Drug Injury Attorney Blog

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 " »

Rite Aid is suing Ranbaxy Laboratories in an effort to recover the cost of litigation Rite Aid spent while fighting lawsuits against Ranbaxy's drug metoclopramide, the generic version of Reglan.

Patients have been filing lawsuits by the thousands against Wyeth’s brand name Reglan over its increased adverse side effects — tardive dyskinesia, among others. According to Rite Aid’s complaint filed in U.S. Eastern District Court of Pennsylvania, Rite Aid is seeking compensatory damages in excess of $75,000.

The claim also said that Ranbaxy refused to defend Rite Aid in the lawsuits and that Ranbaxy's inaction was a breach of their agreement. Rite Aid says it has a “Defense and Indemnity Agreement” with Ranbaxy that holds Ranbaxy liable “to defend indemnify and hold Rite Aid, its shareholders, officers, agents and subsidiaries from any and all losses" (incurred because of the litigation).

Since Ranbaxy didn’t hold up its end of the agreement, Rite Aid claims that the company is in breach. Rite Aid believes that Ranbaxy owes it money for the financial damages the company sustained in paying attorney's fees, and other costs and expenses.

Of course, Ranbaxy has said it can't comment.

"As a company policy we do not comment on ongoing litigation," a spokesperson for Ranbaxy said. "This complaint is being evaluated and ... shall be addressed accordingly."

There is no word about whether if Ranbaxy will choose to settle out of court or take it to trial.

Patients are claiming that they weren’t properly warned about the side effects of generic and brand name Reglan before being prescribed the drug for periods longer than the 12 weeks approved by the FDA.

A federal civil lawsuit has been filed against Wyeth, the makers of Effexor, claiming that the drug company didn’t tell the truth about the drug’s clinical data and used false lawsuits as a means of keeping a monopoly over the controversial antidepressant.

The lawsuit was filed on Tuesday by Uniondale Chemists Inc., a retail pharmacy. Pfizer, which now owns Wyeth, has so far denied the allegations against it by standing behind its portfolio for Effexor. Right now, Effexor is part of the class of depression medication called an SSRI. The drug is known to cause various side effects that can include aggressive behavior, suicidal thoughts, severe mood swings and even suicide. One of the reasons Pfizer stands by Effexor is because the company says that it has benefited millions of patients.

According to the lawsuit, Effexor’s patent expired in June 2008, but that Wyeth lied so that it could keep the patent on Effexor’s XR (extended release version). Uniondale Chemists is saying that there were $4.5 billion in sales of Effexor while the generic drugs were supposed to already be on the market. It sounds like the lawsuit is claiming that Wyeth used bad tactics to try to prevent or lower sales of Effexor XR by filing lawsuits against generic drug makers as a stalling tactic.

Perhaps Wyeth filed the lawsuits to stall the generic sales as a means of recouping some of their financial losses from all of the lawsuits being filed against the company over the drug’s side effects. Thousands of lawsuits have been filed claiming that Wyeth didn’t properly warn the public against the severe side effects associated with Effexor. Some studies have also claimed that SSRI drugs like Effexor may not even work to combat depression any more than a placebo would. This may have been Wyeth’s motivation in using stall tactics.

Now that many patents are expiring on some of the world’s most popular brand name antidepressants like Paxil and Effexor, second generation medications are going to have to fight harder if they want to compete for sales.

When the patents expire on the brand name drugs, generic drug makers start to offer their versions of the popular drugs. Common medications that are used to treat depression and anxiety symptoms like Paxil and Effexor are being sold in generic versions by so many companies that it is thought that the next generation of antidepressants will have to offer something new that Paxil and Effexor don’t offer.

Most of the leading SSRI medications will lose their patents between 2012 and 2015. Newer generations of these medications might benefits the most if they can avoid some of the severe side effects that these other medications have been causing. Most SSRIs have been proven to cause severe mood swings, aggressive behavior, suicidal thoughts and even suicides in certain users. Many lawsuits have been filed against the makers of these drugs amid claims that the manufacturers hid the risks associated with them. Studies have also come out proving that these drugs may not work any better than placebos at treating depression. Second generation drugs would do best to avoid these safety pitfalls.

