The Supreme Court on Monday, November 3, 2008, 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.

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.