The Supreme Court appeared headed for another close decision in today's hearing of Wyeth vs. Levine, a case seen as a key test of whether FDA labeling pre-empts “failure to warn” lawsuits against drug companies in state courts.
Chief Justice John Roberts and Justice Antonin Scalia appeared sympathetic to Wyeth, observers said, while Justices David Souter, Ruth Bader Ginsburg and Anthony Kennedy seemed inclined towards the plaintiff, Diana Levine, a musician whose right arm had to be amputated after a botched injection of Wyeth's anti-nausea drug Phenergan caused gangrene. Justices John Paul Stevens and Stephen Breyer were tougher to read.
Justice Clarence Thomas typically votes with Justices Scalia and Roberts, as does Justice Samuel Alito, though Justice Alito wondered: “How could the FDA [have] concluded that IV push was safe and effective when on the benefit side of this you don't have a life-saving drug, you have a drug that relieves nausea, and on the risk side, you have the risk of gangrene?”
Justice Ginsburg asked: “No matter what benefit there was, how could the benefit outweigh that substantial risk?”
Justice Souter said: “As I understand it, the company, Wyeth, could have gone back to the FDA at any time and said….We think the label ought to be changed to say ‘Don't use IV push.' Wyeth could have done that at any time, and it simply didn't do it.”
Levine's gangrene was caused when an IV push, designed to speed delivery of the drug into her bloodstream to counteract nausea caused by a migraine, hit an artery instead of a vein. Wyeth and FDA were aware of the danger, which was indicated in the labeling, but Levine's lawyers argue that the warning was insufficiently strong and that Wyeth should have strengthened cautions. Wyeth argues that its hands were tied by the agency's labeling.
Wyeth lawyer Seth Waxman said: “We cannot have a world in which the very day after an intensive process – the FDA says you may distribute this drug, but you must use this specific language – either, A) manufacturers can just run in and change the label and ask for permission down the road, or …. a state legislature or 50 state legislatures can decide because you could have gone back and asked, we can impose an obligation on you that you must have done so or must have changed the labeling.”
Edwin Kneedler, representing the government, agreed. “It's been the FDA's long-standing interpretation that only new information would justify a change [in labeling],” said Kneedler.
David Frederick, representing the plaintiff, argued that “the label itself is not set in stone….Manufacturers change their labels all the time as new drug risks come in, and the regulations provide that the manufacturer is responsible not only for the label but for monitoring post-market information.”
Justice Scalia took issue with Frederick's rationale, and said: “It would not promote public safety if you believe that the name of this game is balancing benefits and costs, and if you are simply eliminating certain drugs which people who have real desperate need for could benefit by.”
Frederick countered that “the FDA itself said….That even an original label may be misbranded if the drug manufacturer subsequently learns that it was not adequate for the safe use of the drug.”
“You're saying whenever it's unsafe, whatever the FDA has approved, you have a lawsuit,” said Scalia.
At stake in the case is a broad legal defense against product liability suits on FDA-approved products. "If the FDA is the final word, then following FDA rules is sufficient," said Coalition for Healthcare Communication head John Kamp, who attended the hearing. "If there is no pre-emption, then you have to follow the FDA and guess what every single jury is going to think you should have said."