torts; negligence; genetics; health law; variant of unknown significance


In December 2019, seven women from one family underwent highly invasive surgeries based on genetic test results that indicated that each were at significant risk of developing cancer by age seventy. Subsequently, after procedures that (among other things) permanently scarred and disfigured their bodies and ended their chances of having biological children, they learned that their particular mutation was not, in fact, pathogenic.

This Article focuses on a previously under-recognized problem: what happens when a patient’s previously classified pathogenic variant is downgraded to uncertain (or even benign) status? Intuitively, it might seem that the genetic testing company, the surgeons, or others who participated in or influenced the family’s decisions should be liable. However, while there is demonstrable harm, no one was negligent. This Article contextualizes the “harm without negligence” problem within the universe of medical harms more generally. It explores a pervasive—but often unrecognized—problem in medicine: harms arise when individuals act in the wake of uncertainty, and common-law negligence rules and current regulations fall short. It concludes by identifying potential tort, regulatory, and intellectual property answers, recognizing that a problem seemingly grounded in tort law may instead have regulatory or other solutions.