Product Liability Attorney Blog

Plaintiff Jennifer Berg evidently has agreed to settle her lawsuit against the makers of the popular antidepressant known as Paxil. Berg had brought the suit against the company because, in her estimation, it was exposure to the medicine that lead to her infant son's death from a heart defect.

Berg's son, Nathan, was born on August 20, 2004, and died two months later from Persistent Pulmonary Hypertension (PPHN), a deadly condition in which the body cannot properly process oxygen taken in through the lungs. While not always fatal, it does have a serious effect on infants, and in Nathan's case was ultimately too much to combat. Mrs. Berg had been prescribed Paxil during her pregnancy, leading her to file the suit after she had examined the matter.

The lawsuit essentially holds that Glaxo Smith Kline, Paxil's manufacturer, should have done more to inform Mrs. Berg of the demonstrated relationship between SSRI antidepressants and the formation of birth defects in children whose mothers take the medicine during pregnancy. Among these, PPHN is one of the most frequently-occurring and serious conditions.

Mrs. Berg could not be reached for comment. News of the settlement has been indicated by the filing of court records rather than any public announcements.

The settlement comes at a tricky time for Glaxo Smith Kline. The pharma giant recently announced that it intend to set aside more than $2 billion to deal with the assorted legislation against its flagship products so that the company can move forward instead of being bogged down in legal matters. Last October, for example, one woman was awarded $2.5 million for her Paxil birth defect case.

The settlement itself is still tentative, however. Court filings indicate that a settlement is being sought, but no specific filings to that effect have yet appeared. Additionally, any specific terms are merely a matter of speculation at this time.

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Research continues to be done into the link between prenatal exposure to antidepressants in the SSRI or SNRI class (such as Effexor and Effexor XR) and the development of birth defects or difficulties. The newest information comes from a recent Danish study that observed 904 pregnant women. Four hundred and fifteen of the women in the study took Effexor and similar antidepressants, while the remaining 489 did not. This divided the group roughly in half, which is a useful benchmark in any study.

According to the researchers following the cases, the study did suggest that antidepressants taken during pregnancy did in fact have an effect on fetal brain development. They added the caveat that as with all such studies, more time will provide more information, as well as better understanding of what this could mean for public health in general.

The FDA has moved Effexor and related medicines into the C category, indicating that there is strong evidence that suggests a connection between the medicine and the formation of birth defects. While not demonstrated conclusively by FDA standards, the relationship is strong enough to warrant at least some packaging warning.

There are a number of different birth defects that have been proposed as having a relationship to antidepressant intake during pregnancy, including cardiac defects such as an incomplete valve arch, pulmonary defects such as persistent pulmonary hypertension, brain and spinal cord defects of the neurosystem, craniosynotosis or a malformed skull that is too big or small. Others include Omphalocele, a condition in which the abdominal wall is malformed and the inner organs are partially exposed, clubbed foot, cleft lip or palate, or even anal atresia (where the anus is partially or even completely fused).

None of these conditions can be dismissed. Each one has a direct and long-lasting impact on children and families affected by them, both emotionally and financially.

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There has been a great deal of reporting on the settlements that Paxil manufacturer Glaxo Smith Kline, the UK's largest drug manufacturer, has agreed to in recent weeks. While not acknowledging whether the lawsuits were factually correct, the pharma giant met with the plaintiffs privately after several test cases showed that juries were willing to award in favor of the plaintiffs. The exact terms of the suits were not made clear, but the general perception is that the patients were to be compensated in exchange for forgoing further lawsuits against GSK in the future.

The sheer scale of the decision is put into context with a look at the larger picture. According to GSK representatives, the company has settled the majority of Paxil claims, as well as claims stemming from another medication, Avandria. The company has set aside $2.4 billion dollars to handle these cases. This is as large as the budget for some government organizations, and more than most people can readily comprehend. While it may not be enough money to make a dent in GSK's impressive market share - indeed, company shares rose after the announcement of this settlement - it still illustrates the scale of the damage that people perceived being done.

Interestingly, the biggest comment in the Paxil case specifically hinges on the failure to disclose information, rather than the allegation of birth defects in the medicine. While this might be true for the majority of cases, particularly those where the medicine was prescribed despite its known risk of suicidal thought aggravation to children under 18, the failure to acknowledge the significant number of cases dealing with birth defects is sure to frustrate the plaintiffs in those cases. Further complicating the issue is the US-lead investigation of some of GSK's manufacturing plants, particularly those associated with Avandria. Clearly not all the information that could be available is readily at-hand, and this case may be far from as settled as first it seems.

