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Preemption Justice: Restoring the Legal Rights of Persons Injured by Medical Devices and Generic Drugs
AuthorMaltese, Joseph J.
AdvisorRichardson, James T.
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AbstractThis study reviews the U.S. Constitutional foundations that empowered the Congress to preclude state regulation of medical devices, vaccines and generic pharmaceutical drugs approved for marketing and distribution by the U.S. Food and Drug Administration (FDA).The study initially travels through the history of how the states, under their "police powers," attended to the health and welfare of the public, by regulating food and drugs and how the Congress and the FDA through the "Supremacy Clause" and the "Commerce Clause" of the U.S. Constitution encroached into that domain incrementally over the past 100 years. In the past decades the FDA has almost totally dominated the area of drug, vaccine and device safety standards empowered by a series of federal statutes and regulations. But the greatest domination over the states has been through a few recent U.S. Supreme Court decisions that have expanded federal regulatory preemption into precluding state common law suits by individuals, who sought compensation from the manufacturers of FDA approved medical devices and generic drugs, which they claimed caused them injury or death.This study addresses the competing national interest of maintaining the public health with the necessity of maintaining a business environment where drug and device manufacturers can conduct research and development while limiting the cost of defending lawsuits throughout the fifty states and territories, with their disparate regulatory schemes and restoring the legal rights of individuals, who are injured by medical devices and generic drugs.To accomplish these goals, this study proposes Congressional legislation expressly preempting state regulation of FDA approved drugs and devices while also precluding individuals from suing drug and device manufacturers in state or federal courts for injuries or deaths caused by those FDA approved products. The same proposed legislation would create a specialized non-jury court to adjudicate claims where the Secretary of the U.S. Department of Health and Human Services, rather than drug and device manufacturers, will be the defendant in such actions, which is similar to the National Childhood Vaccine Injury Act of 1986. Medical expenses of the injured persons would be paid for by the affordable health care act mandatory health care insurance policies. Compensation for claimants' pain and suffering, and other compensatory damages such as lost wages along with attorney fees would be paid from an established fund to pay and administer those claims. An excise tax on FDA approved drugs and devices will be levied on the sales of such products to finance the fund.