STORY FROM: Drugs & Medical Devices

3rd Cir. Reinstates Failure-To-Warn Claims in Fosamax MDL, Says Preemption Issue is Fact Dependent

PHILADELPHIA — A federal appeals court has reinstated failure-to-warn claims asserted against Merck in the federal Fosamax femur fracture multidistrict litigation, ruling that the issue of preemption is a question of fact for the jury and cannot be decided at the summary judgment stage.

In a March 22 opinion, the 3rd Circuit U.S. Court of Appeals explained that under the “clear evidence” standard set forth in Wyeth v. Levine, the factfinder must conclude that it is highly probable that the FDA would not have approved a label change. The term refers solely to the applicable standard of proof, and therefore ...

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