U.S. Supreme Court Issues Decision in Wyeth v. Levine; Court Rejects Preemption

March 4, 2009

By Kurt R. Karst –      

Earlier today, the U.S. Supreme Court issued its highly anticipated opinion in Wyeth v. Levine.  By a 6-3 vote (Justice Alito, Chief Justice Roberts, and Justice Scalia dissenting), the Court ruled that FDA labeling approval does not preempt state laws.  We previously reported on the background and Oral Argument in this case.  Below is the Court’s syllabus from the opinion (which totals 80 pages).  We anticipate a future post once we have had a chance to digest the ruling.

(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 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 the Food, Drug, and Cosmetic Act (FDCA) and the FDA’s regulationsthat the manufacturer bears responsibility for the content of its labelat all times.

(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.

Categories: Drug Development