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Plaintiffs Lovie Armstrong, Cecil Brown, Darrell Griggs and Bessie Smith have filed two new, separate lawsuits against the manufacturers and distributors of Levaquin, a popular antibiotic marketed to the elderly. Levaquin has been linked to damage in the tendons, leading to ruptures and serious injuries as a result. The cases were filed in Illinois county courts, and name Ortho McNeill, Johnson and Johnson and Walgreens as defendants.

These are, of course, merely the newest cases to go forward in the ongoing Levaquin lawsuit series. The medicine's effects are becoming increasingly well known, and in some cases the discussion is not about if but when the defendants will choose to settle, and under what terms. Still, the matter is not yet decided, and there are many formalities to move through.

Hundreds of lawsuits have been filed against the makers and sellers of Levaquin since these tendon incidents became known. Many of the cases focus on the fact that the black-box labeling that the FDA eventually required on the medicine should have been mandated much sooner, which may have prevented many debilitating or crippling injuries that since have been suffered.

The highest-level lawsuits have been consolidated at the federal level for pretrial hearings. This is a serious step, allowing for a great deal of information to be brought together and gathered centrally.

Additionally, the first six cases were green lighted for a “bellwether” test. Such cases, also called early trials, are used as representatives of the movement as a whole. They go forward and are argued out so that each side can both present and refine their arguments at large, to give both plaintiffs and defendants a look at how a much larger trial might go at a later date.

Frequently, the bellwether cases decide how the rest of the matter will go. This is typically where decisions to settle are reached in such mass cases, so it's an exciting and anxious time, to be sure.

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With the FDA giving pharma producer Teva permission to manufacture a generic version of the antidepressant Effexor XR, this is a good time to review some of the differences between Effexor and Effexor XR, as well as reinforcing the similarities between the medications.

Many of the problems that arise in cases where a medicine is responsible for damage done to patients can be attributed to a lack of understanding and education. Doctors prescribe a medicine, so the patients taking it assume it is safe. After all, why would a doctor prescribe something unsafe? Similarly, when new versions of older medicines come out, it's assumed they are improved in general, rather than in one or two specific ways such as extended release medications.

Effexor XR does not have any significant changes over standard Effexor as far as the core medicine. It is still an SNRI type antidepressant, chemically identical with standard Effexor in the main ingredients. This means it is still tentatively linked with the risk of suicidal thoughts in patients, and with the risk of birth defects in the children of patients who take it while pregnant.

The name is part of the problem here. In contracting the name to XR, the manufacturers have eliminated some of the recognition quality. It isn't as obvious that it simply stands for extended release, rather than hinting at some new style upgrade to the original medication.

The only purpose of the change is to reduce the number of pills a patient has to take during the day. The absolute amount of medicine changes slightly because one pill lasts the patient longer, requiring only a single dose at the beginning of the day rather than several doses throughout the day. It still requires several weeks to take effect, and has the same side effects as the parent medication.

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Further evidence continues to mount in the ongoing struggle between the manufacturers of antibacterial prescription Levaquin and the patients who claim that the medicine is directly responsible for aggravated tendon injuries they suffered while taking it.

Texas resident Kenneth Edward Adams has filed the newest lawsuit against Levaquin makers Johnson & Johnson, Ortho-McNeil Pharmaceutical Inc. and Johnson & Johnson Pharmaceutical Research and Development as of June 29 of 2010. Adams' central argument is that the Levaquin-induced tendon injury involves the degradation of the tendon tissue, leading to severe and permanent injuries, according to the Southeast Texas Record.

Further, Adams' suit argued that the companies named as defendants have not only failed to disclose information about the potential risks of the drugs in question, but have willfully concealed and misrepresented the dangers of the medicine, downplaying them to the risk of patients. In addition, the suit points to the fact that drugs of a similar class to Levaquin have been repeatedly pulled from the market due to similar dangers.

Adams is requesting a jury trial to hear the case, and the compensations he is demanding are significant. They include just about everything one might expect — compensatory damages, an award of special damages for medical expenses, lost income, permanent disability, permanent instability, lost balance, pain and suffering, triple damages, attorneys' fees, expenses, court costs and interest.

He is making these claims based on the charges of strict liability, negligence, breach of express and implied warranties, fraud, violation of unfair and deceptive trade practices acts, and unjust enrichment. In more simplified language, the case argues that the manufacturers and designers of the drug knew full well the damage the medicine could cause, as evinced by the black-label warning that the FDA required Levaquin packaging to carry, and yet they still implied the medicine was generally safe to take by virtue of still selling it for prescription.

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A great deal already has been made about the expiration of Effexor XR's patents and its opening up to the market. Wyeth's signature antidepressant now is in the hands of Teva, which has a 180-day exclusive marketing period to promote the drug and establish its production.

