Drug Injury Attorney Blog

Drug giant GlaxoSmithKline recently lost a ruling when U.S. District Judge Timothy Savage rejected the company’s attempt to have a Paxil lawsuit thrown out of state court and moved to federal courts in Philadelphia instead.

Glaxo’s goal was to try to maintain that even though the company is based in Philadelphia, the company’s "nerve center" was actually in Delaware. They argued that because of this, the case should be tried in federal court instead of state court. The lawsuits brought up in this ruling were originally filed in the state court in Philadelphia, but Glaxo wanted the cases removed to federal court in Philadelphia by claiming that the plaintiffs were each from different states. The tactic of claiming citizenship in Delaware didn’t work with the judge, however, because the judge ruled that Glaxo’s pharmaceutical and consumer healthcare business is "directed, controlled and coordinated from Philadelphia." The judge also stated that Glaxo is the "primary and significant part," of the holding company that is based in Delaware, and that the company's "nerve center" in Pennsylvania.

Judge Savage’s report stated that GlaxoSmithKline "is a Pennsylvania citizen and cannot remove a case from a Pennsylvania state court on the basis of federal diversity jurisdiction."

Paxil is an SSRI medication that is used to treat a variety of conditions, including depression, anxiety and obsessive compulsive disorder. Paxil has been linked to a variety of serious adverse side effects as well, such as aggressive thoughts and behavior, suicidal thoughts and behavior, and birth defects in babies whose mothers use the drug while pregnant. These adverse side effects have exposed Glaxo and Paxil to a blizzard of negative publicity and subjected Glaxo to thousands of lawsuits.

Studies have even been able to show that the side effects may not even be worth the risk, since the drug doesn’t work any better than placebos at curing depression symptoms. For this reason, many doctors are now prescribing lifestyle changes like exercise and talk therapy instead.

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 " »

A recent article posted on AlterNet.org summed up the FDA’s official mode of operation with accuracy when the author posted: “It’s said that it takes 22 FDA safety officers to change a light bulb: 12 to defend the decision to install it, 8 to call in another lighting option, 6 to quote Big Pharma studies and one to say it doesn’t need changing, it just needs a better label.” The FDA’s recent panel meeting about Yaz resulted in a vote saying that all that is needed to protect the public against the drug’s harmful side effects is to write better and clearer warnings.

Bayer’s “magic birth control pill” was launched in 2006 and marketed as a cure for everything from acne to PMS. The problem with that is that women began suffering from serious side effects after taking it. Yaz and its sister pill Yasmin started causing women to developed blood clots (which led to heart attacks, strokes, thromboembolisms and pulmonary embolisms) and gallbladder disease. These serious and life-threatening side effects are what caused the newsletter Worst Pills Best Pills to warn the public that drospirenone, the main ingredient in Yaz and Yasmin, could cause “serious heart and other health problems such as a change in acid balance of the blood and muscle weakness.”

The FDA had an opportunity to investigate the dangers of Yaz and Yasmin nine years ago; instead, regulators decided to ban the newsletter’s editor, Sidney Wolfe, MD, head of the Public Citizen Health Research Group, from participating in the vote that took place recently during a panel advisory meeting on the drug. The FDA based its decision on the fact that it deemed Wolfe to have an “intellectual conflict of interest” since he deemed Yaz a “do not use” drug.

This is not the first time that the FDA tried to stop Wolfe from speaking, either. Back in 2010, during the hearings about Jazz Pharmaceuticals’ drug Rekinla, the regulators turned off Wolfe’s microphone after he asked “why the manufacturer’s guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings.”

Since the FDA refuses to recall Yaz or Yasmin, and Bayer stubbornly stands by the safety of the drugs, the lawsuits likely won’t stop anytime soon as women will continue to suffer the serious and potentially deadly consequences of taking the pills.

The "patent cliff," a term used to describe the ongoing expiry of various prescription medications, has started. As a result of this patent cliff, India's pharmaceutical companies hope to make millions in profits by capitalizing off of generic versions of name brand medications like Levaquin.

In the next three years, countless prescription medications like Levaquin will lose their patent protection. When this happens, drug companies in various countries like China and India can make a huge profit off of generic versions of these drugs. Patents generally protect the original makers of name brand drugs for about 20 years of exclusive rights to sell them. Once that time period expires, other drug companies can start making cheaper versions of the pills and sell them. What this means is that when the patent protection expires, the first company to challenge the patent will get to sell the drug exclusively for a period of 180 days. That is plenty of time to profit before other companies start selling their own versions.

