Anna C. Mastroianni, Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy, 16 Health Matrix 351 (2006), https://digitalcommons.law.uw.edu/faculty-articles/383
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 oversight of human subjects research is inadequate in appropriately balancing patient safety and medical progress. The deficiencies in relying on the current approaches are further highlighted in a legal review and case study analysis of one surgical innovation that stimulated a wave of legal claims in the 1990s. A comprehensive legal analysis ultimately leads to a critique of current policy approaches and the recommendation of a three-pronged policy approach distinctly tailored to surgical innovation, which includes monitoring, local institutional oversight, and educational initiatives. As will be observed, complicating this examination is the cultural context in which surgical innovation takes place, lack of consensus about the appropriate treatment of surgical innovation, and the wide variation in procedures that could conceivably fall within a definition of surgical innovation.
Part I of this article briefly examines the practice and culture of surgical innovation, describing the high value placed on innovation and professional autonomy and the definitional challenge in characterizing innovative surgery. Part II introduces the two currently available alternate legal pathways relevant to concerns for patient safety—the medical practice pathway and the human subjects research pathway—and describes the surgeon's critical role in determining the pathway. Part III discusses the medical practice pathway and the conclusions that can be drawn from the law on point, particularly in the areas of negligence and informed consent, and analyzes their implications for the treatment of innovative surgery. Part IV describes the human subjects research pathway in detail. It begins with a discussion of the federal system of regulatory oversight and protection, its history and potential application to innovative surgery. It continues by examining the potential cause of action for research negligence, followed by conclusions and implications for the treatment of innovative surgery. Part V analyzes and extracts lessons from one example of surgical innovation, its legal pathways and malpractice history. Lastly, this article concludes by examining some of the legal implications of current policy approaches and ultimately recommends a distinct approach designed to balance medical progress with greater accountability and opportunities for improved patient safety