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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 prev
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