Below, Michael Blaisdell previews this morning’s argument in Wyeth v. Levine (No. 06-1249).  A discussion of the oral argument will be available later this week on the Wyeth SCOTUSwiki page, here.    

Argument Preview

Federal preemption is back before the Supreme Court in No. 06-1249, Wyeth v. Levine, giving the Justices another chance to mediate the relationship between organic, common-law jury verdicts and the cold machinery of the Supremacy Clause. After its February 2008 decision in Riegel v. Medtronic, in which it held that federal law expressly preempted common-law suits against manufacturers of FDA-approved medical devices, the Court now considers the scope of federal preemption in the pharmaceutical industry, whose applicable federal regulations contain no express preemption clause.

Background

The issue comes to the Court in near-melodramatically tragic packaging: Diana Levine, a bass player and author of children's music in Vermont, visited a clinic to receive treatment for headache-related nausea but wound up developing tissue deterioration and gangrene in her arm, ultimately leading to its amputation.  The cause?  Clinic staff attending to Ms. Levine had administered the antihistamine Phenergen using a delivery technique known as an "IV push," inadvertently injecting the drug into one of Ms. Levine's arteries in the process. Although both Wyeth (the drug's manufacturer) and the FDA were aware that the "IV push" created a risk of inadvertent arterial injection and gangrene, the FDA had nevertheless approved labeling for Phenergen that warned against "“ but did not prohibit "“ IV push administration.

Ms. Levine brought a common-law negligence claim in Washington Superior Court against Wyeth, claiming that Phenergen's labeling was inadequate because it did not prohibit IV push delivery. Wyeth countered that because use of the warning label was mandated by the FDA pursuant to its authority under the Food, Drug and Cosmetic Act (FDCA), Ms. Levine's state tort suit was impliedly preempted by federal law in two ways:  (1) it was impossible for Wyeth to satisfy both the labeling requirement of the FDA and the demands of Vermont's common law; and (2) state liability for use of an FDA-approved label would present an obstacle to the federal objectives of the FDCA.

The superior court instructed jurors that they could consider the FDA's approval of the label in making their negligence determination, but that the label's compliance with FDA rules did not establish the adequacy of the warnings therein. At the conclusion of the trial in 2005, the jury found in Ms. Levine's favor, awarding her more than $6 million in damages.

Wyeth appealed, and in October 2006, a divided Vermont Supreme Court upheld the ruling. Judge Johnson, writing for a 4-1 majority, found that because an FDCA provision provides that FDA approval is not required to strengthen warnings, Wyeth could, in fact, comply with both state and federal law. Moreover, because FDA rules create only minimum labeling requirements, state tort liability for approved labels would not frustrate the objective "“ promotion of public health "“ that led Congress to enact the FDCA. Importantly, the Court did not afford any deference to recent FDA statements claiming otherwise.

Chief Judge Reiber was the lone dissenter. Although he agreed that the FDCA would allow a company to unilaterally strengthen a warning, he framed Ms. Levine's claim as demanding that "IV push" be removed from the label's listing of Phenergen's appropriate uses "“ a demand that (in his view) conflicted with FDA's conclusion that the "IV push" was an acceptable, albeit more dangerous and less optimal, method of administration. He also disputed the majority's analysis of the lawsuit's interaction with federal objectives, finding the jury verdict "“ that Phenergen as labeled was unreasonably unsafe "“ to be in direct conflict with the FDA's approval of the drug and its label. Emphasizing the competing public health considerations behind each FDA determination, he contended that jury awards should not be allowed to override these determinations.

Petitions for Certiorari

Wyeth petitioned for certiorari, asking the Court to review the "basic and fundamental doctrinal errors" made by the Vermont Supreme Court in its application of conflict preemption principles. Wyeth contended that that court had misinterpreted the scope of an FDCA provision allowing manufacturers to modify product labels without FDA approval, suggesting that the provision only allowed changes when new risks had been discovered. This misreading, Wyeth argued, undermined the Vermont Supreme Court's finding that it would be possible to comply with both the federal regulation of the drug and the state judgment. Wyeth also argued that the Court should grant review to clarify both the applicability of a "presumption" against preemption in an area "“ like the pharmaceutical industry "“ that is heavily regulated by the federal government and the weight to be afforded FDA statements regarding the preemptive effect of its own regulations.

