By Robert Barnes
Washington Post Staff Writer
Thursday, March 5, 2009
The Supreme Court ruled yesterday in favor of a woman who had her arm amputated after an improper injection of an anti-nausea medication and said drugmakers could not rely on federal regulation to shield them from lawsuits brought under state consumer protection laws.
The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.
In 2006, the Food and Drug Administration changed its policy and adopted rules that said the agency's approval of a drug insulated drugmakers from state lawsuits.
But Justice John Paul Stevens, writing for the majority, said there was "powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."
He added that the FDA has "limited resources" for overseeing the more than 11,000 drugs on the market, and that "state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly."
The court ruled in favor of Diana Levine, a guitar-playing children's musician from Vermont whose right arm had to be amputated after an improper injection of Wyeth Pharmaceutical's drug Phenergan, a common nausea treatment. She had gone to a clinic for treatment of a migraine.
Phenergan can be injected into muscle, through a drip, or directly into a vein, in what is called an IV-push. The latter method is riskier, because if the drug reaches an artery, gangrene is immediate and irreversible, and that is what happened to Levine.
After settling her suit against the clinic, Levine convinced a jury that Wyeth could have strengthened its warnings about the dangers of the drug without the involvement of the FDA and won an award of almost $7 million.
Levine said in a conference call with reporters that the Supreme Court decision in Wyeth v. Levine has brought her "unrestrained joy" and added, "Next to getting my hand back, it's the best they could do, and it's the least they could have done."
David Frederick, Levine's attorney, said the "landmark case" will have a "transformative effect on [Levine's] life and the life of consumers" harmed by the side effects of drugs.
The issue is vital for the business community, which argues that meeting a federal standard should protect companies from huge awards imposed by juries that might be swayed by the emotional aspects of the cases before them.
Thousands of product-liability suits have flooded state courts in recent years, with more than a third filed against drug companies.
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."