The newer drugs may also benefit from listening to the physician survey which shows that psychiatrists view Forest's and Lundbeck's SSRI drug Lexapro (escitalopram) to be “the leading depression treatment, with a superior efficacy and tolerability profile to other antidepressant brands.” Drug makers should be thinking of what is already being done right to treat depression, and what is likely to come about in depression treatments in the future and meet those needs in the safest manner possible.

A woman from California has filed a Levaquin lawsuit after she suffered a tendon rupture while taking the controversial antibiotic.

Geraldine Harris filed her lawsuit in the St. Clair County Circuit Court on June 3. She is suing Johnson & Johnson, Ortho-McNeil Pharmaceutical Inc. and Johnson & Johnson Pharmaceutical Research & Development LLC for negligence, breach of warranties and consumer fraud.

Levaquin is commonly prescribed as a treatment for various infections like bronchitis and sinusitis. In her lawsuit, Harris maintains that research has proven that the drug increases a patient's risk of developing tendon ruptures and subsequent injuries, especially in people over the age of 60. She says that the research findings to that effect have been known by the drug makers since 1997 and that the company tried to hide the risks before eventually making various label changes to reflect the risk of taking Levaquin.

With Johnson & Johnson trying to hide the risks from the public in the past, many people like Harris have taken the drug and have suffered tremendous injuries as a result of it. The amount of her lawsuit is not specified, but she is asking for court costs, medical expenses and damages. Harris has requested a jury.

Harris’ lawsuit is just one of thousands that have been filed against Johnson & Johnson amid claims that the company hid the information about the risks associated with Levaquin. One plaintiff, John Shedin, won his lawsuit and was awarded $1.8 million. However, a second lawsuit filed by Calvin Christenson was lost under the same claim.

In a new twist on Levaquin lawsuits, Harris contends that a Japanese company, Daiichi, developed levofloxacin during the 1980s even though the drug has been “promoted, sold and distributed in the United States by Johnson & Johnson as Levaquin since 1997.”

It’s anyone’s guess as to how Harris’ case will turn out, but one thing is for certain: Many people will be watching the next Levaquin ruling.

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 " »

Julie deMahy sued generic drug maker Pliva over Reglan, alleging that the company didn't properly warn her about the risks of her developing tardive dyskinesia on the label. Her case wound up all the way at the Supreme Court before it got a ruling on Thursday. The decision was a landmark one that was very divided — but in the end, the high court ruled 5-4 against her.

According to the Supreme Court, the makers of generic drugs can't be held liable for alerting the public of the dangers of their drugs on the labels if the brand name version doesn't actually list the warnings on their versions of them. DeMahy's case, which also included another plaintiff, Gladys Mensing, has a lot of people speaking out while the generic drug makers claim that federal government regulations force them to put only the same information and warnings that are on the brand name versions of their drugs, in this case Reglan. Since Reglan didn't have a warning about tardive dyskinesia, Pliva didn't have to put one on the label, either.

The Supreme Court said federal laws trumped the victims' complaints. deMahy's lawyer, Brian Glorioso, said, "It's a great disappointment, not only for our client, but for clients across the country who are victims of generic drugs. In the major opinion, they say that the decision makes little sense. If you took the generic you don't have a case, but if you took the name brand you do."

With more and more Americans buying generic drugs these days (75 percent of drugs dispensed in the U.S.), this decision has set a terrible precedent. Judge Sonia Sotomayor put this in perspective when she stated, "As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The court gets one thing right: This outcome makes little sense."

Defendant Pliva asserts that it is not the company's legal responsibility to ask for label changes and that the lawsuits that are filed in state courts are infringing on the FDA's enforcement. While generic drug companies are not legally responsible to ask for the label changes, many people feel that they should be. Otherwise, the generic drug companies are just saying that if they can get away with it, they will keep excluding the dangers of their drugs from the public no matter what the cost to the consumer… including their lives.

