Zofran Caused Birth Defects? Thelitigation over Zofran, GlaxoSmithKline’s anti-nausea drug, continues to move forward with more than 200 plaintiffs alleging that Zofran caused birth defects. GlaxoSmithKine (GSK) is accused of failing to warn about the risk ofbirth defects associated with Zofran. GSK has also been accused of marketing Zofran off-label for morning sickness, even though the FDA only approved the drug to treat nausea in patients undergoing chemotherapy or surgery.
According to court records, the two parties disagree on GSK’s proposal for Sequenced Discovery, or the order in which the discovery should occur. The discovery period occurs when both sides gather information about the case; both parties may request information from one another in order to avoid surprises during a trial. GSK seeks to focus on questions of general causation and federal preemption first. The question of generation causation focuses on whether Zofran caused the type of birth defects alleged in the lawsuits.
The plaintiffs strongly disagree with GSK’s proposal
The question of federal preemption focuses on whether or not GSK failed to disclose important safety information to the FDA. If the company omitted information, it would have affected the FDA’s evaluation of Zofran’s risks versus benefits. The plaintiffs strongly disagree with GSK’s proposal, arguing that this sequence of discovery allows the company to avoid the question of liability. They allege that, by focusing on causality, GSK dodges discovery of whether Zofran was promoted off-label for pregnant women.
Most cases allege Zofran caused congenital heart defects, cleft palate, or cleft lip. In fact, a Harvard study published in 2012 found that prenatal exposure to Zofran was associated with a two-fold increased risk of cleft palate.