Document Type

Congressional Testimony

Publication Date

5-12-2009

Abstract

I start with a brief history of the Medical Device Amendments of 1976 and explain why that history demonstrates that Congress quite clearly intended to preserve state liability law, not wipe it away. I will then turn to the Court's ruling in Riegel and address why the Court's wooden, textual approach to the Amendments -- which ignores their purpose -- led the Court to conclude, wrongly, that Congress intended the Amendments to preempt state liability claims for devices approved by FDA under the pre-market approval process. Next, I discuss the impact Riegel has had in the courts, resulting in the wholesale dismissal of device-related tort litigation and the denial of redress to thousands of patients injured by defective devices. Finally, I address the policy arguments against preemption and point out that the Court's more recent decision in Wyeth v. Levine underscores the need for Congress to overturn Riegel.