The decision in the blockbuster case of Wyeth v. Levine is just out, and Lyle Dennison’s early commentary is here.
To summarize: In an opinion by Stevens, joined by Kennedy, Souter, Ginsburg, and Breyer, the Court held that FDA approval of a drug’s labeling does not preempt state-law failure-to-warn claims. The plaintiff, Diana Levine, developed gangrene after her arm was injected with Phenergan, a drug manufactured by the defendant, Wyeth. Levine sued in Vermont state court, claiming that Wyeth had failed to provide adequate warning about the risks of the method by which the drug was administered, and the jury awarded damages. Wyeth appealed, arguing that the Food, Drug, and Cosmetics Act, as well as FDA regulations requiring FDA approval of drug labels, preempted the state-law claim, providing a complete defense to it. The Court today rejected that argument.
After reading the opinion, and refamiliarizing myself with the facts and law of the case, I share Alito’s view: “This case illustrates,” his dissenting opinion begins, “that tragic facts make bad law.”
Getting to five in this case–that is, winning in the Court–was going to require Kennedy and Breyer, given Thomas’s well-known skepticism of implied preemption on textual grounds (on display today, in fact). Breyer and Kennedy are not resolutely opposed to preemption (as Justice Stevens seems to be), and the 4-4 split in Warner-Lambert v. Kent provided some indication that the two might be open to it in the drug context. (Justice Roberts sat that one out.)
So what was different this time around? The facts, or at least what the media made of them. Story after story (see, e.g., here and here) focused on Diana Levine, a musician who lost her arm to gangrene after being administered Phenergan, Wyeth’s drug, via IV-Push injection. But in that simple summary, so many facts are lost:
- The drug’s label did warn about the risk of gangrene due to “intra-arterial injection”–exactly what happened to Levine.
- The doctor who injected the case used a disfavored, though not contraindicated (i.e., banned) method of injecting the drug.
- The doctor injected twice the maximum labeled dose.
- The doctor continued to inject the drug despite Levine’s complaints of pain.
- IV-push, the method of administration at issue in the case, is a particularly quick-acting and effective way to administer the drug, though it does carry with it some (labeled) risks, such as gangrene.
In short, then, this really wasn’t about “failure to warn”–because the warnings were there–but failure to outright ban a method of administration that already carries heavy warnings but that the FDA, balancing all the interests at stake, determined should still remain available.
(And if that method is misused, as seems to have been the case here? That’s a malpractice claim.)
But there’s no way to square today’s decision with the FDA’s role in making these kinds of determinations. The majority, unfortunately, sweeps that fact under the rug, arguing (unconvincingly) that expert determinations and jury decisions on drug safety can somehow coexist.
Hard facts make bad law, goes the old saw, and now we have Alito’s new formulation of that lament. If only the facts of the case, rather than the facts of the plaintiffs’ bar’s media blitz, had carried the day, the Court might not have found this case so hard or made such bad law.