Federal Preemption of State Tort Suits under the Medical Device Amendments of 1976

Abstract

Historically, plaintiffs injured by allegedly defective medical devices were able to bring tort suits against manufacturers in state court. With the passage of the Medical Device Amendments of 1976 (“MDA”) – a federal law containing an express preemption clause – many wondered whether such lawsuits would still be viable. Courts, FDA, device manufacturers, and the public alike have struggled to understand the scope of federal preemption under the new regime. This paper documents that struggle, beginning with the passage of the MDA in 1976. It then focuses on the Supreme Court’s landmark ruling on the issue twenty years later in Medtronic v. Lohr. It discusses the evolution of MDA preemption doctrine in the post-Lohr decade, and then addresses the Court’s most recent word on the subject – Medtronic v. Riegel. The paper concludes with a description of the most current understanding of federal preemption under the MDA and implications for the future of the field.