Saturday, December 22, 2007

Merry Xmas to Pharma! SG's Brief in Wyeth v. Levine

The Solicitor General has finally filed its long-awaited brief recommending whether the Supreme Court should grant certiorari in Wyeth v. Levine, which we previously described as the most important of the preemption trilogy that the Court may hear this Term.

We have just three things to say:

Ho, ho, and ho!

Unfortunately, we can't yet post a link to the brief. The brief is not yet available on the SG's website, and, given the holidays and all, neither of us is able to create the necessary link. [Update: At long last, here's a link to the brief.]

But trust us, when you finally see the brief, you'll like it!

On the things that matter to the pharmaceutical industry as a whole, the SG didn't miss a trick. In Levine itself, Levine's claims "are impliedly preempted by the FDCA because they challenge labeling that FDA approved, after being informed of the relevant health risk, based on its expert weighing of the risks and benefits of requiring additional or different warnings. The Vermont Supreme Court's contrary conclusion rests on [a] mistaken view." Brief at 7.

The discussion then opens with this delightful subheading:

FDA’s approval of a drug, including its labeling, gen-
erally preempts state law claims challenging the
drug’s safety, efficacy, or labeling

Id. at 8.

The SG then analogizes between the premarket approval process for medical devices and the approval process for drugs, concluding that both involve careful consideration of the safety and efficacy of the product and the propriety of the labeling. (Needless to say, that analogy raises the stakes in the pending case of Riegel v. Medtronic, where the Court will decide the preemptive effect of the PMA approval process for medical devices.)

The SG then puts the lie to the usual plaintiff's argument that the FDA merely polices minimum standards of drug safety. A "warning in a drug’s labeling must strike a balance between notifying users of potential dangers and not unnecessarily deterring beneficial uses." Brief at 10-11. FDA thus interprets the Food, Drug and Cosmetic Act "to establish both a ‘floor’ and a ‘ceiling’ with respect to drug labeling." Id. at 11.

Next up is the standard plaintiff's contention that the Change Being Effected regulation permits a manufacturer to make unilateral changes to drug labeling. We've been saying repeatedly that that ain't so, and the government squarely agrees with us: "If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval, based on information that was
previously available to FDA, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted." Id. at 12. Manufacturers can add warnings about newly-discovered risks from drugs, but not known risks that the FDA previously considered. Id. at 13. And, the SG points out, the FDA's view on that issue is entitled to Auer deference. Id. at 14.

The brief goes on to explain that the 1962 Amendments to the FDCA did not displace ordinary implied preemption principles (id. at 15), and that the Preemption Preamble and the generally applicable rule of decision discussed in the SG's Levine brief are consistent with the law of implied preemption. Id. at 18.

Finally, the only arguable fly in the ointment: The SG does not recommend that the Supreme Court immediately grant certiorari in Wyeth v. Levine, but rather recommends that the Court hold the case pending its decisions in Riegel and Kent. (One of our earlier posts about Riegel and Kent is here.) That doesn't particularly bother us. That leaves open the possibility of a win for industry after Riegel and Kent come down, or a grant of cert after the decisions in Riegel and Kent, or a grant of cert next Term in another case that presents the same issue raised by Levine. (This issue isn't going away any time soon.) Any of those results are okay with us.

The Supreme Court may or may not grant cert despite the SG's recommendation that the Court hold Levine temporarily. The Court did, after all, grant cert in Riegel despite the SG's recommendation to the contrary.

As for the timing of all this, the Court is likely to decide whether to accept Levine at its January 11, 2008, conference.

If the Court chooses to hold Levine, then the stakes go way up in Riegel and Kent, and the stakes also go up in Colacicco. Because the Third Circuit already heard argument in Colacicco (on December 10), Colacicco is likely to be decided before the Supreme Court decides Kent (which is not scheduled for argument until February 25.)

2007 was fun, but 2008 is going to be a blast!

And to all a good night!

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