Wyeth V. Levine - Reasoning

Reasoning

Questions of federal preemption "must be guided by two cornerstones of our pre-emption jurisprudence":

• "First, 'the purpose of Congress is the ultimate touchstone in every pre-emption case.' Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (internal quotation marks omitted); see Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)."
• "Second, 'n all pre-emption cases, and particularly in those in which Congress has "legislated in a field which the States have traditionally occupied, start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." ' Lohr, 518 U.S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218 230 (1947))"

In its first argument, Wyeth is incorrect that relabeling the drug to conform to Vermont law would necessarily have violated federal labeling regulations.

• Although a manufacturer generally needs FDA approval before changing a drug label, the agency's "changes being effected" (CBE) regulation permits certain unilateral labeling changes that improve drug safety. Wyeth's misreading of this regulation is based on the 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. Pp. 11–16.

In its second argument, Wyeth is incorrect that permitting states to require stronger warnings would interfere with Congress' purpose of entrusting an expert agency with drug labeling decisions because it was not Congress's intent, in writing the Food, Drug, and Cosmetic Act, to preempt state-law failure to warn actions.

• Wyeth's argument misconstrues the intent of congress behind the FDCA. Congress did not intend the FDCA to pre-empt state-law failure-to-warn actions.
• Wyeth's argument also misconstrues the capacity of agencies to preempt state law, as Wyeth's argument relies 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 pre-empt 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 pre-empt 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, 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 pre-emption 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.