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).

Annals of Health Law, Forthcoming

17 Pages Posted: 18 Mar 2020 Last revised: 22 Feb 2021

See all articles by Alexandra Foulkes de la Parra

Alexandra Foulkes de la Parra

Susman Godfrey, LLP

Jessica L. Roberts

Emory University School of Law

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; VANDERBILT UNIVERSITY Medical Center

Barbara J. Evans

University of Florida Levin College of Law

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 de la Parra, Alexandra and Roberts, Jessica L. and Appelbaum, Paul and Chung, Wendy K. and Clayton, Ellen Wright 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). , Annals of Health Law, Forthcoming, Available at SSRN: https://ssrn.com/abstract=3542537 or http://dx.doi.org/10.2139/ssrn.3542537

Alexandra Foulkes de la Parra (Contact Author)

Susman Godfrey, LLP ( email )

Houston, TX
United States

Jessica L. Roberts

Emory University School of Law ( email )

1301 Clifton Road
Atlanta, GA 30322
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)

VANDERBILT UNIVERSITY Medical Center ( email )

Center for Biomedical Ethics and Society
2525 West End Ave., Suite 400
Nashville, TN 37203
United States
6153221186 (Phone)

Barbara J. Evans

University of Florida Levin College of Law ( email )

P.O. Box 117625
Gainesville, FL 32611-7625
United States

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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