Wyeth v. Levine, Tragic Facts, a Bad Ruling

The Supreme Court today released its 6-3 opinion in Wyeth v. Levine, holding that a Vermont woman could sue in state court for harm caused by the improper injection of Phenergan anti-nausea drug, despite the FDA’s approval of the labeling of the drug. (Opinion here.)

Justice Alito, writing the dissent, says it well: “This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs.”

Andrew Grossman of the Heritage Foundation has an excellent post at Point of Law hitting the salient points, including the PR elements of the case:

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.

So now individual trial juries in the separate states will, in effect, establish the nation’s regulatory regime for the administration of prescription drugs. The public will certainly not be served by the uncertainty, capricious awards and costs that result. Trial lawyers certainly will be served, as one can gather from the American Association for Justice’s release on the decision.


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  • Aubrey says:

    Actually, this may have been a very badly chosen case to raise an important principle. The issue at stake is whether she has the right to sue, not whether she is right. There are far better cases which involve the same principle.

    So this is not a case of “a tragic case making bad law” – precisely because the case is in fact irrelevant.

    The warning may have been apopropriate, and data may not have been hidden from prescribers, in which case she will lose.

    The argument above is a bit like saying that a case coming to the supreme court that turns on whether a black person is allowed to file a murder charge (because he is black) is somehow nullified if the particular case of murder is ill founded.

    Aubrey B

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