The antibiotic medication Levaquin is set to be one of those drugs. Levaquin is used to treat various infections, including sinus infections. The drug has also been linked to adverse side effects including tendon ruptures which have caused many patients to file lawsuits. The tendon ruptures are generally linked to elderly patients and those who are taking corticosteroids, but younger patients have also suffered from tendon ruptures after taking Levaquin. Some people have even accused the makers of Levaquin of purposely marketing the drug to seniors, who are more susceptible to the adverse effects. If that claim is true, senior patients in countries like China and India are more likely to suffer from adverse effects linked to Levaquin.

With so many dangers linked to the drug in the United States, it is a wonder that other countries want to sell it at all.

On November 3, 2011, another Yaz lawsuit filed in the Court of Common Pleas of Lawrence Country, Pennsylvania, was removed to the United States District Court for the Western District of Pennsylvania. The court order states that Bayer, the defendant in the case, is planning on calling the case a potential “tag along” to the current Yaz/Yasmin MDL that is happening in Illinois.

This newest Yaz lawsuit was filed by Phil Gallo and Randi Daugherty on behalf of their daughter, Michala Gallo. Michala suffered from gallbladder disease, blood clots and a pulmonary embolism after taking Yaz. Each of those side effects is serious and potentially life-threatening. The plaintiffs are claiming that Michala had also suffered from chronic cholecystitis after taking Yaz, which is a condition that causes the gallbladder swell and get irritated, which can also lead to patients developing gallstones. This alone is terrible, but that wasn’t the end of Michala’s trials.

Aside from the gallbladder disease, the plaintiffs are claiming that Michala also suffers from acid reflux, nausea, diarrhea and large hematomas. They feel as if Yaz caused those complications as well. Yaz has been linked to many life-threatening side effects, including gallbladder disease and blood clots that can lead to heart attacks, strokes, pulmonary embolisms and deep vein thrombosis.

Most recently, the FDA announced that it was trying to get the labels of Yaz and Yasmin updated to include more in-depth warnings against the blood clots that have been the source of a lot of controversy and panel advisory meetings as of late. The first of the Yaz Bellwether trials are to begin early in 2012, with more to follow soon after them. Thousands of patients and their families have filed lawsuits against Bayer, the makers of Yaz and Yasmin, after suffering from debilitating side effects linked to the pills. This newest tag along case to the MDL is just a drop in the bucket in comparison.

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 " »

The FDA has decided that it is going to ask that more warning information be added to birth control pills like Yaz. The desire of the regulators is to ensure that full warnings are provided about Yaz and its potential to cause blood clots that can lead other potentially fatal conditions.

The FDA had previously announced that with conflicting reports about just how dangerous Yaz is as it pertains to blood clots, there is a large need for the warning label clarification. In fact, FDA scientists said, "We believe that, because of the consistency in recent reports of an increased risk, product labeling should reflect that very real possibility," Canada's CBC News reported.

These blood clot dangers forced the FDA to launch an investigation into Yaz oral contraceptives after Bayer allegedly tried to hide the blood clots risks from them. The commissioner of the FDA, David Kessler, stated that the reports that Bayer sent them did not include a draft opinion from Bayer’s own researchers that showed Yasmin’s increased likelihood of causing blood clots over other birth control pills.

"Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin," Kessler said. "The company also promoted the oral contraceptive for unapproved uses, particularly for treatment premenstrual syndrome."

The FDA also has announced plans to block a move to remove the age limitations on patients looking to buy the "Plan B" contraception. At the moment, consumers cannot purchase the Plan B contraceptives unless they are at least 17 years old. However, the FDA does want to have the Plan B pills placed next to condoms in the drugstores, but Kathleen Sebelius, Human Services Secretary, intervened and prevented it.

Yaz has been a problem for Bayer for the past couple of years, once it got out that the pills came with serious adverse side effects. Some of those side effects include gallbladder disease and blood clots that can lead to heart attacks, strokes, pulmonary embolisms and deep vein thrombosis.

A recent federal study finds that foster kids are being overtreated with psychotropic drugs, including antidepressants like Paxil. It turns out that foster children who are on Medicaid are being treated with prescription medications more antipsychotics and antidepressants more than other kids who are covered by Medicaid.

This new Government Accountability Office (GAO) study has various healthcare professionals and lawmakers concerned that physicians are overprescribing powerful antidepressants like Paxil to foster children. Since the kids are state wards, many of them are coping with various emotional difficulties after living such difficult lives at home, and because of that they are being given rather high doses of antidepressants and antipsychotic drugs as a means of coping.

