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.