Riegel v. Medtronic, Inc.
2008 United States Supreme Court case / From Wikipedia, the free encyclopedia
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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]
Quick Facts Riegel v. Medtronic, Inc., Argued December 4, 2007 Decided February 20, 2008 ...
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 no. | 06-179 |
Citations | 552 U.S. 312 (more) 128 S. Ct. 999; 169 L. Ed. 2d 892 |
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, Kennedy, Souter, Thomas, Breyer, Alito; Stevens (except Parts III–A and III–B) |
Concurrence | Stevens (in part) |
Dissent | Ginsburg |
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It modified the rule in Medtronic, Inc. v. Lohr.[2]