As ever, this matter comes with certain consequences — ones that might not be immediately apparent. Effexor remains under review over its potential link to increased suicidal thoughts and the birth defects caused in infants whose mothers took the medicine while pregnant, on a doctor's advice.

William S. Marth, president and CEO of Teva North America, was quoted as saying, "Through the current patent settlement process, we are able to launch this product 7 years early, thus bringing significant savings to patients … and relieving some of the burden on the U.S. healthcare system."

Admittedly, these are noble sentiments. People want quality medications sooner rather than later. Depression is a serious affliction and having options to deal with it is one of the many splendid benefits of a modern society.

And yet, there are advantages to a slow and steady approach to things, as well. The comment about being seven years early should send off a few warning bells, particularly since it's the result of a “settlement.” Why the rush? Why so early compared to other medicines that still are being delayed and evaluated? The makers of Paxil just settled a major series of lawsuits relating their medicine to birth defects, so why would a similar drug be put into the generic market seven years ahead of schedule?

There may be good answers to these questions. However, when discussing the potential dangers of a medication, these answers should relate to studies demonstrating a medicine is safe or unsafe. They shouldn't immediately jump to questions of price or relieving the healthcare system as a whole.

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This week, the FDA gave the go-ahead for manufacturers to begin producing generic formulations of the popular antidepressant Effexor XR (extended release). Prized because the XR version doesn't give its effects in a single heavy dose, leading to periods of highs and lows, this medication is being declared by FDA official Dr. Keith Webber as an example of the FDA's commitment to ensuring wider access to "safe and effective" medications.

While there is no doubt that in the great majority of cases Effexor XR is indeed safe for use, there are many concerns about it that have not yet been answered. The same article that quotes Webber on the “safety” of Effexor XR states that it carries serious labeling warnings about the potential for the medicine to aggravate suicidal thoughts during the first months of its use, particularly among teens and younger people prescribed the medication.

A medicine goes “generic” when the patents on the original formulation expire. This frees manufacturers other than the original developer to produce and sell their own versions of the medicine. However, only the original formula is open onto the market. But between the original development of a medicine and the patents expiring, a number of additions and modifications may have been introduced into the drug line.

As an example, consider Yaz and its generic formulation, Gialla. Gialla's manufacturer ended up in court claiming that it was identical to Yaz when this wasn't the case — Gialla did not have Yaz' shelf-life-extending technology added to its formula. The article announcing Effexor XR's release to generic manufacture stresses that it might not be identical to the name-brand formula.

This creates a two-level problem with the generic formulation and the information the public has about it. Allowing a drug to go generic might suggest the mindset that since more people are allowed to make it, it must be entirely safe. Then there's the perception that “generics are the same, but cheaper,” which could lead to a lack of critical thought about the medicine and its additives.

This blog urges everyone who's been prescribed Effexor XR or will be prescribed one of the generic reproductions of the medicine to read all the warning literature and speak candidly with their doctor about all possibilities.

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Recently, Paxil elected to settle nearly 200 cases related to birth defects allegedly caused by its popular SSRI antidepressant, Paxil. As usual, this raises a number of questions about the nature of a settlement.

Not every case goes all the way through a trial; rather, a major portion of litigation is settled out of court. Given the nature of litigation in modern society, there are some misconceptions about the nature of the process and what it means to “settle.” Even the use of the term is a confusing one, because it brings up the implication of “settling for less,” which has a generally negative connotation in modern language. In a certain sense this is the truth, but it ignores the subtleties of the arrangement.

Litigation is not an easy process. It can take years out of the litigants' lives. Legal dramas and movies make the process seem fairly straightforward, but they don't show the repeated trips to legal offices to check and double check filings. Fees pile up, as do the costs in real life. Time spent in the courtroom and in negotiations between parties is time that can't be spent enjoying yourself, making money or picking up the pieces after tragedy has struck.

A settlement, if reached amicably and mutually between the involved parties, cuts a great deal of this waiting time away. Money is brought to hand and the plaintiffs can move forward with their lives. There is no reason to consider a settlement in a pejorative sense if the parties involved agree mutually. It is an acceptable compromise for those who simply want help going forward, rather than a complete court case victory.

However, a settlement is also not an admission of guilt. Usually it includes terms that require the client to forgo any future litigation against the company. It does not create any binding on the company to change its practices, nor to cease the manufacture and prescription of the drug in question.

A settlement, like any other decision, is composed of many variables and must be considered in the full light of legal precedent and personal necessity.

