5th Cir. Reverses Taxotere MDL Court’s Preemption Ruling

  • Opinion

NEW ORLEANS — The 5th Circuit U.S. Court of Appeals has reversed the Taxotere MDL court’s ruling that failure-to-warn claims asserted against the generic manufacturer defendants are not preempted because there was evidence they had “newly acquired evidence” warranting a label change under the FDA’s Changes Being Effected process.

In a May 24 opinion, the appellate panel found the MDL court did not enforce the requirement that newly acquired information must “reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.”

The panel remanded the action to the U.S. District Court …


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