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Court Rejects Preemption in Wyeth v. Levine

The decision is just out, and Lyle Dennison's early commentary is here.

No doubt, there will be much more commentary throughout the day. I'll add links to this post.

For what it's worth, 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 physician's assistant who injected the case used a disfavored, though not contraindicated (i.e., banned) method of injecting the drug.

  • Twice the maximum labeled dose was injected.

  • The physician's assistant 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, goes the old saw, make bad law, 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.

Update: Thoughtful commentary (as always) by drug and device law gurus Beck and Herrmann:

Levine isn't good news for our side by any means, but it's no Lohr. The Court did not hold that there's no preemption at all, or no preemption without an express regulation, either of which it could have done. It didn't impair either Riegel (which, being an express preemption case, is completely different) or Buckman. In short, Levine doesn't make preemption impossible, just a lot more difficult. After Levine it's pretty clear though that implied preemption is going to depend quite a bit on what the FDA has to say about specific drug risks, and not very much on what the FDA has to say about preemption.

Update: Jonathan Adler, writing on the Volokh Conspiracy, makes the point that Wyeth, as well as the Court's decision from earlier this term rejecting preemption in Altria v. Good, is "evidence that early proclamations that the Roberts Court is a 'pro-business' court were premature."

In an additional posting, Lyle Dennison prognosticates on the effect of the decision: "The Court no doubt will have other federal-vs.-state regulation cases to sort out as time goes on, because consumer advocates are sure to try to make the most of the Wyeth ruling to support their lawsuits in state courts over what they claim are defective products. "

Update: A victory for federalism and "states' rights"? Several commentators, including a number of plaintiffs' attorneys, think so. (Do we get referral fees for these links?)

Update: The Journal's Jess Bravin on the takeaway from Wyeth and the other recent preemption cases: "All three of these cases wound up being primarily about statutory interpretation. The Court in each looked at the specific statute and determined whether or not it could exist side-by-side with state tort law. But in each it was an individualized examination."

CEI's Greg Conko faults the Court for its broad rule substituting jury decisions for FDA experts' "balanc[ing] the benefits and risks of new medicines." He concludes, "[N]ot only is the majority's decision bad policy, it's also bad law."

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.