It is official! The FDA has formally added Pancreatitis to its list of identified Yaz side effects. The rest of the list includes blood clots, pulmonary embolism, deep vein thrombosis, strokes, heart attacks and more.

After clinical studies showed that pancreatitis was a serious side effect for women taking Yaz, the FDA told the makers of Yaz to add it to the warning to the labels back in March. The warning was to be placed on all of the drugs that contained estrogen and drospirenone. Now a lot of patients are wondering just how common the new side effect really is.

The FDA says that women who are suffering from hypertriglyceridemia, or who have a family history of it, are more at risk of developing pancreatitis from taking Yaz or Yasmin. Hypertriglyceridemia causes triglyceride levels to rise. Triglycerides are the chemical form of the body’s fat and foods which are found in blood plasma. Hypertriglyceridemia is most often caused by diabetes and obesity. Women that are being treated for hyperlipidemias are considered more likely to suffer from pancreatitis, or higher cholesterol.

Pancreatitis is what happens when the pancreas goes through inflammation. The pancreas is used by the body to secrete digestive enzymes into the gastrointestinal system. It also keeps the body’s insulin and glucagon regulated. If a patient has pancreatitis, it causes the digestive enzymes to start attacking the pancreas and its nearby tissues. Some of the symptoms of pancreatitis can include abdominal pain, nausea, vomiting and rapid pulse. However, pancreatitis can also lead to more troubling conditions like heart arrhythmia, severe abdominal pain and swelling, shock, organ failure of the heart, lungs and kidneys and even death.

As to how it took the FDA so long to notice the connection between pancreatitis and Yaz, it is anyone’s guess, but there will likely be even more lawsuits against the makers of the drug now that it has been added. There are currently more than 7,000 Yaz lawsuits working their way through the legal system.

A nurse in Washington State is facing charges for allegedly conducting a sexual relationship with a patient whose mental health issues he was treating with various medications, including Effexor.

Michael Alan Gregory is being charged by the state's Nursing Care Quality Assurance Commission with unprofessional conduct. Gregory is a registered nurse and advanced registered nurse practitioner. The current sanctions for sexual misconduct can range in severity from Gregory getting a reprimand, to monitoring him while he works, to having his licenses revoked, says Mary Dale, discipline manager for the commission.

"It really depends on the specific details of the case," Dale said.

For now, however, Gregory can still work at Village Family Health in Bellingham. He did make a statement on June 10.

"I am cooperating with an ongoing investigation by the Nursing (Care) Quality Assurance Commission, relating to a former patient I provided care to several years ago," Gregory said. "I continue to be hopeful for a fair and impartial review of this case."

Gregory is accused of taking advantage of a woman known as patient A after her treatment began on August 8, 2007. They got involved in a sexual relationship within two months. Gregory is said to have diagnosed the woman with an adjustment disorder, major depressive disorder and insomnia caused by a mental disorder. To treat her, Gregory prescribed the woman Effexor, Cymbalta, lorazepam and Ativan.

The victim is believed to be vulnerable to his advances due to her history of mental disorders, substance abuse and sexual abuse. The commission stated, "Because of her history and her diagnoses, Patient A was particularly vulnerable."

Gregory is said to have added post-traumatic stress disorder to her list of diagnoses after he started having sex with her, but didn’t say why he gave her that diagnosis on her chart. Gregory and Patient A continued their sexual relationship until 2009.

In cases of defective medical devices, I rely heavily as a pharmaceutical liability lawyer on the testimony of experts who can explain the medical events and causes behind my clients’ injuries. So I was interested to see an 11th U.S. Circuit Court of Appeals ruling excluding certain testimony from one victim’s treating doctors, which ended her case. In Williams v. Mast Biosurgery USA, Wanda Williams of Georgia sued the maker of SurgiWrap, a surgical barrier used on her reproductive system. She alleged that SurgiWrap tore holes in her colon, requiring doctors to remove part of it and giving her a serious infection.

