Wyeth v. Levine (2009) - discussion slides
Content
Wyeth v. Levine 129 S. Ct. 1187 (2009) “Changes being effected” - the post-marketing duty to warn
Wyeth v. Levine
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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. Wyeth v. Levine
2
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. Wyeth v. Levine
3
Wyeth
QUESTION PRESENTED Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (“FDA”) pursuant to FDA’s 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. Wyeth v. Levine
4
Levine
QUESTION PRESENTED Whether Food and Drug Administration (“FDA”) approval of a prescription drug’s 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. Wyeth v. Levine
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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 manufacturer’s use of labeling that the Food and Drug Administration approved after being informed of the relevant risk. Wyeth v. Levine
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The FDA Preamble
Levine: FDA’s Inconsistent Position Is Entitled To No Weight
Wyeth v. Levine
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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.”
Wyeth v. Levine
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Levine: Wyeth has not met the burden
Nothing in the FDCA’s 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.
Wyeth v. Levine
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The Court
the preamble is at odds with what evidence we have of Congress’ purposes, and it reverses the FDA’s own longstanding position without providing a reasoned explanation, including any discussion of how state law has interfered with the FDA’s regulation of drug labelingduring decades of coexistence. Wyeth v. Levine
10
The Court: a floor not a ceiling
The FDA’s 2006 position plainly does not reflect the agency’s own view at all times relevant to this litigation. Not once prior to Levine’sinjury 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. Wyeth v. Levine
11
U.S.
Federal law does not permit manufacturers to make unilateral changes to FDA-approved labeling based on previously available information
Wyeth v. Levine
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Levine: Changes to labeling
FDA Regulations Encourage And Permit Changes In Labeling To Increase Safety
Wyeth v. Levine
13
The Court
The weight we accord the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness... Under this standard, the FDA’s 2006 preamble does not merit deference.
Wyeth v. Levine
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Wyeth - impossibility
RESPONDENT’S 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 Wyeth v. Levine
15
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
Wyeth v. Levine
16
No obstacle?
Levine: Wyeth Can Comply With The Vermont Judgment Without Changing Its Label
Wyeth v. Levine
17
Levine
CONGRESS’S LONG ACCEPTANCE OF STATE-LAW FAILURE-TO-WARN CLAIMS AGAINST DRUG MANUFACTURERS DECISIVELY UNDERMINES WYETH’S IMPLIED PREEMPTION ARGUMENT
Wyeth v. Levine
18
U.S.
B. FDA’s approval of a drug preempts claims challenging the FDA-approved design or labeling when FDA has been made aware of the relevant risk
Wyeth v. Levine
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Thomas, concurring in the judgment
Vermont’s judgment did not “directly conflict with federal law and is not preempted” This court’s “purposes and objectives preemption jurisprudence” e.g. in Geirer v. Honda is “freewheeling, extra-textual” “It leads to…illegitimate..invalidation of state laws”
Wyeth v. Levine
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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.
Wyeth v. Levine
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Wyeth v. Levine
1
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. Wyeth v. Levine
2
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. Wyeth v. Levine
3
Wyeth
QUESTION PRESENTED Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (“FDA”) pursuant to FDA’s 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. Wyeth v. Levine
4
Levine
QUESTION PRESENTED Whether Food and Drug Administration (“FDA”) approval of a prescription drug’s 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. Wyeth v. Levine
5
The United States
QUESTION PRESENTED
Whether state-law tort claims are preempted to the extent that they would impose liability for a drug manufacturer’s use of labeling that the Food and Drug Administration approved after being informed of the relevant risk. Wyeth v. Levine
6
The FDA Preamble
Levine: FDA’s Inconsistent Position Is Entitled To No Weight
Wyeth v. Levine
7
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.”
Wyeth v. Levine
8
Levine: Wyeth has not met the burden
Nothing in the FDCA’s 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.
Wyeth v. Levine
9
The Court
the preamble is at odds with what evidence we have of Congress’ purposes, and it reverses the FDA’s own longstanding position without providing a reasoned explanation, including any discussion of how state law has interfered with the FDA’s regulation of drug labelingduring decades of coexistence. Wyeth v. Levine
10
The Court: a floor not a ceiling
The FDA’s 2006 position plainly does not reflect the agency’s own view at all times relevant to this litigation. Not once prior to Levine’sinjury 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. Wyeth v. Levine
11
U.S.
Federal law does not permit manufacturers to make unilateral changes to FDA-approved labeling based on previously available information
Wyeth v. Levine
12
Levine: Changes to labeling
FDA Regulations Encourage And Permit Changes In Labeling To Increase Safety
Wyeth v. Levine
13
The Court
The weight we accord the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness... Under this standard, the FDA’s 2006 preamble does not merit deference.
Wyeth v. Levine
14
Wyeth - impossibility
RESPONDENT’S 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 Wyeth v. Levine
15
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
Wyeth v. Levine
16
No obstacle?
Levine: Wyeth Can Comply With The Vermont Judgment Without Changing Its Label
Wyeth v. Levine
17
Levine
CONGRESS’S LONG ACCEPTANCE OF STATE-LAW FAILURE-TO-WARN CLAIMS AGAINST DRUG MANUFACTURERS DECISIVELY UNDERMINES WYETH’S IMPLIED PREEMPTION ARGUMENT
Wyeth v. Levine
18
U.S.
B. FDA’s approval of a drug preempts claims challenging the FDA-approved design or labeling when FDA has been made aware of the relevant risk
Wyeth v. Levine
19
Thomas, concurring in the judgment
Vermont’s judgment did not “directly conflict with federal law and is not preempted” This court’s “purposes and objectives preemption jurisprudence” e.g. in Geirer v. Honda is “freewheeling, extra-textual” “It leads to…illegitimate..invalidation of state laws”
Wyeth v. Levine
20
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.
Wyeth v. Levine
21
