GSK Renews Summary Judgment Motion on Preemption Grounds in Zofran MDL

  • Order

BOSTON — GlaxoSmithKline has renewed its motion for summary judgment on preemption grounds in the Zofran multidistrict litigation, arguing there is clear evidence that the Food and Drug Administration would have rejected enhanced warnings regarding the risk of birth defects.

In a July 18 motion filed before Judge F. Dennis Saylor of the U.S. District Court for the District of Massachusetts, GSK contends that epidemiological studies found no evidence that Zofran can cause birth defects. Moreover, the drug maker argues, the FDA has “reviewed vast amounts of information,” including epidemiological data and animal data, and “repeatedly concluded that no reasonable …


HarrisMartin's Webinar Series: The Hottest Upcoming Device Projects - Strattice Hernia Mesh & Exactech Hip Implants

November 09, 2022


HarrisMartin’s Webinar Series: Acetaminophen ASD/ADHD Product Liability Litigation

October 21, 2022