Legal Liability, Not Improved Healthcare, May Be Spur to Develop ‘Personalized Medicine’
Legal liability is the driver that could dramatically hasten the development of “personalized medicine”, according to a newly published article by genetics and law experts.
Broadly, personalized medicine is defined as using information about a person’s genetic makeup to tailor strategies for the detection, treatment or prevention of disease. It can specifically refer to the use of a medicine only after it has been shown to be compatible with, or not dangerous to, a patient’s specific genetic makeup.
Such testing, called pharmacogenomic testing, is rarely performed at present, and most hospitals and few physicians have access to such technology. But side effects from prescription drugs kill more than 100,000 people a ear, according to The Journal of the American Medical Association, and experts say that many such deaths could be prevented by prescribing a drug only after genetic testing on a patient has shown it to be safe for that patient.
Testing could reveal a polymorphism (a common variation or mutation in DNA) or some biomarker (a molecular marker associated with some biological function) that shows susceptibility to a specific drug. Armed with this knowledge, physicians can tailor drug treatments for each patient and avoid trouble.
Legal Trouble, Not Health Trouble
Although personalized medicine appears to offer more predictable outcomes and overall better healthcare, it is the threat of medical malpractice lawsuits that will drive its development and wider use, according to many legal experts.
Healthcare consumers (and their lawyers) are going to become more familiar with the existence of the technology, and failure to use it will lead to a new class of litigation when faulty diagnostics and prescription drug side effects lead to patient injury or death.
“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 (ASU), in the article “Legal Pressures And Incentives For Personalized Medicine,” published in the current issue of Personalized Medicine, a journal of Future Medicine.
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 may 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.
“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 healthcare providers, and the attorneys representing them, should start preparing now for preventing and defending a new class of personalized medicine lawsuits.”