You are here

Supreme Court Decides Wyeth: A Victory for Diana Levine and the Constitution

March 4, 2009

In a resounding victory not only for a woman who was seriously injured by corporate wrongdoing, but also for the Constitution, the Supreme Court today upheld a state court jury verdict won by Diana Levine against pharmaceutical giant Wyeth, whose drug, Phenergan, caused Ms. Levine to suffer gangrene requiring the amputation of much of her right arm, destroying her livelihood. Levine, a professional musician suffering a serious migraine, had been injected with Wyeth’s anti-nausea drug in a risky procedure (IV push) that Wyeth knew could result in the loss of a limb. A Vermont jury agreed with Levine that Wyeth’s warning on the drug label was insufficient, and awarded her $7 million in damages. Wyeth argued to the Supreme Court that this jury verdict was preempted by federal drug labeling law, an argument soundly rejected today by the Court’s 6-3 ruling.

The majority opinion, written by Justice Stevens and joined by Justices Souter, Kennedy, Ginsburg, and Breyer, held that the Food and Drug Administration’s (FDA) approval of the Phenergan drug label did not provide a defense to Ms. Levine’s state lawsuit. Rejecting Wyeth’s attempt to shift responsibility onto the FDA, the Court stated that the “manufacturer bears responsibility for the content of its label at all times.” Accordingly, it was entirely proper for the Vermont jury to hold Wyeth responsible for failing to do more to protect Ms. Levine.

In a key part of its ruling, the Court applied the “presumption against preemption” that the Court has used to preserve the traditional authority of the states to protect their citizens, describing it as one of the two “cornerstones of our preemption jurisprudence.” The majority slapped down the attempts by the Bush Administration to assist big business and preempt state “failure to warn” laws through regulatory preambles and litigation positions that deviated from decades of settled expectations that state consumer protections and federal drug labeling laws could exist in harmony, holding that a Bush Administration “preemption preamble” here was entitled to no deference at all.

The Court also rejected Wyeth’s claim that allowing state court consumer protection remedies against inadequately labeled drugs would pose an obstacle to the federal regulatory scheme created by Congress. Both the majority opinion and the separate concurrence by Justice Thomas avoided the worst aspects of “implied obstacle” preemption, which promotes a freewheeling analysis by judges into the “purposes,” rather than the textual provisions, of federal statutes, a danger that CAC warned of in our brief filed in Wyeth. Indeed, Justice Thomas’ concurrence incorporates much of CAC’s argument, noting that only duly enacted federal law, not purposes or objectives, displaces state law under the Supremacy Clause. As Justice Thomas explained, an open-ended, judicially enforced “frustration of purposes” theory of preemption risks upsetting the Constitution’s carefully crafted federal-state balance of power. Justice Thomas is right, but the majority is not far off: while Justice Stevens’ opinion retains the doctrine of “implied obstacle preemption,” it does cabin the inquiry far more effectively than the Court has in earlier obstacle preemption cases.

But while the majority and concurrence generally got things right, the dissent -- written by Justice Alito and joined by Chief Justice Roberts and Justice Scalia -- got it very wrong. A palpable anti-jury sentiment runs throughout the dissent—nevermind that the role of the jury as a bulwark of liberty was so sacrosanct to our Nation’s founders that three Bill of Rights Amendments protect juries. The dissent’s novel argument that the presumption against preemption should not apply to any preemption claims would open the door to sweeping, judge-created rulings that displace state protections and trial juries, contrary to our basic constitutional design.

While this ruling cannot fully compensate Ms. Levine for her ordeal, it vindicates her right to seek justice from a drug manufacturer that could have done more to prevent her injuries, as well as the role that states play, under our constitutional system, in protecting their citizens, and their right to have that role respected by the federal government and the Supreme Court.

CAC celebrates this victory (our brief in Wyeth was the first to bear CAC’s name) and will continue to work to move Supreme Court preemption jurisprudence further back in line with the Constitution, to protect access to valuable state law remedies, and to provide justice to victims of corporate misconduct and wrongdoing.

Case Reference: