Jury Sides with Family in Paxil Birth Defect Case - Pharmaceutical Executive

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Jury Sides with Family in Paxil Birth Defect Case

GlaxoSmithKline, yesterday, lost its first battle to prove that its antidepressant Paxil led to birth defects. The company will have to pay $2.5 million in damages to the family of Lyam Kilker—a small drop in the bucket for a pharma company, but scary when you consider that it has 600 more cases on the docket.

Lawyers on the side of the plaintiff fought in a Philadelphia court to prove that a child’s heart defects were directly related to its mother’s use of Paxil while she was pregnant.

“GlaxoSmithKline disagrees with the verdict and will appeal,” the company stated in a release. “While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy.”

The company insisted that it carried out the appropriate clinical trials before approval and that FDA regulators were aware of all side effects. It also updated the warning label to include new information about pregnancy risk and properly monitored the treatment after it was released to the public.

According to Bloomberg, the jury believed that GSK knew that the drug caused birth defects and purposefully covered it up to avoid losing sales on its blockbuster drug. They also felt that GSK didn’t continue trials to prove that the risk of birth defects was higher than initially believed.

GSK denies all of these allegations and said that it will appeal the decision.

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