The Supreme Court seemed divided today while hearing oral arguments in Levine v. Wyeth.
Levine, a musician, had her arm amputated after gangrene set in. The 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.
Levine’s Attoreny, David Frederick, argued that Wyeth and FDA were aware of the danger, which was indicated in the labeling, but that the warning was insufficiently strong and that Wyeth should have strengthened cautions.
Wyeth argues that the FDA did not allow such a label change.
Chief Justice John Roberts and Justice Antonin Scalia appeared to be siding with Wyeth. 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.
Justices David Souter, Ruth Bader Ginsburg, Samuel Alito and Anthony Kennedy seemed inclined towards the plaintiff.
Justice Samuel 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.”
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.”
The full transcript of the hearing is available at http://www.supremecourtus.gov/oral_arguments/argument_transcripts/06-1249.pdf