Wyeth v. Levine

by the Supreme Court of the United States

Supreme Court of the United States

555 U.S. 555

Wyeth  v.  Levine

Certiorari to the Supreme Court of Vermont

No. 06-1249  Argued: November 3, 2008 --- Decided: March 4, 2009

Syllabus

Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the "IV-push" 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 included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Declining to overturn the verdict, the trial court rejected Wyeth's argument that Levine's failure-to-warn claims were pre-empted by federal law because Phenergan's labeling had been 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's label did not contain an adequate warning about the IV-push method of ad ministration. Pp. 563–581.

1. The argument that Levine's state-law claims are pre-empted be cause it is impossible for Wyeth to comply with both the state-law duties underlying those claims and its federal labeling duties is rejected. Although a manufacturer generally may change a drug label only 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. Pur suant 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 Phenergan label would have violated federal law governing unauthorized distribution and misbrand ing of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. It is a central premise of the Federal 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. 568–573. ⁠[p556]
2. Wyeth's argument that requiring it to comply with a state-law duty 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 pre-empt state law. The history of the FDCA shows that Congress did not 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 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. 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 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. Geier v. American Honda Motor Co., 529 U.S. 861, is distinguished. Pp. 573–581.

183 Vt. 76, 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, post, p. 581. THOMAS, J., filed an opinion concurring in the judgment, post, p. 582. ALITO, J., filed a dissenting opinion, in which ROBERTS, C.J., and SCALIA, J., joined, post, p. 604.

Counsel

Seth P. Waxman argued the cause for petitioner. With him on the briefs were Paul R. Q. Wolfson, Bert W. Rein, Allan R. Keyes, and R. Joseph O'Rourke.

Then-Deputy Solicitor General Kneedler argued the cause for the United States as amicus curiae urging reversal. With him on the brief were former Solicitor General Clem- ⁠[p557]⁠ ent, then-Assistant Attorney General Katsas, Daryl Joseffer, Douglas N. Letter, Peter R. Maier, and Gerald F. Masoudi.

David C. Frederick argued the cause for respondent. With him on the brief were Scott H. Angstreich, Scott K. Attaway, Brendan J. Crimmins, and Richard I. Rubin.

 

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•   Briefs of amici curiae urging reversal were filed for the Chamber of Commerce of the United States of America by Alan E. Untereiner, Robin S. Conrad, and Amar D. Sarwal; for DRI – The Voice of the Defense Bar by Daniel E. Troy, Rebecca K. Wood, Eamon P. Joyce, and Michael W. Davis; for the Generic Pharmaceutical Association by Jay P. Lefkowitz and Michael D. Shumsky; for PhRMA et al. by Robert A. Long, Jr., and Paul W. Schmidt; for the Product Liability Advisory Council, Inc., by Kenneth S. Geller and Andrew E. Tauber; for the Washington Legal Foundation et al. by Eric G. Lasker, Daniel J. Popeo, and Richard A. Samp; and for John E. Calfee et al. by Joe G. Hollingsworth, Katharine R. Latimer, and Eric G. Lasker.

Briefs of amici curiae urging affirmance were filed for the State of Vermont et al. by William H. Sorrell, Attorney General of Vermont, Kevin O. Leske, Assistant Attorney General, by Dan Schweitzer, and by the Attorneys General for their respective States as follows: Troy King of Alabama, Talis J. Colberg of Alaska, Terry Goddard of Arizona, Dustin McDaniel of Arkansas, Edmund G. Brown, Jr., of California, John W. Suthers of Colorado, Richard Blumenthal of Connecticut, Joseph R. Biden III of Delaware, Bill McCollum of Florida, Thurbert E. Baker of Georgia, Mark J. Bennett of Hawaii, Lawrence G. Wasden of Idaho, Lisa Madigan of Illinois, Steve Carter of Indiana, Tom Miller of Iowa, Steve Six of Kansas, Jack Conway of Kentucky, James D. "Buddy" Caldwell of Louisiana, G. Steven Rowe of Maine, Douglas F. Gansler of Maryland, Martha Coakley of Massachusetts, Lori Swanson of Minnesota, Jim Hood of Mississippi, Jeremiah W. (Jay) Nixon of Missouri, Mike McGrath of Montana, Catherine Cortez Masto of Nevada, Kelly A. Ayotte of New Hampshire, Anne Milgram of New Jersey, Gary K. King of New Mexico, Andrew M. Cuomo of New York, Roy Cooper of North Carolina, Wayne Stenehjem of North Dakota, Nancy Rogers of Ohio, W. A. Drew Edmondson of Oklahoma, Hardy Myers of Oregon, Thomas W. Corbett, Jr., of Pennsylvania, Patrick C. Lynch of Rhode Island, Henry McMaster of South Carolina, Lawrence E. Long of South Dakota, Robert E. Cooper, Jr., of Tennessee, Mark L. Shurtleff of Utah, Robert F. McDonnell of Virginia, Robert M. McKenna of Washington, Darrell V. McGraw, Jr., of West Virginia, J. B. ⁠[p558]⁠ Van Hollen of Wisconsin, and Bruce A. Salzburg of Wyoming; for AARP et al. by Charles L. Becker, Bruce Vignery, Stacy J. Canan, and Michael R. Schuster; for the American Association for Justice by Louis M. Bograd, Francine A. Hochberg, and Les Weisbrod; for the California Medical Association by Collyn A. Peddie and Francisco J. Silva; for the Center for State Enforcement of Antitrust and Consumer Protection Laws, Inc., by Thomas W. Merrill and Stephen D. Houck; for the Constitutional Accountability Center by Elizabeth B. Wydra, Sean H. Donahue, and David T. Goldberg; for Constitutional and Administrative Law Scholars by Ernest A. Young and Erin Glenn Busby; for the Consumers Union of United States, Inc., by Mark R. Savage; for DES Action by Aaron M. Levine; for former FDA Commissioner Dr. Donald Kennedy et al. by David C. Vladeck; for Members of Congress by Jonathan S. Massey; for the National Conference of State Legislatures by Elizabeth J. Cabraser; for the New England Journal of Medicine Editors and Authors by Gerson H. Smoger, Arthur H. Bryant, and Leslie A. Brueckner; for the Senior Citizens League by John S. Miles, Herbert W. Titus, and William J. Olson; for the Texas Medical Association et al. by R. Brent Cooper, Diana L. Faust, Jay H. Henderson, and Donald P. Wilcox; for Anju Budhwani, M.D., et al. by Stanley D. Bernstein; for Daniel Paul Carpenter et al. by Gregory S. Coleman and Christian J. Ward; for Mark P. Gergen et al. by Michael F. Sturley; for David B. Ross, M.D., Ph.D., et al. by Michael J. Quirk, Mark R. Cuker, and Esther E. Berezofsky; and for Kim Witczak et al. by Earl Landers Vickery and W. Mark Lanier.

Briefs of amici curiae were filed for the Citizens Commission on Human Rights by Kendrick L. Moxon; and for the National Coalition Against Censorship by Erwin Chemerinsky and Sharon J. Arkin.