Diana Levine, a musician, sued Wyeth for tort damages after her arm was amputated due to gangrene caused by a physician assistant's gross misuse of a permissible method of intravenous administration ("IV-push") of Wyeth's anti-nausea drug, Phenergan. Phenergan's FDA-approved label warned--partly in bold, enlarged type--that "extreme care" must be exercised because injections that enter an artery can cause gangrene requiring limb amputation. (Her doctor and careless PA, who settled with Levine, were so upset about contributing to her injury that they agreed to testify against Wyeth.) The Vermont Supreme Court upheld a jury verdict of $7.4 million against Wyeth, which appealed to the U.S. Supreme Court.
Wyeth's main defense was the constitutional principle of preemption, which makes federal law binding by preempting state decisions that conflict with it. Precisely what "conflict" means here lies at the heart of a large number of implied preemption disputes in the courts, yet the Supreme Court has never defined it clearly--and didn't do so yesterday.
Justice John Stevens, writing for a six-justice majority, upheld Levine's state court victory. The jury's desire for a stronger warning about the danger of the IV-push method trumped the FDA's view that the warning label was adequate. Because Wyeth could have warned more strongly without obtaining the FDA's prior approval, the majority held, there was no conflict. This strikes me (and the dissenters) as a weak argument: The FDA had actually considered a stronger warning as recently as 1998, but did not require it. It may have reasoned that IV-push is more beneficial than the alternative (IV-drip) in situations like Levine's when speed is essential, and that IV-push is safe when the clinician heeds the clear warnings. (Although the Court majority noted "evidence of at least 20 reports of amputations similar to Levine's since the 1960s," it did not say what caused these outcomes). Balancing these kinds of tradeoffs is precisely the kind of technical judgment calls that FDA was established to make.
The alternative, which the Court supported in its decision yesterday, is that juries will make such determinations. Juries have great virtues in many kinds of cases, but making these medical cost-benefit tradeoffs is not one of them. They sit in only one case, and the plaintiff's lawyer makes sure that the severely injured, extremely sympathetic plaintiff whom they see is not representative of the much larger group of those who reap the drug's benefits when it is properly administered. The trial lawyers intentionally seek jurors who know nothing about the subject at hand. The jury's verdict is completely opaque and unexplained. It is accountable to no one. And juries in different states make different decisions on the same drug--hardly a recipe for the uniformity and predictability to which manufacturers should be entitled.
A jury's flaws are inherent in its design. In contrast, the FDA's flaws--and they are many--can at least be remedied by Congress, to which it is highly accountable.
Empowering institutionally limited lay juries to make life-and-death decisions about drugs is a foolish way to make public policy, especially when the real culprit is not the manufacturer but the malpracticing clinician. However, as a matter of law--the confusing law that the Court has created in this area--the Court majority may have been correct. In the statute that governs the FDA, Congress expressly gave the FDA preemptive power over state tort law as to medical devices, but has never done so for drugs, leaving the implication that it did not want preemption as to drugs. (Justice Thomas, ordinarily no friend of plaintiff's lawyers, joined the majority for this reason.) Indeed, the FDA did not even claim preemptive authority until 2006, and even then did so in a most elliptical and unexplained manner. So if juries are to be ousted from their new central role in drug regulation, Congress, not the Court, will have to do so. Congress should authorize FDA preemption in the drug area under carefully prescribed conditions, and if victims like Levine are preempted by the FDA-approved warnings, they can still sue (as Levine did) the clinicians who injured them by not heeding those warnings.
Will Congress do so? We shall soon see how much influence the pharmaceutical industry has in Obama-led Washington.
--Peter H. Schuck