Reading Wyeth v Levine: Preemption narrowly interpreted
When I reported on the implications of Riegel v Medtronic for device manufacturers in February of last year, I indicated that the related Wyeth v Levine case would have potentially farther reaching implications for the pharmaceutical industry. Yesterday, the US Supreme Court issued its 6-3 opinion in the case. Let’s have a look at the arguments made in the case (written briefs can be found here), and the majority and dissenting opinions. In a future post, I will review what others are saying about the implications of this decision and give my own thoughts on the subject.
The key question presented to the Supreme Court was the following:
Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (”FDA”) pursuant to FDA’s comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
The facts of the case are simple, summarized here by the Supreme Court:
Petitioner Wyeth manufactures the antinausea drug Phenergan [NB. first approved for US marketing in 1955; its label was last updated in 1996]. After a clinician injected respondent Levine with Phenergan by the “IV-push” method [in 2000], whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The Vermont jury determined that Levine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claims were pre-empted by federal law because Phenergan’s labeling had been approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.
As a bit of background, I should note that preemption–in this case, the notion that US Federal law regulating drug safety labeling supersedes state failure-to-warn laws when there is a “direct and positive conflict” between the two–has been a tenet held by the industry and the US government for some time, increasingly in this decade. Indeed, the US government submitted a brief supporting Wyeth in this case. The trial court in Vermont, however, disagreed with the notion of preemption in the original Levine failure-to-warn case, finding that:
…FDA’s regulation of labeling sets only minimum standards and thus cannot conflict with additional state-law labeling requirements, and that the FDA’s CBE regulation [CBE gives FDA discretion to not take action against a manufacturer that makes a label change prior to FDA approval to strengthen warnings when faced with new safety information] would have permitted Wyeth to strengthen the warnings on Phenergan’s labeling without prior FDA approval [(above summary taken from the Wyeth Supreme Court brief)].
The Wyeth argument is essentially summarized as follows, using selected quotes from their brief strung together:
…[Phenergan] labeling already contained numerous warnings about the risks associated with IV injection of Phenergan [and the] respondent never showed or even contended that Wyeth had any material new information about those risks that FDA had not already taken into account when it approved Phenergan’s labeling. [Therefore,] it would have been impossible for Wyeth to comply with the purported state-law duty to modify Phenergan’s labeling to contraindicate intravenous administration of Phenergan without violating the FDCA.
Moreover, enforcement of this state-law duty [as implied by the preceding Vermont Court decision] would nullify the ex ante expert and statutorily mandated balancing of therapeutic benefits and safety risks that FDA performed in approving Wyeth’s Phenergan labeling. It would substitute the ex post judgment of lay jurors whose members consider drug safety through the lens of a single patient’s injury, rather than from the perspective of the overall public health, with the countervailing benefits of the drug to the entire potential patient population in mind. Indeed, counsel for respondent expressly invited the jury to override FDA’s decision, telling them “[t]he FDA doesn’t make the decision, you do.”
The counterargument, made by the counsel representing Levine is likewise summarized:
Consistent with the FDCA’s misbranding provision, which requires drug labeling to contain “adequate warnings” against “unsafe dosage or methods or duration of administration or application,” 21 U.S.C. § 352(f), the Vermont courts found that Wyeth’s failure to warn of the greater risks of IV-push administration of Phenergan, or to instruct clinicians not to use that method of administration, violated a state-law duty to warn.
Wyeth’s claim of conflict preemption,…rests not on any specific conflict between a particular conclusion [reached by FDA] in reviewing the Phenergan labeling and state-law duties to warn, but rather on the mere fact that FDA approved the Phenergan labeling and authorized Wyeth to market the drug.
FDA’s support of preemption [is based on] a never-before-advanced approach…that failure-to-warn claims should be preempted where FDA has received information about the general risks at issue. That approach, however, would inoculate manufacturers from liability when they advise FDA of side effects without informing physicians of the significantly greater risks….
When neither Wyeth nor FDA performed any benefit-risk analysis of different ways of administering Phenergan, preemption simply provides a windfall for the drug maker. It decreases manufacturers’ incentives to improve safety and to inform FDA of risks, impedes FDA’s ability to protect consumers, and denies compensation to victims for catastrophic but avoidable injuries.