Williams’ gynecologist, Dr. Adcock, wanted to remove adhesions (buildup of tissue between organs, often from surgery) from her abdomen to increase her chances of conceiving. After surgically removing the adhesions, Adcock put SurgiWrap on the area to prevent more adhesions. A month later, Williams came back to the office with pain, fever, diarrhea and other problems. Adcock admitted her to the hospital, where another doctor found hard pieces of plastic inside her colon, some embedded in the walls of the organ. Surgery to repair the damage found more pieces of plastic in her colon, ultimately requiring part of it to be removed and doctors to give Williams a colostomy (opening in the abdomen for removing feces).

Williams sued, alleging SurgiWrap had a manufacturing defect that caused her injuries. She asked all of the doctors who treated the problem to testify as experts, but Mast challenged their testimony. After their depositions, the court ruled that the doctors had offered a mix of lay, expert and inadmissible testimony. Importantly, their testimony that SurgiWrap was the foreign body was ruled inadmissible. Because there was no admitted testimony establishing that SurgiWrap was defective, the court granted summary judgment to Mast.

Williams appealed, arguing first that the court should have admitted testimony that SurgiWrap was defective. The Eleventh disagreed. Treating physicians like these are not always experts, the court wrote. When they offer a hypothesis rather than an account of how they treated the patient, they are experts, and thus subject to the test of Daubert v. Merrill Dow Pharmaceuticals. Because the doctors fail this test, their testimony was correctly excluded, the court wrote. Williams also cannot use lay testimony from Adcock as evidence for her claim, it said. Adcock’s admissible testimony said the only substance left in her body was the SurgiWrap, but the court said it does not necessarily follow that SurgiWrap was defective. No admissible evidence explained whether it was performing as intended or whether it caused the injury. Thus, the Eleventh upheld the trial court’s ruling ending the case.

As a defective medical device attorney, I am disappointed that Williams did not get a chance to present her claim after such a serious injury. Expert witnesses are usually not treating physicians, and this ruling showcases some of the reasons why. These doctors have personal experience with the patient and the problem, but not always the expertise necessary to identify the product and explain how it is supposed to work. As a result, plaintiffs who rely on their treating physicians to be experts can suffer the same fate Williams did — having the case dismissed entirely. Those patients may still call their doctors as witnesses, but as a dangerous medical device lawyer, I prefer to use separate experts to establish vital evidence.

Continue reading " Treating Doctors’ Testimony Insufficient in Medical Device Defect Case – Williams v. Mast Biosurgery USA " »

According to information from a Market Report by companiesandmarkets.com, Americans use more medications to treat anxiety disorders than any other country. This information is based on a report that shows that it costs $42 million (or what amounts to a third of U.S. expenditures on mental health) to treat Americans for their anxiety.

That is saying something since, in Europe, more than a quarter of the population is thought to suffer from various types of brain-related conditions, but most specifically, depression. Meanwhile, it is thought that there is a speedy growth of 5 percent for such conditions expected in the Asia-Pacific region. Treatment for these conditions vary, but most of the time, it starts with patients being prescribed some sort of Selective Serotonin Reuptake Inhibitors (SSRIs), such as Effexor and Paxil.

The market report was based on 619 pages of research that included historical data and forecast data between 2003-2017. Antidepressants are the most commonly used medications for a lot of these brain disorders like depression, anxiety and obsessive-compulsive disorder, but many of those drugs like Paxil and Effexor cause severe side effects. Research is also showing that Paxil and Effexor may not even work any better than a placebo at curing the disorder.

With Americans being viewed as having the highest stress levels, some are wondering just what triggers this stress. Could it be the economy, the fact that the population is aging — or could it simply be that the drug companies are helping to push diagnoses on the population as a means of selling their drugs? Whatever the reason for anxiety-ridden Americans, one thing is sure: Drug companies are going to be making a clean $5.9 billion by the year 2017 in anti-anxiety medication sales.

Reglan lawsuits are still getting a lot of attention lately as lawyers are waiting anxiously for a Supreme Court decision about whom is to be held liable for Reglan side effects.