In addition, it is not uncommon for children involved with Medicaid to be sent to general practitioners instead of counselors for treatment.

Child psychiatrist Jon McClellan, University of Washington, stated that, “The high-risk practices identified by the GAO study raise significant concerns regarding the treatment of severely mentally ill and vulnerable youth.”

The study also pointed found that foster children were also many times more likely to be taking more than five different psychotropic drugs at a time compared to other children on Medicaid. Paxil was only one of the antidepressants used in the study; Abilify, Risperdal and Cymbalta were also mentioned in the study, as well as Ritalin and Stratter, which are used to treat attention deficit hyperactivity disorder.

This news is likely to be very alarming to doctors, many of whom feel that these drugs carry too many adverse side effects to be given to children at all. Paxil, for example, has been proven to cause patients to suffer from homicidal and suicidal behaviour, and should not be prescribed to vulnerable children; especially those in foster care who are more vulnerable than most. And it is especially risky to prescribe antidepressants like Paxil when research has also shown that the drug may not be any better at treating depression and anxiety any better than a change of lifestyle, placebos and talk therapy.

The menopause drug Prempro is a major area of interest right now for pharmaceutical liability attorneys like me. Prempro was prescribed widely about a decade ago for symptoms of menopause, such as hot flashes, but fell out of favor in 2002 after studies connected it to an increased risk of cancer. Since then, manufacturer Pfizer has faced numerous lawsuits alleging that the drug is responsible for their new breast cancer diagnoses. One of these, in Pennsylvania state court, ended with a victory for three women, according to Bloomberg News. Susan Elfont, Bernadette Kalenkoski and Judy Mulderig received a verdict totaling $72 million in their Prempro cancer lawsuit. This is the tenth loss of 18 Prempro lawsuits that have gone to trial, the article said.

All three women are in their late sixties, and none had a family history of breast cancer before being diagnosed. Kalenkoski, a former nursing home aide, took Prempro for more than four years; the others took a combination of the prescription drugs Premarin and Provera, which were combined in Prempro starting in 1995. In all three cases, experts testified that their use of the drugs was likely the reason for the cancer. The initial cancer finding came from a long-term FDA study of 16,000 women taking either Prempro or a placebo. The study was stopped in 2002 after researchers found a much greater rate of breast cancer, stroke and heart attacks in the Prempro patients. The finding halved the number of American women on hormone replacement therapy and led the FDA to require its strictest warning label starting in 2003. A follow-up study in 2010 found that Prempro patients were twice as likely to die.

As a dangerous drug lawyer, I’m pleased to hear that these patients have won their lawsuit. The article mentions that Pfizer has put aside $772 million to settle or try Prempro cancer lawsuits, so it is clearly expecting many more. That’s good, because at the height of the drug’s popularity, six million American women were taking it. Though not all of those patients will be diagnosed with Prempro-related breast cancer, even a fraction of those six million could add up to many thousands who would have the right to seek fair compensation from Pfizer. To make matters worse, there is some evidence that the company’s Wyeth division tried to plant shoddy research in medical journals to downplay the bad results. Suppressing or downplaying negative research may protect profits, but it can put thousands of patients at risk.

At Carey, Danis & Lowe, we represent clients who suffered serious injuries or lost a family member because they took a prescription drug they thought they could trust. Just like all manufacturers, the makers of prescription medications have a legal responsibility to make sure their products are safe to use as directed and carry adequate warnings to patients. When they fail to do this, they are legally liable for any injuries suffered by patients. That includes the loss of a loved one to an avoidable cancer diagnosis or other serious illnesses. Our defective drug attorneys help clients across the United States claim financial damages, including money for all of their medical costs, lost wages and other financial expenses and compensation for their pain, suffering and emotional losses.

Continue reading " Jury Awards $72 Million to Women Who Developed Breast Cancer After Taking Prempro " »

Many lawsuits have centered around plaintiffs 60 years of age or older developing tendon ruptures after taking Levaquin, but a recent filing is shedding light on a much younger group's suffering.

Plaintiff Michael Majetic is only 42 years old and has suffered from a tendon rupture after taking the controversial antibiotic Levaquin. He took the pills to treat a sinus infection back in October 2005. According to his complaint, Majetic first started taking the drug in October 2005, and kept taking it on an on and off basis for five more years. He started suffering from Levaquin side effects including two tendon ruptures to his Achilles tendons.

