6th Circuit Finds Medication Guide Suit Preempted
The 6th Circuit Court of Appeals says a lawsuit alleging failure of a generic drug company to provide a Medication Guide with a prescription for the anti-arrythmia drug amiodarone is preempted by federal law. Attorney Michelle Yeary (Reed Smith) writes in an online blog post that this was the first case involving failure to distribute a medication guide to be heard by an appeals court.
In the case, the plaintiff said her husband did not receive the medication guide because the drug company, Upsher-Smith Labs, failed to make sure they were available. “This failure to provide the medication guide was the sole basis for plaintiff’s strict liability and negligence failure-to-warn claims,” Yeary writes. She says that the claim does not argue that the warning on the drug’s labeling was insufficient or inadequate.
The court found that providing a medication guide is required under the Federal Food, Drug, and Cosmetic Act and not under any parallel state law in Tennessee, meaning that it is preempted by the federal law.