Can Clinical Genetics Laboratories be Sued for Medical Malpractice?

Alexandra L. Foulkes et al., Can Clinical Genetics Laboratories be Sued for Medical Malpractice? 29 Annals Health L. & Life Sci. 153 (2020).

17 Pages Posted: 18 Mar 2020

See all articles by Alexandra Foulkes

Alexandra Foulkes

U.S. District Court Western District of Oklahoma

Jessica L. Roberts

University of Houston Law Center

Paul Appelbaum

Columbia University - Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics

Wendy K. Chung

affiliation not provided to SSRN

Ellen Wright Clayton

Vanderbilt University - Law School

Barbara J. Evans

University of Houston Law Center

Gary E. Marchant

Arizona State University - College of Law

Date Written: February 21, 2020

Abstract

Clinical genetics laboratories are handling more patient information than ever before, including genetic data that has no established clinical significance. Those labs could face legal liability if that previously uncertain information gains clinical significance and a laboratory fails to notify the impacted patients. Should patients choose to sue clinical genetics labs, what body of law will govern: medical malpractice or ordinary negligence? We conducted a fifty-state survey assessing whether clinical laboratories are “health care providers” for the purposes of medical malpractice to answer this question. We found that six states expressly include laboratories or laboratory personnel in their statutory definition of health care provider, fifteen states have judicial opinions that treat laboratories as health care providers, and four states have caselaw concluding that laboratories are not health care providers. Thus, twenty-five states have yet to decide this important threshold matter. We therefore conclude that the legislatures in these states should provide clarity regarding the potential medical malpractice liability of clinical genetics laboratories.

Keywords: Reclassification, Genetics, Bioethics, Biolaw, Fifty-State Survey, Medical Malpractice, Torts

Suggested Citation

Foulkes, Alexandra and Roberts, Jessica L. and Appelbaum, Paul and Chung, Wendy K. and Wright Clayton, Ellen and Evans, Barbara J. and Marchant, Gary E., Can Clinical Genetics Laboratories be Sued for Medical Malpractice? (February 21, 2020). Alexandra L. Foulkes et al., Can Clinical Genetics Laboratories be Sued for Medical Malpractice? 29 Annals Health L. & Life Sci. 153 (2020). . Available at SSRN: https://ssrn.com/abstract=3542537 or http://dx.doi.org/10.2139/ssrn.3542537

Alexandra Foulkes (Contact Author)

U.S. District Court Western District of Oklahoma ( email )

Washington, DC
United States
8322966382 (Phone)
73162 (Fax)

Jessica L. Roberts

University of Houston Law Center ( email )

4800 Calhoun Road
Houston, TX 77204
United States

Paul Appelbaum

Columbia University - Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics ( email )

United States

Wendy K. Chung

affiliation not provided to SSRN

Ellen Wright Clayton

Vanderbilt University - Law School ( email )

131 21st Avenue South
Nashville, TN 37203-1181
United States
615-322-1186 (Phone)
615-322-4548 (Fax)

Barbara J. Evans

University of Houston Law Center ( email )

4604 Calhoun Road
Houston, TX 77204-6060
United States
713-743-2993 (Phone)

Gary E. Marchant

Arizona State University - College of Law ( email )

Box 877906
Tempe, AZ 85287-7906
United States
(480) 965-3246 (Phone)
(480) 965-2427 (Fax)

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