Riegel v. Medtronic, Inc.
Riegel v. Medtronic, Inc. | |||||||
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Argued December 4, 2007 Decided February 20, 2008 | |||||||
Full case name | Charles R. Riegel, et ux. v. Medtronic, Inc. | ||||||
Docket nos. | 06-179 | ||||||
Citations | |||||||
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 | |||||||
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Case opinions | |||||||
Majority | Scalia, joined by Roberts, Stevens, Kennedy, Souter, Thomas, Breyer, Alito | ||||||
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 challenges the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.
It modified the rule in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
See also
- Eli Lilly & Co. v. Medtronic, Inc.
- FDA Preemption
- List of United States Supreme Court cases, volume 552
Further reading
- Syllabus and opinion in printable format from Justia.com
- 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.