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The Wyeth Case, pre-emption and federalism ctd.

What follows is my two cents' worth on the Wyeth v Levine case, already discussed on this blog.

First, it is important always to understand that appellate courts are bound by the procedural posture of a case. This case rose out of a plaintiff's jury verdict in a "failure to warn" suit. Now, I fully agree that there was indeed ample warning in this case. But the Vermont jury decided to the contrary, and appeals are not "do-overs" of trials. To prevail on appeal the defendant must claim that the case should never have gotten to the jury (because, the defendant Wyeth claimed, the warning's content had been pre-empted by the FDA-approved label and therefore the plaintiff's theory should not have been submitted to the jury). If there is no pre-emption, the adequacy of Wyeth's warning is for state courts, not the federal court, to decide. Therefore, and with respect, I take serious issue with that part of Justice Alito's dissent that emphasizes that the warning was adequate. That can only be obiter dictum. The Supreme Court's sole task was to determine whether there had been federal pre-emption. Discussing the content of Wyeth's warning is relevant to the absurdity of Vermont products liability law, not to the pre-emption question.

As regards pre-emption, I expected a 5-4 decision (I wasn't sure in which direction), with Justice Breyer favoring pre-emption based on his prior pragmatic approach to interstate commerce and federal regulation, and of course I was wrong on that count. I also expected Thomas to concede that the Geier v Honda case was good law, and this he did not do, enabling him to dissent on grounds of federalism. Last but not least, I found the majority's distinguishing of Geier to be almost pathetically weak and most unpersuasive.

I think the Wyeth case severely weakens the effect of Geier, possibly generally (if the court is to be principled, which I doubt, given its pre-emption history) and certainly as regards pharmaceutical litigation. Ultimately, the effect of the decision may be confined to FDA matters, because of the lack of a pre-emption clause in the statute. That clause should not make a difference, conceptually, given the logic of the Geier case, as both the dissent and Justice Thomas's concurrence maintain, but these four Justices did not prevail on this point.

Express pre-emption, all concede, occurs in "a case in which state law penalizes what federal law requires." But the Geier case (disallowing a state lawsuit based on design defect for failure to equip a Honda with an air bag, when federal regulations had required a certain percentage of Hondas to be so equipped, and Honda had complied with that regulation) saw pre-emption in "a case in which state law penalizes what federal law explicitly allows." That was precisely the case in Wyeth -- the warning deemed defective was explicitly allowed (if not mandated) by the FDA. But Geier is no more -- at least as regards the FDA.

Meanwhile, Justice Thomas's insistence on federal principles is, I think, welcome. He clearly (alone among Justices) would explicitly overrule Geier, thereby possibly forcing the hand of the federal government to expressly pre-empt state product liabiilty law if it wishes to trump state sovereignty. Thomas's concurrence is coherent, unlike Justice Stevens,' in my opinion. As for Justice Breyer's opaque concurrence, the most that can be said for it in my opinion is that it follows his increasingly explicit pragmatism -- it is unprincipled, but pragmatism disdains principles.

Supreme Court pre-emption jurisprudence has been even less satisfying, intellectually, than Supreme Court punitive damages jurisprudence. Wyeth is the latest in a back-and-forth that now brings us back to the pre-Geier days when, essentially, pre-emption was minimized. It remains to be seen whether the Court will in the future restrict Wyeth to the drug field, as I suspect, in which case an express pre-emption cause in the Food, Drug and Cosmetic Act would at last be welcome.

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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.