Wyeth v.

Levine
129 S. Ct. 1187 (2009) Changes being effected - the post-marketing duty to warn

Wyeth v. Levine

Vermont Supreme Court Levine v. Wyeth (2006)

FDA approval of a drug label [is] but a first step in the process of warning consumers. When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action If it fails to do so, it cannot rely on the FDA's continued approval of its labels as a shield against state tort liability.
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Vermont Supreme Court Levine v. Wyeth (2006)

Such a duty does not create a conflict with federal requirements because the FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers.
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Wyeth

QUESTION PRESENTED Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (FDA) pursuant to FDAs comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., preempt state-law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
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Levine

QUESTION PRESENTED Whether Food and Drug Administration (FDA) approval of a prescription drugs labeling preempts state-law failure-to-warn claims in the absence of any express preemption provision in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., or any evidence that FDA considered the risks and benefits of the specific method of administering the drug that caused the injuries upon which the state-law claim is premised.
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The United States

QUESTION PRESENTED

Whether state-law tort claims are preempted to the extent that they would impose liability for a drug manufacturers use of labeling that the Food and Drug Administration approved after being informed of the relevant risk.
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The FDA Preamble

Levine: FDAs Inconsistent Position Is Entitled To No Weight

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Levine: The presumption against preemption

Wyeth therefore must show a conflict between the FDCA and the Vermont judgment that is strong enough to overcome the presumption that state and local regulation of health and safety matters can constitutionally coexist with federal regulation.

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Levine: Wyeth has not met the burden

Nothing in the FDCAs history suggests that Congress either viewed state-law claims intended to promote public safety and compensate injured patients as conflicting with the federal scheme or intended to allow FDA to immunize drug manufacturers from such claims.

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The Court

the preamble is at odds with what evidence we have of Congress purposes, and it reverses the FDAs own longstanding position without providing a reasoned explanation, including any discussion of how state law has interfered with the FDAs regulation of drug labelingduring decades of coexistence.
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The Court: a floor not a ceiling

The FDAs 2006 position plainly does not reflect the agencys own view at all times relevant to this litigation. Not once prior to Levinesinjury did the FDA suggest that state tort law stood as an obstacle to its statutory mission. To the contrary, it cast federal labeling standards as a floor upon which Statescould build and repeatedly disclaimed any attempt to preempt failure-to-warn claims.
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U.S.

Federal law does not permit manufacturers to make unilateral changes to FDA-approved labeling based on previously available information

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Levine: Changes to labeling

FDA Regulations Encourage And Permit Changes In Labeling To Increase Safety

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The Court

The weight we accord the agencys explanation of state laws impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness... Under this standard, the FDAs 2006 preamble does not merit deference.

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Wyeth - impossibility

RESPONDENTS CLAIMS ARE PREEMPTED BECAUSE IT IS IMPOSSIBLE FOR WYETH TO COMPLY WITH BOTH THE STATE-LAW DUTIES THOSE CLAIMS IMPOSE AND ITS FEDERAL LABELING DUTIES A. The FDCA And Vermont Law Imposed Irreconcilable Requirements On Wyeth B. The Vermont Court Misinterpreted the CBE Regulation
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Levine not impossible

IT IS NOT IMPOSSIBLE FOR WYETH TO COMPLY WITH FEDERAL LAW AND THE STATE-COURT JUDGMENT The FDCA Did Not Compel The Specific Warning Found Inadequate In This Case And Permits Drug Manufacturers To Strengthen Warnings

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No obstacle?

Levine: Wyeth Can Comply With The Vermont Judgment Without Changing Its Label

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Levine

CONGRESSS LONG ACCEPTANCE OF STATE-LAW FAILURE-TO-WARN CLAIMS AGAINST DRUG MANUFACTURERS DECISIVELY UNDERMINES WYETHS IMPLIED PREEMPTION ARGUMENT

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U.S.

B. FDAs approval of a drug preempts claims challenging the FDA-approved design or labeling when FDA has been made aware of the relevant risk

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Thomas, concurring in the judgment

Vermonts judgment did not directly conflict with federal law and is not preempted This courts purposes and objectives preemption jurisprudence e.g. in Geirer v. Honda is freewheeling, extra-textual It leads toillegitimate..invalidation of state laws

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Alito, dissenting

Where the FDA determines, in accordance with its statutory mandate, that a drug is on balance "safe," our conflict preemption cases prohibit any State from countermanding that determination.

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