Wyeth v. Levine
Encyclopedia
Wyeth v. Levine, 555 U.S. 555
(2009), is a United States Supreme Court case holding that Federal regulatory approval of a medication
does not shield the manufacturer from liability under state law.
when she was injected with Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals. She won a jury verdict in Vermont, under the theory (inter alia) that Wyeth had inadequately labeled the drug.
.
:
, writing on behalf of a 6-3 court, rejected both Wyeth's arguments.
In its first argument, Wyeth is incorrect that relabeling the drug to conform to Vermont law would necessarily have violated federal labeling regulations.
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.
wrote separately, concurring only in the judgment. He criticized the majority for implicitly endorsing a "far-reaching implied pre-emption doctrine" where the Court can invalidate state laws based on perceived conflicts with federal statutes by extrapolating from evidence not found in the text of the statute.
. He disagreed with the Court's holding that a jury, rather than the FDA, is ultimately responsible for regulating warning labels for prescription drugs. He argued this is incompatible with Geier v. American Honda Motor Co., which established the principles of conflict preemption.
Case citation
Case citation is the system used in many countries to identify the decisions in past court cases, either in special series of books called reporters or law reports, or in a 'neutral' form which will identify a decision wherever it was reported...
(2009), is a United States Supreme Court case holding that Federal regulatory approval of a medication
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
does not shield the manufacturer from liability under state law.
Vermont jury trial
The plaintiff lost her hand to gangreneGangrene
Gangrene is a serious and potentially life-threatening condition that arises when a considerable mass of body tissue dies . This may occur after an injury or infection, or in people suffering from any chronic health problem affecting blood circulation. The primary cause of gangrene is reduced blood...
when she was injected with Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals. She won a jury verdict in Vermont, under the theory (inter alia) that Wyeth had inadequately labeled the drug.
Phenergan's regulatory background
The trial record shows that the FDA first approved injectable Phenergan in 1955. In 1973 and 1976, Wyeth submitted supplemental new drug applications, which the agency approved after proposing labeling changes. Wyeth submitted a third supplemental application in 1981 in response to a new FDA rule governing drug labels. Over the next 17 years, Wyeth and the FDA intermittently corresponded about Phenergan's label. The most notable activity occurred in 1987, when the FDA suggested different warnings about the risk of arterial exposure, and in 1988, when Wyeth submitted revised labeling incorporating the proposed changes. The FDA did not respond. Instead, in 1996, it requested from Wyeth the labeling then in use and, without addressing Wyeth's 1988 submission, instructed it to "retain verbiage in [the] current label" regarding intra-arterial injection. After a few further changes to the labeling not related to intra-arterial injection, the FDA approved Wyeth's 1981 application in 1998, instructing that Phenergan's final printed label "must be identical" to the approved package insert.Wyeth's motion for judgment as a matter of law
Wyeth argued that this Vermont law was federally preempted because it was in "actual conflict [with] a specific FDA order" regarding drug labeling. The trial court rejected this argument, as did the Supreme Court of Vermont, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation. The Supreme Court granted certiorariCertiorari
Certiorari is a type of writ seeking judicial review, recognized in U.S., Roman, English, Philippine, and other law. Certiorari is the present passive infinitive of the Latin certiorare...
.
Issue
If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling? Wyeth presented two arguments in favor of FDA preemptionFDA Preemption
FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue...
:
- It is impossible for Wyeth to comply with both the state-law duties and federal labeling regulations, see Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, since the latter forbids it from changing its label without FDA approval.
- Permitting states to require stronger warnings creates an unacceptable "obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. DavidowitzHines v. DavidowitzHines v. Davidowitz, is a case applying the law of conflict preemption. The United States Supreme Court held that a state system of alien registration was superseded by a federal system because it was an "obstacle to accomplishment" of its goals.-Background:Pennsylvania passed a statute...
, because it substitutes a lay jury's decision about drug labeling for the expert judgment that Congress sought to entrust with drug labeling decisions when it created the FDA.
Holding
Justice John Paul StevensJohn Paul Stevens
John Paul Stevens served as an Associate Justice of the Supreme Court of the United States from December 19, 1975 until his retirement on June 29, 2010. At the time of his retirement, he was the oldest member of the Court and the third-longest serving justice in the Court's history...
, writing on behalf of a 6-3 court, rejected both Wyeth's arguments.
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. LohrMedtronic, Inc. v. LohrMedtronic, Inc. v. Lohr, , is a United States Supreme Court case dealing with the scope of federal preemption.-See also:* List of United States Supreme Court cases, volume 518* List of United States Supreme Court cases...
, 518 U.S. 470, 485 (1996) (internal quotation marks omitted); see Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)." - "Second, '[i]n all pre-emption cases, and particularly in those in which Congress has "legislated in a field which the States have traditionally occupied, [we] 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.Rice v. Santa Fe Elevator Corp.Rice v. Santa Fe Elevator Corp. 331 U.S. 218 , is a case dealing with "field preemption": the United States Supreme Court held that when a federal law regulates a field traditionally occupied by the states, the police powers of the States in that area of law are not necessarily preempted; Congress...
, 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.Skidmore v. Swift & Co.Skidmore v. Swift & Co., 323 U.S. 134 was a United States Supreme Court decision that held that an administrative agency's interpretative rules will be given deference according to their persuasiveness.-Background of the case:...
, 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.
Concurrence
Justice Breyer noted that, while the issue was not present here, the FDA may create regulations that pre-empt state law tort claims.Concurrence only in judgment
Justice Clarence ThomasClarence Thomas
Clarence Thomas is an Associate Justice of the Supreme Court of the United States. Succeeding Thurgood Marshall, Thomas is the second African American to serve on the Court....
wrote separately, concurring only in the judgment. He criticized the majority for implicitly endorsing a "far-reaching implied pre-emption doctrine" where the Court can invalidate state laws based on perceived conflicts with federal statutes by extrapolating from evidence not found in the text of the statute.
Dissent
Justice Samuel A. Alito dissented and was joined by Chief Justice John G. Roberts and Justice Antonin ScaliaAntonin Scalia
Antonin Gregory Scalia is an American jurist who serves as an Associate Justice of the Supreme Court of the United States. As the longest-serving justice on the Court, Scalia is the Senior Associate Justice...
. He disagreed with the Court's holding that a jury, rather than the FDA, is ultimately responsible for regulating warning labels for prescription drugs. He argued this is incompatible with Geier v. American Honda Motor Co., which established the principles of conflict preemption.
See also
- Riegel v. Medtronic, Inc.Riegel v. Medtronic, Inc.Riegel v. Medtronic, Inc., 552 U.S. 312 , is a decision by the Supreme Court of the United States holding that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received...
(2008) - FDA PreemptionFDA PreemptionFDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue...
- List of United States Supreme Court cases, volume 555
- List of United States Supreme Court cases
External links
- Scotus Wiki - Wyeth v. Levine (comprehensive list of resources)