Majetic is claiming that because of his injuries, he can’t perform regular daily tasks anymore like he used to, and that the injuries have severely diminished his quality of life. His suit names the makers of the drug, Ortho-McNeil Pharmaceuticals and Johnson & Johnson, and alleges that the companies didn’t properly warn him of the dangers linked to the drug before he took it. He cites the numerous studies that have been published highlighting the dangers of tendon ruptures linked to Levaquin in his lawsuit.

Majetic's experiences prove that it is not only elderly patients who are susceptible to tendon ruptures. Thousands of other Levaquin patients have filed lawsuits, but only three have had a chance to make it to a courtroom so far. Each of the lawsuits involved elderly patients.

Chances are many more potential plaintiffs out there who are under 60 years old haven’t filed lawsuits under the misguided belief that their claims would be dismissed because of their age. This recent filing just shows that age has nothing to do with whether a patient suffers from adverse side effects of drugs.

Research is showing that elderly people are twice as likely to have to go to the emergency room because of adverse drug side effects as patients under the age of 65. One of the reasons for that is because older bodies cannot eliminate drugs with the same amount of ease as younger bodies. Another reason is because senior patients are more likely to take a variety of drugs at one time, which increases their chances of suffering from a risky side effect.

“If you take three medications that have sedation as a possible side effect, then the compounding effect may not be 1+1+1=3, but 3x3x3=27,” Todd Semla, an expert on drug treatment for older adults, told “Consumer Reports on Health.”

With anxiety and depression symptoms getting more and more attention these days, many older people are starting to take prescription medications like Paxil and Effexor. Research has shown these medications to be extremely dangerous on their own, but can be lethal when mixed with other drugs. Some of the harmful side effects that have been linked to antidepressant medications in seniors include aggressive behavior, suicidal thoughts and behavior, stomach upset, insomnia, and countless others.

A more recent study even discovered that when patients who are taking antidepressant medications like Paxil in combination with antipsychotic medications like Seroquel, have a higher risk of suffering from a sudden cardiac death (SCD). This Finnish study, which was published in the European Heart Journal, also showed that patients taking these drug combos who are already suffering from a cardiac event have an even higher risk of SCD than those not suffering from a cardiac event. The point here is that seniors are very susceptible to the worst side effects that medications cause than younger patients, and this is why it is more important than ever for doctors and drug companies to keep patients fully informed of adverse side effects linked to prescription drugs before giving them to older patients.

More evidence has come about that confirms the previous theory that Class D antidepressant medications taken during the first trimester of pregnancy increases the risk of the baby being born with birth defects.

This newest Finnish study, which was conducted by the Teratology Information Service at the Helsinki University Central Hospital, basically just confirmed what other studies have already determined: that there is an increased risk of birth defects in developing fetuses that were exposed to SSRIs in the first trimester of gestation. This is alarming, since SSRIs are the second most commonly prescribed medications in the U.S. and are also the most popular form of antidepressant on the market. This increased popularity made studies on the safety of SSRIs like Paxil taken during pregnancy necessary, and Paxil has remained one of the primary focuses of these studies.

Earlier studies have caused Paxil to be downgraded to a Category D class pregnancy drug after revealing the dangerous side effects to fetuses. This newest Finnish study also showed that along with Paxil, other antidepressants like Celexa, Zoloft, Lexapro and Prozac were just as dangerous to fetuses. The study was conducted with researchers analyzing data from some of their nationwide birth registries over the past 11 years. This amounted to 635,583 babies. The data showed that 6,976 of those babies had been exposed to SSRIs during the first trimester, and all of those babies had a higher likelihood being born with various birth defects compared to the babies that weren’t exposed to SSRIs.

Some of the defects that were linked to the SSRIs like Paxil include neural tube defects, cleft palate and PPHN. That is not all the study showed. It was also discovered that the babies were 10 times as likely to be born with fetal alcohol syndrome when exposed to SSRIs like Paxil during gestation as well.

As a defective drug attorney, I’ve kept an eye on the problems plaguing St. Louis-area drug maker KV Pharmaceutical. The company’s Ethex subsidiary was permanently shut down in 2010 after officers pleaded guilty to knowingly allowing oversized, defective drugs to be sold, including drugs for which an accidental overdose could prove fatal. This grew out of a series of reported managerial problems at KV, which resulted in a series of drug recalls, a shutdown by the FDA, drastic management changes and lawsuits over both drug safety and corporate management. Now, the St. Louis Post-Dispatch reported Dec. 6, KV has agreed to pay $17 million to settle allegations of defrauding the federal government by lying about its eligibility for Medicare and Medicaid reimbursements.

