Biotech Values

[DewDiligence]

JAMA Joins NEJM Against Industry in Wyeth v. Levine

http://blogs.wsj.com/health/2008/10/21/jama-opposes-drug-industry-in-wyeth-v-levine

›October 21, 2008
by Jacob Goldstein

The Journal of the American Medical Association has come out against the drug industry in Wyeth v. Levine, a case whose outcome could have a big effect on drug makers’ exposure to patient lawsuits.

With the Supreme Court set to hear oral arguments next month, the influential journal just published an editorial arguing that the right to sue drug makers in state court is an important protection for patients.

That runs counter to Wyeth’s argument that patients shouldn’t have the right to sue in state court for harms caused by drugs that met federal standards. The company’s position is based on a doctrine called preemption, because it turns on the notion that federal law preempts state law. (The particular circumstances of this case, in which a Vermont woman wound up losing part of her arm, are described in this post.)

Here’s an excerpt from the JAMA editorial:

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…the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. …If the court rules in favor of Wyeth, endorsing preemption, patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA.
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The current and former editors of the New England Journal of Medicine have already weighed in on the case [#msg-31501261] — they filed an amicus brief opposing Wyeth earlier this year. The drug industry trade group PhRMA and the Bush administration have both filed briefs backing Wyeth.‹