers

Zicam products reeled in about 40 percent of Matrixx's $111.6 million in sales last year. While Matrixx decides what its next move will be, the FDA has advised people who have experienced any sense of smell loss or other problems after use of any of the three Zicam products to consult their health care professional. I would add that they should consult a Missouri dangerous drug attorney directly after. The loss of one of life's most basic and crucial senses is a possibility no one -- not even Matrixx -- can afford to ignore.

If you or someone you love has experienced a loss of sense of smell and has used Zicam products, or has experienced serious side effects after taking any product labeled as "homeopathic," please contact The Lowe Law Firm right away. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, plus lost wages and compensation for your injuries.

Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients across the nation who have been hurt by defective medications and over-the-counter remedies. If you would like to learn more about your rights and options, please contact the Lowe Law Firm online, or call toll-free at 1-877-678-3400 for a free, confidential consultation.

Upset with the U.S. Food and Drug Administration, Zicam maker Matrixx Initiatives Inc. has withdrawn two of its cold remedy nasal products even though company officials maintain the products are safe.

The FDA said it received more than 130 complaints from consumers saying they have lost their sense of smell after using the products.

Jennifer Warren, a former school teacher who lives in Huntsville, Ala., said she lost her sense of smell after using Zicam to prevent the duration of a cold a few years ago, but had never complained to the FDA or the company because she figured there was no way to prove Zicam caused her anosmia.

She said she doesn’t want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even after learning others have had the same experiences.

“I don’t think Zicam was created to hurt anyone,” she said. “We sit here and we rip and we rave about all these drugs not being allowed on the market. The first time anything goes wrong, everybody wants to go sue, sue, sue. That drives me nuts. I honestly believe the people were trying to do something to help people not get sick.”

William Hemelt, acting president and chief operating officer of Matrixx, said the FDA action was taken without reviewing research he would have been more than willing to provide.

“We think the science does not support this allegation at all,” he said. “Quite honestly, we would not be selling the product if we thought it was unsafe.”

Zicam products use a homeopathic remedy called Zincum Gluconicum 2x, which means they require FDA approval.

Dr. Sam Benjamin, a medical doctor with a homeopathic license, said he can’t figure out why the FDA has taken so long to deal with the issue.

“I can think of no part of alternative medicine that summons up more worry to conventional physicians than homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdays at 2 p.m. and 1,000 followers on Twitter. “There are so many drugs around that cause problems, why would one event want to expose people to any danger.”

Brett Berty, a senior recall strategist at Stericycle Inc. in Lake Forest, Ill., is coming to Phoenix this week to meet with Matrixx officials to see if he can help the company with damage control.

Usually, he said, companies will voluntarily recall a product before the FDA gets involved. That’s not how it happened with Matrixx. The FDA stepped in and warned Matrixx that it had received more than 130 consumer complaints and that the company needed to stop marketing the product until it can put a warning label on its packaging that it could cause anosmia.

Over the past 10 years, Berty has worked with manufacturers to conduct about 1,300 recalls, including Vioxx.

“Typically, hopefully, the manufacturer will work with me prior to approaching the regulatory agency,” he said. “The most important thing for Matrixx is you can turn a seemingly awful situation into an opportunity if you’re judged by the public as being part of the solution. How swiftly do they execute that will demonstrate their concern for the public’s safety.”

When the FDA sent the warning letter to Matrixx and advised consumers not to use certain Zicam cold remedies, on June 16, Matrixx’s stock plummeted 70 percent to $5.78 a share. It bounced up a bit to $6.13 a day later, but nowhere near its 52-week high of $19.74, near its trading point before the FDA sent the warning letter.

For the fiscal year ended March 31, Matrixx reported $13.8 million in net income on $112 million in net sales, up from $10.4 million in net income on $101 million in net sales a year ago.

Hemelt said he will be meeting with FDA regulators to discuss the issue. He also scheduled a conference call with investors.

The FDA advises against using:

The FDA made an official statement today, saying it has requested class of asthma drugs called leukotriene modifiers be labeled with a "precaution" warning of potential psychiatric side effects, including suicidal thoughts and behavior. This family of drugs includes zileuton, marketed by Cornerstone as Zyflo and Zyflo CR; zarfirlukast, marketed by AstraZeneca as Accolate; and montelukast, marketed as Singulair, Merck & Co.'s number-one-selling drug.

In March of last year, the FDA began an ongoing safety review of a possible association between suicidal tendencies and leukotriene modifiers. In early January, the FDA said clinical trial data suggested that the products were not associated with an increased risk of mood changes or suicidal behavior. But in April, as the agency completed a review including not only clinical trial data but also post-marketing reports, it began to change its tune. The post-marketing reports included cases of neuropsychiatric events including agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior including suicide, and tremors.

Singulair has been associated with psychiatric side effects for some time; Merck began labeling Singulair to reflect those possible side effects in March 2007. In response to today's FDA request, Merck stated that precautionary language is already included in Singulair's labeling, and that the language will simply be moved from a section labeled as "side effects" to a higher section labeled as "precautions." Merck also says it will provide health care providers with informative leaflets and communicate these latest findings to prescribing professionals face-to-face. Speaking as a St. Louis defective drug lawyer, I believe Merck not only should be held to these claims, but also should be held accountable for keeping consumers informed. AstraZeneca and Cornerstone have also said they will add precautionary language to their drugs' labeling; they too should be held to their claims.

According to Reuters, analysts from Morningstar and BMO Capital Markets say the distinction between side effect advisements and precaution labeling will have little effect on sales. As a Southern Illinois harmful drug attorney, I say this is all the more reason for consumers to remain vigilant. That same article says Singulair's U.S. sales are estimated at $4.4 billion for 2009; if the FDA is reporting an association between suicidal thoughts and these drugs in documented cases, imagine how many undocumented cases exist in the U.S. today.

If you or a loved one have had suicidal thoughts or other psychiatric side effects while taking Singulair, Accolate, Zyflo, Zyflo CR, or any of their generic equivalents, you have rights, and the Lowe Law Offices can help you protect them. With offices in St. Louis, Missouri and Belleville, Illinois, our pharmaceutical liability lawyers represent people who have suffered serious illnesses or injuries because they took a dangerous medication. In a defective drug lawsuit, you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for serious injury, permanent disability or the loss of a loved one. If this sounds like your situation, we can help you learn what your options are at a free, confidential consultation. To set one up, please contact the Lowe Law Firm online or call us toll-free at 1-877-678-3400.

On June 4, the U.S. Food and Drug Administration issued a warning to healthcare professionals associating the risk of liver damage and failure with the use of the anti-thyroid drug propylthiouracil. The drug is prescribed for the treatment of Graves' disease, an autoimmune disorder that leads to overactivity of the thyroid gland. The FDA's notification linked the use of propylthiouracil to serious liver injury, including liver failure and death, in both adult and pediatric patients.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research, in the report. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

The FDA discussed these findings on April 19, 2009 with the American Thyroid Association (ATA) at a public workshop on propylthiouracil-related liver toxicity in Washington, D.C. According to the FDA, a total of 32 cases of serious liver injury associated with the use of propylthiouracil were reported to the FDA's Adverse Event Reporting System, from when the system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant. In contrast, only five cases of serious liver injury were identified for methimazole, which was approved for marketing in 1950. All five cases were in adult patients, and three resulted in death.

The report did not definitively conclude that there was a causal relationship between propylthiouracil and liver toxicity, nor did it advise healthcare professionals to stop prescribing the product. However, the FDA did advise caution in prescribing the drug, and that each case should be examined individually. For example, because a rare birth defect has been reported with methimazole and not with propylthiouracil, propylthiouracil may be more appropriate for patients with Graves' disease who are in the first trimester of pregnancy, the report said.

