Wyeth v. Levine

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Authorship: Michael Blaisdell

1 Briefs and Documents
2 Pre-Argument Articles
3 Opinion
- 3.1 Further Analysis
4 Links and further information

[edit] Briefs and Documents

Docket: 06-1249

Issue: Whether federal law preempts state torts claims imposing liability on drug labeling that the FDA had previously approved.

Opinion below (Supreme Court of Vermont)
Petition for certiorari
Brief in opposition
Petitioner’s reply
Amicus brief of the Pharmaceutical Research and Manufacturers of America (in support of the petitioner)
Amicus brief of the Product Liability Advisory Council (in support of the petitioner)
Invitation brief of the United States (recommending hold)

Merit briefs

Amicus briefs

Oral Argument: Transcript

Decision: AFFIRMED in an opinion by Justice Stevens

[edit] Pre-Argument Articles

[edit] 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.

[edit] 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.

[edit] 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.

[edit] 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.

[edit] Opinion

Lyle Denniston wrote the following.

The Supreme Court, voting 6-3, ruled on Wednesday that federal approval of labels giving warnings about effects of drugs does not bar lawsuits under state law claiming inadequate warnings of a health risk. The ruling came in the case of Wyeth v. Levine (06-1249). This was the only decision of the day.

The history of the federal law on drugs shows, Justice John Paul Stevens wrote for the Court, that Congress did not intend to bar failure-to-warn lawsuits that are based on state law. The decision also rejected a claim by the pharmaceutical company, Wyeth, that a 2006 regulation of the Food and Drug Administration expressing concern about the impact of state failure-to-warn lawsuits on federal regulation should mean that such cases are barred. The Court said that, since Congress has not authorized a federal agency directly to preempt state lawsuits, the Court would give less weight to FDA’s views on that issue.

Justice Stevens stressed, however, that the Court was not ruling on the preemptive effect of any official rule that FDA might impose that had the force of law. Justice Stephen G. Breyer, who joined the Stevens opinion, made that comment the centerpiece of his separate concurrence.

Also joining the Stevens opinion were Justices Ruth Bader Ginsburg, Anthony M. Kennedy and David H. Souter. Justice Clarence Thomas wrote separately, supporting only the outcome, not the majority’s reasoning.

Justice Samuel A. Alito, Jr., joined by Chief Justice John G. Roberts, Jr., and Justice Antonin Scalia, dissented.

The case involved a lawsuit over the injection of an anti-nausea drug which Wyeth sells under the trade name Phenergan. The manufacturer’s label allowed the drug to be administered by direct injection as a highly potent way of delivering the drug to get prompt effects. It also warned that if the drug entered an artery, it could cause gangrene. However, it did not tie that risk to direct injection. That label, and the method of administration, won FDA approval in 1997.

A lawsuit under Vermont law, at the center of Wednesday’s decision, arose when a patient, Diana Levine, went for treatment of a severe migraine headache and associated nausea and dehydration. She went to the Northeast Washington County Community Health Clinic in Montpelier, Vt., in August 2000.

She was given an intra-muscular injection of Phenargen, but it did not provide much relief. She returned later in the day and was given a given “push injection” of the drug (as opposed to an IV-drip). She developed complications from an apparent mistake in the injection, with the drug entering an artery, resulting in gangrene. She ultimately had to have her forearm amputated, ending her career as a musician.

She won a $700,000 malpractice settlement against the clinic, but then sued Wyeth in state court, arguing that the pharmaceutical firm should have revised its FDA-approved label to bar IV-push injections. A jury ruled in her favor, and awarded $6,774,000.

The Vermont Supreme Court ruled that Wyeth was obliged to comply with a Vermont common law duty not to use a particular form of risky drug administration — here, direct IV injection.

Wyeth took the case on to the Supreme Court, arguing that “there are tens of thousands of individual claims, and potentially millions of class action lawsuits, currently pending in the lower courts, in which plaintiffs contend that a manufacturer’s use of FDA-approved labeling for its prescription drug is inadequate to satisfy state-law duties to warn.”

