Upsher-Smith manufactures a generic form of the prescription drug amiodarone hydrochloride (amiodarone). The FDA approved amiodarone in its brand-name formulation as a drug of last resort for patients suffering from ventricular fibrillation and ventricular tachycardia, both life-threatening heartbeat irregularities. As a generic manufacturer of amiodarone, Upsher-Smith has an ongoing duty to ensure that it includes the same labeling approved for its brand-name counterpart. One of those labeling requirements is to make “Medication Guides” available for distribution to each patient with each prescription, by providing them—or the means to produce them—to distributors, packers, or authorized dispensers of the drug. Medication Guides explain the approved uses of a drug and its side effects to a patient “in nontechnical, understandable language” that is clearly presented in at least 10-point font. The Medication Guide for amiodarone warns patients that the drug “should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias.” Lung damage is listed as a “serious side effect” of taking the drug, along with related symptoms such as shortness of breath and wheezing.

Because “the medicine stays in your body for months after treatment is stopped,” these adverse effects may continue even after ceasing treatment.

Rita McDaniel, Johnny’s widow, sued Upsher-Smith on behalf of her late husband’s estate. In general, she alleges that her husband died in July 2015 because he had been taking amiodarone. More specifically, Johnny’s doctor prescribed him a course of amiodarone to treat his non-life-threatening atrial fibrillation. Johnny apparently did not receive the corresponding Medication Guide when he filled his prescriptions in May and June 2015 because Upsher-Smith neglected to ensure its availability. Thus, he was unaware that only adults with life-threatening heartbeat problems who had unsuccessfully sought alternative treatments should take the drug. McDaniel sued on multiple theories under Tennessee law: strict-liability failure-to-warn, negligent failure-to-warn, and negligence-perse claims. The failure-to-warn claims are premised solely on Upsher-Smith’s failure to provide a Medication Guide. Upsher-Smith moved to dismiss for failure to state a claim. The district court granted Upsher-Smith’s motion and dismissed the failure-to-warn claims with prejudice, holding that they were impliedly preempted under the FDCA. The court explained that McDaniel failed to cite any Tennessee duty paralleling the federal duty to provide a Medication Guide. Said differently, the claims would not exist in the absence of the FDCA.

What is the “duty of sameness” as defined by the court, and how is it relevant in this case? Who are the relevant stakeholders in this case?

How did the court rule?