Amiodarone Failure-To-Warn Claims Preempted, N.J. Federal Judge Rules

CAMDEN, N.J. — A New Jersey federal judge has dismissed without prejudice a multi-plaintiff lawsuit against the manufacturer of generic amiodarone, ruling that their claims of failure-to-warn are preempted because they impermissibly seek to challenge the drug’s FDA-approved warnings.

In a May 28 order, Judge Michael Shipp of the U.S. District Court for the District of New Jersey explained that Zydus Pharmaceuticals USA Inc. is barred by federal law from unilaterally changing the warnings in amiodarone’s label and Medication Guide, which are identical to those in the brand name drug’s labeling.

Wyeth Pharmaceuticals Inc. received Food and Drug Administration …