Status of Federal Preemption of Medical Device Litigation

In its February 2008 Riegel v. Medtronic, Inc. decision, the Supreme Court found that a federal preemption clause in the Medical Device Amendments of 1976 barred all product liability suits based on the failure of a medical device which had undergone FDA Class III approval. The consequences of the Riegel decision are explored in detail by examining the specific device-related and clinical issues in individual cases preempted by Riegel. The latest legislation amd legislative history, if any, introduced in response to the Riegel decision in both the House and Senate are presented as well. Likely outcomes of this proposed legislation in both the House and Senate are identified based upon interviews with all the principal stakeholders in the medical device product liability litigation and regulatory processes.