The Upcoming Supreme Court Case of Wyeth v. Levine and the Preemption Temptation: Part One in a Two-Part Series
By ANTHONY J. SEBOK and BENJAMIN C. ZIPURSKY
|Tuesday, Sept. 23, 2008
In November, the Supreme Court will hear arguments in the case of Wyeth v. Levine, which concerns a healthy guitarist in Vermont who lost her arm to gangrene caused by Wyeth's anti-nausea drug Phenergan. Wyeth is challenging a plaintiff's verdict of over $6.7 million dollars on the ground that state failure-to-warn claims for FDA-approved warnings are preempted by the federal agency's action.
While Levine is one of a string of preemption cases the Court began hearing last year, it could be the most important by far. For reasons we will indicate in this and the next installment in this two-part series of columns, we believe the Court should decide Levine quite narrowly (however it decides) and we are cautiously optimistic that it will do so.
However, it is no exaggeration to say that the case presents the Roberts Court with the opportunity to eliminate most of pharmaceutical liability under state tort law in one fell swoop, if it so chooses.
The Question Presented in the Case, and Different Views on It
Broadly speaking, the question in Levine is whether a manufacturer that complies with the warning requirements dictated by the FDA for the particular drug in question can be held liable under state tort law for not supplying adequate warnings.
Overwhelmingly, federal courts have held that FDA requirements are a floor, and not a ceiling, and that the federal Food, Drug, and Cosmetic Act contains neither text nor history justifying a broad preemption defense. The Supreme Court, however, has never addressed the question and the Roberts Court has begun to amplify a pro-preemption proclivity begun in the Rehnquist Court.
Under the Bush Administration, federal agencies, including the FDA, have advocated a strongly top-down anti-state line on preemption, and the Court last Term agreed 8-1 with the FDA preemption argument regarding an important class of medical devices in Riegel v. Medtronic (involving a different statute).
Of equal importance, in our view, some clusters of pharmaceutical cases have presented what might be called (with some irony) sympathetic fact patterns for the defendant pharmaceutical companies. The briefs and parties and amici in Levine present the Court with an unenviable challenge of crisscrossing state tort law, administrative law, and federalism issues.
The Facts of the Levine Case, and the Jury's Verdict
Levine's facts present a shocking tragedy of the sort that can overwhelm juries and judges. On Diana Levine's second visit in one day to a local medical clinic for a severe migraine, a physician's assistant gave her a second dose of Wyeth's anti-nausea drug Phenergan. Unlike the first dose, which had been given intramuscularly, the second dose was given by a direct intravenous shot in the arm ("IV push"). The Phenergan was intended to go into a vein, but some of it leaked into an artery, causing the plaintiff - a healthy guitarist in her mid-fifties -- to develop gangrene in her arm. The arm had to be amputated.
Wyeth was aware of the risk that Phenergan given in an IV push could cause gangrene if it leaked into an artery, and indeed warned of this risk on its package insert, where it also indicated that it was preferable to give Phenergan from a dilute IV drip, and explicitly cautioned the medical professional tasked with injecting the Phenergan to use extra care. But the language of Wyeth's package insert did not prohibit IV push as a method of delivery and, plaintiff contends, the warning language should have been stronger.
Levine sued Wyeth for failure to warn, and the jury returned a verdict of $7.4 million against Wyeth, which the Vermont Supreme Court affirmed (after it had been reduced to $6,774,000 pursuant to a stipulation). Before the trial court and later the Vermont Supreme Court, Wyeth argued that the FDA had approved its warning and that Levine's claim was therefore preempted.
Wyeth's arguments for implied preemption were, from boldest to most nuanced, that:
(1) a 2006 FDA Preamble declaring that FDA requirements are both a floor and a ceiling should be given great deference henceforth in all state failure-to-warn litigation over pharmaceuticals, entailing across the board preemption for failure to warn claims; (2) federal regulations requiring FDA approval for alterations of warning labels entail that "conflict preemption" principles rule out state failure-to-warn litigation except for newly discovered risks; (3) in a significant range of scenarios like this one, state failure-to-warn claims present an obstacle to the realization of important federal policies, and are therefore preempted under frustration principles like those announced in Geier v. American Honda Motor Co.. Whether the Supreme Court of Vermont was correct to reject Wyeth's preemption defense, in all three of these versions, is the issue now before the United States Supreme Court.
