'Innovating Preemption or Preempting Innovation? ' by David A Simon, Carmel Shachar and I Glenn Cohen comments
Medical devices diagnose disease, prolong life, and improve health. But when defective, they can injure, disable, and kill. To successfully sue manufacturers for injuries caused by medical devices, patients must overcome the defense that federal law preempts, or displaces, state law claims. The Supreme Court has provided a framework for answering this question with respect to most devices. However, it has never confronted how it would apply the framework to an innovative but growing class of devices-de novo devices-that may incorporate novel technologies like artificial intelligence and machine learning. This Essay tries to answer this question as a predictive and normative matter. From a predictive perspective, the Essay argues that the Court's increasingly textualist orientation suggests it will reject preemption of claims against manufacturers of de novo devices, though the result is not certain. From a normative perspective, the Essay argues that allowing claims against de novo device manufacturers forces risk internalization, provides a regulatory failsafe for innovative technology, and preserves innovation without sacrificing patient health.
