A claim that a drug manufacturer failed to properly warn under Tennessee law based on its failure to include a medication guide required by FDA regulations is impliedly preempted by federal law.
In McDaniel v. Upsher-Smith Laboratories, Inc., No. 2:16-cv-02604 (6th Cir. June 29, 2018), plaintiff brought suit after her husband died after taking medication manufactured by defendant. Plaintiff claimed that defendant’s “failure to ensure that a Medication Guide accompanied the prescription led to her husband ingesting—and dying because of—a drug that wasn’t meant for him.” Plaintiff’s husband had been prescribed a generic form of a medication intended as a “last resort for patients suffering from ventricular fibrillation and ventricular tachycardia.” The husband, however, was suffering from non-life threatening atrial fibrillation. Plaintiff asserted that because defendant did not include the required medication guide, her husband “was unaware that only adults with life-threatening heartbeat problems who had unsuccessfully sought alternative treatments should take the drug.” He thus suffered from a serious lung side effect and died.