Document Type

Article

Publication Date

2025

Abstract

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory adequacy and intermediary expertise, policy failures will result.

This Article makes three key contributions to the FDA regulatory and AI products liability discourse.  First, this Article provides a comprehensive account of medical device regulatory processes and their relationship with tort recovery, describing the extent of FDA discretion and noting an overall trend towards less rigorous interventions with a lack of expert AI knowledge.  Second, this Article describes the potential for substantial impediments to tort recovery, noting how courts relying on FDA interpretation and action and physician expertise will increase the probability of plaintiffs being denied just compensation.  Finally, noting potential issues bringing products liability claim challenges more generally for AI device failures, this Article poses an alternative view of how courts can appropriately and justly weigh FDA process discretion in AI medical device products liability cases.

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