Amiodarone Failure-To-Warn Claims Preempted, 3rd Cir. Rules

CAMDEN, N.J. — The 3rd Circuit U.S. Court of Appeals has upheld dismissal of a multi-plaintiff lawsuit against a manufacturer of generic amiodarone, ruling their claims are preempted because they would require the defendant to issue communications to doctors that go above and beyond those implemented by the name-brand manufacturer.

On July 24, the appellate panel explained that federal law prevents generic manufacturers like Zydus Pharmaceuticals USA Inc. from engaging in communications that surpass the labeling provided by the name-brand manufacturer because they would run the risk of “inaccurately implying a therapeutic difference between the brand and generic drugs and …