By Susan Lasser, J.D.
Sixth Circuit’s preemption ruling in an action concerning a drug maker’s failure to provide a medication guide as required by the Food and Drug Administration will stand.
The U.S. Supreme Court has denied an appeal of an appellate court decision holding that failure-to-warn claims asserting that a drug manufacturer failed to provide a federally mandated medication guide to a patient who died after taking the manufacturer’s antiarrhythmic drug were preempted by federal law. The U.S. Court of Appeals for the Sixth Circuit affirmed a federal district court in Tennessee which determined that the federal Food, Drug, and Cosmetic Act (FDCA) impliedly preempted the deceased patient’s widow’s failure-to-warn claims premised solely on the manufacturer’s failure to provide the medication guide as required by Food and Drug Administration (FDA) regulations [see Products Liability Law Daily’s July 9, 2018 analysis]. The lower court had explained that the widow failed to cite any Tennessee duty paralleling the federal duty to provide a medication guide. The Sixth Circuit agreed, finding that Tennessee law did not require the drug maker to provide a medication guide, which meant that the core of the widow’s claims rested on the manufacturer’s alleged failure to comply with a federal regulation that only the federal government could enforce (McDaniel v. Upsher-Smith Laboratories, Inc., Docket No. 19-1246, petition filed October 31, 2018; cert. denied October 5, 2020).
Upsher-Smith Laboratories, Inc., which makes a generic drug of last resort for heartbeat irregularities, was sued by the wife of a man who died after taking a generic form of the prescription drug amiodarone hydrochloride. She argued that the drug maker failed to warn about the dangers of the drug because her husband was not provided with a medication guide along with his prescription. That medication guide, required by the FDA under the FDCA, would have put her husband on notice that the drug could cause lung damage and breathing problems, and that it was meant only as a drug of last resort for life-threatening heartbeat irregularities, according to the lawsuit.
Petition denied. In her petition to the High Court, the widow presented the following question: Whether a state-law, failure-to-warn claim that parallels a defendant’s failure to follow FDA labeling regulations is impliedly preempted. She argued that the Supreme Court should grant her petition because the Sixth Circuit’s decision was inconsistent with decisions by other courts of appeal, the question presented was "important and recurring," and the Sixth Circuit’s decision was incorrect. The widow claimed that the appellate court’s opinion conflicted with the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). She said that unlike other appellate courts, the Sixth Circuit interpreted Buckman as precluding a state-law claim mirroring a violation of federal FDA regulations. The widow asserted that most appellate courts have held that Buckman does not preempt state-law claims that parallel federal regulations, even if the allegations mirror the language of the federal regulation. In the case of medical devices, she continued, the allegations must track the language in the federal regulation. The Sixth Circuit, however, held that the widow’s failure-to-warn claim was preempted because it included an allegation that the drug maker failed to provide an FDA-mandated warning effectively, the widow claimed. As such, she argued, the Sixth Circuit interpreted Buckman "more broadly than other courts of appeals and ignored the presumption against preemption." The High Court denied the widow’s petition.
The case is Docket No. 19-1246.
Attorneys: Edward Kirksey Wood Jr. (Wood Law Firm, LLC) for Rita McDaniel; Cary Silverman Jr. (Shook, Hardy and Bacon LLP) for Upsher-Smith Laboratories, Inc.
Companies: Upsher-Smith Laboratories, Inc.
MainStory: TopStory SupremeCtNews WarningsNews PreemptionNews DrugsNews
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