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64 Food & Drug L.J. 291 (2009)
Life after Riegel: A Fresh Look at Medical Device Preemption One Year after Riegel v. Medtronic, Inc.

handle is hein.journals/foodlj64 and id is 305 raw text is: Life After Riegel: A Fresh Look at Medical Device Preemption One Year After Riegel v. Medtronic, Inc. GREGORY J. WARTMAN* 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 fed- eral 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). Although the issue was not raised on appeal, the Court stated that claims seeking to impose obligations parallel to those imposed by FDA under a device's PMA approval would not be preempted. Since Riegel, plaintiffs have revamped their claims in an effort to overcome device manufacturers' motions to dismiss and motions for summary judgment on preemption grounds. Manufac- turers challenged these alleged parallel claims leading to a significant number of post-Riegel preemption rulings. Many commentators have reviewed the Riegel decision and discussed its prudence or imprudence, but no one has yet summarized comprehensively what the courts, in endeavoring to apply Riegel, have done in trying to make sense of the ruling in a broader context. 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: Type #1: Courts evaluating whether plaintiffs' alleged parallel claims are preempted as a matter of law. Type #2: Courts evaluating whether the plaintiffs' alleged parallel claims are simply repackaged Riegel-like claims that sought to impose obliga- tions that were additional to or different than federal requirements of the device's PMA approval. Type #3: Courts evaluating whether alleged parallel claims are either sufficiently pled or supported by the evidentiary basis required under state law. Type #4: Courts evaluating whether alleged parallel claims based on the withholding or misrepresentation of information to FDA (e.g., fraud-on- the-FDA) are preempted in accordance with the United States Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee. Type #5: Courts evaluating whether Riegel applies to situations where the alleged defect was discovered after FDA granted PMA approval. Mr. Wartman is an Associate in the law firm of Saul Ewing LLP, Philadelphia, PA.

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