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Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath

Washington Law Review

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, …