A Philadelphia judge has dismissed the first Paxil birth defects lawsuit to go to trial after determining that evidence presented by the plaintiffs was insufficient to proceed.
What’s the Problem?
May 2, 2016 – The lawsuit was filed by plaintiff Braden Rader and his mother Elizabeth Balser, according to PennRecord. Braden was born with tetralogy of fallot, a combination of 4 congenital heart defects that cause oxygen-depleted (blue) blood to be transported from the heart to the rest of the body.
According to the lawsuit, Balser was prescribed Paxil (generic: paroxetine) at the outset of her pregnancy in 2003, and her son’s defect was the direct result of her taking the drug. At the time, Paxil carried a mild warning about the risk of birth defects, but the drug was upgraded in 2005 to Pregnancy Category D. Medications in this class are associated with “positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans,” according to the U.S. Food & Drug Administration (FDA).
Judge Kenneth J. Powell Jr. dismissed the case on April 5, due to a lack of evidence to support their claims. “Based on the testimony presented by the plaintiff, all the jury could do is guess. I cannot permit the jury to speculate,” he said.
Powell did not allow the jury to view a videotaped deposition from Balser’s physician, Dr. Robert Kiehn, who said he would not have prescribed Paxil to her had it been classified in Pregnancy Category D at the time of her pregnancy.
The judge cited in his decision to bar Kiehn’s deposition a pretrial order that prevented any mention to the jury of remedial measures GSK may have taken to address issues with Paxil. These measures included the upgrading of Paxil’s warning label to “Category D”.