The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly allow these injured individuals to bring such a claim, and, accordingly, someone injured by a medical device or drug may be limited to bringing a suit under state tort law in order to obtain compensation for the resulting injuries. The Supreme Court has evaluated medical device and drug preemption cases on a number of occasions over the past two decades, and the results have been mixed: in some instances a person injured by an allegedly dangerous drug or device is barred from suing a manufacturer, whereas in other cases, the Court has allowed a suit to go forward. Specifically, the report addresses the types of state-law tort claims that are commonly brought against drug and medical device manufacturers. With the background on the general subjects of preemption, tort law, and federal regulation of drugs and devices in mind, the report concludes by examining the major Supreme Court FDCA preemption cases and analyzing possible judicial and legislative developments that may affect this complicated and ever-changing area of law. With respect to express preemption, the Medical Device Amendments of 1976 (MDA) added a provision to FDCA which states,
... no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act. The Supreme Court has generally found that under the provision, the ability of an individual to bring a state tort lawsuit alleging certain defects with a medical device can hinge on, among other things, how that device received marketing approval from the FDA. Riegel v. Medtronic

In 2008, the Supreme Court examined the scope of the MDA preemption provision for the second time in Riegel v . Medtronic , holding that state tort law claims for injuries related to a medical device that received premarket approval were preempted by federal law. In 2001, the Supreme Court in Buckman v. Plaintiff's Legal Committee examined whether federal law preempted state-law tort claims that alleged fraud on the FDA. Finally, the Court distinguished the Buckman case from its decision in Lohr . While the Supreme Court has generally found that under the MDA preemption provision, the ability of an individual to bring a state-law tort suit alleging certain defects with a medical device can turn on how that device received marketing approval from the FDA, (i.e., through either the § 510(k) process or premarket approval), the inquiry is not this straightforward, and questions remain about which state-law tort claims brought against medical device manufacturers are preempted by federal law. The current NDA holder of a brand-name drug may change a drug's labeling, but a generic drug manufacturer cannot and must ensure that its labeling remains the same as the labeling for the listed drug. Preemption and Prescription Drugs

In contrast to its provisions on medical devices, the FDCA does not contain an express preemption clause with respect to its prescription drug mandates. Nonetheless, the elaborate premarket approval scheme for drugs created by the FDCA has the potential to clash with state tort law, raising questions as to whether federal drug law preempts state tort law. The Court, beginning in 2009, handed down three landmark rulings that clarified when the FDCA's drug requirements preempt state tort law. The pharmaceutical company argued on appeal to the Supreme Court that Ms. Bartlett's strict liability claims, just like the failure-to-warn claims in Mensing , were preempted by the federal sameness requirement for generic drugs. However, the addition of language that explicitly states that state tort claims are not preempted by the FDCA may do little to alter the results of Mensing and Bartlett , as the Court has held that the existence of an express preemption clause or a savings clause does not prevent the Court from examining whether a law impliedly preempts state law.
The interaction between state tort laws and the federal regulation of medical devices and drugs has been a source of constant litigation in recent years. In the last two decades, the Supreme Court has issued several decisions concerning whether the Federal Food, Drug, and Cosmetic Act (FDCA) preempts state tort law. The results have been mixed: in some cases a person injured by an allegedly defective drug or device is barred from suing a manufacturer, whereas in other cases, the Supreme Court has allowed a lawsuit to proceed. Following these decisions, ambiguities exist concerning the scope of federal preemption in these medical device and drug cases.
With respect to medical devices, state-law tort claims brought against device makers are restricted by a provision of the FDCA that expressly preempts state "requirements" that are "different from, or in addition to" federal requirements applicable to a device and that "relate[] to the safety or effectiveness of the device." The Supreme Court has generally found that under this provision, the ability of an individual to bring a state-law tort suit alleging certain defects with a medical device can hinge on, among other things, how that device received marketing approval from the Food and Drug Administration (FDA). In Medtronic v. Lohr, the Court found that state-law claims involving "substantially equivalent" medical devices cleared through the § 510(k) process were not barred by the FDCA's express preemption provision. However, in Riegel v. Medtronic, the Court concluded that if the FDA grants approval to a medical device under its more rigorous premarket approval process, the device manufacturer is immune from certain suits under state tort law. The Court has also found in Buckman v. Plaintiff's Legal Committee that state-law tort claims stemming from violations of the FDCA may be impliedly preempted by federal law. Despite these three decisions, questions remain about what state-law tort claims survive federal preemption.
In contrast to its provisions on medical devices, the FDCA does not contain an express preemption clause with respect to its prescription drug mandates. Nonetheless, the elaborate premarket approval scheme for drugs created by the FDCA has the potential to clash with state tort law, raising questions as to whether these laws may be preempted. The Court has recently handed down three landmark rulings that clarify when the FDCA's drug requirements preempt state tort law. In 2009, the Supreme Court, in Wyeth v. Levine, held that a person hurt by a brand name drug could sue the manufacturer under state tort law for a failure to properly warn about the dangers of the drug. However, in a second case, PLIVA v. Mensing, the Supreme Court ruled that a person hurt by a generic drug could not bring the same failure-to-warn claim because changing the labeling of a generic drug would conflict with federal law that requires a generic drug to be the "same" as its branded equivalent in all material respects, including its labeling. Finally, in Mutual Pharmaceutical v. Bartlett, the question for the Court was whether a person harmed by a generic drug could obtain relief on a theory other than a failure-to-warn claim. The Court held that such claims, much like the failure-to-warn claims in Mensing, by imposing heightened duties that would conflict with the "sameness" requirements of federal law regarding generic drugs, were preempted by the FDCA.
This report provides background on the doctrine of preemption and the types of state-law tort claims that have been brought against medical device and prescription drug manufacturers. The report also addresses the federal regulation of medical devices and drugs under the FDCA. With that background in mind, the report discusses the major FDCA preemption cases that have been recently issued by the Supreme Court. Finally, the report covers possible judicial and legislative developments that may affect this dynamic area of law.