I am pleased that the FDA has brought this issue to the attention of the ATA and issued an official public warning on its website. However, as a Missouri dangerous drug attorney, I must stress that these are only the first steps of many that should be taken to protect patients from the potential negative effects of this drug. Drug companies bear a great responsibility to take the initiative in keeping consumers current on the risks of the products they sell. This means proper labeling, warnings and marketing that properly reflects the risk entailed in using their product. If they fail to do those things, they can be held legally responsible for any injuries that result, through a pharmaceutical injury lawsuit.

The FDA said it is continuing to monitor these serious reported adverse events, and is working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. It also said that it intends to update its information on this issue when additional information or analyses become available. In the meantime, FDA says, adverse reactions or quality problems experienced with use of the propylthiouracil may be reported to the FDA's MedWatch Adverse Event Reporting program. Their contact information is available online.

Speaking as a Missouri dangerous drug lawyer, I feel it is especially important to address injuries caused by drugs, including those in generic circulation, as soon as possible. Since this particular medication has been marketed for quite some time -- since 1947, according to the FDA -- millions of Americans could have suffered these adverse effects already. It is important for those people to know what their rights are. That's why, even if there already is an existing class action suit against a particular drug that may have harmed you, you should contact The Lowe Law Firm immediately for a free, confidential consultation. The personalized attention you receive will help you to determine your specific rights and any potential case you may have.

Based in St. Louis, The Lowe Law Firm is a national law firm that specializes in representing people who have been injured by, or lost a loved one to, dangerous prescription drugs. Our Missouri defective drug attorneys represent people in the Midwest and across the United States. To set up an appointment with an experienced defective prescription drug attorney, please contact us today through our website, or call us toll-free at 1-877-678-3400.

In a meta-analysis of 17 studies, researchers have found that the cancer drug Avastin substantially increases the risk of developing holes in the stomach and intestines, U.S. News & World Report said May 25. Researchers looked at 17 studies of Avastin, none of which have proven a significant association between the drug and perforations in the gastrointestinal tract. However, in their analysis, the researchers at Stony Brook University Cancer Center in New York found that patients were twice as likely to develop perforations when they took Avastin, and that the rate of perforations went up as the dosage did.

Avastin (bevacizumab) is approved in the United States to treat several types of cancer. In fact, the FDA in early May approved the drug for treatment of brain cancer. It attacks cancerous tumors by preventing new blood vessels, which keep cancer tissue alive, from forming. In the Stony Brook study, researchers looked at 17 studies involving nearly 13,000 patients who received Avastin along with chemotherapy. Those who received 2.5 milligrams of Avastin were 61% more likely to develop perforations than those not taking Avastin. At twice that dose, 5 milligrams, patients were 167% more likely to develop a perforation. The risk was highest in patients with coleorectal and renal cancer and lowest in those with pancreatic cancer.

Perforations in the stomach and bowels are a serious and potentially life-threatening medical emergency. When these holes develop, they allow stomach acids, food and feces to leak from the organs where they belong into the abdomen. This leads to a bacterial infection of the abdomen called peritonitis. Patients feel abdominal pain that gets worse when they move, nausea, vomiting and sometimes fever. Doctors generally must perform surgery to close the hole and wash away the matter that leaked.

As a Missouri prescription drug injury attorney, I am disappointed to learn that there’s accuracy to reports of Avastin’s dangers. This is the first strong evidence connecting Avastin to stomach and bowel perforations, but other studies have turned up evidence for the association. In fact, the drug was approved for use in breast cancer patients over the objections of the FDA’s own panel of experts. Avastin didn’t seem to prolong lives, they argued, so those and other side effects may not be worthwhile. Nonetheless, it was approved and now carries a black box warning, the strongest available, about its potential to cause gastrointestinal problems.

If you are taking Avastin and you believe it’s responsible for holes in your digestive tract that led to a medical emergency, you should call The Lowe Law Offices as soon as possible. People should never be injured or killed by prescription drugs that are supposed to help. If the drug’s manufacturer failed to warn patients and the public about this risk, patients who were harmed have the right to sue the drug manufacturer for all of their physical, financial and emotional injuries. That includes the cost of more medical care and all other costs related to the injury, as well as the physical pain, emotional trauma and any death or disability caused by the defective drug.

Based in St. Louis, the Lowe Law Offices is a national law firm specializing in representing people who were hurt by dangerous prescription drugs or lost a loved one. Our Illinois defective drug lawyers represent people in the Midwest and around the United States. And we offer free, confidential consultations, so you risk nothing to learn more about your rights and any potential case. To set up an appointment with an experienced dangerous prescription drug attorney, please contact us online or call toll-free at 1-877-678-3400 today.

Federal regulators and pharmaceutical company Baxter International are investigating the cause of two deaths linked to blood-thinning drug heparin, the Wall Street Journal reported May 11. Two patients at a hospital in Lewes, Delaware died after using the heparin, and a third suffered unspecified medical problems; a spokeswoman for Baxter said their symptoms include intracranial bleeding. A hospital administrator told the newspaper that the problem had not yet been identified, but the use of heparin was the only thing they found tying the three cases together.

This is the second serious safety problem in two years for heparin and Baxter. Heparin is a blood thinner, used to treat dangerous blood clots, certain heart problems and people on life support. Contaminated heparin imported from China killed 81 people and sickened 785 more in 2008, sending them into shock and dangerously lowering blood pressure. The culprit was oversulfated chondroitin sulfate -- a supplement that is cheaper than heparin but mimics its effects, suggesting that it was used intentionally to cut costs. In response, Baxter and other manufacturers were forced to recall their versions of the drug. However, the article noted, the drug in the current outbreak comes from a North American source and patients’ symptoms are different.

As a dangerous prescription drug attorney, I hope regulators can find the problem and recall any tainted medication before more patients fall ill. The symptom mentioned in the article, intracranial bleeding, is the medical term for a hemorrhage inside the skull, including in the brain. This is considered a medical emergency because it can create pressure inside the skull that leads to brain damage -- and thanks to the heparin, the bleeding won’t be stopped by the body’s natural blood clotting ability. Patients with the serious medical problems treated with heparin are already weak, and they tend to be older -- those who died in Delaware were 64 and 71. A drug that causes severe pressure on the brains of these patients could kill them or leave them with permanent brain damage.

Based in St. Louis, The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously harmed by a defective pharmaceutical product. Our defective medication lawyers help people who fell ill or lost a loved one to a dangerous drug hold pharmaceutical companies legally responsible for their actions. In a drug injury lawsuit, you can claim compensation for a death, serious illness or permanent disability, as well as compensation for all of the medical costs caused by the drug’s flaws. To learn more about how you can take action at a free, confidential consultation, please contact The Lowe Law Firm online today or call us toll-free at 1-877-678-3400 from anywhere in the United States.

The U.S. Food and Drug Administration has warned consumers that they should immediately stop using an over-the-counter diet aid called Hydroxycut, the Associated Press reported May 1. The dietary supplement is associated with serious liver problems, the article said, including the death of a teenaged boy. Its maker, Iovate Health Sciences, has agreed to recall all 14 Hydroxycut products. Consumers who have any of those products should return them to the store where they were purchased, an FDA press release said, and report any negative effects of using the supplement to their doctors and the FDA. More information from Iovate can be found at HydroxycutInformation.com.

Hydroxycut is one of the most popular weight-loss supplements on the market, selling 9 million packages last year according to the Associated Press. The FDA recalled it after receiving 23 reports of serious liver problems in otherwise healthy people, including the death of a 19-year-old young man from liver failure. (Iovate disputes that Hydroxycut was responsible for the death.) Patients using the recommended amount of the supplement have reported jaundice (a yellowing of the skin), seizures, heart problems and a form of muscle damage called rhabdomyolysis, which can lead to kidney failure. Symptoms of serious liver problems include jaundice, brown urine, excessive tiredness, nausea and vomiting, itching and loss of appetite.

