Drug Manufacturer Fraud Litigation - Monday, July 26, 2010 9:25 - 0 Comments

Paxil Birth Defects Cases Settled

GlaxoSmithKline (GSK), the manufacturer of Paxil, has agreed to settlements in nearly 200 individual cases alleging that the antidepressant caused birth defects. Most of the cases alleged that babies born to mothers taking Paxil suffered from heart defects. The leading case, brought on behalf of Lyam Kilker, contended that he was born with no fewer than three cardiac defects, including a hole between the two chambers of his heart that disrupted the aorta. That case was tried last October and resulted in a $2.5 Million verdict.

During the Kilker trial, it was proved that animal testing put the manufacturer on notice that the drug might cause problems, and that the company failed to follow up sufficiently with additional tests. Even worse, a company memo introduced into evidence talked about covering up any test results that showed a potential danger. The 1997 memo by GSK executive Bonnie Rossello, before any tests were conducted, read, “If neg, results can bury.” Even though GSK still defends the drug, it’s significant that the company made a decision to settle hundreds of cases less than a year later.

In 2005, the Food and Drug Administration warned doctors about a study showing that babies born to women who took Paxil during the first trimester of pregnancy had a higher rate of major birth defects. The study, which involved 3,500 pregnant women, showed that those on Paxil were twice as likely to have a child with defects than women on other antidepressants. In the wake of the study, the FDA put out a statement warning that “[h]ealthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.”

The terms of the recent settlements are confidential. At least 600 cases have been filed alleging that Paxil is responsible for congenital birth defects. Up to 100 other cases have already settled. GSK has also paid approximately $1 billion in settlements of Paxil-related cases not involving birth defects. It should be noted that Paxil, which was introduced in 1992, generates nearly $3 billion in annual sales. The drug is used to treat a wide variety of psychological maladies, including depression, anxiety, and obsessive-compulsive disorder.

If you want more information on the Paxil litigation, contact Chad Cook, a lawyer in our firm’s Mass Torts Section at 800-898-2034 or by email at Chad.Cook@beasleyallen.com.

Source: ConsumerAffairs.com