Medtronic, Inc. v. Lohr: Is Federal Pre-emption a Heartbeat away from Death under the Medical Device Amendments?

Abstract

This Note will explore the historical, judicial, and social ramifications of the Court's decision in Medtronic, Inc. v. Lohr. Part II describes the history of the Federal Food, Drug and Cosmetic Act of 1938 (FDCA), the Medical Device Amendments of 1976 (MDA), federal pre-emption in general, and federal pre-emption under the MDA. Part III presents the facts and judicial history of the case. In Part IV, this Note critically analyzes Justice Stevens's plurality opinion and the concurring and dissenting opinions. Part V discusses the judicial and social impacts of the case with particular attention to the implication for the biotechnology and medical device industries. Part VI concludes by observing that various public policy concerns permeate the Court's pre-emption analysis and may signal a new approach for judicial decisionmaking.