Riegel v. Medtronic, Inc. (2007)
- Docket
- 06-179
- Decided
- 2007-01-01
Summary
Question: Does Section 360k(a) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempt state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Conclusion: The Court, in an 8-1 decision, affirmed the Second Circuit and granted summary judgment in favor of Medtronic. The Court's opinion, written by Justice Antonin Scalia, noted that the MDA pre-empted state common law claims for defective devices such as this one. Riegel's negligence and strict liability claims relating to the safety and effectiveness of the catheter were based on New York's requirements and were therefore "different from, or in addition to" the federal requirements. Only Justice Ruth Bader Ginsburg dissented.