The iRobo-Surgeon conundrum: comparative reflections on the legal treatment of intraoperative errors committed by autonomous surgical robots

Abstract

ABSTRACT The bridge towards fully autonomous, context-aware surgical robots is fraught with challenges, not least of which is ascribing legal responsibility in the event of inadvertent patient injury or death. Of the civil liability frameworks potentially applicable to AI-related harm, this article examines the substantive rules of the Restatement (Third) of Torts: Products Liability and the European Commission’s newly proposed directive on liability for defective products to determine whether a plaintiff would be entitled to redress against a manufacturer should patient injury or death occur during an operation performed by a fully autonomous surgical robot. Specifically, the comparative analysis discusses the concepts of ‘product’ and ‘defectiveness’ and information disclosure provisions, anticipated to be the primary legal battlegrounds in this area. Overall, the article contends that the existing product liability framework in the US and the regime proposed in Europe would not be entirely inadequate for protecting the fundamental rights of patients in the context of autonomous robotic surgery.