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date: 20 September 2018

Abstract and Keywords

This article examines the law of drug product liability in the United States. It first considers the liability for adverse effects of prescription drugs under the older regulatory deference model before turning to a discussion of the current debate over liability for the risks even properly prepared drugs. It then looks at drug withdrawals and the growing distrust of the Food and Drug Administration’s approval and surveillance process for prescription drugs. It also reviews the arguments and a number of court decisions about the FDA’s approval of drug labels, with particular focus on the arguments for the preemption of tort claims preemption of tort claims that such labels failed to warn of the drug’s adverse effects, as well as the direct challenge to FDA approval presented by “design-defect” claims. The article concludes with an analysis of recent challenges to the traditional protection afforded by the learned intermediary doctrine and tort challenges to “off-label” uses which the FDA tacitly permits.

Keywords: law, drug product liability, United States, prescription drugs, regulatory deference model, drug withdrawals, Food and Drug Administration, court decisions, drug labels, design-defect claims

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