Reprinted with permission of DRI, all rights reserved

Although attention has been focused on preemption in the medical device and prescription drug contexts following the recent United States Supreme Court opinions in Riegel v. Medtronic, Inc., 552 U.S._,128 S. Ct. 999 (2008) and Wyeth v. Levine, 555 U.S._, 173 L. Ed. 2d 51 (2009), prac-titioners should not overlook preemption in cases involving over-the-counter (OTC) products. Over the last several years, OTC manufacturers have successfully argued that plaintiffs’ state-law based claims were preempted under Section 379r of the Food and Drug Administration Modernization Act (FDAMA). Defendants have found the most success obtaining dismissal of plain-tiffs’ claims based on the FDAMA’s express preemption provision, particularly where plaintiffs only assert claims for economic harm. Practitioners, however, should also consider preemption in personal injury cases involving OTC products. This arti-cle begins with a brief overview of the reg-ulatory scheme governing OTC products, and then examines recent OTC preemp-tion cases, including the impact of Riegel and Levine on OTC preemption defense arguments.

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