A Philadelphia jury has found that the antidepressant Paxil was responsible for the heart birth defects suffered by a three-year-old boy, and has awarded his family $2.5 million. The child’s mother had taken Paxil while pregnant with him.
The plaintiffs were awarded more than double the $1.2 million they had sought. The jury found 10-2 that GlaxoSmithKline officials “negligently failed to warn” the doctor treating the child’s mother, Bloomberg.com 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.” According to the Philadelphia Inquirer, the jury deliberated for just seven hours over two days.
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.
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).
Glaxo, which faces another 600 Paxil birth defects lawsuits, says it plans an appeal of the Pennsylvania verdict.
