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.
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
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.