STORY FROM: Drugs & Medical Devices

Negligence Claims Against Generic Cordarone Makers Not Preempted, Texas Federal Judge Rules

SAN ANTONIO, Texas — Claims based on generic drug manufacturers’ failure to provide a plaintiff or his physician with FDA-approved warnings concerning the risks of amiodarone allege a violation of both state and federal law and are therefore not preempted by federal law, a Texas federal judge has ruled.

On May 11, Judge Xavier Rodriguez of the U.S. District Court for the Western District of Texas explained that such claims are “parallel” and therefore not preempted. The judge further held that questions of fact exist as to whether the learned intermediary doctrine bars the claims because it is not ...

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