Why Levine is a Very Poor Vehicle for the Court to Use to Use to Answer the Question Presented
Our next column in this two-part series will look more closely at the merits of the pro-preemption position. We conclude that only quite a narrow framework of implied preemption should be recognized in pharmaceutical cases, and suggest that the Court's decision about whether Levine is determined to fall inside or outside that framework is far less important than the selection of the framework itself. Our aim in this column is quite simple: to indicate how poorly-suited Levine is to be the focus for the Court's inquiry into this extraordinarily important question of federalism and tort law.
The problem with Levine is that the jury and the judges in Vermont handed Wyeth a loss it clearly did not deserve, because they stretched tort law to its limit (and perhaps beyond) to respond to the gripping facts before them. For any number of basic reasons, the result in Levine is pathological as a matter of products liability law.
First, and most basically, Wyeth simply did, in fact, warn of the risk of gangrene, and did so clearly and strikingly: The label printed by Wyeth noted that if the drug is used intravenously, "extreme care" should be taken because of the risk of "inadvertent intra-arterial injection" which can lead to "gangrene requiring amputation." On this ground alone, Wyeth should have won summary judgment, perhaps on the pleadings.
Second, even if one assumes that Wyeth should have used a bolder and more alarming warning, it defies belief that a healthcare provider who failed to respond to the warning that was there, more probably than not would have changed his or her behavior with a stronger warning; summary judgment on causation thus would have been appropriate, too.
Third, even assuming a failure to warn, Wyeth had a powerful comparative negligence argument (and perhaps a superseding cause argument) directed at the clinic and the physician's assistant, who settled for only $700,000. The clinic and/or the assistant appear to have been highly negligent for selecting the risky IV-push method unnecessarily (evidently, without informed consent) and for executing it carelessly, just as Wyeth warned against doing.
Finally, adding a defensible, but nevertheless remarkably anti-corporate touch to its decision, the Vermont Supreme Court rejected Wyeth's plausible argument that the jury should have been instructed to consider the comparative negligence of the clinic and its employee, and that Wyeth should only be held liable for only its degree of fault, as required under a Vermont tort reform statute.
A "Poster Case" for the Tort Reform Movement
At each of these junctures, the Vermont courts went out of their way to make the big drug company pay for this injury. If the tort reform movement was looking for a case with a fact pattern perfectly suited to deliver the message that state judges and juries across America are hostile to big corporations, they could hardly have done better than Levine. The Justices of the U.S. Supreme Court - like the sole dissenting justice of the Vermont Supreme Court - will be sorely tempted to correct what they see as an aberrant legal result by imposing a powerful federal preemption defense.
If the Justices do so, however, they risk overreacting, and their decision may do serious collateral damage to the individual right, under state tort law, to sue pharmaceutical manufacturers who do conceal significant drug risks. Moreover, a broad decision in Wyeth's favor here might also reverse the public health benefits that flow from a system of checks that is not exclusively dependent on the FDA. In short, there are untenable judgments of tort law and tort policy reflected in Levine, but they are mistakes that the state of Vermont is entitled to make for itself.
Levine is an especially tricky case because there is a way for the Court to redescribe it that simultaneously depicts Vermont law to be more rational and permits the United States Supreme Court to enter the fray while doing genuine federal law. Suppose one interprets the jury as having decided that Wyeth should have prohibited the use of IV push as a method of delivering Phenergan, rather than merely warning more urgently about its risks. On this interpretation of the jury's verdict, the causation problems and even the comparative negligence problems recede substantially; one imagines caregivers simply taking IV push off the table as an option.
If the Court chooses to interpret this as a "prohibition" case, in other words, Wyeth's implied preemption argument looks better, for the FDA does seem to have decided not to prohibit IV push. The Vermont Supreme Court did not appear to understand the lower proceedings in this manner, and we are inclined to think that as a matter of federalism doctrine, the U.S. Supreme Court ought to leave the state court's understanding intact. But we leave to our next column in this series the exploration of that issue, and of the substantive merits of the preemption arguments themselves. For now, we simply wish to flag the risks of permitting such a poor specimen of state tort law to be the focus of the Court's most important pharmaceutical case in decades.