Court Rules For Musician In Drug Case

The Supreme Court ruled Wednesday people injured by drugs can file lawsuits against the manufacturers in state courts, even when the drugs involved had been approved by the Food and Drug Administration. The ruling came in the case of a guitarist who lost an arm because of a botched anti-nausea injection.

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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.

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Court Weighs Reach Of Drug Warning Labels

The Supreme Court on Monday heard arguments in a case that could shield drug companies from consumer lawsuits.

The pharmaceutical industry, after failing to get Congress to write an explicit shield into federal law, is now arguing in court that there is an implicit shield that prevents injured patients from suing drug companies for failure to warn about risks.

The patient in this case is a Vermont musician named Diana Levine who got gangrene and had to have her arm amputated as the result of an injection of the anti-nausea drug Phenergan.

Levine sued drug maker Wyeth, claiming that the Phenergan label should have ruled out one method of administering the drug. That method, called IV push, has a small risk of error. If the drug is sent into the artery instead of the vein, it causes irreversible gangrene.

"This whole thing was avoidable," Levine says. "The only reason it happened is 'cause Wyeth had not changed their label to disallow this method of administration."

A jury agreed with Levine and awarded her $6 million in compensatory damages.

Wyeth appealed to the Supreme Court. Former Solicitor General Seth Waxman told the justices that the FDA had weighed the risks and benefits of the drug, had approved the label, and that the company could not on its own change the label to add additional warnings once the label was approved.

Justice Anthony Kennedy didn't seem to buy that argument.

Justice Kennedy: "You argue that it's impossible for Wyeth to comply with state law" on adequate warnings and "at the same time comply with the federal label" requirements. "I don't understand that. ... I think I could design a label that meets both requirements."

Justice Samuel Alito: How could the IV push method "be safe and effective when, on the benefit side, this is not a lifesaving drug, this is a drug that relieves nausea; and on the other side, it poses the risk of gangrene?"

Justice Ruth Bader Ginsburg: "How could the benefit outweigh the substantial risk?"

Justice Souter: "Wyeth could have gone back to the FDA at any time" to change the label, "and it didn't."

Answer: In the absence of new information, we could not change the label.

Supporting Wyeth in the Supreme Court was the Bush administration, which in a sharp break with decades of FDA policy, is now siding with the pharmaceutical industry. Justice Ginsburg asked why the administration has changed positions, but got no answer from Deputy Solicitor General Edwin Kneedler.

Justice Ginsburg: "There are 11,000 drugs on the market. Is the FDA really monitoring all of them to see if there is new information that should be noted on a label?"

Justice Stephen Breyer: "Why isn't the fact that a certain number of people are getting gangrene — why isn't that new information" that justifies the manufacturer strengthening the warnings on the label? "If you read the regulation, it says the manufacturer can do that. End of case."

Answer: The risk of gangrene is not new information.

Levine's lawyer, David Frederick, rebutted that answer when he stood to argue. In the years since the label was approved by the FDA, he said, there have been more than 20 amputations in cases involving the IV push method. Wyeth knew about these, but did not connect the dots, he said, to warn that the IV push method should not be used.

Justice Antonin Scalia and Chief Justice John Roberts, with voices raised, went after Frederick.

Justice Scalia: "Excuse me, those risks were set forth on the labeling approved by the FDA"

Answer: The FDA never considered the relative risks of the IV push method and other methods of administering the drug.

Chief Justice Roberts: "People can say it's safe for you to walk down the sidewalk. That doesn't mean there is NO risk that you get hit by lightning or something else."

Justice Scalia: "If you're telling me that the FDA acted irresponsibly, then sue the FDA."

Answer: "The idea that the label is set in stone for all time misunderstands the way the process works. When the FDA approves a drug and its label," it does so based on small clinical trials, "one or two thousand people." When the drug is marketed and goes to lots and lots of people, and the adverse reactions start occurring in greater numbers, the regulations permit a drug maker to supplement the label with that information.

Chief Justice Roberts: "So your case depends on us finding that there was a new risk" here that the FDA did not consider?

Answer: "The question is what did the manufacturer know and when did it know it. ... The manufacturer has a duty of due care, a duty to analyze new information on risk, and to make appropriate changes in the warning to reflect that. ... It didn't live up to that duty."

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