Opposing certiorari, Ms. Levine argued for the Vermont Court's interpretation of the FDCA, under which Wyeth was free to strengthen a contraindication in Phenergen's labeling without FDA approval. This option, respondent argued, as well as record evidence that the FDA had not considered, much less rejected, a label prohibiting IV push administration, made Wyeth's claims of impossibility preemption unfounded. Moreover, Ms. Levine noted, all Wyeth was required to do to comply with the trial court's verdict was pay a damage award; whether to re-label its product to avoid future liability was a choice left to Wyeth.  Ms. Levine also argued that the Vermont verdict promoted, rather than interfered with, the FDCA's objective of promoting public health, and that certiorari was inappropriate on the question of deference to the FDA's views on the statute's preemptive scope because the events giving rise to the case pre-dated any relevant FDA statements.

On invitation from the Court, the Solicitor General filed a brief recommending that the Court decide Riegel before rendering its decision on the Wyeth cert petition, given the overlapping issues in the two cases. The Court nevertheless granted certiorari on January 18, 2008, several weeks before the Riegel decision.

Merits Briefs

In its brief on the merits, petitioner maintains that Ms. Levine's lawsuit is impliedly preempted by both doctrines of conflict preemption. The arguments hit many of the same points as the cert. filings:  petitioner again suggests that the Vermont court misinterpreted the FDCA as allowing manufacturers to unilaterally change product labels, when in fact this narrow exception to the pre-approval rule merely permits label changes prior to FDA approval to reflect new information about drug risks.  Moreover, petitioner emphasizes, courts should defer to the views of the FDA, which has itself has endorsed this narrow interpretation of the statute. Under this proper reading of the statute, Wyeth contends, it would be impossible for Phenergen to be labeled in a way that would satisfy both its federal and state masters when the FDA had repeatedly instructed Wyeth to retain Phenergen's current labeling, only to have a Vermont jury find the label wanting and the company liable.

Petitioner also reiterates that the Vermont court's verdict conflicted with the objectives of the FDCA. Each FDA labeling determination, petitioner explains, involves a careful weighing of the competing considerations. When the agency approved Phenergen's label, it knew that IV push administration carried with it a risk of inadvertent arterial injection and resultant gangrene, but it nonetheless decided that the benefits of allowing doctors to use this method of treatment outweighed those risks. According to Wyeth, this expert determination does not represent a "floor" level of safety that states are free to raise, and a state jury verdict that did so would conflict with the FDA's carefully calibrated directive to an affected company.

As amici in support of petitioner, the government filed a brief arguing, like petitioner, that FDA labeling directives are binding on manufacturers, with deviations permitted only when newly available risk information is discovered. The brief echoed petitioner's belief that the FDA's risk-benefit analysis is more than a federally imposed baseline of safety, making the additional claim that judicial second-guessing of such determinations would be unpredictable and intrusive on agency prerogatives. The Government also asked the Court to defer to the FDA's preemption position, noting a line of administrative law cases pronouncing it "uniquely qualified" to determine when its objectives are threatened.

In its brief on the merits, respondent traces the history of pharmaceutical regulation in the United States, and suggests that Congress has consistently recognized state tort suits and FDA regulation to be discrete and compatible checks on the safety of drugs in the marketplace. The absence of preemptive intent, it argues, supports a reading of the FDCA that would merely require federal regulators to ensure that a manufacturer's proposed labeling is "adequate," rather than compelling drug manufacturers to use specified labels and warnings; manufacturers are free to alter labels towards "increased safety" of their own accord. Respondent also discounts petitioner's "new" argument that labeling changes must be based on new risk information as unsupported by the statutory text, and, most simply, points out that the Vermont court's verdict does not actually require Wyeth to change Phenergen's labeling. The company could, if it chose, simply pay the damage award and continue marketing the drug as labeled "“ an option that, according to respondent, undercuts petitioner's impossibility preemption claim.

For respondent, the legislative history makes clear that Congress's chief objective in giving the FDA authority to regulate the pharmaceutical industry was to ensure public safety. Equally clear, it argues, is that this regulation must evolve over time, and that by offering dynamic review of a particular drug's merit, tort lawsuits support that objective. Respondent attacks petitioner's argument that the FDA's careful risk-benefit analysis is upset by such jury verdicts as a "caricature" of the approval process unsupported by the record. There is no evidence, Respondent contends, that the FDA performed such an analysis into the "IV-push" administration of Phenergen; if it had, the inescapable conclusion, as expressed by experts at trial and unopposed by petitioner on review, would have been that the risks of the delivery method far outweighed the negligible benefit.

Finally, respondent argues that, under the applicable Skidmore framework, the FDA's recently changed position on the preemptive effect of the FDCA is not entitled to significant deference by the Court.

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