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Journal of Long-Term Effects of Medical Implants
Abstract of "Corporate Immunity After Riegel and the Need for Regulatory Reform"
Andrea K. Scott
Bioethics International Ltd., Los Angeles, CA 90077; UCLA, Los Angeles, CA 90095
Warren S. Grundfest
cedars-Sinai Medical Center and executive Director, Bioethitec Institute
The general principal of tort liability, that all persons have a duty not to create unreasonable risks of harm to others, is a fundamental building block of our common law legal system, which dates back to England more than four hundred years ago. Between the founding of the United States in 1776 and the early twentieth century, the sale of pharmaceuticals, cosmetics, food, and beverages was entirely unregulated by the federal government. Such matters were left to the states pursuant to their police powers until Congress passed the Pure Food and Drug Administration Act of 1906. The 1906 Act mandated an official federal standard for the strength and purity of these items before they could be sold to the public. Another three decades passed before Congress authorized the Federal Food, Drug, and Cosmetic Act of 1938, which gave rise to the Food and Drug Administration (FDA). Historically, medical devices were regulated, if at all, exclusively by the states until Congress enacted the Medical Device Amendments of 1976 (MDA).The MDA require manufacturers to obtain premarket approval from the FDA based on "a reasonable assurance" of their products' safety and efficacy. (In contrast, pharmaceutical manufacturers must actually prove that their products are both safe and effective.) For the past three decades, the public's shield against fraud and abuse by unscrupulous medical device manufacturers was a combination of complimentary protective layers of the MDA, FDA regulations and oversight, and state product liability laws. On February 20,2008, in Riegel v. Medtronic, 128 SCt 999 (2008) (Riegel), the Supreme Court used the doctrine of federal preemption to effectively prevent consumers (e.g., patients) from bringing suit against medical device manufacturers in state court after they have been injured by devices with premarket approval. We posit that the effects of Riegel include a bar to common law claims in state court, a denial of all legal recourse for the majority of consumers injured by defective medical devices, and a grant of virtual legal immunity to device manufacturers. We argue this decision is remarkable for its (i) disregard of legal precedent; (ii) denial of the historic record, generally, and Congressional history, specifically; (iii) valuation of corporate profits over consumer welfare; and (iv) myopia concerning the long-term consequences of deregulation combined with chronic underfunding and understaffing of the FDA. The authors then discuss the parallel legal action Wyeth v. Levine, 128 SCt 1118 (2008) (Wyeth), which is presently before the Court. The question in Wyeth is whether or not the Federal Food, Drug, and Cosmetic Act (FDCA) impliedly preempts state liability claims against pharmaceutical manufacturers. If the Riegel majority applies the same interpretation of preemption to drugs, patients injured by new medical products approved by the FDA will just have to grin and bear it while corporate immunity is greatly expanded. We close with a series of steps they believe all three branches of government should take to protect the public from foreseeable injury caused by defective medical devices and to provide legal recourse in state court for those so injured.
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