Liability Issues in Pharmacogenomics

8 Pages Posted: 25 Nov 2009 Last revised: 2 Jun 2013

See all articles by Mark A. Rothstein

Mark A. Rothstein

University of Louisville - Institute for Bioethics, Health Policy, and Law; University of Louisville - Louis D. Brandeis School of Law

Date Written: 2005

Abstract

Liability concers involving toxicogenomics inevitably raise broad issues of ethics and policy. The first of these issues, often called "genetic exceptionalism" deals with wether genetic is so unique that is should be considered seperately from other medical information. In other words, is there something different about pharmacogenomics as opposed to any other pharmaceutical research discipline? Is there something unique about drug development strategies and drug regulation involving pharmacogenomics compared with traditional drug development strategies and regulation? Is there something different about liabilty issues for manufacturers and health care providers involved with this technology? These question will inform our analysis of pharmacogenomics.

Keywords: genetics, genomics, pharmacogenomics, products liability, negligence, pharmaceuticals, FDA, direct to consumer advertising, off-label uses

JEL Classification: K31, K32

Suggested Citation

Rothstein, Mark A., Liability Issues in Pharmacogenomics (2005). Louisiana Law Review, Vol. .66, 117-124, 2005. Available at SSRN: https://ssrn.com/abstract=1512663

Mark A. Rothstein (Contact Author)

University of Louisville - Institute for Bioethics, Health Policy, and Law ( email )

Louisville, KY 40202
United States

HOME PAGE: http://www.louisville.edu/bioethics

University of Louisville - Louis D. Brandeis School of Law ( email )

Wilson W. Wyatt Hall
Louisville, KY 40292
United States

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