The Court asked the U.S. Solicitor General for the federal government’s views on the case, and was urged not to hear the case even though contending that the Vermont Supreme Court decision was wrong. But review, the SG said, was not warranted “at this time” because there was no conflict among lower courts on the issue. The Court nevertheless granted review on Jan. 18 last year, and heard argument in early November.

[edit] Further Analysis

Amid much critical commentary about the way federal drug regulators are doing their job, a Supreme Court majority on Wednesday provided a ringing endorsement of lawsuits in state courts to fill in for lapses at the national level — in particular, lawsuits that claim drugmakers have not given doctors and patients enough warning about side-effects. The six Justices who joined in upholding a verdict of nearly $6.8 million against the pharmaceutical company Wyeth have sent their own warnings: to the industry, and to the Food and Drug Administration.

Justice John Paul Stevens’ opinion speaking for five Justices, and Justice Clarence Thomas’ separate opinion joining in the result, provided in combination a reinforcement of these ideas: that drug companies are primarily responsible for keeping their warning labels up to date and complete (and may pay for it if they don’t), and that the FDA not only needs to police the industry more closely — even if it lacks resources – but that it also had better have the clearest mandate from Congress before it tries to scuttle patients’ lawsuits in state courts.

Justice Stevens, conceding that “the FDA has limited resources to monitor the 11,000 drugs on the market,” wrote a lengthy — and telling — footnote recounting a whole series of studies lamenting the agency’s inability to use its drug approval authority to ensure that the pharmaceutical companies are doing all that they must do to warn doctors and patients about the risks of new drugs, and of the methods of administering them to patients.

And, by contrast, Justice Stevens had fervent praise for the function that patients’ lawsuits — based on state, not federal, law — may serve. “State tort suits,” he wrote, “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”

When those lawsuits are based on claims (as in the Wyeth case) of manufacturers’ failure to warn about risks, Stevens added, they “lend force to the promise [of federal law] that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.”

The main opinion also is notably critical of the FDA for abandoning, during the Bush Administration, what Stevens calls its long-standing view that “state law offers an additional, and important, layer of consumer protection that complements FDA regulation.”

Justice Thomas’ opinion took a markedly different approach, but comes out at the same place, practically. He announced a firm new position that he would no longer support the idea that state lawsuits seeking not just to protect patients but consumers in general can be blocked just because they seem to intrude on federal regulation by impliedly conflicting with it. Only if Congress, in language it actually puts into a federal law regulating business or commerce, expressly bars state lawsuits in the same field are those lawsuits preempted, according to Thomas’ newly declared position.

While Thomas’ position appears to address the whole question of federal takeover of a field of commerce, and seeks to limit the scope of that dominance, it is unclear whether the Stevens opinion will also find application for industries other than those making pharmaceuticals. Some of the language of that opinion seems to sweep broadly, on spelling out what Congress must do if it wants to make federal protection of consumers exclusive. But the opinion also reads in many parts as if it were confined to drug regulation alone.

The FDA, those parts of the opinion make clear, cannot expect the Supreme Court — or federal courts in general — to take that agency’s word for it when it simply opines that U.S. oversight of the drug industry displaces anything the states may do. The courts, Stevens wrote, will defer to this supposedly expert agency only when it can point to either a specific federal law that puts it solely in charge, or only when the agency writes a binding regulation that has “the force of law.” And, to be able to get by with the latter approached, Stevens indicated, the agency must be able to point to specific authority granted by Congress.

The Court no doubt will have other federal-vs.-state regulation cases to sort out as time goes on, because consumer advocates are sure to try to make the most of the Wyeth ruling to support their lawsuits in state courts over what they claim are defective products. Only Congress, by the obviously politically risky tactic of scuttling consumer complaints, would seem to be able to thwart that effort.