Admissibility Hurdles for 510(k) Evidence in Medical Device Litigation

"12 C.Medtronic, Inc. v. Lohr: Contrasting 510(k) and PMA The U.S. Supreme Court's 1996 opinion in Medtronic, Inc. v. Lohr,13 rooted in an analysis of whether certain state law claims were preempted under 21 U.S.C. 360k(a), quickly became the touchstone for any examination of the FDA'...

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Bibliographic Details
Published inDefense counsel journal Vol. 87; no. 1; pp. 1 - 11
Main Authors Simpson, Robert R, Hampton, Caycee D
Format Journal Article
LanguageEnglish
Published Chicago International Association of Defense Counsels 01.01.2020
International Association of Defense Counsel
Subjects
Compliance
Defense (Civil procedure)
District courts
Evidence
Evidence (Law)
Exceptions (Law)
FDA approval
Federal court decisions
Laws, regulations and rules
Marketing
Medical device industry
Medical equipment
Medical technology
Preemption (Legislative power)
Product defects and recalls
Product liability
Product safety
Products liability
Regulation
Safety and security measures
State court decisions
Trends
Trials
United States > US
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Summary:"12 C.Medtronic, Inc. v. Lohr: Contrasting 510(k) and PMA The U.S. Supreme Court's 1996 opinion in Medtronic, Inc. v. Lohr,13 rooted in an analysis of whether certain state law claims were preempted under 21 U.S.C. 360k(a), quickly became the touchstone for any examination of the FDA's regulatory scheme for medical devices in federal court. [...]substantial equivalence determinations provide little protection to the public. III.Admissibility Trends A. Appellate Decisions Excluding 510(k) Evidence Plaintiffs arguing for the exclusion of 510(k) evidence received a boost from the Eleventh Circuit in Eghnayem v. Boston Scientific Corp.17 In affirming a final judgment in favor of the plaintiff who alleged injuries caused by a transvaginal mesh prescription medical device, the court explained: "[I]t is clear that the district court did not abuse its discretion when it concluded that the 510(k) review process is not relevant to a product's safety. "18 The court further agreed with the district court's explanation that, "if 510(k) does not go to a product's safety and efficacy - the very subjects of the plaintiff's products liability claims - then evidence of [the manufacturer's] compliance with 510(k) has no relevance to the state law claims in this case.
ISSN:0895-0016
2376-3906