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."