Court Rules For Musician In Drug Case
ROBERT SIEGEL, Host:
This is ALL THINGS CONSIDERED from NPR news. I'm Robert Siegel.
MELISSA BLOCK, Host:
And I'm Melissa Block. The Supreme Court today rejected a major attempt by the pharmaceutical industry to shield drug makers from consumer lawsuits. The court's six to three ruling upheld a $6 million jury award to a Vermont musician whose life was irrevocably changed by one trip to the doctor. NPR legal affairs correspondent Nina Totenberg reports.
NINA TOTENBERG: Diana Levine's successful music career came crashing down nine years ago when she was injected with the drug Phenergan for a migraine headache and nausea. The drug was administered by the so-called IV push method, which carries with it a small risk that the drug will enter the artery causing irreversible gangrene. Within hours, Levine's hand and arm were turning purple and black.
BLOCK: And I could tell by the doctor's face right away how serious it was. I actually saw tears in his eyes.
TOTENBERG: Her arm was amputated. And she sued the drug manufacturer, Wyeth, charging failure to adequately warn both patients and doctors of the risks of the IV push method.
BLOCK: The whole thing was avoidable. The only reason it happened is because Wyeth had not changed their labels to disallow this method of administration.
TOTENBERG: A unanimous jury awarded her $6 million in compensatory damages. The Vermont Supreme Court affirmed the judgment and Wyeth appealed to the U.S. Supreme Court, contending that when the Food and Drug Administration approved the drug label, that effectively immunized the manufacturer from any consumer lawsuits for failure to warn.
In a dramatic turnaround for the federal government, the Bush administration sided with Wyeth in the case, abandoning the position taken by all previous administrations Republican and Democratic. But today the Supreme Court, by a six-to-three vote, rejected the industry's arguments and sided with Diana Levine.
Writing for the court majority, Justice John Paul Stevens said that the FDA approved label is, in essence, a floor when it comes to safety, and that while most labeling changes do have to be approved by the FDA, the agency explicitly allows a company to unilaterally make labeling changes to improve safety. The court said that the broad assertions of immunity made by the industry and the Bush administration misread the federal law. Congress, the court noted, has repeatedly refused to enact any sort of bar to state lawsuits over drug safety problems.
Indeed, said the court, both the FDA and Congress have traditionally viewed the agency's enforcement powers as complemented by state laws providing for lawsuits. The FDA has limited resources to monitor the 11,000 drugs on the market, the court said. And once a drug is approved, it is the manufacturers who have superior access to information on problems that arise.
Said the court, state lawsuits have often uncovered unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. Because of all this, the court said, the Bush administration's recently adopted position to the contrary is entitled to no weight.
Dissenting were Justices Samuel Alito, Antonin Scalia and Chief Justice John Roberts. They said the FDA is better qualified to decide drug safety issues than a jury of laymen. Former FDA officials, however, hailed the decision, among them David Kessler, who served as head of the agency under the first President Bush and under President Clinton.
BLOCK: It's a very important decision for consumer protection that keeps the incentive on the drug manufacturer to act quickly and responsibly, to generate data and act to detect serious adverse reactions once a drug is on the market.
TOTENBERG: Today's ruling has implications beyond the pharmaceutical industry. Beginning in 2002, the Bush administration began enacting regulations on dozens of subjects, seeking to shield various industries from state lawsuits. The theory was similar to the one in this case, that federal rules preempt state action. But the agencies and products were different, ranging from mattresses to banking services to seatbelts. Industry advocate Victor Schwartz concedes today's ruling will make it more difficult to block lawsuits by pointing to government regulation.
BLOCK: You better follow the roadmap of what the court says if you're going to do it through regulation. And the roadmap is not an easy one to follow, but you better follow that roadmap.
TOTENBERG: Georgetown Law Professor David Vladeck, who filed a brief against the drug industry, however, sees today's ruling as a major repudiation of the position put forth by industry and the Bush administration.
D: This case was seen by everyone as the bellwether for the rest of these regulatory preemption arguments. And I think the force with which the court rejects that argument is a signal that the courts generally are not going to be receptive to the Bush administration's arguments on this issue.
TOTENBERG: In short: A big loss for industry.
Nina Totenberg, NPR News, Washington.