Court Rules Against Drug Companies in Amputation Case

Wyeth attorney Bert Rein said the company thinks it was prohibited by federal law from changing the warnings the way the Vermont jury in Levine's case thought necessary.

"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine," he said. Wyeth is being bought by rival Pfizer for $68 million.

Rein and another lawyer who represents drug companies, Mark Herrmann, said the decision seems to leave drug companies some limited room to argue that federal regulation protects them, such as when the FDA has taken an active role in labeling decisions for a particular drug. That could be important in pending cases involving antidepressants and suicide risks, Herrmann said.

He said the decision "narrows although does not eliminate" the claim that federal regulation preempts state laws.

It is the second time this term that the court has ruled that lawsuits filed under state consumer protection laws are not "preempted" because of federal regulatory authority. Earlier, in another opinion written by Stevens, the court said federal laws about cigarette labeling do not stand in the way of suits under state laws regulating fraudulent marketing practices.

The cases, and one decided last year in favor of business, make a powerful argument that the court believes that if federal regulation is to trump state consumer protection laws, Congress must make an express statement to that effect, said Frederick, who also argued the cigarette case, Altria Group v. Good.

Stevens's opinion was joined by Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer. Justice Clarence Thomas agreed with the judgment, but he did not join the reasoning of the majority.

Justice Samuel A. Alito Jr. dissented, saying, "This case illustrates that tragic facts make bad law. The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs."

Alito said the agency looks at both the benefits and costs of toxic but lifesaving drugs and should not, in effect, be overruled by juries, which lack the expertise to see the big picture.

"And the FDA conveys its warnings with one voice, rather than whipsawing the medical community with 50 (or more) potentially conflicting ones," Alito wrote. "After today's ruling, however, parochialism may prevail."

Had the decision gone the other way, Democratic leaders on Capitol Hill had been poised to introduce legislation making clear that FDA regulations did not preempt the lawsuits.

Instead, they praised the court for a decision that, in the words of Senate Judiciary Committee Chairman Patrick J. Leahy (Vt.), "soundly rejects the anti-consumer position of the Bush administration and reaffirms Congress' primacy concerning the extraordinary power to preempt state law."