Chevron's Sliding Scale in Wyeth V. Levine
Dickinson, Gregory M., Harvard Journal of Law & Public Policy
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. …