It is unclear which ingredient in Hydroxycut is behind the liver problems, the Associated Press said. The FDA does not have the power to review or test supplements before they go on the market, and Iovate has changed the supplement’s formula several times. However, a safety researcher interviewed by the Associated Press said the problem may be a fruit enzyme called hydroxycitric acid, which has been linked to liver problems in a scientific study.

As a Missouri dangerous drug attorney, I fear that this may only be the beginning of larger problems with this supplement. Hydroxycut is one of the most popular weight-loss supplements on the market, selling tens of millions of units over seven years. With so many users, it’s possible that far more than 23 users have encountered problems, but not connected them to using the supplement. Unfortunately, this is especially likely because the FDA has little regulatory power over dietary supplements. Instead, it must rely on post-consumption reports of problems from users of the supplements, and many consumers -- or their doctors -- don’t think to report their problems right away. In fact, the death believed to be related to Hydroxycut took place in 2007, but was reported only in March.

If you are one of the thousands of Americans who has used Hydroxycut and you now believe it’s responsible for serious health problems, you have legal rights. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, as well as lost wages and compensation for your injuries. The Lowe Law Firm can help. Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients around the nation who have been hurt by defective medications and dietary supplements.

If you would like to learn more about your rights and your options at a free, confidential consultation, please contact the Lowe Law Firm online or call toll-free at 1-877-678-3400 today.

Federal drug regulators warned consumers Friday to stop using the popular Hydroxycut line of weight-loss products, citing reports of a death due to liver failure and other instances of serious health problems.

Hydroxycut is sold as pills, drinks and powders.
In all, the Food and Drug Administration said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said.

The Hydroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the F.D.A.

That company, Iovate Health Sciences of Oakville, Ontario, and its American distributor are voluntarily recalling 14 of the products. Two other products, Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall. Calls to the company’s Canadian headquarters reached a recorded message that directed callers to the Hydroxycut Web site.

The recall of one of the best-known weight-loss brands is the latest in a series of incidents that raise the question of whether the Food and Drug Administration has adequate authority to regulate the dietary supplement industry and provide consumer protection.

At issue is the difference in the way the agency oversees drugs — defined as products that prevent or cure disease — and dietary supplements, which can offer general health benefits but cannot claim to treat specific diseases or symptoms.

Unlike drugs, whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products.

According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale.

“Part of the problem as you know is that F.D.A. looks at dietary supplements from a postmarket perspective, so that an isolated incident is often difficult to follow,” Dr. Linda Katz, interim chief medical officer of the agency’s Center for Food Safety and Applied Nutrition, said Friday.

The agency has been on a campaign to identify and warn consumers about tainted weight-loss pills that illegally contain prescription drug ingredients. Since December, the F.D.A. has issued a list of 70 brands that contained hidden and potential hazardous drugs including an antiseizure medication.

Representatives of the industry said that current regulations were adequate to protect consumers because manufacturers conducted their own safety tests.

“Nobody goes to market without testing,” said John Hathcock, vice president of scientific and international affairs at the Council for Responsible Nutrition, a trade group. He added that neither drug makers nor supplement manufacturers could ensure total product safety once an item moved from a testing lab into mass circulation.

The F.D.A. said that a new law that requires manufacturers to notify the agency of any reports of serious health problems helped officials identify a pattern of adverse events linked to Hydroxycut users. In addition, the agency cited reports in medical journals of serious liver disease being diagnosed in six people who had taken Hydroxycut.

The agency said the consumers were healthy before using Hydroxycut and took the recommended dose. Because the formula for Hydroxycut has changed over time and because the product contains different amounts of a proprietary blend of ingredients, the agency said it had not yet determined which of the product’s ingredients might constitute a health hazard.

Vitamin Shoppe and GNC said they were removing Hydroxycut products from their Web sites and stores. Several months ago, the companies stopped selling another well-known weight-loss brand, StarCaps, that was found to contain a powerful prescription diuretic.

A GNC spokeswoman wrote in an e-mail statement Friday, “As soon as we become aware of potential problems with any product, we take immediate action, as we have done in this situation.”

A court has ordered Neligen Pharmaceuticals and its parent company, Advent Pharmaceuticals, to immediately cease distributing more than 50 of its drugs. According to an April 10 Associated Press story, the U.S. Food and Drug Administration has a permanent injunction against the companies, barring them from manufacturing and distributing drugs that are adulterated, misbranded or not approved by the FDA. The drugs are mainly prescription cough and cold medicines -- but none have gone through the FDA approval process, so their safety, labeling and effectiveness are all in doubt.

According to the FDA press release, the companies (which also do business as Unigen Pharmaceuticals Inc.) agreed to a consent decree that requires them to destroy all of the drugs they currently have and stop manufacturing any new medications without FDA approval. They must hire outside experts to advise them on complying with regulatory standards, and may not resume operations until they have written permission from the FDA. After they do, the FDA may order them to stop their operations at any time if it finds a regulatory violation. The agency may fine the companies $1,000 per violation and up to $5,000 per day for any continuing legal violations.

As a defective prescription drug attorney, I am pleased to see the FDA cracking down on drug companies that abuse the public’s trust. Most of us assume that a drug wouldn’t even be on the market without FDA approval, so we trust that prescription medications are safe to use and adequately labeled. Companies that illegally bypass the FDA approval process betray that trust and expose consumers to potential serious injury from defective drugs or unannounced drug interactions. As a dangerous prescription medication lawyer, I have seen too many pharmaceutical companies’ cynical marketing tactics to believe that they would all be immune from the temptation to cut costs if they were not held accountable.

Based in St. Louis, The Lowe Law Firm represents people in Missouri, southern Illinois and throughout the United States. Our pharmaceutical liability lawyers sue on behalf of people who have lost a loved one or been seriously harmed because of a prescription or over-the-counter medication they thought they could trust. In these defective drug lawsuits, victims can win the money they need to pay for medical care or other bills related to the tainted medication; replace lost wages while they are out of work; and compensate them for a serious injury or illness, permanent disability or loss of a loved one. To learn more at a free, confidential consultation, please contact the Lowe Law Firm today.

Pharmaceutical company Genentech announced April 8 that it would remove its drug Raptiva (efalizumab) from the market for safety reasons. Raptiva is an injectable medication given weekly to patients who have psoriasis, a chronic skin condition. According to Forbes magazine, the move came almost two months after the U.S. Food and Drug Administration confirmed the medication’s link to a rare but deadly disease called progressive multifocal leukoencephalopathy, a viral infection of the brain. Patients using Raptiva are strongly encouraged to contact their doctors right away to discuss alternative treatments.

Ironically, the problems with Raptiva may stem from its effectiveness. Psoriasis is a chronic, lifelong condition that produces raised patches of scaly or inflamed skin. Doctors are not sure what causes it, but many believe it’s an autoimmune disorder in which an overactive immune system produces too many skin cells. Raptiva addresses the problem by partially suppressing the immune system -- stopping white blood cells from reaching tissues. Because of the suppressed immune system, Raptiva carries a risk of side effects including infection with viral meningitis and fungal disease.

Most recently, the FDA has discovered that it also raises the risk of progressive multifocal leukoencephalopathy (PML), a disease caused by infection with a common virus. Authorities believe most people have this virus, but it is latent in people with healthy immune systems. The most likely victims are people with immune problems, such as AIDS, or who are on immunosuppressant drugs after a transplant. PML inflames the white matter of the brain, destroying the myelin sheath on nerve cells and causing weakness, paralysis, blindness, speech impairments and eventually death. It resembles multiple sclerosis, but progresses much more quickly. There is no known cure.

Thus far, the FDA has identified two confirmed cases of deaths from PML in Raptiva patients, and suspects PML in a third death. A fourth patient has PML but has not died. Since October of 2008, the agency has revised the drug’s labeling twice and issued a public advisory once on the risk of PML. During that time, the European Union’s equivalent to the FDA has suspended all sales of the drug. Genentech is working with other regulatory agencies to inform them about Raptiva’s withdrawal from the U.S. market, but it has not stopped worldwide sales. According to Forbes, 46,000 people around the world have used Raptiva since 2003.

