Concurrence By Justice Thomas?

Major new preemption decision by the Supremes — sanity has been (somewhat) restored:



No. 06–1249. Argued November 3, 2008—Decided March 4, 2009

Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the “IVpush” method, 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 includedan adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as aprofessional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claimswere pre-empted by federal law because Phenergan’s labeling hadbeen approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration. Pp. 6–25.

(a) The argument that Levine’s state-law claims are pre-empted because it is impossible for Wyeth to comply with both the state-lawduties underlying those claims and its federal labeling duties is rejected. Although a manufacturer generally may change a drug labelonly after the FDA approves a supplemental application, the agency’s“changes being effected” (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. 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 2 WYETH v. LEVINE


such a labeling change. Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenerganlabel 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, bearsprimary responsibility for drug labeling. It is a central premise of theFood, Drug, and Cosmetic Act (FDCA) and the FDA’s regulationsthat the manufacturer bears responsibility for the content of its labelat all times. Pp. 11–16.

(b) Wyeth’s argument that requiring it to comply with a state-lawduty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to preempt state law. The history of the FDCA shows that Congress didnot intend to pre-empt 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 statelaw 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 obstacleto achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to pre-empt state law directly, theweight this Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency,and persuasiveness. Cf., e.g., Skidmore v. Swift & Co., 323 U. S. 134. 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 positionthat state law is a complementary form of drug regulation without providing a reasoned explanation. Geier v. American Honda Motor Co., 529 U. S. 861, is distinguished. Pp. 17–25.

___ Vt. ___, 944 A. 2d 179, affirmed.

STEVENS, J., delivered the opinion of the Court, in which KENNEDY, SOUTER, GINSBURG, and BREYER, JJ., joined. BREYER, J., filed a concurring opinion. THOMAS, J., filed an opinion concurring in the judgment. ALITO, J., filed a dissenting opinion, in which ROBERTS, C. J., and SCALIA, J., joined.

Wow — I never thought I would see the day I would find myself agreeing with something Justice Thomas said:

Because such a sweeping approach to pre-emption leads to the illegitimate—and thus, unconstitutional—invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they “stan[d] as an obstacle to the accomplishment and execution of the full purposes and objectives” of federal law.

Justice Thomas, a serious legal scholar on preemption?

I better read the opinion again.