Medical Device Safety Act of 2009: Hearing Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 111th Cong., May 12, 2009 (Statement of David C. Vladeck, Prof. of Law, Geo. U. L. Center)
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.