Preemption Update: Wyeth v. Levine

On Monday, November 3, 2008, the United States Supreme Court heard oral argument in Wyeth v. Levine, and we have the full draft transcript available for you here: Wyeth v. Levine (Oral Argument Transcript)

Diana Levine developed gangrene and lost her arm to amputation following intravenous injection of Wyeth’s drug, Phenergen, which was administered to treat her nausea. She sued Wyeth alleging, inter alia, that the company failed to adequately warn her physician that Phenergen should not be administered intravenously. Following trial, she won a verdict of approximately $6.7 million, and the trial court denied Wyeth’s motions for summary judgment and judgment as a matter of law based upon preemption. The Vermont Supreme Court affirmed, and Wyeth petitioned the United States Supreme Court for certiorari.

For consumers and plaintiff lawyers, the oral argument started out well, with Justice Kennedy challenging Wyeth’s lawyer, Seth Waxman, on Wyeth’s claim that it would have been unable to comply both with federal law and its Vermont common law duty to warn. Justice Kennedy interrupted Mr. Waxman at the very beginning of his argument, commenting: “You argue that it’s impossible for Wyeth to comply with the State law and at the same time the Federal label. … But as a textual matter, as a logical matter, as a semantic matter, I don’t agree with it.” Transcript, at 3-4.

Justices Ginsburg, Alito, and Chief Justice Roberts each followed with their own challenges, with the Chief Justice noting the distinction between the Medical Device Act, which contains an express preemption provision, and federal prescription drug laws, which contain no analogous provision. When Mr. Waxman responded to the Chief Justice’s comment by pointing out the similarities between the FDA’s processes for device approval and the drug approval, the Chief Justice pressed further: “If that’s true, you would have expected the Federal Drug Act to have a similar express preemption provision. And one reason perhaps that it didn’t is that when the Drug Act was passed you had an established background of State actions; when the Medical Device Act was passed you didn’t.” Transcript, at 10.

Perhaps the capstone to the Justices’ challenge of Wyeth’s position came from Justice Souter, who posited that Wyeth could have done precisely what the Plaintiff’s Vermont lawsuit called for – i.e., strengthen its warning – without any federal impediment. Justice Souter harkened back to Justice Kennedy’s original question: “[W]here is the conflict?” Transcript, at 12.

The United States, as amicus curiae on behalf of Wyeth, was represented by Deputy Solicitor General of the Department of Justice, Edwin Kneedler, who fielded questions from the Court following Mr. Waxman. Mr. Kneedler conceded that the FDA does not believe, as a general matter, that all tort remedies for prescription drug injuries are preempted. Justice Scalia queried what sort of claims would survive, eventually cornering Mr. Kneedler’s position:

JUSTICE SCALIA: … [W]hat if you brought [a risk] to the FDA’s attention and the FDA just hasn’t acted on it? You would be authorized to change the label on your own.

MR. KNEEDLER: You would be authorized, but if FDA then … rejects the labeing –

JUSTICE SCALIA: I understand, but in the interim, you could – could you be subject to a State tort suit for not changing the label when – when you had the power to do so?

MR. KNEEDLER: … [I]f FDA has taken no action at all, then I think … you could be.

Transcript, at 17-18. Certainly, it would not be surprising if this exchange portends the outcome and holding of the case.

Of course, the day was not all sunshine and roses for Diana Levine’s position, as Justice Scalia charged hard at Levine’s lawyer, David Frederick, concerning, inter alia, the Plaintiff’s position that holding manufacturers to a duty to warn promotes public safety. Justice Scalia insisted: “It would not promote public safety if you believe the name of this game is balancing benefits and costs. … And if you are simply eliminating certain drugs which people who – who have real desperate need for … could be benefited by, you’re not benefiting the public.” Transcript, at 35-36.

All in all, the transcript reveals that the Court, although unlikely to reach a sweeping holding that will eliminate all prescription-drug-based tort suits, may divide closely on where the line is to be drawn.