Document Type
Brief
Publication Date
8-14-2008
Abstract
Amici are scholars who teach and write about federal preemption of state law. Mindful of the gap that sometimes exists between the academy and the concerns of the bench and bar, we seek to bring our scholarship to bear on the particular preemption questions at issue in this case. Our scholarly interest in preemption arises from teaching and writing in a variety of related fields, including constitutional law, administrative law, health law, and torts.
This case implicates three critical issues in the law of preemption. First, Petitioner's amici have launched a broad attack on this Court's longstanding "presumption against preemption," Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), arguing that it is generally inconsistent with the original understanding of the Supremacy Clause and, in any event, inapplicable in conflict preemption cases. We argue, to the contrary, that the Rice presumption is not inconsistent with the original understanding of the Supremacy Clause, and it plays an essential role of protecting state autonomy in a world where national regulatory authority has been construed much more broadly than the Framers anticipated.
The second issue concerns the preemptive effects of federal regulatory regimes that involve federal administrative approval of a product before that product can be marketed. There is no basis for construing federal premarket approval of drugs to preempt state common law liability for failures to warn. Despite a history of high profile tort litigation involving drugs, consistent efforts by industry to secure an express preemption clause similar to that in the Medical Devices Amendments (MDA), and recent statutory amendments to other aspects of the drug regime, the Food, Drug, and Cosmetic Act continue to include no express preemption provision.
Finally, this case implicates a broad set of issues concerning preemptive actions and interpretations by federal administrative agencies. This Court should accord little or no deference to the FDA's position that preemption is warranted. That position is a 180-degree reversal of the agency's longstanding view that state law provided a valuable supplement to federal regulation, and the new policy lacks the procedural indicia that this Court has generally required as a predicate to deference. Instead, the FDA's "preemption pre amble" represents an effort to achieve tort reform by regulation following Congress's refusal to endorse such efforts.
Recommended Citation
Mendelson, Nina A., "Wyeth v. Levine: Brief of Amicus Curiae Constitutional and Administrative Law Scholars in Support of Respondent" (2008). Appellate Briefs. 19.
https://repository.law.umich.edu/briefs/19
Comments
Amicus: Blais, Professor Lynn E.; Buzbee, Professor William W.; Frickey, Professor Philip; McGarity, Thomas O.; McGreal, Professor Paul E.; Mendelson, Professor Nina; Ruger, Professor Theodore; Siegel, Professor Neil S.; Wagner, Professor Wendy E.; Young, Professor Ernest A.