Featuring Daniel E. Troy, Executive Vice President, Chief Legal Officer and General Counsel of Valo Health; Robert E. Johnston, a partner with Hollingsworth LLP; and Daniel J. Feith, a counsel with Sidley Austin LLP.

Publication Summary: The Food, Drug and Cosmetic Act grants the Food and Drug Administration plenary authority over prescription drug review, marketing approval, and post-marketing oversight. A pharmaceutical manufacturer must strictly comply with FDA’s labeling requirements in order to market their product. FDA interprets that authority very broadly.

Whether the health warnings that FDA requires drug makers to include on product labels are adequate is a question that arises frequently in product-liability lawsuits filed under state law. Plaintiffs in such cases allege that the manufacturer’s failure to warn of certain risks caused their injury. Such an argument beget a potential collision of authority: Can a judge, applying state law, require a new or different warning than that which FDA has required?

In such circumstances, pharmaceutical defendants may argue that federal law preempts the application of state-law warning mandates as a remedy in product-liability litigation. A 2008 U.S. Supreme Court decision, Wyeth v. Levine, set out some parameters for such a preemption defense. The Court has issued several drug preemption decisions since Wyeth, including a 2019 ruling that placed assessment of defendants’ “impossibility preemption” arguments in the hands of judges.

In this WLF Conversations With publication, a group of attorneys who have considered federal preemption as trial counsel, senior federal officials, in-house counsel, and judicial clerks join us to discuss the latest federal-court jurisprudence on such key questions as what constitutes “newly acquired information” and whether judges can make factual determinations when evaluating preemption claims.

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