ABSTRACT
The US Food and Drug Administration’s recent approval of the first polygenic risk score test has been met with powerful criticism. The test, AvertD, was approved to assess an individual’s genetic risk of developing opioid use disorder. However, evidence indicates that the test is unreliable, often resulting in false positives and false negatives. And even if the test could accurately predict an individual’s relative risk of developing opioid use disorder, the individual and societal implications of incorporating such a test into clinical practice are vast. Genetic test results that purport to predict opioid use disorder – or really, any behavioral or psychiatric trait or diagnosis – have enormous consequences for individual lives and communities.
Reliance on sociobehavioral polygenic risk score tests in making clinical decisions will lead to both individual patient injuries and population-level harms. Individual patients may be harmed due to the denial of appropriate pain relief or the inadvertent (and counterintuitive) triggering of an opioid use disorder, or by intensifying existing stigma. At the societal level, reliance on a polygenic risk score for opioid use disorder could increase existing racial and other inequities in medicine, divert resources from addressing the root causes of the opioid crisis, and exacerbate – rather than mitigate – the opioid crisis.
This Article concludes that existing legal rules and policy tools are insufficient to address these concerns. They fail to address addiction’s physiological, psychological, spiritual, and societal dimensions. Antidiscrimination laws, expanded regulatory authority over genetic tests, and reimbursement incentives are all unlikely to address individual and population-level harms that arise with the introduction of polygenic risk scores for behavioral traits or psychiatric illnesses. And building on the author’s work evaluating existing tort frameworks for these tests, the Article concludes that tort law remedies are also ill-equipped to mitigate the patient harms that the test presents. Rather, stakeholders should prioritize accuracy, clinical utility, and equity in genetic innovation to avoid introducing tools that disproportionately harm vulnerable populations or exacerbate health disparities. Only then can stakeholders ensure that genetic technologies are integrated into clinical practice in ways that are safe, equitable, and effective.
Gutmann Koch, Valerie, The Opioid Crisis Meets Genomics (March 23, 2025), 56 Seton Hall Law Review (forthcoming 2025).
Leave a Reply