Paxil Birth Defects Trial Now in Jury’s Hands

The first of more than 600 lawsuits claiming the makers of the antidepressant Paxil hid evidence that its drug caused birth defects in order to boost profits is now in the hands of a Philadelphia jury.

Testimony in the state-court trial, which began in September, wrapped up yesterday. Jury deliberations have begun and a verdict is expected sometime in the coming days or week, court watchers said.

The lawsuit involves allegations from Michelle David, who claims drug maker GlaxoSmithKline concealed negative study results linking Paxil to a life-threatening heart malformation in newborns of women who took the drug during pregnancy. The company marketed Paxil for treating pregnant women with anxiety, despite knowing about the apparent connection to birth defects, David contends.

David took Paxil while pregnant with her son, Lyam Kilker, who was born with life-threatening heart defects. The boy is now four and has fully recovered after being hospitalized as a newborn and undergoing multiple surgeries to repair his heart.

Glaxo’s lawyers argued during the trial that there is not sufficient evidence to prove that use of Paxil caused Lyam’s birth defects.

‘Test Case’ for Future Paxil Litigation

As the first of hundreds lawsuits alleging Paxil birth defect injuries, David’s case is being closely watched. The outcome could help shape the future of litigation against Glaxo for injuries allegedly caused by Paxil. A win for David could pave the way for other Paxil victims to receive the financial compensation they deserve for medical bills, pain and suffering, and other injuries.

Paxil was approved in 1992 and generated about $942 million in sales for Glaxo in 2008. The drug belongs to a class of antidepressants called selective serotonin reuptake inhibitor (SSRI), the most prescribed type of antidepressants in the world that also includes big-name drugs like Prozac, Celexa, Lexapro, and Zoloft.

Paxil Warnings Were Ignored for Years

Glaxo knew about the possibility that Paxil could cause birth defects as long ago as the late 1980s, David’s attorneys argued during the trial. Laboratory testing of the drug on rats showed animals injected with Paxil had pups that did not live past four days. However, Glaxo failed to further investigate the problem with Paxil for 20 years, according to the attorneys.

Concerns about heart-related birth defects in babies born to Paxil users prompted the FDA in 2005 to require GlaxoSmithKline to revise the drug’s labeling to warn of the risks. The FDA also warned women about the dangers of taking Paxil during pregnancy and the increased risks of birth defects.

Within five years of Paxil being released, in 1997, Glaxo had received reports of 50 miscarriages or intrauterine deaths in women taking the drug during pregnancy, David’s attorneys argued. Company scientists called the number of birth defects “alarming” but that opinion was not included in a report to the FDA, her attorneys said during the trial.

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