The allegations are against the now-defunct Ethex subsidiary. That company is accused of exaggerating the regulatory status of two drugs: nitroglycerin extended-release capsules and hyoscyamine sulfate extended-release capsules. The FDA decided in the 1990s that both were ineligible for reimbursement from federal health care programs, and they never received full FDA approval. A whistleblower lawsuit in Boston federal court alerted the government to the deception, which was in false statements in quarterly reports submitted to the government. The $17 million settlement includes $10.2 million to the federal government and $6.8 million to the states. Of the federal money, $1.5 million will be paid to the whistleblower. The money will be paid out over five years. It comes nearly two years after Ethex was hit with $27.6 million in fines and restitution for failing to report the oversized drugs problem to the FDA.

As a dangerous drug lawyer, I’m pleased to see that the penalties are so steep for placing profit above patient safety. FDA approval is not just a technical hurdle. In order to be FDA-approved, drugs must pass several trials showing safety and efficacy in human patients. Even with approval, drug makers don’t always end up with a product free of defects. That’s one reason why the approval is mandatory for Medicare and Medicaid eligibility — because taxpayers should not be asked to subsidize risky, unproven drugs. The question is whether the $17 million, and the $26.7 million before it, are more money than Ethex and KV made from sales of their unsafe and deceptive products. Only if the penalty outweighs the profits can unethical drug makers be expected to change.

At Carey, Danis & Lowe, we focus our practice on defective and unsafe pharmaceuticals. Patients trust that their doctors wouldn’t prescribe drugs that are unsafe — but when doctors and the FDA aren’t aware of the safety problem, they can’t protect patients. That’s why Missouri and Illinois state laws give drug manufacturers a legal responsibility to ensure that their products are safe and free of obvious defects. When pharmaceutical companies fail in this duty, they can and should be held legally responsible for any injuries or illness to the people who placed their trust in the products. In a lawsuit, our pharmaceutical injury attorneys can help you claim compensation for your injuries, any permanent disability or wrongful death, all medical costs and any pain, suffering or other damages.

Continue reading " KV Pharmaceutical Will Pay $17 Million to Settle Claims of Fraud on Federal Health Care Programs " »

Plaintiffs have secured what is being touted as a huge win in the generic Reglan lawsuits because Judge Sandra Mazer Moss in the Philadelphia Common Pleas Court has decided to deny the defendants' bid to have all of the claims against them dismissed.

The lawsuits are a part of a mass tort that is currently happening in Pennsylvania. The defendants' motion for a dismissal was to be based on the Supreme Court’s controversial decision in the Pliva v. Mensing case. In that case, it was decided that generic manufacturers do not have to face drug injury cases after making generic versions of name brand name drugs as long as the warning labels were the same as the original. However, regardless of the Supreme Court’s decision, Judge Moss refused to allow generic drug makers to get away scott free in the many Reglan lawsuits in Pennsylvania. That is great news for the plaintiffs, who will now get to be heard in court.

There have been thousands of lawsuits filed against drug makers of Reglan and generic versions of Reglan after plaintiffs have been developing tardive dyskinesia while taking the drug for longer than the time recommended by the FDA (12 weeks). The acid reflux drug makers have all been accused of not properly warning patients of the dangers linked to the drug before they started taking it. Patients with tardive dyskinesia suffer from symptoms including: involuntary puckering and smacking of the lips, grimacing, fluttering of the eyes, etc.

Now that Moss has allowed plaintiffs to continue on with their generic Reglan lawsuits, at least they have a chance at receiving compensation for the often permanent condition that they have to deal with. Hopefully, in allowing these cases to go to trial, the drug makers will finally understand that they will be held liable for the pain and suffering they cause patients that take their drugs.

Emails from Bayer officials seem to show that the company is looking for ways to get around federal laws and illegally promote its popular and controversial oral contraceptive Yaz.

Bloomberg News reportedly got ahold of the potentially damaging emails which are said to show the drug giant’s officials in talks to promote Yaz as a treatment for premenstrual syndrome (PMS) despite the fact that the FDA has not approved the drug for such use. One of those e-mails, which was written by Matt Sample (who was a sales consultant with Berlex Laboratories, a Bayer subsidiary), drew attention to an article in Woman’s Day to support the promotional effort. The article itself was meant to be viewed by the email's recipient as an example of how to promote Yaz as a treatment for PMS in a broad sense.

