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Consumers Union files brief against federal pre-emption in Medtronic case

This article was originally published in The Gray Sheet

Executive Summary

The publisher of Consumer Reports files an amicus curiae brief Aug. 27 with the Supreme Court in favor of the Riegel family, which sued Medtronic for defective design, among other things, after an Evergreen balloon catheter burst inside Charles Riegel's artery during an angioplasty procedure in 1996. A district court decision that Medtronic is protected against state suits by federal pre-emption was upheld on appeal in November 2006 (1"The Gray Sheet" July 2, 2007, p. 3). Device firms have successfully used federal pre-emption in several other cases tried in lower courts. But Consumer Reports says the purpose of the Food, Drug and Cosmetic Act is to protect consumers. "The Court should be exceptionally chary of an interpretation of the statute that would use a new regulatory layer (like the Medical Device Amendments) to sweep away an old one (state based remedies of the common law)," the group says in its brief...

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