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# 6th Circuit Finds Medication Guide Suit Preempted
- URL: https://www.fdaweb.com/6th-circuit-finds-medication-guide-suit-preempted/
- Published: 2018-07-09T12:00:00.000Z
- Updated: 2026-09-15T00:17:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141814

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](https://www.lexology.com/library/detail.aspx?g=5bc72d94-c6e1-446a-883b-0b8251362a3f&utm%5Fsource=Lexology+Daily+Newsfeed&utm%5Fmedium=HTML+email+-+Body+-+General+section&utm%5Fcampaign=Lexology+subscriber+daily+feed&utm%5Fcontent=Lexology+Daily+Newsfeed+2018-07-05&utm%5Fterm=) 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.