Genetic Duties' by Jessica L. Roberts and
Alexandra Foulkes in
William & Mary Law Review (Forthcoming)
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Our genes don’t change but the results of our genetic tests might. The first is basic biology. The second, a product of the reality that we are still learning about the human genome. A person who took a genetic test in 2010 could take the same test with the same lab in 2020 and get a different result. The law, however, does not reflect this difference. At present, no legal duty requires laboratories or physicians to inform patients when a laboratory reclassifies a genetic variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, we hope to offer much needed guidance to the physicians and the laboratories that may face liability and to the courts that will inevitably hear these cases.
The authors argue
At present, genetic testing laboratories and physicians have no recognized legal duties to take any action when a VUS gains clinical significance. This Article considers the need for these genetic duties. Failing to inform patients of variant reclassifications can have life-or- death consequences. While we appreciate the gravity of this topic, we also recognize the potential costs that these duties could impose on labs and on doctors.
Our proposal for imposing genetic duties has three parts: (1) proactive measures, (2) a legal duty to reinterpret, and (3) a legal duty to recontact. First, we encourage laboratories and physicians to act proactively by educating patients about the possibility of variant reclassification and by outlining the steps that they will take to share the updated results. However, when that is not possible, we suggest that courts split the legal duties related to variant reclassification. Drawing from the concept of the cheapest cost avoider, we argue that labs are in the best position to reinterpret genetic test results, whereas ordering physicians are in the best position to contact patients. Our liability framework would therefore impose the duty to reinterpret on the lab and the duty to recontact on the physician. Given the potential impact that legal liability could have on genetic testing and clinical care, we encourage courts to proceed with caution and to make these determinations on a case-by-case basis. Thus, while we advocate recognizing these duties, what constitutes a breach may vary significantly depending on the individual circumstances.
This Article is novel in at least two ways. One, it is among the first in the legal literature to address the need for potential legal duties related to variant reclassification. Two, it proposes a solution to the cutting-edge question of how to fairly impose those potential duties. As such, it provides an important contribution to the conversation surrounding the variant reclassification and can serve as a valuable resource for lawyers, medical professionals, judges, and scholars alike.
We discuss the legal implications of variant reclassification in three Parts. Part I gives the relevant scientific background and explores the existing tort doctrines likely to apply to variant reclassification. In Part II, we consider the arguments in favor of genetic duties related to variant reclassification, noting that laboratories are the cheapest cost avoiders with respect to reinterpretation, while the ordering physicians are the cheapest cost avoiders when it comes to recontacting patients. Part III proposes our framework for providing patients with access to updated test results. We begin by urging laboratories and physicians to take action now by developing policies to educate patients and to inform them of variant classifications. In older cases, when these processes would not apply, we argue for bifurcating the duties associated with variant reclassification into (1) a duty to reinterpret and (2) a duty to recontact and imposing those duties on their respective cheapest cost avoiders. We then analyze what would constitute a breach of these novel legal duties using a variety of case studies. We conclude by considering some of the additional hurdles that plaintiffs will face when filing tort claims related to variant reclassification, even with clear, legally recognized genetic duties.
