Law Commons^™

Liability, Regulation And Policy In Surgical Innovation: The Cutting Edge Of Research And Therapy, Anna C. Mastroianni

Articles

This article examines the implications of the foregoing competing claims from a U.S. legal perspective, focusing particularly on how the legal system addresses patient safety concerns and autonomous decision-making of surgeons in the context of surgical innovation. The lack of oversight and the risks borne by patients during surgeons' development and subsequent refinement of a novel procedure must be balanced with the need to encourage medical progress through the development of improved techniques designed to benefit the health of current and future patients. This article argues that current reliance on the medical malpractice system and the federal regulatory system of …