First Paxil Birth Defects Trial A Loss for Glaxo

GlaxoSmithKline has lost the first <"">Paxil birth defects lawsuit to go to trial, with a Pennsylvania state jury ordering the drug maker to pay $2.5 million to the family of a 3-year-old boy. The child was born with heart defects, which his mother attributed to her use of Paxil while pregnant with him.

Paxil is one of a class of drugs known as selective serotonin reuptake inhibitors (SSRI). On two occasions in 2005, the Food & Drug Administration (FDA) requested that the labeling of Paxil be changed to include warnings on three studies that found an increase risk of birth defects. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). That same year, the FDA also classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

The Philadelphia jury awarded the plaintiffs more than double the $1.2 million they had sought. The jury found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating the child’s mother, said. It also concluded the antidepressant was a “factual cause” of the child’s heart defects. However the plaintiffs were not awarded punitive damages because the jury did not find Glaxo’s handling of the drug to be “outrageous.”

As we’ve reported previously, during the trial, attorneys for the plaintiffs presented internal Glaxo documents, including e-mails and memos, that showed the company’s own scientists and executives were aware of Paxil’s link to birth defects, yet minimized the risk to doctors. Other evidence presented suggested Glaxo aggressively promoted Paxil for use in pregnant women even after suspecting the risk.

According to the Philadelphia Inquirer, the jury deliberated for just seven hours over two days.

Glaxo is disputing the verdict, and plans to appeal, said. The company must still defend 600 other Paxil birth defects lawsuits.

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