As we now know, the US Supreme Court majority sided with the respondent (Levine). As above, I’ll summarize the majority opinion delivered by Justice Stevens:
Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, and there is no evidence that the FDA would ultimately have rejected.
Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act (FDCA) and the FDA’s regulations that the manufacturer bears responsibility for the content of its label at all times.
The history of the FDCA shows that Congress did not intend to preempt state-law failure-to-warn actions. In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA’s statutorily prescribed role. Although an agency regulation with the force of law can preempt conflicting state requirements, this case involves no such regulation but merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to preempt state law directly, the weight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness….Under this standard, the FDA’s 2006 preamble does not merit deference: It is inherently suspect in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation.
We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA. Accordingly, the judgment of the Vermont Supreme Court is affirmed.
In his concurring opinion, Justice Breyer offered up a scenario, not at issue in this case, in which preemption could apply to FDA enforcement of FDCA labeling regulations:
The FDA may seek to determine whether and when state tort law acts as a help or a hindrance to achieving…safe drug-related medical care….It may seek to embody those determinations in lawful specific regulations describing, for example, when labeling requirements serve as a ceiling as well as a floor. And it is possible that such determinations would have pre-emptive effect.
The dissenting opinion from Justices Alito, Roberts, and Scalia was written by Justice Alito, who begins with the declaration that “tragic facts make bad law.”
The Court frames the question presented as a “narro[w]” one—namely, whether Wyeth has a duty to provide “an adequate warning about using the IV-push method” to administer Phenergan. But that ignores the antecedent question of who—the FDA or a jury in Vermont—has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings. Moreover, it is unclear how a “stronger” warning could have helped respondent; after all, the physician’s assistant who treated her disregarded at least six separate warnings that are already on Phenergan’s labeling, so respondent would be hard pressed to prove that a seventh would have made a difference.
The real issue is whether a state tort jury can countermand the FDA’s considered judgment that Phenergan’s FDA-mandated warning label renders its intravenous (IV) use “safe.” Whether wisely or not, the FDA has concluded—over the course of extensive, 54-year-long regulatory proceedings—that the drug is “safe” and “effective” when used in accordance with its FDA-mandated labeling. The unfortunate fact that respondent’s healthcare providers ignored Phenergan’s labeling may make this an ideal medical malpractice case. But turning a common-law tort suit into a “frontal assault” on the FDA’s regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and our conflict preemption jurisprudence.
Through Phenergan’s label, the FDA offered medical professionals a menu of federally approved, “safe” and “effective” alternatives—including IV push—for administering the drug. Through a state tort suit, respondent attempted to deem IV push “unsafe” and “ineffective.” To be sure, federal law does not prohibit Wyeth from contraindicating IV push, just as federal law did not prohibit Honda from installing airbags in all its cars. But just as we held that States may not compel the latter, so, too, are States precluded from compelling the former.
To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades. But this case is far from peaceful coexistence. The FDA told Wyeth that Phenergan’s label renders its use “safe.” But the State of Vermont, through its tort law, said: “Not so.” The state-law rule at issue here is squarely pre-empted.
And there you have it, what might reasonably be seen as a narrowly interpretive majority opinion siding with Vermont’s findings in the case: that FDA judgment as represented by a drug’s label, does not necessarily preempt a failure-to-warn tort in state court. And a contradictory dissent fueled by discomfort with apparent state-tort second-guessing of FDA’s ability to assure contemporary best-prescribing practices via approved labeling. The case clearly illustrates the difficulty of being a Supreme Court justice; I think it just as clearly illustrates how current public opinion sways the Court.
As a demonstration of this, try re-reading the Court’s opinions with the following strongly held conception of FDA, substituting it for whatever conceptions you happen to actually hold: FDA nearly always makes the correct scientific judgment; its scientists are among the finest in the country, without exception; its leadership is in no way politically motivated or influenced; its decisions are made as timely as possible, its public pronouncements and teachings promulgated to every healthcare practitioner without unnecessary delay. Now, do you think the Court majority would have reached the same opinion?
March 6th, 2009 at 4:04 pm
[...] « Reading Wyeth v Levine: Preemption narrowly interpreted [...]