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- W2201116114 abstract "It has been extensively argued that an agency adjudication system to supplant state tort claims is preferable in a plaintiff’s winning case, based on the presumption that a jury would only see the injury caused by the medical product and ignore the benefit brought about by the same product. The view is best reflected by the Supreme Court’s opinion in Riegel v. Medtronic, Inc. The Riegel Court expressly stated its disfavor of juries in a medical-device context. The Court advanced a policy argument that “tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation.” Nevertheless, there are cases that never have a chance to reach the jury. They are the plaintiffs’ losing cases.Factor VIII cases are the plaintiff’s losing case. They are a class of cases sharing the same or similar factual context: hemophiliacs who contracted AIDS by using HIV-infected blood products in the early 80s. They represent a class of cases that tort law cannot resolve. Contrary to a plaintiff’s winning case, Factor VIII cases may help to illustrate why an agency adjudication system is favorable even in a plaintiff’s losing situation.The dissent’s major concern in Riegel was that an outright preemption of state common-law suits would “remove all means of judicial recourse.” Even though the Riegel holding only applies to medical devices that are subject to FDA’s pre-market approval, FDA’s regulation of drugs and food additives provided the model for its regulation of medical devices. Therefore the Supreme Court did not exclude extending preemption to FDA approved drugs and additives. Whether or not preemption would eventually extend to FDA approved drugs, an agency adjudication system to supplant common-law suits may be preferable or favorable in most, if not all, medical-product-liability contexts.An agency adjudication system is generally exercised by appointed experts, rather than lay jurors. As the Riegel Court has stated in the dicta, “[a] state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA.” In addition, the Court acknowledged that “while the common-law remedy is limited to damages, a liability award can be, indeed is designed to be, a potent method of governing conduct and controlling policy.” Adopting an agency adjudication system on a no-fault basis to supplant common-law suits in a medical-product-liability context would provide recourse to the victims without contradicting with the Riegel Court’s concern." @default.
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- W2201116114 date "2009-09-30" @default.
- W2201116114 modified "2023-09-23" @default.
- W2201116114 title "Revisiting Factor VIII Cases: Is it Time for an Agency Adjudication System?" @default.
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