Needles, Haystacks, and Next-Generation Genetic Sequencing

Abstract

Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing that is conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as “incidental” or “secondary.” In 2013, the American College of Medical Genetics (ACMG) recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG’s recommendations galvanized critical responses by the genetics and ethics community. One of the most important open questions concerns the scope of negligence liability for clinical laboratories if they failed to provide any of these SFs to patients who never requested them. To answer this question, this article argues that while there might be an ethical or professional obligation to share knowledge about these specific genetic mutations, laboratories should not be subject to tort liability for failure to share secondary findings directly with patients. The paper analyzes traditional common law doctrines surrounding the duty to warn to explain why the harm is not foreseeable enough and the burden is too great.