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Waxman report on drug preemption

Beck and Herrmann give it a much deserved skewering (more skewering from former FDA official Sheldon Bradshaw at American Lawyer; and background). John Calfee has a new Health Policy Outlook for AEI with a calmer and more reasoned view:

These analyses [by JAMA and New England Journal editorialists, among others] largely ignore three crucial points. First, the liability system is a clumsy tool that can easily do more harm than good, and its record in the pharmaceutical market is particularly bad. Second, the FDA faces powerful incentives to overregulate and overwarn, meaning that warnings and contraindications imposed by litigation will usually impede--rather than improve--medical care. Finally, contraindications imposed through litigation (as in Wyeth v. Levine) are especially likely to leave patients worse off.

White Coat Rants has been writing persuasively (here and here) about the harmful effect on medical practice of a plaintiff victory in Wyeth v. Levine.

Beck & Herrmann also have a new post up providing a comprehensive look at Wyeth v. Levine and the implied drug preemption issue, broadly taking the view that a defense victory at the high court would be 1) less sweeping in forestalling future mass tort claims than is often assumed, but 2) more difficult for Congress to override than the express pre-emption that came up in Riegel. One of the points they make adds perspective to the oft-touted endorsement of the plaintiff's case by NEJM and JAMA: both doctors and drugmakers are often defendants in these cases, and the effect of sticking the latter with more of the liability will often be to stick the former with less of it. (In other words, the doctors have reason to throw the drugmakers under the bus; put differently, the Litigation Lobby is great at playing "divide and conquer".) B&H also recently cautioned against too ready a concession to the claim that pharmaceutical tort litigation actually has a favorable effect on safety in the first place, the evidence for which appears surprisingly sparse.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.