I applaud Genentech for doing the right thing and withdrawing this potentially deadly medication from the market. But as a dangerous prescription drug attorney, I wonder how long the company has known about this risk and what measures it took to detect it. Accidents happen, but I know that some drug companies are willing to suppress unfavorable safety information or manipulate scientific studies to ensure that their sales stay high. If investigation shows that Genentech knew about the risk, or even failed to do adequate testing, the manufacturer would be legally liable for all of the deaths and deadly illnesses that resulted. That could mean millions of dollars’ worth of defective prescription drug lawsuits.

Based in St. Louis, the Lowe Law Firm handles dangerous pharmaceutical legal claims throughout the United States. Our defective drug lawyers represent people who have lost a loved one or been seriously hurt because they trusted the wrong prescription drugs. If you are in this situation and you’d like to learn more about your options, we offer free, confidential consultations. To set one up, please contact the Lowe Law Firm online today or call 1-877-678-3400.

An email sent by an official at drug maker AstraZeneca admits that the company suppressed three clinical trials of its drug Seroquel because of unfavorable results, Bloomberg News reported Feb. 27. The message was revealed as part of an ongoing series of pharmaceutical injury lawsuits alleging that AstraZeneca knowingly failed to warn customers that Seroquel could cause diabetes and related health problems. In the December 1999 message, AstraZeneca official John Tumas told colleagues that the company “cherry-picked” data from one Seroquel study and failed outright to publicize two others that were unfavorable to its product.

Seroquel, an “atypical” antipsychotic, is approved to treat schizophrenia and bipolar disorder. Originally thought of as a vast improvement over older psychiatric medications, it came under fire in 2004, when a group of medical research organizations named it as one of six antipsychotics (along with Risperdal and Zyprexa) that promote diabetes, high cholesterol and obesity. At least 9,000 lawsuits have been filed alleging that AstraZeneca failed to warn patients of this risk. Many also allege that the company promoted its drug for illegal off-label uses. Spokesman Tony Jewell told Bloomberg News that the company acted responsibly and appropriately in its research and marketing.

The unsealed documents suggest that not everyone agrees, according to Bloomberg. In the 1999 email, Tumas chastised company officials for not disclosing the full results of the “cherry-picked” study, suggesting that the company’s reputation for ethical behavior was in danger. In another unsealed message, AstraZeneca official Richard Lawrence said the company had engaged in a “great smoke-and-mirrors job” with U.S. and Canadian regulators. And documents from 2000 show that company officials knew that the drug was linked to high blood-sugar levels, even though a 2000 FDA filing from the company said it had no documented evidence of a relationship between Seroquel and diabetes.

The Lowe Law Firm is actively pursuing lawsuits over injuries from taking Zyprexa, another of the atypical antipsychotics under fire for its connection with diabetes. If you or someone you care about has developed diabetes, obesity or another serious health problem from taking Seroquel, we would like to hear from you. In a successful defective drug injury lawsuit, you can win compensation for all medical bills related to an injury from Seroquel, as well as compensation for living with a serious health condition caused in part by a company’s failure to warn you of the dangers. Based in St. Louis, Missouri, the firm represents people with serious defective drug injuries around the U.S. To set up a free, confidential consultation, please call toll-free at 1-877-678-3400 or contact us online.

As a pharmaceutical injury lawyer, I was delighted with the U.S. Supreme Court’s March 4 ruling that drug manufacturers may not escape legal liability simply because their warning labels comply with FDA regulations. Wyeth v. Levine (06-1249). As the New York Times reported, the court ruled 6-3 that there is no implied preemption in federal law that would stop state juries from hearing drug injury lawsuits. The case was closely watched by pharmaceutical companies as well as drug injury lawyers around the country, because it had the potential to stop all drug injury claims, no matter how valid the claim or serious the injury.

The case was brought by Vermont resident Diana Levine, who visited a health clinic for migraine headache treatment. For her nausea, she was given an injection of Phenergan, a drug made by Wyeth. Phenergan is safe when injected into a vein, but causes swift and irreversible gangrene when exposed to blood in arteries. The assistant at the clinic made a mistake, and Levine lost her hand and lower arm -- and her livelihood as a musician. She sued and settled with the clinic, but also sued Wyeth, arguing that the manufacturer failed to sufficiently warn users about the risks of administering Phenergan incorrectly.

At trial, Wyeth argued that it should not be held responsible for Levine’s injury because it had followed all of the FDA labeling regulations that applied to the drug. It said the court should find that federal law preempts state claims through implied, not explicit, language. The Supreme Court rejected that argument, saying that Congress had explicitly stated that several federal laws preempt state laws and had the opportunity to include such language in drug regulations -- but chose not to. In fact, wrote Justice John Paul Stevens, the FDA welcomed dangerous drug lawsuits as a complement to its own work until 2006, when it underwent “a dramatic change in position” under the Bush Administration. He also criticized the FDA at length for its toothlessness in recent years.

As a dangerous prescription drug lawyer, I am delighted with this ruling, which ensures that people who have suffered permanent injury or lost a loved one to a defective medication can continue to seek justice through state courts. If the court had found that federal law does preempt state claims, it would have eliminated many valid pharmaceutical liability lawsuits brought by seriously hurt people. The painkiller Vioxx, for example, became the subject of thousands of lawsuits after it was revealed to quadruple patients’ chances of serious heart attacks and withdrawn from the market amid allegations that drug maker Merck knew about the problem long before it took action. None of those people would be able to hold Merck responsible for their injuries, or the deaths of their loved ones, if the preemption argument had prevailed.

I can always practice a different kind of law. But for my clients, a ban on dangerous drug litigation leaves them with no recourse if they have been seriously harmed by a drug maker’s irresponsibility -- even if, as was alleged with Vioxx, the manufacturer knowingly exposed its customers to serious harm. Thanks to the Supreme Court, patients still have that option. If you or someone you love was seriously hurt by a defective prescription drug, The Lowe Law Firm can help. To set up a free consultation about your defective drug claim, please contact us through our Web site or call 1-877-678-3400.

An over-the-counter weight-loss drug was recalled by the FDA due to serious safety risks, the Miami Herald reported Jan. 29. Venom Hyperdrive 3.0 was recalled after it tested positive in FDA laboratories for substantial amounts of sibutramine, a Schedule IV controlled substance not listed on the drug's label. The FDA is warning consumers to stop taking the drug immediately and contact their doctors for further medical instructions. They can also contact the manufacturer, Applied Lifescience Research Industries, at legal@alrindustries.com for instructions on returning the product for a refund.

As a controlled substance, sibutramine is illegal to dispense without a doctor's prescription. More importantly, the lack of warning makes the recalled supplement dangerous for people with heart disease, arrhythmia or a history of heart failure or stroke, because sibutramine increases blood pressure and heart rate. It's also contraindicated for people with several common conditions, including depression, eating disorders, a history of alcohol abuse or glaucoma. And it's not safe to mix sibutramine with certain other kinds of drugs, including opioid painkillers and a class of antidepressants called monoamine oxidase inhibitors.

This recall comes on the heels of a wider FDA recall of 69 weight-loss supplements that contain undeclared active ingredients, including drugs that are carcinogenic, controlled or not approved for use in the United States. Under these circumstances, selling a substance without telling consumers what it is may well be prosecuted as a crime. Even if it's not, this illegal and irresponsible behavior could kill many patients or cause them to develop serious or permanent health conditions. And that would expose manufacturers to hundreds or even thousands of drug injury lawsuits from people who have developed serious health conditions or lost a loved one to side effects of the supplements.

