In order to elucidate the Supreme Court's decision in Riegel v. Medtronic, Inc. , this report begins by providing background on the Food and Drug Administration's (FDA's) premarket regulation of medical devices and an overview of federal preemption of state law. The report discusses arguments for and against federal preemption of state law tort claims with respect to medical devices. The report then explains the Supreme Court's decision in Riegel v. Medtronic, Inc. , as well as the concurring and dissenting opinions. Finally, the report analyzes the implications of the Court's decision in Riegel for Congress, consumers, medical device manufacturers, and preemption jurisprudence. This report focuses on Class III medical devices because it is federal preemption of state law requirements that are "different from, or in addition to" federal requirements for Class III devices with premarket approval (PMA) that was at issue in Riegel . Class III devices generally require a premarket notification as well as PMA. Preemption

This section will first provide an overview of federal preemption of state law. Where express preemption provisions are not present, federal law may preempt state law implicitly. Arguments Against Federal Preemption of State Law Tort Claims with Respect to Devices

In contrast, arguments against federal preemption of common law in the medical device field focus on (1) congressional intent and legislative history; (2) protections for consumers, who may otherwise be left without a remedy; (3) the change in the FDA's view with regard to preemption, as well as the general presumption against preemption; (4) viewing FDA approval as a preliminary step—a "floor" rather than a "ceiling"—that does not hold manufacturers accountable for safety concerns; and (5) questioning the agency's capabilities in terms of resources and its reliance on industry. The FFDCA contains an express preemption provision with respect to medical devices. The patient and his wife raised New York state common law claims of "strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter." The Supreme Court found that the Medical Device Amendments of 1976 (MDA) preempted state tort law claims because the common law negligence and strict liability claims fell into the category of "any requirement" in the bolded language below. and (2) If the answer to the first question is yes, are the plaintiffs' common law claims (such as negligence in the design, labeling, and marketing of the catheter) based on state requirements that are "different from, or in addition to" the federal requirements, "and that relate to safety and effectiveness"? To the extent that the lawsuit raises claims that "'parallel' rather than add to, federal requirements," such as a state "damages remedy for claims premised on a violation of FDA regulations," it does not appear that such suits would be preempted. Legislative Proposals

In the 111 th Congress, bills were introduced that would have overturned the Court's decision in Riegel by modifying the statute at issue: H.R. 1346 , H.R. 4816 , and S. 540 . Similar legislation has not been introduced in the 112 th Congress.
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.