This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of "product stewardship"). Frustrated by the inherent limitations of preapproval clinical trials, the failure of the Food and Drug Administration (FDA) to demand rigorous postapproval testing, and the minimal information communicated directly to patients, these commentators have urged judges to draw on the common law tradition in order to remedy these and other alleged failings of the regulatory system.
Platitudes about Product Stewardship in Torts: Continuing Drug Research and Education,
Mich. Telecomm. & Tech. L. Rev.
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