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Thursday, January 26, 2012

Riegel v. Medtronic, Inc.: Federal Preemption of State Tort Law Regarding Medical Devices with FDA Premarket Approval

Vanessa K. Burrows
Legislative Attorney

In Riegel v. Medtronic, Inc., the United States Supreme Court held in an 8 to 1 decision that if the Food and Drug Administration (FDA) grants premarket approval (PMA) to a medical device, the device manufacturer is immune from certain suits under state tort law, due to an express preemption provision in the Medical Device Amendments of 1976 (MDA). This holding establishes that FDA PMA preempts claims such as strict liability, breach of implied warranty, and negligence in design, testing, manufacturing, labeling, distribution, sale, inspection, or marketing of the device to the extent that such state law claims are “different from, or in addition to” federal PMA requirements. However, the Supreme Court held that the MDA’s express preemption provision did not prohibit state “claims premised on a violation of FDA regulation.” The Court stated that such claims “‘parallel,’ rather than add to, federal requirements.” Post- Riegel, the lower courts have come to differing conclusions when determining whether particular state law claims, such as manufacturing defect claims, “parallel” federal requirements, and thus are not preempted, or rather are state requirements “different from, or in addition to” federal requirements, and thus are preempted under Riegel.

The Supreme Court’s decision has been a cause for concern for some Members of Congress who disagree with the ruling, as well as trial lawyers and patients. However, advocates of more limited tort liability, including the previous Administration, agree with the ruling. The decision has broad implications for consumers of Class III medical devices, who are prevented from suing device manufacturers on most state common law claims, as well as manufacturers, who are shielded from many suits if their device receives FDA PMA. In the 111th Congress, bills were introduced—H.R. 1346, H.R. 4816, and S. 540—that would have overturned the Court’s decision in Riegel by modifying the statute at issue. As of the date of this report, similar legislation has not been introduced in the 112th Congress.

This report will provide a brief overview of federal premarket regulation of medical devices. The report then provides an overview of federal preemption of state law, as well as arguments for and against federal preemption of state law tort claims with respect to medical devices. The report explains the Supreme Court’s decision in Riegel and examines the concurring and dissenting opinions. Finally, the report analyzes the legal, procedural, policy, and legislative implications for Congress, consumers, and medical device manufacturers.

Date of Report: January 13, 2012
Number of Pages: 29
Order Number: R40534
Price: $29.95

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