“… This Article examines the Court’s decision in Albrecht and new issues expected to arise as lower courts interpret it. The Article’s goal is to assist judges and others as to whether a branded drug manufacturer has made a sufficient showing, for preemption purposes, that the FDA’s action or inaction provides clear evidence that the agency would not approve a warning change. Part I discusses the Supreme Court’s preemption jurisprudence regarding pharmaceutical products to provide an overview of the legal environment in which Albrecht was decided. It then examines the Albrecht decision. Part II analyzes outstanding issues in the wake of Albrecht and suggests how they should be resolved. It further discusses judges’ required branded drug preemption analysis. Part III examines the role of preemption regarding FDA-approved drugs now and in the future.
The Article concludes that the Supreme Court opened the door in Albrecht to potentially broader availability of branded drug preemption. The Court’s decision to vest the authority to make preemption determinations in the pharmaceutical context exclusively with judges, as well as other statements, reflect the notion that preemption should be available where the FDA has directly or indirectly rejected a proposed warning change after receiving all of the material drug information. In that regard, and to give full effect to the Court’s decision, judges should avoid an overly rigid or inflexible approach to preemption determinations regarding branded drugs …”
Victor E Schwartz and Christopher E Appel, Where’s the Beef?: A Guide to Judges on Preemption of State Tort Litigation Involving Branded Drugs, 89 University of Cincinnati Law Review 597 (2021).