STORY FROM: Drugs & Medical Devices

Warning Claims Asserted Against Generic Cordarone Maker Preempted, Ala. Federal Judge Rules

BIRMINGHAM, Ala. — An Alabama federal judge has dismissed with prejudice a failure-to-warn claim accusing the maker of generic Cordarone of marketing the drug for off-label uses, finding it is preempted by federal law because it seeks to enforce Food and Drug Administration Regulations.

On Aug. 18, Judge R. David Proctor of the U.S. District Court for the Northern District of Alabama also dismissed the plaintiff’s off-label marketing claim without prejudice, ruling that it sounds in fraud and failed to meet the heightened pleading requirements for fraud claims.

Charles Elliott was diagnosed with non-life threatening atrial fibrillation and was prescribed ...

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