STORY FROM: Drugs & Medical Devices

Strict Liability, Warning Claims Against Generic Amiodarone Maker Preempted, N.Y. Federal Judge Rules

NEW YORK — Claims accusing a generic drug maker of failing to provide patients with medication guides detailing the risks of amiodarone are impliedly preempted because they impermissibly seek to enforce the Food, Drug and Cosmetic Act, a New York federal judge has ruled.

On March 9, Judge Vincent Briccetti of the U.S. District Court for the Southern District of New York further held that the plaintiffs’ strict liability and failure-to-warn claims are preempted because they would require Taro Pharmaceuticals U.S.A. Inc. to unilaterally change its FDA-approved label to contain stronger warnings regarding amiodarone’s risks.

In 1985, Wyeth Pharmaceuticals ...

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