Sunday, March 08, 2009

Wyeth v. Levine: SCOTUS Gets One Right

Not so long ago I declared that the fix was in — that the Supreme Court was preparing to cede complete regulatory authority over drug safety to a pharma-friendly Food & Drug Administration that can't be bothered to intercede to protect the American people, when there's all this money to be made in RLS suppression and chemical erections.

Turns out I may have spoken too soon on this subject. (But what did you expect — a moderate, modulated wait-and-see attitude? Two days ago I accused a guy of murder on scant circumstantial evidence.) SCOTUS voted 6-3 last week to uphold the plaintiff's verdict in Wyeth v. Levine. Holy crap.
Ms. Levine brought suit against a health center, her doctor, and Wyeth after the doctor, in the course of administering an "IV push" of Wyeth's anti-nausea drug Phenergan, tapped into an artery instead of a vein. As the Court explains, Phenergan "is corrosive and causes irreversible gangrene if it enters a patient’s artery." The mistake resulted in the amputation of Ms. Levine's right arm and ended her career as a professional musician. Ms. Levine settled claims against the clinic and the doctor; her claim against Wyeth went to trial, and a jury awarded her $7.4 million.

The jury found that Wyeth did not satisfy its duty to warn the clinician and Ms. Levine of the specific dangers associated with a Phenergan IV push. Wyeth raised the defense that the FDA had approved its marketing of the drug for intravenous delivery, subject to specific FDA-agreed warning language on the product's packaging; that approval, Wyeth argued, "preempted" any state law judgment that it failed to provide adequate warning of the drug's dangers — first, because any additional warning language interposed by state law (here, Vermont's) would require Wyeth to deviate from the specific language approved by the FDA (so that the packaging would violate federal law), and second, because the verdict would undermine federal law by substituting a "lay jury's" judgment on the matter for "the expert judgment of the FDA."

Six Justices — Stevens (who wrote the opinion), Ginsburg, Souter, Breyer, Kennedy, and Thomas — sided with the plaintiff. It ruled that responsibility for the content of a drug label resides with the drug company: it cannot simply rely on what the FDA regards as sufficient. The Court held, as well, that the several federal statutes and regulations that govern drug labeling were all created against a backdrop of state tort litigation. For generations now the FDA has reviewed and approved drugs for the market, and where — notwithstanding the FDA's conclusions — those drugs have proved to be unreasonably dangerous, injured parties have been entitled to sue the drug companies under state law. The Court wrote last Term that the FDA's approval of a medical device preempted any state law claim against the manufacturer for product defects or failure to warn. It drew the line here, because it could not say with a straight face that Congress ever intended to write out these remedies against drug companies.

Justice Alito's dissenting opinion — joined by Scalia and the Chief Justice — would have turned this 70+ years of law on its head. It's worth repeating that Chief Justice Roberts put himself forward in the confirmation hearings as a cautious incrementalist (AHEM! gun rights!), and we were to expect no dramatic upheavals in the law on his watch. Alito's tact here was to heap scorn on the "Vermont jury," whose word on the question of what a drug company should say on its labels should, in the majority's view, be final — even over FDA experts:
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.     [T]he real issue is whether a state tort jury can countermand the FDA’s considered judgment . . . By their very nature, juries are ill-equipped to perform the FDA’s cost-benefit-balancing function.

Of course, we trust juries to assess the merits of complicated scientific and forensic evidence in criminal cases, when the defendant's liberty — and in many cases his life — is on the line. God forbid a drug company's earnings should be subject to the whimsy of twelve angry men over the "considered judgment" of an industry lackey with a plum government job.

This case provides yet another occasion to consider the hypocrisy of the conservative justices, who argue so fullthroatedly in favor of their judicial philosophies in some cases, but not others. Here Alito, Scalia, and Roberts, ardent defenders of "text" and bitter critics of the presumption of judges who would interject their notion of legislators' "intent," would invoke the judge-created doctrine of "implied preemption" to invalidate the Vermont jury's verdict, based on a review on Congress's objectives that is necessarily speculative and self-indulgent. And here, too, these three, who routinely invoke "states' rights" and "federalism" to curb individual civil rights set forth in federal law, freely abandon these principles when a federal regulation supports a pro-business outcome.

By contrast, Justice Thomas comes off as principled for voting with the majority here, and for writing a separate concurring opinion in which he argues that only federal statutes — and not the decisions of agencies — should have a preemptive effect. But I've seen Clarence ditch his jurisprudential principles in support of conservative outcomes too often: I'm suspicious that here he simply took the opportunity to appear principled, because the majority already had their five votes. If Thomas had had to break a 4-4 tie, where would he have landed?

But this was a good result, and I shouldn't let These Four drag me down. No dramatic overhaul of the justice system here: FDA approval doesn't release Big Pharma from its duty to review and re-review its product offerings to make sure they're safe — and to tell consumers when they aren't. Hooray!

1 comment:

Mithridates said...

Here's my two cents on the issue. Actually, you can get my two cents, well, my $7.4MM/300MM people = 2.5 cents, from my increased health insurance premium.

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