STORY FROM: Drugs & Medical Devices

Learned Intermediary Doctrine Bars Amiodarone Warning Claims, 4th Cir. Rules

RICHMOND, Va. — The learned intermediary doctrine defeats claims that the manufacturers of generic Cordarone failed to properly warn of its risks because the prescribing physician was aware of the drug’s side effects, a federal appeals court has ruled.

In an April 8 opinion, the 4th Circuit U.S. Court of Appeals concluded that the drug maker defendants fulfilled their state-law duty to warn the prescribing doctor of the risk of pulmonary toxicity.

Hubert E. Bean Jr. was prescribed Cordarone (amiodarone) to treat his non-life-threatening atrial fibrillation. There is no dispute that, at the time of the prescription, Bean’s physician, ...

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