A defective drug lawsuit holds manufacturers legally responsible for their actions, but it also helps victims of unsafe prescription drugs recover some of the high financial costs of a sudden and serious health problem. An emergency room visit even for a minor problem can easily reach five figures; lifetime medical care for someone with a serious chronic condition can exceed the multi-million-dollar lifetime caps on health insurance plans. And of course, no price is high enough to compensate people who suddenly lose a loved one.

If you're facing these issues after you or someone you love took a defective prescription drug, the Lowe Law Firm can help. Our experienced defective prescription drug lawyers help people in Missouri and throughout the United States hold drug makers responsible for their carelessness. And we offer free consultations, so there's no risk in speaking to us about your case. To set up a free consultation today, contact the Lowe Law Firm online or call us at 1-877-678-3400.

Because I'm a drug injury attorney in St. Louis, I have been following the news about KV Pharmaceuticals, a troubled St. Louis generic drug manufacturer. The most recent news, reported Jan. 26 by Fierce Pharma, is that KV has recalled all of the products that it manufactures itself, which is more than 100 drugs and the majority of its products. It's the fifth drug recall for KV Pharmaceuticals in a year, following closely after November and December recalls of specific products.

As I've blogged here before, the December recall was of oversized pills of hydromorphone, a morphine-related painkiller, which raised concerns about possible overdoses. In fact, the same oversized pill problem prompted all of the 2008 recalls, although different drugs (including morphine and dextroamphetamine) were involved. The company already faces lawsuits from patients, as well as lawsuits over corporate governance matters that led the company to replace its president and CEO in December. The article says KV is being investigated by both the FDA and the SEC.

The FDA has not yet announced the newest recall, although KV's press release suggests that it eventually will. The release does not specify why the company recalled its entire line of drugs, but given the serious financial problems KV is facing, they must have had a very good reason. And given the oversized pill problems it had throughout 2008, more manufacturing defects could be the culprit. While the drugs involved are different, any drug with an oversized pill presents a risk of an overdose, and an overdose of a powerful prescription drug is a serious matter. Depending on the drug, patients could risk death, heart attacks, hallucinations and other very serious side effects.

Patients who have suffered these effects after taking defective drugs from KV Pharmaceuticals -- or any other company -- have the right to hold the careless manufacturer legally responsible for the results. Based in St. Louis, the Lowe Law Firm handles these pharmaceutical liability cases for clients in Missouri and throughout the United States. To speak with our experienced defective drug lawyers at a free consultation, please contact us online or call 1-877-678-3400 today.

A St. Louis-based drug maker has recalled some lots of generic Hydromorphone HCl and suspended shipments of other drugs because of manufacturing problems. According to an FDA press release, Ethex Corporation, a division of KV Pharmaceutical, recalled the painkiller Dec. 23 because the manufactured pills were larger than intended. This could cause an overdose of the drug, a morphine product with addiction potential and a federal Schedule II classification, leading to low blood pressure, breathing problems and sedation. People who think they might have the recalled drug (Lot #90219) should visit KV's Web site for more information on how to identify and return it.

This is the fourth recall by Ethex and KV over the last few months, according to an article by the St. Louis Post-Dispatch. Like this one, at least some of the past recalls involved oversized pills. At least two of them also involved morphine products that had the potential to addict patients or cause a fatal overdose. KV fired its longtime CEO for cause in December, has lost value on the stock market and doesn't expect to resume manufacturing its products until spring.

Morphine products are both useful and potentially dangerous because they are derived from opium. In addition to being highly addictive, they can slow the heartbeat and breathing, sometimes dangerously so. Oversized pills like the ones that were recalled could potentially give patients more of the drug than intended or marked on the packaging. In addition to raising the potential for a fatal overdose, this could also sedate patients more than intended, causing problems with driving or other everyday activities and raising the potential for a harmful drug interaction.

The article doesn't say how the corporate problems with this company may have affected its drug safety problems. But if a drug manufacturer or its decision-makers have suppressed important information about a drug's safety, the company is liable for a dangerous prescription drug lawsuit. In this case, that could mean multiple morphine overdose lawsuits filed by families who have lost a loved one to dangerously oversized pills. The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously injured by a pharmaceutical company's failure to warn patients of their products' defects. If you or someone you love has been seriously hurt in this way and you’d like to learn more, please contact us online for a free evaluation of your case.

The Lowe Law Firm has actively investigated cases of serious injuries and diseases stemming from the use of Zyprexa (olanzapine) in Missouri and throughout the United States. So we were pleased to see in the St. Louis Business Journal that Zyprexa's maker, Eli Lilly & Co., has agreed to an $800 million settlement with the U.S. Department of Justice over Zyprexa marketing practices. The settlement covers civil claims by federal and state Medicare and Medicaid agencies, as well as a $615 million fine for violating the federal Food, Drug and Cosmetic Act. Missouri's Medicaid agency will receive nearly $18 million as part of the settlement and Illinois will receive a combined $44 million for Medicaid and the state itself.

The claims stemmed from Eli Lilly's choice to market Zyprexa for off-label uses. The drug was approved by the FDA as an anti-psychotic for use with patients who have schizophrenia or bipolar disorder, but the company marketed it for a variety of maladies, including anxiety, age-related dementia and addiction to gambling. Marketing a drug for uses not approved by the FDA is illegal under the Food, Drug and Cosmetic Act. Unfortunately, Zyprexa has also been linked by research to serious blood-sugar and pancreas disorders, including diabetes, hypoglycemia and pancreatitis.

These are serious, chronic medical conditions that generally must be managed over the patient's entire lifetime. If they aren't detected and treated in time, they can lead to other serious medical problems, including diabetic comas, amputations and loss of eyesight. Just like other companies, drug makers like Eli Lilly have a responsibility to take reasonable care to avoid harming their customers. In this case, that could mean complete honesty about any information they may have had about Zyprexa and blood sugar disorders. It could also mean not encouraging primary care doctors to prescribe the medication for uses that weren't approved or intended by regulators.

When drug makers deliberately break laws and fail to warn the public about the risks of their products, they are legally liable for any harm they cause to their customers. In a defective drug lawsuit, consumers can win reimbursement for the cost of treating the side effects of dangerous medications; replace any income they lost; win compensation for the loss of their good health or a loved one; and ensure that the drug maker is forced to stop its deceptive and abusive practices. The Lowe Law Firm handles Zyprexa injury lawsuits and claims over many other defective prescription drugs, in Missouri and throughout the United States. If you believe you have a claim and would like to know more, please contact us today for a free consultation.

PriCara, a division of Johnson & Johnson, has recalled two lots of Duragesic, a chronic pain medication delivered through the skin using an adhesive patch. According to financial news site RTT News, the patches may have tears in the area containing the active ingredient. This disables their time-release system for dispensing the drug, an opiate called fentanyl, which can lead to an overdose. Like other opiates, fentanyl has potentially fatal effects in an overdose, including breathing problems, seizures and slow heartbeat. Information about the recall is available on Duragesic's Web site.

This is the second Duragesic patch recall by PriCara within 12 months. The patches were last recalled on Feb. 12, 2008, because of similar problems with tears in the drug's reservoir. Another recall in 2004 led to at least three successful lawsuits filed by people whose loved ones died because of a Duragesic patch overdose. The FDA has not taken the drug off the market in the United States, but its Canadian equivalent, Health Canada, issued a warning Jan. 7 that patients may need to change their dosage of fentanyl to avoid an overdose.

Because I am a defective prescription drug lawsuit attorney, I know that overdoses are not uncommon with transdermal patches. In my pharmaceutical liability practice, I represent clients who have lost a loved one or had serious medical problems because of defective Ortho Evra patches. Ortho Evra is a form of birth control similar to the Pill, but it delivers about 60% more estrogen than pills, sharply increasing the number of women who developed dangerous blood clots as side effects. Johnson & Johnson has paid at least $68 million to settle Ortho Evra lawsuits, but the patch is still on the market.