The Supreme Court’s ruling will be the deciding factor in whether the makers of brand name Reglan or the makers of generic metoclopramide will hold the blame for a failure to properly warn the public about the side effects of taking Reglan for longer than the 12 weeks that is recommended by the FDA. Lawyers on both sides of the argument have been waiting for this answer for a while now, and will likely not get the final decision handed down by the Supreme Court until July. However, the final answer to the question of blame is even more complicated because everyone is wondering whether state or federal law will govern the actions of the drug makers in the future.

If you don’t recall, the case that I’m talking about is Pliva Inc. v. Mensing. Two plaintiffs in the case developed tardive dyskinesia after taking the generic form of Reglan which was manufactured by Pliva Inc. The judges on the Supreme Court have made their opinions known in this case and are divided. Right now federal laws don’t force generic drug makers to list warnings on the labels, but state laws do, and that is what makes this decision by the Supreme Court so interesting.

With so many lawsuits against Wyeth, the makers of brand name Reglan, by patients that are developing tardive dyskinesia, the makers of metoclopramide will want to know if they will be able to be held liable for adverse side effects. It is only fair that generic drug makers get some of the blame since they are capitalizing on the potentially harmfully drugs, so they may as well be willing to pay for some of the damages.

According to a recent study, more women are turning to longer-lasting birth control methods such as IUDs because it is easier than taking daily pills like Yaz. The study, conducted by researchers at the Guttmacher Institute, reviewed information from the National Survey of Family Growth from 2006 and 2008. They found that more women are using IUDs like the Copper T or the levonorgestrel intrauterine system (commonly known as Mirena).

Women are also using implants that are inserted under the skin in the arm. The Implanon implant is getting a rise in popularity, for example. These reversible, but long-lasting birth control methods have seen an increase of 2.4 percent usage in 2002 to 5.6 percent in 2008. Public health experts say that women like these devices more and more because they work and require almost no maintenance once inserted, whereas birth control pills like Yaz have to be taken daily.

It’s possible that women are also trying to avoid the many health risks that are associated with pills like Yaz and Yasmin, which have been the subject of thousands of lawsuits. Health Canada and the FDA have been reviewing Yaz risks for blood clots after thousands of lawsuits have accused the makers of Yaz of hiding the risks from the public. Some of those risks include blood clots, heart attack, stroke, pulmonary embolisms and even sudden death.

Now that more women are switching to IUDs, it is believed that women that have already had babies are the ones more likely to use the implants and IUDs, as well as older women.

"With childbearing occurring at later ages, the fertile period before childbearing can be as long as that after childbearing," wrote the authors. "The potential for long-acting reversible contraceptive methods to decrease unintended pregnancy rates and subsequent abortions is gaining much-needed attention."

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 " »

Johnson & Johnson has won its most recent Levaquin lawsuit when the jury decided that 84-year-old plaintiff Calvin Christenson's tendon ruptures were not caused by a lack of proper warning by the drug company; however this outcome is not surprising, in fact, it was practically expected.

Calvin sued Johnson & Johnson and its Ortho-McNeil unit amid claims he tore his Achilles tendon while taking Levaquin by claiming that he wasn't properly warned against the associated risk of tendon ruptures, but the Minneapolis judge who oversaw the case didn't agree and ruled in favor of the drug giant. From the beginning of the case, Johnson & Johnson denied any accusations that said it failed to warn the public about the risks of Levaquin and contended that Calvin needed Levaquin to treat the pneumonia. The jury made their decision on June 17th.

One of J&J's lawyers said, “The jury took a good, hard look at all the evidence and correctly concluded that Ortho-McNeil-Janssen Pharmaceuticals, Inc. acted responsibly and properly in disclosing the risks associated with this effective and life-saving medicine."

This is the second Levaquin case that went to trial; more than 2,500 pending claims in the American courts all are claiming the same thing. During the first trial, J&J and Ortho-McNeil lost when the jury awarded an 82-year-old John Schedin $1.8 million after he ruptured both of his Achilles tendons. Unfortunately for Calvin, the jury this time wasn't hearing it, but this is not surprising to anyone involved because the Bellwether trial process alternates between plaintiff’s trial picks and defendant trial picks. Calvin’s case just happened to be one of the defendant’s trial picks.

