Harm Without Negligence

In December 2019, the Wall Street Journal reported that seven women from one family underwent highly invasive surgeries, based on genetic test results that indicated that they each had an 84 percent chance of developing cancer by age 70. 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 underrecognized problem: what happens when a patient’s previously-classified pathogenic variant is downgraded to uncertain (or even benign)? 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 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.