A similar delivery malfunction with a potent opiate like fentanyl could easily kill hundreds of people who use Duragesic and other fentanyl patches regularly to manage chronic pain. If it does, and the manufacturing or design of the patch is to blame, Johnson & Johnson could be held legally responsible for the results -- physical, financial and emotional. If you or someone you love was seriously hurt by a malfunctioning patch or other prescription drug, The Lowe Law Firm can help. We offer free, confidential case evaluations to potential clients. If you believe you may have a claim and you would like to know more, please contact us today for a free consultation.

A final report on the deadly contamination of the blood thinner heparin confirms that the problem was caused by a man-made chemical that was added to batches of the drug imported from China, The Washington Post recently reported.

The crisis, which began in November 2007, resulted in 152 adverse reactions and as many as 81 deaths in the United States. The Chinese heparin, contaminated with the chemical oversulfated chondroitin sulfate (OSCS), was found in at least 10 countries, according to federal officials.

Published in the December 18, 2008 issue of the New England Journal of Medicine, the report "describes the adverse reactions caused by the contaminant" and links it to a specific substance, Dr. Priti R. Patel, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention, explained. The reactions included a drastic drop in blood pressure, nausea and shortness of breath, starting within 30 minutes after the administration of the heparin.

"There is a definite link between this contaminant and the patients who had these reactions," Dr. Patel said.

Continue reading "Heparin from China found to be contaminated with man-made chemical--defective drug attorney." »

The U.S. Food and Drug Administration has warned consumers not to use any of 69 defective over-the-counter diet drugs, USA Today reported Jan. 7. The drugs covered by the warning have several active ingredients that are not listed on the labels, despite the fact that many are marketed as "natural" or "herbal" dietary supplements. The active ingredients include rimonabant, which failed to win FDA approval, and has been withdrawn from the market in Europe after authorities there linked it to five deaths and 720 adverse reactions. A full list of the affected drugs is available in the FDA's press release; consumers who have taken the drugs are urged to speak to doctors immediately.

Other unlisted but potentially dangerous active ingredients in the drugs include phenytoin, an anti-seizure medication; phenolphthalein, a suspected carcinogen; and sibutramine, a controlled substance related to the defective diet drug Fen-Phen. Sibutramine is approved for sale in the United States as Meridia, but has a wide variety of serious side effects, including high blood pressure, seizures, partial paralysis, breathing problems, serotonin toxicity and suicidal thoughts. Because of those side effects and potential drug interactions, it is not prescribed for people taking certain antidepressants and migraine medications, as well as those with heart and blood pressure problems, seizures, hyperthyroidism or certain psychiatric disorders.

By selling sibutramine, rimonabant and other potentially dangerous drugs without disclosing their ingredients, the manufacturers of these diet pills bypass the safeguards in our prescription drug system. This puts the drugs' users at risk of death or disabling chronic medical conditions -- when they thought they were taking harmless dietary supplements. The drug makers, most of which are located in China, may face criminal charges after an investigation. But for victims, criminal charges almost always come too late, after they've lost a loved one or suffered grave complications due to the defects in these "natural" supplements.

Treating a serious medical emergency can cost tens of thousands of dollars; a permanent chronic illness or disability can run into six or seven figures over a lifetime, not counting lost income for those who can no longer work. And these figures don't take into account the devastating personal losses suffered by victims and their families. To recover those costs and hold pharmaceutical companies responsible for their actions, many victims choose to bring defective drug lawsuits. The Lowe Law Firm has substantial experience with these dangerous medication claims. Based in St. Louis, we represent clients in Missouri, southern Illinois and throughout the United States. For a free consultation about your own claim, you can contact us online or call toll-free 1-877-678-3400.

Levaquin, Cipro and other fluoroquinolone antibiotics continue to be over prescribed despite the risks of suffering the disabling side effects of tendinitis and tendon rupture.

This family of drugs includes Cipro (ciprofloxacin), Proquin (ciprofloxacin hydrochloride), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin (ofloxacin).

According to a recent article in the Atlanta Journal-Constitution, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics in 2007. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and in patients given these antibiotics in conjunction with steroid therapy.

Some studies have concluded that the powerful drugs are often prescribed even when no antibiotic is needed or a safer antibiotic is more appropriate.

A study conducted by the University of Pennsylvania found that out of 100 patients prescribed fluoroquinolones, 81 received it for inappropriate conditions.

Last summer, the Food and Drug Administration told drug makers to add a black-box warning to fluoroquinolone antibiotics that come in pill and injectable form. Pharmacists are also required to provide an FDA-approved guide to patients who pick up prescriptions for this class of antibiotics.

The push to finally get out information is long overdue. Even some doctors don’t know about the dangers.

Dr. J.T. Cooper of Marietta, Georgia told the AJC that he didn’t know about the potential side effects when he began taking Levaquin for pneumonia. He suffered a near rupture of his Achilles tendon last September. Cooper was hospitalized for six days and lost two weeks of work. He has spent several weeks in a boot brace and won’t be able to resume driving until the end of the month.

Adverse reactions to prescription drugs cause more injuries and deaths in the United States than illegal drugs. If you have suffered medical complications from a prescription medicine or over-the-counter drug, an attorney with experience can advise you on your right to recover compensation for medical expenses, lost wages and pain and suffering.

For more information, fill out our online contact form or call 314-678-3400 or toll free 877-678-3400.

Two different medications from the same manufacturer will get a “black box” warning from the FDA, the Washington Post reported Dec. 11. The FDA issued the warning for OsmoPrep and Visicol, drugs used to clear out the bowels before a colonoscopy, after discovering a strong association between the drugs and acute phosphate nephropathy (acute kidney damage). Both drugs are made of sodium phosphate by Salix Pharmaceuticals. The FDA has ordered the manufacturer to distribute materials informing patients of the problem and conduct a new clinical trial of the drugs.

According to an FDA doctor quoted in the article, the agency has received 20 reports of kidney injury associated with OsmoPrep, with an onset ranging from several hours to 21 days after use of the drug. The agency in 2006 warned patients with kidney problems to avoid the drugs, and has now added children, older patients and patients with certain health problems or taking certain medications to that list. Patients and their doctors can choose alternative drugs not containing sodium phosphate.

It is interesting to me, as a dangerous drug lawyer in Missouri and Southern Illinois, that this is the second warning in two years about this drug and acute kidney damage. The article doesn’t say whether or when Salix and the FDA knew that the high levels of phosphates in the drug could be harmful for everyone. But in general, pharmaceutical companies have a legal and ethical responsibility to disclose serious health risks of their drugs as soon as they know of them. All too often, they choose not to because of concerns about how bad PR could affect their profits.

When manufacturers place their profits over patient safety, they are legally liable for any deaths or injuries that result. Patients who are harmed in this way have the right to file a defective drugs lawsuit to recover their financial costs (including medical costs and time off work they wouldn’t have otherwise incurred), as well as compensation for a wrongful death or permanent disability.

At the Lowe Law Firm, our experienced dangerous drug lawyers have handled many such cases, including a large confidential settlement for six clients who suffered permanent heart damage from using diet drug Fen-Phen. If you or someone you love has been hurt by a drug whose dangers you believe were covered up and you’d like to discuss your case with us, please contact us for a free initial consultation. We offer house calls and hospital calls for potential clients who are not able to travel.

Avastin one of the new generation of gentler cancer drugs according to a report published in the Journal of the American Medical Association called for a “black box” warning -- the FDA’s strongest, according to USA Today
-- the Nov. 18 report was an analysis of studies on the drug Avastin, which is approved for breast, colon and lung cancer patients.
In the new report, scientists found that about 12% of patients using Avastin developed potentially life-threatening blood clots, giving them a rate of blood clots that was 30% higher than the rate among cancer patients not using the drug. Blood clots can be dangerous because they can block blood flow completely, causing tissue death or a pulmonary embolism that cuts off the patient’s oxygen.

