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.
Author
David A. Simon: Associate Professor, Northeastern University School of Law. Carmel Shachar: Assistant Clinical Professor of Law; Faculty Director, Health Law and Policy Clinic, Harvard Law School. I. Glenn Cohen: James A. Attwood and Leslie Williams Professor of Law & Deputy Dean, Harvard Law School; Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School. Professor Cohen reports that he is a member of the ethics advisory board for Illumina and the Bayer Bioethics Council and an advisor for World Class Health. He was also compensated for speaking at events organized by Philips with the Washington Post, attending the Transformational Therapeutics Leadership Forum organized by Galen Atlantica, and retained as an expert in health privacy, gender-affirming care, and reproductive technology lawsuits.
Copyright 2024 by David A. Simon, Carmel Shachar, I. Glenn Cohen
Cite as: David A. Simon, Carmel Shachar, & I. Glenn Cohen, Innovating Preemption or Preempting Innovation?, 119 Nw. U. L. Rev. Online 137 (2024), https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1344&context=nulr_online.