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Isn’t it nice to see the system work and make things better? Eight months ago, Glaxo Smith Kline (GSK) lost its first test case to defend the company’s flagship antidepressant, Paxil, against allegations the medicine causes severe birth defects. In that case, the jury awarded a stunning $2.5 million settlement. Now with the number of cases steadily increasing, the makers of Paxil have decided to stop fighting the matter and settled nearly 200 of the pending cases out of court.

According to representatives of both GSK and the plaintiffs, the terms of the settlement are and will remain confidential.

Plaintiff liaison Jamie Sheller commented, "When you're dealing with children, with birth defects, that's a concern for any company," according to Law.com. "GSK gave it their all at that trial. ... Despite that, the plaintiffs were successful in the case and that set a tone for their analysis. Even though they mounted an excellent and strong defense, they weren't able to overcome the plaintiffs' position."

GSK has said that while it stands by the efficacy of the antidepressant, the company elected to settle the matter out of court in order to avoid the uncertainties and costs that come with a major litigation. According to Law.com, the spokesman for GSK was quoted as saying that plaintiffs and defendants had actually begun working actively together to resolve the matter, and there was not a great deal of animosity on the part of either party.

The first successful suit, known as the Kilker case, has been described as a cathartic experience that allowed the public and relevant litigators to see just how intense the feelings and legal matters of the cases were, and contributed greatly to GSK's decision to settle rather than continue to fight the cases. While there are still some cases pending, it is clear that GSK has shown willingness to accommodate the position of the plaintiffs.

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Alongside the intense attention that the SSRI Paxil has received for the birth defects associated with its use in pregnant women, there is also the worrying evidence that it may have strong links to the development or aggravation of suicidal thoughts. In the case of Canadian teen Sara Carlin, this link is being brought up following her untimely death by hanging herself.

Ms. Carlin was a student at the University of Western Ontario at the time of her death. She was taking Paxil for a year prior to the event, had been hospitalized for drug and alcohol abuse and had expressed verbal and written thoughts about her difficulty with continuing living.

According to Ms. Carlin's family and their attorney, she was an outgoing and largely happy person before the medication. They stressed adamantly that Sara was not depressed before she was prescribed the medication. Glaxo Smith Kline (GSK), the manufacturers of Paxil, has presented their counterargument via Sara's doctor's testimony. Her physician claimed that Sara had felt better after starting Paxil, had started sleeping better and begun engaging more with her schoolwork and personal activities.

The link between Paxil and suicidal fixations is not yet a conclusive one. The matter remains murky and difficult, partly because GSK has engaged in the usual defenses of its product and resisted the allegations of affected parties. However, a number of studies have demonstrated increased suicidal considerations among 12-19 year olds who are exposed to the medication for an extended period of time. The attorneys involved in the case stressed the point that the U.S. FDA requires Paxil packaging to carry the strong black box warning explaining the potential for increased suicide risks.

Ms. Carlin died in 2007. The case between her family and GSK is as yet unresolved, and looks as if it will continue into the court system proper instead of resolving via settlement.

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Brand names for drugs like Yaz and Yasmin do not last forever. Patents eventually expire, at which point generic manufacturers step in and begin marketing the same drug under different names. For example, Advil and Motrin are the same drug. However, each has advertising claiming it has a unique success in treating inflammation. In the case of Yaz and Yasmin, there are a number of generic formulations already out there. They are the same medication, carrying the same effects, side effects and, yes, the exact same risks for young women taking them.

The problem here is that consumers may not know off the top of their head which drugs are which. The trick is to look for the name of the original formulation, rather than its brand name. Yaz and Yasmin are formulations of a progestin known as Drospirenone. So are the generic versions, Ocella and Gianvi.

Of course, since the drugs are exactly the same, they carry the same risks. These risks stem from the thickening of the blood that results from hormone use, meaning that the women are at a greater risk of developing blood clots. This can lead to cardio-pulmonary complications, such as a clot being thrown loose into the lungs, heart or brain. This can lead to damage of any one of these organs, including a stroke and even in one alleged case, death.

Yet you won't find the advertisements for Ocella or Gianvi explaining that they're the same medicine as the now-controversial Yaz and Yasmin. Given that the advertising companies are not being forthcoming, the FDA has begun issuing stern warnings and fines. The company marketing Ocella and Gianvi, Teva Pharmaceuticals, already has been warned by the FDA for false advertising and improper labeling of its product. This on top of being a drug that already had a history of causing problems under its original names.

Whether it's discerning that Advil and Motrin are both just ibuprofen, or learning the chemical name behind Yaz, patients need to learn to identify the chemical name of the medicines they are taking so they aren't inadvertently taken in by a simple brand name swap — and exposing themselves to the side effects.

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