Emergent Regulatory Systems and Their Challenges: The Case of Combination Medical Products

Abstract

Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap — the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, permitting the Court’s decisions in Medtronic v. Lohr, Riegel v. Medtronic, Wyeth v. Levine, PLIVA v. Mensing, and other cases to be understood as having created an emergent, coherent, multilayered regulatory system that calibrates the requirements imposed by each layer to the deficit in information about the risk of each product category. The model also provides a strong critique of scores of recent lower court preemption decisions involving “combination products,” a new product category whose members consist of both a new drug and a high-risk device. In finding common law actions preempted, these courts claim to have faithfully applied Riegel’s holding. But using the model developed here, it is clear that courts have disrupted the calibrated regulatory system, allowing thousands or millions of people in the United States to be exposed to dangerous products whose risks have not been well characterized. Using the combination products decisions as a cases study, the model also highlights the far-reaching effects that even small changes to any one input may have on the function of an emergent system and the field that it regulates.