The prescription drug paroxetine -- more widely known by the brand name Paxil -- has long been a popular choice among doctors prescribing antidepressive medications for adults.
Paxil has never received regulatory approval, however, for use by pregnant women, a fact that is central in a recent product liability lawsuit filed by an Ohio woman who delivered a child with multiple birth injures in 2001.
The lawsuit alleges that GlaxoSmithKline (GSK), the global pharmaceutical manufacturer that makes Paxil, aggressively touted the drug’s alleged salutary effects in pregnant users despite having knowledge that it posed material risks for that category of consumers.
The child delivered by the plaintiff was born with a ventricular septal defect, coupled with infant respiratory distress syndrome. The lawsuit alleges that GSK knew from marketing studies prior to the woman’s pregnancy that Paxil was linked to heightened cardiac-related birth defects in newborns and failed to sufficiently disclose that risk to the public.
That complaint states that, instead, GSK engaged in a campaign focused on increasing Paxil use among pregnant women by promoting it as a safer alternative to other antidepressant offerings on the market.
“In fact, none of this was true,” the lawsuit contends.
Among many other things, the product liability complaint charges the defendant with multiple counts of negligence for its failure to adequately warn the public of the linkage between Paxil and birth defects. The lawsuit also charges GSK with fraud, breach of various warranties and violation of unfair trade practices and additional counts of wrongdoing.
The plaintiff seeks money damages, reimbursement for medical expenses incurred, earnings losses, punitive damages, court costs and related fees.
Source: The Pennsylvania Record, “GSK faces products liability claim by woman alleging birth defects from Paxil,” Jon Campisi, March 12, 2014