Disease Management and Liability in the Human Genome Era

Abstract

The completion of a rough draft of the Human Genome presents both tremendous potential for improvements in health care delivery and challenges to providing appropriate incentives that will bring forth new treatments while protecting individuals and groups from genetic discrimination. As "genetics" becomes an integral part of health care delivery, there are no existing coherent legal doctrines for balancing the risks and benefits of this technological and scientific achievement. Developing a coherent legal approach to these risks and benefits requires a reexamination of the purposes of the liability doctrines that govern the management of disease processes. At the moment, a genetic approach to human disease primarily involves attempts at prevention - which means genetic screening of individuals, fetuses in utero, and embryos. This screening process requires the cooperation of population groups identified by genotype, or ethnic or social group. The nature of this cooperation, or the "voluntariness" of the consent to donate tissue and other samples of DNA is now the subject of at least one lawsuit in which the plaintiffs claim that the physician/scientist should have disclosed his intention to patent the gene and screening test for a rare genetic disorder. In order to develop a framework to resolve this case and other liability claims in the Human Genome Era, this article analyzes and proposes a coherent theory of liability for mishaps. This theory is based on: 1) the difference between informed consent liability doctrines in research and clinical settings; 2) the relationship between the regulatory scheme for research and liability claims; and 3) the implications of the Nuremberg Code for determining the parameters of informed consent in research settings.