It turns out that Sample even tried to get the sales reps to ask subtle questions to doctors so that their inquiries can’t be viewed as an attempt to promote Yaz’s off label use. The reps were also told to ask the doctors how many of their patients suffer from PMS and how they thought Yaz would fare in treating it.

Bayer seems to keep trying to get around federal regulations; company officials have been warned at least three times already for it by the FDA. In fact, the company has been cited for its previous marketing campaign that used ads as a means of promoting Yaz as a treatment for acne as well as PMS, while at the same time downplaying the dangerous side effects.

The FDA even went so far as to force Bayer to run a $20 million ad campaign designed to correct its old ads by including the drug’s risk of causing blood clots, strokes and other side effects. In addition, the company now has to run its ads by the FDA before they can air them. Still, Bayer is now trying to get around those rules. Since the law doesn’t apply to doctors (who can prescribe drugs for whatever they want to), it appears that Bayer is hoping to promote Yaz’s off-label uses to the doctors instead of the public. While this is a clever tactic by Bayer, patients may end up being harmed unnecessarily in the process.

Yet another plaintiff, Carmin Wilson, filed a Levaquin lawsuit on November 8, 2011 in the U.S. District Court in the District of Minnesota, Illinois. Her lawsuit is claiming that the defendant, Johnson & Johnson, didn’t properly warn her of the controversial antibiotic’s ability to cause her to suffer from severe tendon ruptures.

Wilson’s lawsuit alleges that Levaquin, which is also known as levofloxacin, caused her to suffer from “severe and debilitating tendon injury." Tendon ruptures are the most common adverse side effects linked to Levaquin. Wilson began taking the drug on February 17, 2011 and developed a tendon rupture to her left Achilles by May of 2011. In her lawsuit, she is claiming that she has suffered from “significant pain, swelling, stiffness and lack of independence and is unable to engage in many activities (she) once enjoyed.”

Wilson’s lawsuit also claims that her condition is permanent and accuses Johnson & Johnson of “negligence, product liability, fraud and violation of consumer protection laws." She is seeking in excess of $75,000.

This newest lawsuit joins thousands of others that are all alleging the same thing. Like the other cases, there is no way of knowing how her case will be decided. Three previous lawsuits have made it to trial with only one of them resulting in an award for the injured. However, with thousands of Levaquin lawsuits pending, each case is different in specifics.

If you have suffered from tendon ruptures after taking Levaquin, you should contact an attorney to see if your injuries are eligible for compensation. John Schedin won his case earlier this year with an award of almost $2 million. While the defendants appealed, the decision was upheld. This case proves that not all Levaquin lawsuits are the same and, like Carmin Wilson and thousands of other defendants, your case deserves to be heard in a court of law.

One woman who suffers from tardive dyskinesia after taking Reglan for almost 13 years has filed a lawsuit against Wyeth, the makers of the drug, seeking to have the drug banned from being marketed in the United States as a safe treatment for gastro reflux complications.

Charlene Evans’ lawsuit, Charlene Evans v. Wyeth LLC, is asking the court to stop Wyeth from marketing Reglan as a safe drug to use for periods lasting longer than 12 weeks amid claims that the drug causes patients to suffer from tardive dyskinesia. At the time that Evans was taking Reglan, neither she nor her doctor knew of the risks that were associated with long-term Reglan use. Evans began taking the drug in 1989 and continued taking it until 2002, which is well beyond the 12 weeks that the drug’s label now lists as safe.

Tardive dyskinesia is an involuntary movement disorder that causes patients to suffer from symptoms including “involuntary lip smacking, tongue protrusions, eye blinking, repetitive body movements and disability.” Other serious adverse side effects linked to Reglan use include “neuroleptic malignant syndrome (NMS), secondary Parkinson’s disease, severe anxiety and depression, agitated restlessness, insomnia and paranoia.”

Evans’ lawsuit, which was filed in the Superior Court of San Francisco County on Nov. 1, 2011, points out that using the drug for longer than 12 weeks made patients 100 times more likely to suffer from Reglan side effects than the patients who used it for less time than that. The lawsuit claims that Wyeth knew of this increased risk, but that the company hid this fact from healthcare professionals and the public until the FDA issued a black box warning against the drug in 2009. It is for this reason that Evans wants the drug banned from long-term use. Wyeth is still marketing the drug for short-term use (12 weeks) use in patients suffering from gastro reflux disorders including GERD.