Preemption in Product Liability The Giving And Taking Away Leslie Hayes Russo & Amy Taylor Sevigny


Riegel v. Medtronic, Inc.,1 the Medical Devices Amendments of 1976 (MDA)2


In February 2008, the United States Supreme Court, in held that the preemption clause of barred


state common law claims challenging the safety or effectiveness of a medical device that received pre-market approval (PMA) from the Food and Drug Administration (FDA). In contrast, in March 2009, the United States Supreme Court held in Wyeth v. Levine3


that federal law does not preempt state tort


claims for injuries resulting from inadequate warning labels on prescription (non-generic)4


and their progeny. It also offers some commentary medications. Tis article


delineates the stated scope and limitations of these split decisions,5


on expected lines of attack from the drug industry, and the necessity of continued advocacy in the legislative arena and courtrooms to preserve state consumer remedies.


The Taking Away: Riegel v. Medtronic, Inc. Decision (8-1) Charles Riegel and his wife, Donna, filed suit against


Medtronic, Inc. (Medtronic) after a Medtronic balloon catheter ruptured in Mr. Riegels’ coronary artery during heart surgery (coronary angioplasty). Te catheter, a class III device, had received FDA pre-market approval. Te Riegels alleged that the catheter, in violation of New York common law, was defectively designed, labeled, inspected and manufactured. State law actions included strict liability, breach of implied warranty, as well as claims for negligent inspection, marketing, sale and manufacture.


Medtronic alleged that the actions


were preempted. Te United States District Court for the Northern District of New York agreed, held that the claims were barred insofar as they were not premised on the theory that Medtronic violated federal law.6


Te United States Court


of Appeals for the Second Circuit affirmed. Te United States Supreme Court answered in the affirmative the question “whether the preemption clause


enacted in the Medical Device Amendments of 1976, 21 1 552 U.S. 312, 128 S.Ct. 999, 129 L.Ed.2d 892 (2009). Author’s Note: Citations to the principal decisions will be primarily to the Supreme Court Reporter.


2 21 U.S.C. § 360k(a)(1). 3 Wyeth v. Levine, 555 U.S. ---, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). 4 See footnotes 78, 79, infra, and surrounding text. 5 Justice Scalia delivered the opinion of the Court in Riegel in which Justices Roberts, Kennedy, Souter, Tomas, Alito joined. Justice Stevens filed an opinion concurring in part and concurring in the judgment. Justice Ginsburg filed a vigorous dissenting opinion. See Section I B, Other Views. As to the split in Levine, see infra, at Section II B, Other Views.


6 Te United States District Court later granted summary judgment against the Riegels’ with respect to its claims the device was negligently manufactured in violation of federal standards. Tose claims were not before the Supreme Court. 552 U.S. at [insert], 128 S.Ct. at 1006, fn.2.


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U.S.C.§ 360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA).”7 Preliminarily, the Supreme Court examined the federal regulatory scheme of medical device review, noting that until the enactment of the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FDCA) in 1976, “the introduction of new medical devices was left largely for the States to supervise as they saw fit.”8


In the aftermath


of an onslaught of personal injury/death claims involving the Dalkon Shield intrauterine device, and various (and varying) measures by state legislatures to require pre-market approval of medical devices, the United States Congress enacted the MDA, which, in its view, “swept back some state obligations


7 552 U.S. 312, 128 S.Ct. at 1003. 8 552 U.S. 312, 128 S.Ct. at 1003 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)).


Continued on page 34 Legal matters can be complex.


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Trial Reporter / Winter 2010 31


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