According to a newly published article by genetics and law experts at the Sandra Day O'Connor College of Law, legal liability is a powerful driver that could dramatically hasten the development of personalized medicine.
According to 1998 data published in the American Medical Association Journal, side effects from prescription drugs kill over 100,000 Americans every year and the growing number of these deaths could be prevented by the use of genetic testing - say the experts.
"Individuals injured by adverse drug effects are increasingly likely to bring lawsuits alleging that they have a polymorphism or biomarker conferring susceptibility to the drug that should have been identified and used to alter their drug treatment," wrote Gary Marchant, executive director of the Center for the Study of Law, Science, & Technology at Arizona State University.
The commentary, Legal pressures and incentives for personalized medicine, was published in the current issue of Personalized Medicine, a journal of Future Medicine (www.futuremedicine.com). It was co-authored by Robert J. Milligan, a graduate student in the College's LL.M. in Biotechnology & Genomics program and a shareholder at the Phoenix-based law firm of Gallagher & Kennedy, and Brian Wilhelmi, a second-year law student in the ASU/Mayo Clinic M.D.-J.D. program.
The legal, regulatory and ethical issues surrounding personalized medicine, or pharmacogenomics, is the focus of a March 2 conference at the College of Law. It is defined as using information about a person's genetic makeup to tailor strategies for the detection, treatment or prevention of disease.
The incorporation of personalized medicine into everyday clinical practice faces significant hurdles, the authors wrote. These include scientific uncertainty about the validity of data, social concerns about the potential uses of genetic information, and economic concerns about the costs and benefits of pharmacogenomics.
These concerns are likely to slow the pace at which it becomes a part of medicine, but the authors assert, the risk of liability for not employing pharmacogenomic testing may speed the pace of its adoption.
While drug manufacturers, health insurers, and even pharmacists face some liability risks, physicians are most at risk for lawsuits alleging that they did not recommend genetic tests before prescribing drugs that might harm patients with genetic vulnerabilities. "Physicians are the sitting ducks in this new class of litigation," says Marchant, "both because they lack the legal defenses available to other parties and many doctors have not received the training in genetics they need in the new world of personalized medicine."
Already, a number of filed lawsuits claim physicians can be liable for not recommending or performing certain genetic tests, and that, even when they do, they can be held negligent in the performance of the tests, and the interpretation and communication of them.
The next step, predict Marchant and his colleagues, will be lawsuits for failing to recommend genetic tests before prescribing medications, and the first such lawsuits have already been filed against a drug manufacturer.
"There will likely be an initial calm until there has been a breakthrough case, and then there will be a sudden storm of litigation that will have immediate and enormous implications for defendants," they wrote.
The article also outlines several potential defenses for at-risk parties, and recommends they and the legal community be ready for a new wave of lawsuits.
"If significant liability does occur, its effect will be dramatic, as potentially liable parties will need to undertake immediate and significant changes to protect against large legal liabilities," the authors concluded. "Manufacturers and health-care providers, and the attorneys representing them, should start preparing now for preventing and defending a new class of personalized medicine lawsuits."