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Tort Claims and Federal Regulation of Medical Devices vs Pharmaceuticals—Reply
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In Reply: Mr Green provides another compelling reason why the Supreme Court should have allowed tort actions for medical devices, just as it did for pharmaceuticals. The court's contradictory decisions in Riegel and Wyeth make little sense and leave the field of FDA law in a quandary. The distinction drawn by the court was unfounded because pharmaceuticals and medical devices go through the same FDA approval process, and sometimes it is even unclear whether a particular product is a drug or a device. More importantly, as Green points out, the justification for tort litigation in medical device cases may be even stronger because the FDA does not approve their design features.
Perhaps the most telling point is that for both drugs and devices, the FDA approves the products at the time they are marketed. Health hazards often emerge only after a large patient population uses a product and well after . . . [Full Text of this Article]
Lawrence O. Gostin, JD
gostin@law.georgetown.edu
O’Neill Institute for National and Global Health Law
Georgetown University
Washington, DC
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