Blood clots are a common problem among cancer patients, according to the newspaper -- but evidence from this study shows that they are more common among cancer patients using Avastin. Because the clots are potentially life-threatening, the study’s authors called for an FDA “black box” warning about the risk for patients and their doctors. A spokesperson for Avastin’s maker, Genentech, demurred, pointing out that the FDA already runs a warning about the risk of blood clots on the drug’s label.

As a Missouri defective drug attorney, I hope patients take that warning seriously. In our prescription drugs practice at the Lowe Law Firm, we represent patients of all kinds who have been seriously hurt by prescription drugs that had serious dangerous side effects. In many cases, we have been able to prove that the manufacturer knew about the problem in advance but didn’t disclose it publicly -- sometimes, not until after an aggressive marketing campaign. This dishonest behavior betrays the patients and doctors who trust drug makers, and puts patients in serious danger.

At the Lowe Law Firm, we help victims of this dishonest behavior hold manufacturers legally liable for their actions. To speak with one of our experienced defective drug attorneys about your own case and your legal options, please contact us online or call us toll-free at 1-877-678-3400.

A federal advisory panel concluded that two drugs, Serevent and Foradil, should be banned for use in the treatment of asthma, according to Reuters.

Studies have shown that when Serevent and Foradil are used without a steroid, the drugs can trigger more severe, life-threatening asthma attacks.

The panel of safety experts also recommended that two other asthma drugs, Advair and Symbicort, continue to be used on adults and children. However, the votes were far from unanimous on the question of use by children.

Advair is approved for children ages four and older. The advisory panel voted 13-11 with three abstentions to allow children in the youngest age group to use Advair.

Symbicort is approved for children ages 12 and older. The advisory panel voted 20-5 with two abstentions to allow children that age to use Symbicort.

The four asthma medications contain a drug known as long-acting beta agonist. The drug safety questions were raised after a study showed that Serevent could worsen asthma and even cause death, National Public Radio reports.

Adverse reactions to prescription drugs cause more injuries and deaths in the United States than illegal drugs. If you have suffered medical complications from a prescription medicine or over-the-counter drug, an attorney with experience can advise you on your right to recover compensation for medical expenses, lost wages and pain and suffering.

For more information, fill out our online contact form or call 314-678-3400 or toll free 877-678-3400.

A study released on Dec. 2 confirms what many previous studies have already found: Patients given the anti-bleeding drug Trasylol have a higher risk of dying than those who receive less expensive clotting drugs.

Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. While Trasylol (aprotinin) was found to be more effective at controlling blood loss than lysine analogues, the higher fatality rate associated with the drug as well as its expense outweighed the benefits.

Dr. David Henry, one of the co-authors of the study which will be published in the Jan. 20 issue of the Canadian Medical Association Journal, concluded:

"Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality."

Since 2006, several studies have linked Trasylol to an increased risk for kidney damage, stroke and death. If Bayer, the maker of Trasylol, had removed the drug from the market when it learned of the health dangers, it is estimated that 22,000 lives could have been saved.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

The Journal of the American Medical Association reported last week that it found that artificial blood raised the risk of death by 30 percent and tripled the chances of suffering a heart attack.

The researchers reviewed data collected from sixteen clinical trials and concluded that the dangers were so great that the U.S. Food and Drug Administration should have halted the studies eight years ago.

Because the FDA received the data in 2000, the researchers argued that the agency should have stopped the human trials until a large-scale analysis could be completed. The researchers also blasted a rule that forced the FDA to keep new product information confidential.

In an interview with Bloomberg News, Charles Natanson, one of the study’s authors and a septic shock researcher at the National Institute of Health, said,

“If you have secret science, things like this can happen. Once you’ve randomized patients, your results can’t be a trade secret. It’s a measure of protection to the American public.”

The companies at the center of the blood substitute study include Baxter International Inc., Biopure Corp., Hemosol BioPharma Inc., Northfield Laboratories Inc., and Sangart Inc.

Because actual blood must be refrigerated, has a shelf-life of just over 40 days, carries a disease transmission risk, and may only be used with compatible blood types, pharmaceutical companies have been working on a blood substitute.

Sidney Wolfe, one of the study’s authors and the director of the Washington-based advocacy group Public Citizen, Inc., told Bloomberg News that none of the original trial results were published immediately and the FDA reviewed each study separately.

Wolfe said:

“When we talk about things that make it more likely people will be harmed or killed, and you keep it a trade secret, it's inexcusable.”

Once again, the pursuit of profits by drug companies was left unchecked by an impotent FDA. As was the case with Trasylol, Vioxx, and Avandia, the patient is the one who pays the price.

The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescriptions drugs and medical devices. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

Bayer is finally removing the remaining supplies of Trasylol from the U.S. market after a long-awaited Canadian study confirmed yet again that the anti-bleeding drug is dangerous.

On May 14, the BART study was published in the New England Journal of Medicine. Researchers found that heart surgery patients who were given Trasylol were 53 percent more likely to die than patients who were given cheaper blood clotting drugs.

That same day, Bayer notified the U.S. Food and Drug Administration that it will begin removing remaining Trasylol stock from the American market, most of which can be found in warehouses and with doctors and hospitals.

This should have been done a long time ago. Since 2006, three studies have linked Trasylol to an increased risk for kidney damage, stroke and death. If Bayer had removed the drug from the market when it learned of the health dangers, it is estimated that 22,000 lives could have been saved.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

The results of the long-awaited Canadian study on the anti-bleeding drug Trasylol were announced today in the New England Journal of Medicine.

Researchers found that patients who were given Trasylol, known generically as aprotinin, had a 53 percent higher death rate than patients who were given comparable drugs.

In an editorial that accompanied the BART study, Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University wrote:

“Thus, in all likelihood, this is the end of the aprotinin story.”

Trasylol is made by Bayer. On Jan. 20, 2006, an article suggesting a link between Trasylol and renal toxicity was published in the medical journal Transfusion. Later that same month, the New England Journal of Medicine published an article, co-authored by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.

In the fall of 2006, an FDA advisory board met to decide whether the warning on Trasylol needed to be changed. At the meeting, Bayer failed to disclose the findings of a Trasylol study it had funded. In that study, Dr. Alexander Walker—a professor at the Harvard School of Public Health—reviewed the hospital records of 67,000 patients and found that those given Trasylol had a risk of death 64 percent higher than that of patients who received a comparison drug. It wasn’t until November 2007 that the drug was finally pulled from the market.

The BART study is significant because it was designed as a side-by-side comparison of aprotinin with two other drugs, tranexamic acid sold under the brand name Cyklokapron and aminocaproic acid, sold under the brand name Amicar.

Not only are the comparison drugs safer, they’re much cheaper. According to an article in Reuters, a Trasylol treatment costs between $1,200 and $1,500. The other two drugs cost about $150.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

The Food and Drug Administration’s top staff regulators were against shielding drug makers from lawsuits, the Los Angeles Times reports.

Internal documents released by Rep. Henry A. Waxman (D-Beverly Hills) reveals that top FDA regulators did not trust pharmaceutical companies to warn patients of new risks associated with prescription drugs. However, Bush Administration appointees argued that, under the legal doctrine known as preemption, the FDA process approving drug labels should be sufficient to shield drug makers from consumer lawsuits.

But the FDA’s own experts on the drug approval process disagreed.

Dr. John Jenkins, director of the Office of New Drugs, wrote in a 2003 memo:

"The premise of the basis for much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real-time basis. We know that such an assumption is false."

As the LA Times’ reporter David Savage points out, the FDA has regulated new drugs for more than 100 years. At the same time, the FDA did not attempt to block lawsuits filed against drug makers by patients who were hurt by dangerous drugs.

Now that right is at stake. In a case before the U.S. Supreme Court, Wyeth is asking the Court to shield it from a lawsuit filed by a musician who lost her arm as a result of gangrene caused by an anti-nausea drug.

