Riegel v. Medtronic, Inc.
|Riegel v. Medtronic, Inc.|
|Argued December 4, 2007|
Decided February 20, 2008
|Full case name||Charles R. Riegel, et ux. v. Medtronic, Inc.|
|Citations||552 U.S. 312 (more)|
128 S. Ct. 999; 169 L. Ed. 2d 892
|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.|
|Majority||Scalia, joined by Roberts, Kennedy, Souter, Thomas, Breyer, Alito; Stevens (except Parts III–A and III–B)|
|Concurrence||Stevens (in part)|
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.
- Eli Lilly & Co. v. Medtronic, Inc.
- FDA Preemption
- List of United States Supreme Court cases, volume 552
- Korobkin, Russell (2007). "Who Should Protect the Public? The Supreme Court and Medical Device Regulation". New England Journal of Medicine. 357 (17): 1680–1681. doi:10.1056/NEJMp078142. PMID 17960010.
- Text of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) is available from: Findlaw Justia Oyez (oral argument audio)