“The Unlearned Intermediary,” Charlotte A. Tschider, Assoc. Prof. Loyola Univ. Chicago School of Law

The learned intermediary doctrine forecloses a plaintiff’s state failure to warn product liability claim when physicians are the intended audience for health product manufacturing labels and are expected to advise patients of risks and benefits. Combined with a trilogy of U.S. Supreme Court decisions preempting state medical device product liability actions, plaintiffs harmed by medical device failures face nearly insurmountable challenges in successfully bringing product liability actions against manufacturers. Artificial intelligence (AI) in medical devices intensifies these issues by increasing the probability of unforeseeable device failures, failures that may not be reasonably disclosable, understandable by medical professionals, or avoidable by patients.

This article makes three key contributions to the FDA regulatory and product liability discourse. First, this article reveals the broad, compounding elements of the FDA regulatory-tort relationship wherein regulatory behavior creates nearly insurmountable challenges for injured plaintiffs to recover in tort, illustrating how AI compounds these issues. Second, this article applies the FDA’s regulatory-tort model to complex medical device technologies, illustrating how emerging technologies like artificial intelligence (AI) may exacerbate regulatory-tort policy failures. Finally, following the recent Loper Bright (2024) U.S. Supreme Court decisions overturning Chevron deference, this article proposes specific recommendations for rebalancing the FDA regulatory-tort model to more effectively protect and compensate patients likely to be exposed to AI product harms. 

Professor Charlotte Tschider joined the Loyola University Chicago School of Law in 2020. Tschider’s primary scholarship examines legal issues in artificial intelligence, international data protection, information privacy, cybersecurity law, and healthcare medical device technology. Professor Tschider is the author of International Cybersecurity and Privacy Law in Practice, 2d Ed. (Wolters Kluwer 2018, 2023), Cybersecurity Law: An Interdisciplinary Problem (West 2020, with Derek Bambauer, Gus Hurwitz, and David Thaw), and Cyborg Health (Cambridge University Press, under contract, with Krista Kennedy). Tschider’s 30+ academic works have appeared in the Yale Journal of Law and Technology, Yale Law and Policy Review, Washington University Law Review, Iowa Law Review, Maryland Law Review, and BYU Law Review, amongst many others. Professor Tschider has appeared on NPR’s All Things Considered and has been featured in a variety of news media publications, including USA Today, Forbes, Foreign Affairs, Stat, The Hill, Bloomberg Law, and Morning Consult.