Reassessing the Regulation of High-Risk Medical Device Cases

Abstract

In 1976, Congress enacted the Medical Device Amendments (MDA), plugging a gap between regulation of prescription drugs, which were subjected to a premarket protocol aimed at assuring safety and efficacy, and medical devices, which were solely monitored for adulteration and misbranding after distribution in the marketplace. Class III devices “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury;” they represent the remaining 10% of medical devices and include devices like pacemakers, breast implants, and intrauterine devices. Only Class III devices are required to go through the premarket approval process (PMA)—a process that requires clinical data. In a leading case on the preemption of tort claims, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court had occasion to review the rigor of PMA premarketing oversight and concluded that it was indeed notable for its scrupulousness. On average, the Court noted, the FDA spent 1,200 hours reviewing an application, which included reports of every study and investigation of the device, a description of component parts, samples of products, a specimen of the proposed labeling, and descriptions of the production, manufacturing, packaging, and installation methods. As part of the PMA process, the FDA had discretion to bring in a panel of outside experts and could request more information or data from the manufacturer. Viewing the process through this lens, the Court preempted the plaintiff’s tort claim, which was based on failure to adequately warn of the risk that defendant manufacturer’s balloon catheter would rupture during angioplasty surgery—a risk that came to fruition. According to the Court, Section 360k of the MDA—an express preemption clause barring “any requirement…which is different from, or in addition to, any requirement…[under the Act] which relates to the safety or effectiveness of the device….”—was applicable to the claim. A sharp line was drawn between the PMA process in Riegel and FDA’s 510(k) substantial equivalence review, which only subjects a device to a limited form of review to determine whether it is “substantially equivalent” to a preexisting legally marketed device. Twelve years earlier, in Medtronic, Inc., v. Lohr, 552 U.S. 312 (2008), the Supreme Court found substantial equivalence review insufficiently rigorous to preempt tort claims. Taken together, the two decisions seemed to mark out a persuasive boundary between tort claims that would, if allowed, impermissibly re-tread the same ground covered by the agency (via the PMA process), and claims premised on a risk/utility tort process complementary to the once-over-lightly of “substantial equivalence” review. In this Article, Part I probes more deeply into the case for recognizing a safe harbor from tort claims under the existing regime of FDA premarket assessment of high-risk devices. Part II addresses post-market FDA strategies for assessment of product safety. Part III shifts the focal point to tort, revisiting the shadow cast by preemption over tort as a complementary regulatory strategy. Finally, Part IV offers concluding thoughts on the necessity of a fresh look at the regulatory process in action—and reconsideration of how it might be improved in this vital area of health and safety.