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. 2020 Oct;62(1):143-211.

GENETIC DUTIES

Jessica L Roberts  1 , Alexandra L Foulkes  2
Affiliations

GENETIC DUTIES

Jessica L Roberts et al. William Mary Law Rev. 2020 Oct.

Abstract

Most of our genetic information does not change, yet the results of our genetic tests might. Labs reclassify genetic variants in response to advances in genetic science. As a result, a person who took a test in 2010 could take the same test with the same lab in 2020 and get a different result. However, no legal duty requires labs or physicians to inform patients when a lab reclassifies a variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, it offers much-needed guidance to physicians and labs, who may face liability, and to courts, which will hear these cases.

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References

    1. Some common forms of breast cancer have a large hereditary component. Although several genes play a part in their development, most heredity cases can be attributed to mutations in the BRCA1 or BRCA2 genes. Rebbeck TR, Couch FJ, Kant J, Calzone K, DeShano M, Peng Y, Chen K, Garber JE & Weber BL, Genetic Heterogeneity in Hereditary Breast Cancer: Role of BRCA1 and BRCA2, 59 AM. J. HUM. GENETICS 547, 547 (1996). In fact, 5–10 percent of breast cancers are inherited, and of those, about 50 percent are attributed to BRCA1. Id.; BARBARA T. ZIMMERMAN, UNDERSTANDING BREAST CANCER GENETICS 46 (2004). BRCA1 is a large gene, with about one hundred thousand base pairs. ZIMMERMAN, supra, at 45. And there are about five hundred known mutations of the normal BRCA1 allele. Id. at 45. Although carriers of certain BRCA1 mutations have a higher chance of developing the disease, it is not well understood why some people with a specific mutation develop the condition early in life, while others never go on to develop breast cancer at all. See id. - PMC - PubMed
    1. That said, her family members could still benefit, particularly first-degree family members who will have a 50 percent risk of being carriers.
    1. Soykan Orhan, Biological Sensors for Diagnostics, in MEDICAL DEVICES AND HUMAN ENGINEERING 8–1 (Bronzino Joseph D. & Peterson Donald R. eds., 2015).
    1. Id. There are, however, exceptions to the general rule. Under certain circumstances our DNA and its functions do, in fact, change. See Bird A, Perceptions of Epigenetics, 447 NATURE 396, 397–98 (2007). - PubMed
    1. LEVY JANEY, THE HUMAN GENOME PROJECT 28–29 (2018).

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