Medical device manufacturers scored a major victory against product liability lawsuits as a result of the U.S. Supreme Court's recent decision in Riegel v. Medtronic. The court held that manufacturers of medical devices approved under the Food and Drug Administration's pre-market approval (PMA) process cannot be sued under state law theories of product liability. At the heart of this ruling was a federal statutory provision prohibiting states from imposing requirements "different from, or in addition to" existing federal requirements applicable to medical devices. The court's decision resolved a split among the lower courts, and clarified that PMA approval qualifies as a "requirement" within the meaning of the provision. Thus, products which receive federal PMA approval may not be subjected to state tort claims.
Medical Device Regulation
The Supreme Court's decision rests primarily on the fact that medical devices are heavily regulated by the FDA. But that was not always the case. Before 1976, there were no federal standards governing medical devices. By the mid-1970s, several states, spurred by scandals involving the Copper-7 and Dalkon Shield intrauterine devices, had implemented their own regulations—each one a little different from the other. Without a uniform set of federal regulations, medical device manufacturers faced the prospect of having to comply with fifty different sets of state-law requirements. Then, in 1976, Congress enacted the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), which established a comprehensive federal regulatory scheme—administered by the FDA—to govern medical devices. The statute specifically bars state-law requirements that are "different from, or in addition to" the requirements set by the FDA.
The MDA regulate medical devices at levels commensurate with the risks they impose. Devices that pose only moderate risks are subject to only moderate regulations. However, devices that pose great risks—known as Class III devices—are heavily regulated by the FDA. Class III devices must undergo the FDA's rigorous PMA process. To apply for pre-market approval, a device sponsor must submit copious information, typically several volumes of documents consisting of, among other things, descriptions of the device and its component parts, clinical trial information, and adverse event reports. The FDA spends an average of 1,200 hours reviewing this information, and the agency cannot approve the device unless it provides "reasonable assurance" that it is safe and effective. Once a device is approved, the manufacturer cannot make any changes to the device that affect its safety or effectiveness without prior FDA approval. Although there are other forms of FDA pre-market regulation, the PMA process is its most extensive.
Medical Device Preemption
The focus of Riegel was the interpretation of the MDA's provision prohibiting states from imposing requirements on medical devices that are "different from, or in addition to" existing federal requirements. Lower courts have disagreed over whether and to what extent FDA regulations constitute federal "requirements," and conversely, whether common-law tort claims are state "requirements" within the meaning of the statute.
In 1996, the Supreme Court attempted to clarify the meaning of the MDA's preemption provision in Medtronic v. Lohr. In Lohr, the plaintiff brought a product liability claim against Medtronic over a pacemaker that the FDA had cleared for marketing through the so-called 510(k) process. Section 510(k) of the MDA allows a Class III device to bypass the PMA requirement if the FDA deems it is "substantially equivalent" to a device that was marketed prior to 1976—the year the MDA took effect. Medtronic argued that the plaintiff's claims were preempted under the MDA.
The Supreme Court, in three highly fragmented opinions, ruled that the claims were not preempted, in large part because the 510(k) process was not device-specific or rigorous enough to qualify as a federal "requirement" that would create a conflict with state law. The court left open the possibility, however, that more specific and exacting FDA regulations would qualify for preemption. A majority of the court also agreed that state common law claims did impose "requirements" on medical devices and therefore could be preempted under the MDA. This overturned several lower court decisions that had concluded otherwise.
In the wake of Lohr, state and federal courts had a better grasp on the circumstances under which MDA preemption could apply. However, the Supreme Court's interpretive guidance, though helpful, was incomplete. While the court detailed one federal regulatory scheme that did not preempt state law, it did not describe one that did. Furthermore, it established that state tort claims could be preempted, but did not explain how or when. Thus lower courts, even armed with Lohr, remained divided on the issue of which, if any, medical device regulations preempted state law. Some courts struck down claims against PMA-approved devices, due to the intensive and device-specific nature of the PMA process, while other courts allowed such claims to proceed under Lohr.
The Riegel Decision
On February 20, 2008, the Supreme Court finally addressed whether tort claims involving PMA-approved devices are preempted. In Riegel, the plaintiff underwent an angioplasty with Medtronic's PMA-approved Evergreen Balloon Catheter. During the procedure, the plaintiff's surgeon excessively inflated the catheter, causing it to burst, which resulted in substantial internal trauma. The plaintiff and his wife subsequently filed a tort claim against Medtronic, alleging that the device was defective. The district court held that the FDA's approval of the PMA preempted the plaintiffs' claims and dismissed the case.
The Supreme Court affirmed the dismissal 8-1, with Justice Ginsburg the lone dissenter. In the opinion by Justice Scalia, the court held that unlike the Section 510(k) process at issue in Lohr, the PMA process imposed "requirements" that were specific to the medical devices submitted for review, and therefore preempted state tort claims lodged against manufacturers, at least to the extent the claims were not based on violations of federal requirements.
The court's opinion is significant not only for this result, but also for its implications for the application of preemption in other contexts. In explaining why PMA approval imposed "requirements" on a device, the court described the factors that were significant to its inquiry. Specifically, the court noted that the PMA approval was specific to individual devices, was focused on safety, and could only be achieved if, in the opinion of the FDA, the device offered "a reasonable assurance of safety and effectiveness." In addition, the court stressed that once a device is approved, the FDA requires it "to be made with almost no deviations from the specifications in its approval application."
The court also identified important policies that are served by preempting tort claims involving approved devices. The court stressed that tort claims were "less deserving of preservation" under the MDA than state statutes or regulations, since state law-making entities, unlike juries, would at least attempt to weigh the costs and benefits of a device before taking action. The court noted that a "jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Riegel may foreshadow the court's views on preemption outside of the medical device context, particularly its stance on preemption of tort claims involving pharmaceuticals. Although the statutory provisions applicable to drugs do not contain the same express preemption language found in the MDA, many argue that state tort claims against drug manufacturers should nonetheless be preempted because they conflict with the FDA's regulatory scheme. As Justice Ginsburg noted in her Riegel dissent, the majority of courts have rejected this argument. But the Riegel majority clearly expressed its opinion that the issue was anything but settled, noting "[i]t has not been established&that no tort lawsuits are pre-empted by drug&approval under the FDCA."
This comment likely signals a court majority open to finding that at least some state tort lawsuits are pre-empted by FDA approval of drugs under the FDCA. This is particularly significant in light of the court's current docket which includes two drug preemption cases: Warner-Lambert v. Kent, argued in February and to be decided this term, and Wyeth v. Levine, to be argued and decided next term.
Conclusion
The Supreme Court's decision in Riegel v. Medtronic affords significant protection to medical device manufacturers against product liability lawsuits filed under state law. Looking ahead, the court's decision will not only reduce (if not eliminate) the current caseload of suits involving PMA devices, it should also substantially deter future cases from being brought. In addition, based on very telling comments by the court in Riegel, the opinion may foreshadow the justices' positions in the upcoming battle over drug preemption. A note of caution, however: one should never underestimate the ingenuity of the plaintiffs' bar in finding new ways to bring old claims. While Riegel represents an important victory, tort litigation against medical manufacturers does not appear likely to go away any time soon.
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