Shook Team Obtains Preemption Victory, Ending Litigation in Highly Watched Products MDL

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 Hildy Sastre and Bill Geraghty as lead trial counsel. Shook has served as national counsel for GSK in the Zofran litigation since the creation of the MDL in 2015 and argued the motion for summary judgment.   

“This order granting summary judgment based on federal preemption demonstrates the complexities of navigating detailed scientific and regulatory issues in court,” said Shook Chair Madeleine McDonough, who led the firm’s pharmaceutical and medical device practice for many years. “We are pleased that the court thoroughly considered the extensive evidentiary record and argument and put an end to this litigation.”  

The litigation team consists of Chair Madeleine McDonough, Partners Jennifer Hill, Sean Wajert, Jennifer Stevenson and Tom Sheehan, and Partners Hildy Sastre and William Geraghty who were expected to try the first case. Sastre also co-leads the firm’s Product Liability Litigation Practice. Others attorneys who assisted on the Zofran team include Partners Kimberly Penner, Laurie Henry and Steve Thomas, Of Counsels Chad Coots, Valerie Blevins and Evan Montgomery, and Associate Peiyuan Guo. 

The AmLaw Litigation Daily recognized Shook’s Zofran team as runners-up for “Litigator of the Week,” and Bloomberg, Reuters, Missouri Lawyers Weekly and Law360 covered the summary judgment, along with other publications. Law360 also listed the case in “Top Product Liability Cases of 2021: Midyear Report.”

Shook has represented GSK as national counsel in the MDL since its inception in 2015.

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.