GlaxoSmithKline has requested the federal judge presiding over all federal Zofran birth defect lawsuits to revisit the preemption defense, based on a recent ruling by the U.S. Supreme Court.
According to the court documents, the plaintiffs have alleged GSK failed to provide sufficient pregnancy warnings on Zofran, which is commonly prescribed for symptoms of morning sickness. The drugmaker previously tried to dismiss the case, arguing that the claims are preempted by federal law since the FDA would not have allowed a pregnancy warning. However, U.S. District Judge Dennis Saylor issued a memorandum and order on February 5, denying summary judgment motion filed by GlaxoSmithKline to toss all Zofran birth defect lawsuits and allowed a group of cases to prepare for early bellwether trials.
More than 468 lawsuits have been filed against GSK alleging that the company knew about Zofran's pregnancy risks for several years yet failed to adequately warn the medical fraternity. Zofran lawsuits were centralized in October 2015, before Judge Dennis F. Saylor as a part of a multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) in the District of Massachusetts.