The plaintiff's lawyer was disappointed because they thought that the FDA waited too long to issue the black box warning against the drug that inevitably caused the injury. While this outcome is not good for Calvin, it is not likely that this outcome will affect decisions in future Levaquin lawsuits as each plaintiff’s case and circumstances is different, and Schedin’s previous win against J&J gives future plaintiffs a good reason to be optimistic.

Now that the Levaquin trials have begun, it is slowly becoming clear that plaintiffs might just win their cases. A couple of things come into play when coming to this conclusion, but it can be nearly impossible to decide what a jury will say during a trial.

One reason why things look good for the plaintiffs so far is John Schedin’s verdict against the makers of Levaquin. Schedin won just under $2 million in compensation toward medical bills, as well as his pain and suffering that was the result of his taking Levaquin. Schedin suffered from tendon ruptures of his Achilles heels while he was using the popular but controversial antibiotic. Schedin’s award set a precedent for the new plaintiffs facing trials.

A second plaintiff is hoping to win a monetary award after suffering from a single Achilles tendon rupture. The verdict in that case is expected to be handed down inside of a month. There are many more Levaquin lawsuits taking place later on this year in both federal and state courts.

Yet another reason things are looking good for the plaintiffs is the fact that the FDA warnings of potential harm didn’t come fast enough. More than 2,500 Levaquin lawsuits have been filed in state and federal courts amid claims that Johnson & Johnson did not properly warn doctors or the public of severe risk of tendon ruptures that were linked to the drug.

The FDA didn’t issue a black box warning on the label until 2008. Unfortunately, that warning was too late for many patients who were already suffering from tendon injuries. Even though the next bellwether Levaquin trial is not going to be tried until November of this year, there will be some other trials that will reach court before then. One of them is the first New Jersey Levaquin trial. This trial was delayed back in April, but is set to go on June 20. The main point for the plaintiffs is to prove that the Levaquin was the cause of the injuries and that they took the pills before the FDA black box warning was issued. Naturally, plaintiffs who took the pill before the black box warning was issued have a high chance of winning their argument, but previous awards will play a role in these cases as well. In the end, we will just have to wait and see.

Antibiotics have become a staple in American life, but more and more Americans are beginning to question the safety of their go-to drugs after the many side effects lawsuits that have been filed against drugs like Levaquin.

Patients are increasingly claiming that the drugs are poisoning them; specifically, they are complaining about fluoroquinolone antibiotics like Levaquin. Bobby Grozier was a successful senior software advisor when he was prescribed a toxic combination of ciprofloxacin and Vioxx to treat his diagnosis of prostatitis. A decade later, he suffers from permanent brain damage and is on disability now. When Grozier first started taking the meds, he complained about his ears ringing by calling Bayer and speaking to their pharmacist, who told him to keep taking the drug combo to give it time to take effect.

Soon after he stopped taking the drugs, he suffered from a psychotic episode, during which he couldn’t breathe properly and was hallucinating. Of the episode, Grozier says, "Things in my ears were resonating like I was in an echo chamber and everything was wavy… it was unbearable. I really thought I had a heart attack and was dying."

Grozier had his mother take him to the hospital, where he was given a sedative and told that he was suffering from irritable bowel syndrome. The doctor then prescribed more drugs to him by giving him Xanax. All the extra med did was cause him to have petite mal seizures.

What Grazier and other patients suffering from such toxic reactions to their antibiotics drugs aren't aware of is that flouroquinolone drugs like Levaquin and ciprofloxacin can cause poisoning in patients. Most patients have heard of Levaquin and other flouroquinolones causing side effects like tendon ruptures, but the poisoning is lesser-known. One of the reasons for that is because there aren’t a lot of recorded cases of it, but some people think that this is because many don’t realize it because of how long it can take for some patients to experience the toxicity. It can take as long as months for some patients to react to the drugs, and even when they do, doctors may not be able to link the illness to the meds.

The sad part of stories like Grozier's is that many of these patients are being diagnosed too quickly and given too many prescriptions at once. This is bound to cause more poisonings. No wonder patients are afraid to accept prescriptions these days.