Riegel v. Medtronic, Inc.
Riegel v. Medtronic, Inc. | |
---|---|
Argument | Oral argument |
Holding | |
The MDA's pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. | |
Court membership | |
| |
Case opinions | |
Majority | Scalia, joined by Roberts, Kennedy, Souter, Thomas, Breyer, Alito; Stevens (except Parts III–A and III–B) |
Concurrence | Stevens (in part) |
Dissent | Ginsburg |
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), is a United States Supreme Court case in which the Court held that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.[1]
It modified the rule in Medtronic, Inc. v. Lohr.[2]
See also
- Eli Lilly & Co. v. Medtronic, Inc.
- FDA Preemption
- List of United States Supreme Court cases, volume 552
References
Further reading
- Korobkin, Russell (2007). "Who Should Protect the Public? The Supreme Court and Medical Device Regulation". PMID 17960010.
External links
- Text of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) is available from: Findlaw Justia Oyez (oral argument audio)