Can Clinical Genetics Laboratories be Sued for Medical Malpractice?

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