Like the experienced staff regulators at the FDA, attorneys who represent victims who have been harmed by dangerous drugs understand that drug makers are not eager to disclose all the risks associated with their medicines. Lawsuits play a vital role in protecting the American consumer.

My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

A woman who claimed diet drugs caused her lung-destroying disease has been awarded $3 million by a New Jersey jury, Bloomberg News reports.

The verdict against Wyeth, the maker of Pondimin, was handed down on Oct. 22. The plaintiff, Gloria Stribling filed suit in Bergen County Superior Court after she was diagnosed with primary pulmonary hypertension, an often-fatal illness.

Pondimin and another Wyeth-made drug, Redux, were often combined with phentermine to form the appetite suppressant fen-phen. More than six million people were described the diet-drug cocktail before Wyeth pulled the drugs from the market in 1997 after researchers linked the treatment to heart damage and PPH.

Stribling took the fen-phen combination from November 1995 to October 1996. She was diagnosed with PPH a decade later. The trial against Wyeth began on Sept. 3. The jury concluded that Pondimin was a “substantial contributing factor” in causing the lung disease.

Wyeth, which has set aside $21 billion to cover costs associated with fen-phen litigation, is reviewing post-trial options.

It is now well-established that new cases of PPH caused by the diet drugs are now being diagnosed for the first time. This is because there may be a latency of 10-20 years after cessation of the diet drugs before the PPH disease occurs.

The Lowe Law Firm has tried and or resolved Fen-Phen opt-out cases . We are dedicated to obtaining compensation for people who have this disease through the negligence or deceit of drug companies. Although drug company executives were warned of the dangers of these drugs and knew of many cases of Fen-Phen-related PPH, they hid this information from the public.

If you believe that you or a loved one has contracted PPH from using Fen-Phen, contact The Lowe Law Firm today. We can help you obtain the compensation you're entitled to by law.

Pfizer Inc. has agreed to pay $894 million to settle personal injury and consumer fraud claims involving pain medications Bextra and Celebrex.

The announcement, made on Oct. 17 by New York-based Pfizer, will settle about 90 percent of the lawsuits filed against the drug maker over the COX-2 inhibitor. The Cox-2 family of drugs is suspected of increasing heart attacks.

In 2005, the Food and Drug Administration asked Pfizer to remove Bextra from the market. It has been associated with Stevens-Johnson syndrome and toxic epidermal necrolysis, a pair of rare and potentially deadly skin diseases.

Celebrex is still on the market despite claims that it patients risk blood clots, heart attacks, strokes and other cardiovascular problems if they use the drug.

From the settlement, about $745 million will be used to resolve the personal injury lawsuits. Approximately $60 million will be used to settle claims brought by 33 states and the District of Columbia alleging that Bextra was inappropriately marketed. Another $89 million will be used to settled consumer fraud cases.

My law firm currently represents Bextra and Celebrex victims and their families in lawsuits. The lawyers of The Lowe Law Firm are experienced in helping people injured by defective and dangerous drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

Last month, the preliminary results of a German study were released that suggest stroke patients who take certain anti-anemia drugs increase their chances of dying.

The U.S. Food and Drug Administration warned on Sept. 26 that a clinical trial investigating the use of high doses of epoetin alfa to treat acute ischemic stroke found that patients who received the drugs died nearly twice as often as the patients who received the placebo. Sixteen percent of patients who received the anti-anemia drugs died. Patients who received a placebo had a nine percent death rate.

According to the U.S. News & World Report, epoetin alfa is used in drugs such as Aransep, Procrit and Epogen. Although the drugs are on the U.S. market, they have not been approved for use in stroke recovery.

This past July, the FDA required the makers of Aransep and Procrit warning that the drugs can cause cancer tumors to spread and raise the risk of bleeding. Although an FDA advisory committee recommended keeping the drugs on the market, the committee urged that they not be used in people with curable cancer.

In its most recent safety warning, the FDA indicated it will be reviewing additional data over the course of several weeks. Once the review is complete, the FDA will issue conclusions and recommendations.

The Lowe Law Firm offers a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

On Nov. 3, the U.S. Supreme Court will hear oral arguments in an important case which could threaten the rights of consumers to sue drug makers over dangerous prescription medicines.

In 2000, musician Diana Levine went to the hospital complaining of nausea associated with a migraine headache. Doctors injected the anti-nausea drug Phenergan, which is made by Wyeth, into her muscles. When the medicine failed to rid Levine of her nausea, her physicians decided to administer the drug a second time. Instead of using an IV drip, her doctors gave her the drug by using an “IV push” method in which the medicine is delivered directly into the vein. The drug made contact with her arteries causing gangrene. Her arm had to be amputated as a result.

Levine sued Wyeth in Vermont state court alleging that the drug company failed to warn of the risks associated with an IV push of Phenergan.

The Phenergan label had been approved by the Food and Drug Administration in 1955 and re-approved in the 1980s. Although Wyeth knew that the anti-nausea drug could cause gangrene if it reached the arteries, it did not mention the dangers associated with the IV push method. In addition, there was no evidence that the FDA ever considered whether the label should have contained such a warning.

The jury sided with Levine and awarded her $6.7 million. Wyeth appealed, arguing that the FDA approval process overrides state tort law. The Virginia Supreme Court disagreed, concluding that nothing in federal law prevented Wyeth from providing additional warnings.

On Jan. 18, the U.S. Supreme Court agreed to take the case, Wyeth v. Levine, to consider the preemption issue.

The stakes are high. Friend of the court briefs urging the Court to adopt Wyeth’s position have been filed by pharmaceutical groups, the U.S. Chamber of Commerce and the Bush administration. Amicus briefs urging the Court to uphold the jury award have been filed by a number of consumer groups.

My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases. This legal argument of preemption is the result of an expansion of power by the Bush Administration. Hopefully the Supreme Court will not decide in favor of this unjustified protectionism of drug companies.

My prediction is that there will be limited preemption but not total preemption. Based on the facts of the case the Supreme Court took I think they will hold in a 5-4 decision that if the drug company provided all of the required information to the FDA and the FDA considered it, that an injured person will not be able to claim that the warning is inadequate. We will just have to wait until January 2009 to see. Also if they completely preempt prescription drug cases it looks like there will be a democratically controlled House, Senate, and Presidency, and they can write new legislation overturning the Supreme Courts ruling.

According to an announcement made by the U.S. Food and Drug Administration, Bayer’s clotting drug Trasylol will now only be available for investigational use.

To use Trasylol, a doctor must conclude that a heart surgery patient has a high risk for blood loss, no other medication will work and that the “benefits of the drug clearly outweighs the risks.”

The news was part of a May 14 statement in which the FDA also indicated that Bayer had agreed to pull the remaining stocks of Trasylol from the U.S. market.

Earlier that same day, the Bart study was published in the New England Journal of Medicine. The study concluded that heart surgery patients given Trasylol had a 53 percent higher chance of dying than patients given less expensive, comparable drugs.

Since 2006, three studies have linked Trasylol, also known as aprotinin, to an increased risk for kidney damage, stroke and death.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

According to an announcement made by the U.S. Food and Drug Administration, Bayer’s clotting drug Trasylol will now only be available for investigational use.

To use Trasylol, a doctor must conclude that a heart surgery patient has a high risk for blood loss, no other medication will work and that the “benefits of the drug clearly outweighs the risks.”

The news was part of a May 14 statement in which the FDA also indicated that Bayer had agreed to pull the remaining stocks of Trasylol from the U.S. market.

Earlier that same day, the Bart study was published in the New England Journal of Medicine. The study concluded that heart surgery patients given Trasylol had a 53 percent higher chance of dying than patients given less expensive, comparable drugs.

Since 2006, three studies have linked Trasylol, also known as aprotinin, to an increased risk for kidney damage, stroke and death.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.