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JAMA Editorializes Against Preemption in Wyeth Case

The Journal of the American Medical Association has joined the New England Journal of Medicine (published by the Massachusetts Medical Society) in urging the Supreme Court not to grant immunity to pharmaceutical companies for lapses in FDA-approved prescription labels. 

As we described earlier this week, pharmaceutical giant Wyeth has asked the Court to throw out an award to a patient whose right arm had to be amputated because a Wyeth drug was administered in a way that caused it to enter her arterial bloodstream, which was a well-known hazard. The patient, Diana Levine, persuaded a jury in state court that Wyeth's label should have warned against the method of injection that caused the drug to enter her arterial bloodstream and necessitated the amputation. Wyeth argues that the FDA's approval of its label should immunize it from liability over any of the label's shortcomings, thereby preempting state laws. 

JAMA's editorial says: 

The Wyeth v. Levine ruling will have far-reaching and profound implications for patients and drug safety. 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. 

Medical Marketing & Media has written a summary of the editorial, the first portion of which is available for free on JAMA's Web site. [subscription required to view the entire article] 

Given JAMA's pursuit of limitations on patients' rights to seek redress in court for medical malpractice, its endorsement of the civil justice system's merit as an adjunct to the regulatory system in the context of pharmaceuticals is somewhat surprising and deserving of commendation. Although the publication operates at arm's length from the American Medical Association, its staff serves at the pleasure of its parent association, as longstanding JAMA editor Dr. George Lundberg learned in 1999 when he was fired for fast-tracking an article about definitions of sex to coincide with the Clinton impeachment hearings, which JAMA's management deemed inappropriate. 

This month's editorial may have been influenced by a Dutch study published elsewhere in JAMA's October issue which found that 70 percent of biologicals approved in the United States and Europe between 1995 and 2007 wound up being investigated after they went on the market because of newly discovered side effects. Complications involving 19 of the 136 drugs approved in the United States were so serious that bold, black box warnings – the strongest notices carried on U.S. prescriptions – had to be created for them. Med Headlines has a summary of the study; JAMA has posted the abstract.


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