STORY FROM: Drugs & Medical Devices

Learned Intermediary Doctrine Defeats Generic Cordarone Action, 11th Cir. Affirms

ATLANTA — A federal appeals court has upheld dismissal of a generic Cordarone action, agreeing with the lower court that the learned intermediary doctrine bars the plaintiff’s claims that Sandoz Inc. failed to provide adequate warnings regarding its risks.

In an April 9 opinion, the 11th Circuit U.S. Court of Appeals explained that the plaintiff failed to allege that her doctor would not have prescribed her amiodarone had he known of its dangers.

Barbara Tutwiler was prescribed Cordarone to treat her non-life-threatening atrial fibrillation. The prescription was filled with the drug’s generic equivalent, amiodarone, manufactured by Sandoz.

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