Chevron's sliding scale in Wyeth v. Levine.

• Author: Dickinson, Gregory M.

For years now, courts and commentators have struggled to reconcile the presumption against preemption--the interpretive canon that presumes against federal incursion into areas of traditional state sovereignty--with the Chevron doctrine, which instructs courts to defer to reasonable agency interpretations of ambiguous federal statutes. Last Term, in Wyeth v. Levine, the Court held that the Food and Drug Administration's (FDA) drug labeling requirements did not preempt a state law failure-to-warn claim against a drug manufacturer. (1) In so holding, the Court found no entitlement to deference for an FDA regulatory preamble in favor of preemption. This decision provides further fodder for those critics focused on the Court's long history of seemingly arbitrary reliance on agency input and haphazard application of the presumption against preemption. (2) A close examination, however, reveals both why the Court has been reluctant to apply an across-the-board standard of deference to agency views and what an appropriate framework for agency deference might look like. The Court's inconsistent approach to preemption cases results from its intense focus on congressional intent. A different approach would satisfy critics of the Court's inconsistency while allowing the Court to retain its focus on congressional intent: accord greater deference to agency views when Congress speaks clearly through an express preemption provision and lesser deference when Congress is silent.

In Wyeth, the Court considered the common law negligence claim of Diane Levine against the drug manufacturer Wyeth. Levine, suffering from a severe migraine headache, consented to a physician assistant's administration of Phenergan, a drug manufactured by the defendant. (3) The drug can be administered either intramuscularly or intravenously, and intravenous administration can be performed by either the IV-drip method or the faster but riskier IV-push method. (4) Because her symptoms were severe and an initial administration of the drug had failed to provide relief, the physician assistant administered the drug via the IV-push method, which promises faster relief but also carries a risk of significant side effects. (5) The drug is corrosive, and if it escapes from the vein into surrounding tissue it causes irreversible gangrene. (6) Unfortunately, in Levine's case this precise danger was realized. As the physician assistant administered the drug, it escaped the vein and came in contact with arterial blood, resulting in gangrene and eventually requiring the amputation of Levine's right forearm. (7) As a result of this amputation, Levine incurred substantial medical expenses and was forced to abandon her career as a professional musician. (8)

Levine brought a common law failure-to-warn claim against Wyeth alleging that Phenergan was defectively labeled. (9) Wyeth responded by arguing that federal law preempted Levine's negligence claim. Wyeth urged a finding of both impossibility and obstacle preemption. First, it argued that it would have been impossible for it to comply with a state common law duty to modify Phenergan's label while also remaining in compliance with FDA regulations. Second, Wyeth argued that recognition of the plaintiff's state tort action would create an unacceptable obstacle to the accomplishment of the purposes and objectives of Congress by substituting a lay jury's decision about drug labeling for the expert judgment of the FDA. (10) After a Vermont state trial court rejected Wyeth's motion for judgment as a matter of law on the preemption issue, a jury found Wyeth liable for negligence,n Although the drug's label warned of the danger of gangrene following inadvertent intraarterial injection, its labeling was nonetheless defective because it failed to instruct clinicians to use the IV-drip method as an alternative to the riskier IV-push method. (12) The Vermont Supreme Court affirmed, holding that compliance with both federal and state law would have been possible and that common law liability posed no obstacle to the accomplishment of congressional objectives. (13)

The Supreme Court affirmed. (14) Justice Stevens, writing for the majority (15) and rejecting both theories of preemption, relied on two guiding principles: first, that "the purpose of Congress is the ultimate touchstone in every pre-emption case"; (16) and second, that "the historic police powers of the States [are] not to be superseded by [a] Federal Act unless that was the clear and manifest purpose of Congress." (17) In response to Wyeth's impossibility preemption defense, the Court noted that although a manufacturer generally may not change its label after it is approved by the FDA, federal regulations do provide a mechanism (18) for manufacturers to change a label to add to or strengthen its warnings. (19) Because federal law permitted Wyeth unilaterally to strengthen the warnings on Phenergan's label, it was not impossible for Wyeth to comply with both federal and state requirements. (20)

The Court also rejected Wyeth's obstacle preemption argument. Wyeth argued that Congress intended FDA regulations to establish both a floor and a ceiling for drug labeling requirements and that to allow a state negligence cause of action would interfere with that objective. (21) The Court, however, found no evidence that Congress had expressed such an intent. Looking to the legislative history of the Food, Drug, and Cosmetic Act (FDCA), the Court noted that although Congress intended for the FDCA to bolster consumer protection against harmful products, Congress had intentionally provided no federal cause of action. (22) Instead, Congress had decided to rely on state tort law to provide appropriate relief. Such a policy, the Court reasoned, is inconsistent with the notion that Congress intended to preempt state common law.

In so deciding, the Court also rejected Wyeth's argument for deference to the FDA. In a preamble to a 2006 FDA regulation, the FDA declared that the FDCA should be read to establish both a floor and a ceiling for drug labeling, preempting conflicting state labeling laws. (23) The Court acknowledged that in earlier cases it accorded "some weight" to agency views regarding the impact of state law on federal objectives, (24) but maintained that it never deferred to an agency's conclusion that state law was preempted. (25) Rather, the weight accorded to agency views depends on their "thoroughness, consistency, and persuasiveness." (26) Applying this standard, the majority determined that the FDA's preamble should be accorded no deference. The FDA's notice of proposed rulemaking gave no indication of the regulation's potential federalism implications and did not offer interested parties an opportunity to comment, and the regulation itself reversed the agency's own longstanding position without providing an explanation for its decision. (27)

Justice Breyer concurred, emphasizing that the Court's decision did not reach the question of whether state tort law might interfere with and therefore be preempted by a future, specific regulation bearing the force of law. (28)

Justice Thomas, concurring only in the judgment, (29) agreed with the majority that FDA labeling requirements did not preempt Levine's common law negligence claim, but his rationale was markedly different. Rather than analyzing Wyeth's obstacle preemption argument under the Court's longstanding framework, Justice Thomas rejected as unsound the Court's entire line of obstacle-preemption jurisprudence. (30) Drawing on the theory of dual sovereignty in Federalist No. 51 (31) and the Constitution's Bicameralism and Presentment Clause, (32) Justice Thomas emphasized his "increasing[] reluctan[ce] to expand federal statutes beyond their terms through doctrines of implied pre-emption." (33) Preemption, he argued, must turn on something more than...