title: Life after Riegel: a fresh look at medical device preemption one year after Riegel v. Medtronic, Inc.
abstract: The United States Supreme Court's landmark decision in Riegel v. Medtronic, Inc. in February 2008 altered the landscape of medical device litigation involving Class III medical devices that have received premarket approval from the Food and Drug Administration (FDA).In Riegel, the Court ruled that the premarket approval process establishes federal requirements and that state law tort claims seeking to impose additional or different requirements on device manufacturers are preempted under the express preemption clause of the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA). It is only by examining post-Riegel case law that one can develop an appreciation for where medical device litigation and device preemption are likely to head in the future. This article will conduct this evaluation of post-Riegel decisions by dividing the courts' rulings into various types of cases. This classification of claims provides insights into the strategies employed by plaintiffs to distinguish Riegel or side-step the ruling altogether and how courts have received these efforts.
authors.affiliation: Saul Ewing LLP, Philadelphia, PA, USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Wartman
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D017007:Duty to Warn / Q000331:legislation & jurisprudence; D004868:Equipment Failure; D035082:Federal Government; D005607:Fraud / Q000331:legislation & jurisprudence; D006801:Humans; D016365:Liability, Legal; D010138:Pacemaker, Artificial / Q000009:adverse effects; D013219:State Government; D014481:United States; D014486:United States Food and Drug Administration