Burningham v. Wright Medical Technology, Inc.
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The Supreme Court accepted certified questions of law from the federal court related to a case involving artificial hip implants, answering to what extent implanted medical devices should be immune from strict liability design defect claims under Utah law because they are "unavoidably unsafe," meaning they are "incapable of being made safe for their intended and ordinary use" but their marketing and use is justified because of the benefit they provide.
Specifically, the Court answered (1) while some implanted medical devices are unavoidably unsafe, under current federal regulations, this question should be treated as an affirmative defense and determined by the fact-finder on a case-by-case basis with regard to devices that enter the market through the 510(k) process; and (2) for devices that go through a more rigorous premarket approval process, the Court does not opine on whether such devices might be unavoidably unsafe as a matter of law because they are already exempt from design defect claims under the United States Supreme Court's decision in Riegel v. Medtronic, Inc. 552 U.S. 312 (2008).
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