The U.S. District Court for the District of Massachusetts ended a years-long multi-district litigation against Shook’s client, GlaxoSmithKline. On June 1, 2021, the court granted GSK’s motion for summary judgment based on federal preemption, finding that FDA was fully informed of all relevant information concerning the safety of Zofran when it rejected plaintiffs’ proposed birth defect warnings. The plaintiffs long contended that GSK failed to adequately warn of the alleged risks of Zofran use during pregnancy and that GSK did not provide FDA with relevant scientific evidence. The court rejected those arguments based on an extensive evidentiary record, which demonstrated that FDA repeatedly refused to add the warnings that plaintiffs advocated.
The decision disposes of all 430 cases in the MDL, including the first bellwether case set to be tried in October 2021, with Shook Partners Hildy Sastre and Bill Geraghty expected to try the case.
The litigation team consists of Shook Chair Madeleine McDonough, Partners Jennifer Hill, Sean Wajert, Jennifer Stevenson and Tom Sheehan, and Partners Bill Geraghty and Hildy Sastre as lead trial counsel.
The AmLaw Litigation Daily recognized Shook’s Zofran team as runners-up for “Litigator of the Week,” and Bloomberg, Reuters and Law360 covered the summary judgment, along with other publications. Law360 also listed the case in “Top Product Liability Cases of 2021: Midyear Report.”
The case is In re: Zofran (Ondansetron) Products Liability Litigation, case number 1:15-md-02657, in the U.S. District Court for the District of Massachusetts.
Update: On January 9, 2023, the United States Court of Appeals for the First Circuit affirmed the district court’s grant of GSK’s motion for summary judgment.