STORY FROM: Drugs & Medical Devices

GSK Renews Summary Judgment Motion on Preemption Grounds in Zofran MDL

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 ...

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