Federal Preemption of Product Liability Claims in the United States

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(No Transcript)
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Federal Preemption of Product Liability Claims
in the United States

• British Institute for International Comparative
  Law
• Product Liability Mass Torts in a Global
  Marketplace
• London - June 2007

Tripp Haston
3
Federal Preemption of Product Liability Claims in
the United States

• Framework of Federal Preemption
• Dual Legal Systems State Federal
• Which Legal System Has Priority?
• It Depends
• U.S. Constitution Supremacy Clause provides
  that federal law can preempt state law in certain
  circumstances
• Consequence of Preemption?
• Nullifies applicable state law with regard to
  rights or remedies provided and federal law
  controls

4
Federal Preemption of Product Liability Claims in
the United States

• Types of Federal Preemption
• Express Preemption
• Implied or Field Preemption
• Conflict Preemption
• Sometimes lines blurred between Implied/Field
  Conflict Premption

5
Federal Preemption of Product Liability Claims in
the United States

• Express Preemption
• Instances in which Constitution itself or
  Congress declares a federal law or federal
  agencys decisions completely preempt state law
  in a particular field.
• Examples
• Constitution Foreign Affairs, National Defense
  Immigration Policy
• Statutory Airline Deregulation Act
  Securities Litigation Uniform Standards Act

6
Federal Preemption of Product Liability Claims in
the United States

• Implied Preemption
• Instances in which Congress legislative scheme
  or a federal agencys regulatory scheme in a
  particular field is sufficiently comprehensive to
  make reasonable inference that it left no room
  for state regulation
• Examples
• Regulation of Airline Schedules FAA/NRA
• City of Burbank v. Lockheed Air Terminal Inc.,
  411 U.S. 624 (1973)
• Regulation of Ports/Waterways PWSA
• United States v. Locke, 529 U.S. 89, 112-16
  (2000)

7
Federal Preemption of Product Liability Claims in
the United States

• Conflict Preemption
• Instances in which compliance with both federal
  and state law is either impossible or stands
  as an obstacle to full purposes and objectives
  of federal law. Examples
• Examples
• Fraud on the FDA claims
• Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S.
  341 (2001)
• Certain Automobile Design Defect claims
  Geier v. American Honda Motor Co., Inc., 529
  U.S. 861 (2000)

8
Federal Preemption of Product Liability Claims in
the United States

• Food Drug Administration
• New Rule on Labeling Content Format
• (21 C.F.R. 201.56 201.57 eff. June 30,
  2006)
• Consumer Products Safety Commission
• New Rule Setting Mattress Flammability Standards
• (16 C.F.R. 1633 eff. July 1, 2007)
• National Highway Traffic Safety Administration
• New Rule Setting Roof Auto Crush Resistance
• (70 Fed. Reg. 49223 (2005)

9
Federal Preemption of Product Liability Claims in
the United States

• FDA Preemption of State Law Products Claims
• New FDA Rule on Labeling Content Format
• (21 C.F.R. 201.56 201.57 eff. June 30,
  2006)
• Background?
• Major Overhaul of Labeling Format
• Justifiable Industry Concern
• Significance?
• State Law Pharma Claims Failure to Warn
• FDA First Time Spoken Broadly on Preemption
• Its Labeling Decisions Both a Ceiling a
  Floor.
• Specifically Described Broad Categories of
  Preempted Claims

10
Federal Preemption of Product Liability Claims in
the United States

• Significant Illustrative Preempted Claims
• Failing to include contraindication or warning
  for information that fails to meet FDA rules for
  inclusion of such information
• Failing to include timely warnings that
  Sponsor submitted to FDA, if that information was
  not required by FDA, unless proven Sponsor
  intentionally withheld information from the FDA
• Failing to include information or warnings which
  the FDA had prohibited Sponsor from including
• Including information in Label or Advertising
  which FDA approved

11
Federal Preemption of Product Liability Claims in
the United States

• Judicial Interpretation of FDAs Position
• Issue Does Chevron deference apply?
• Chevron U.S.A., Inc. v. National Resources
  Defense Counsel, Inc., 467 U.S. 837 (1984)
• Courts affording substantial deference do so
  because
• Absence of clearly expressed Congressional
  intent
• FDA is uniquely qualified to administer complex
  regulatory scheme involving technical subject
  matter, and/or
• FDA is final authority over labeling revisions
• Cases
• Sykes v. GSK, 2007 WL 957337 (E.D. Pa. Mar. 28,
  2007)
• Colacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa.
  May 25, 2006)
• In re Bextra, 2006 WL 2374742 (N.D. Ca. Aug. 16,
  2006)

12
Federal Preemption of Product Liability Claims in
the United States

• Judicial Interpretation of FDAs Position
• Issue Does Chevron deference apply?
• Chevron U.S.A., Inc. v. National Resources
  Defense Counsel, Inc., 467 U.S. 837 (1984)
• Courts affording little to no deference do so
  because
• FDA attempts to supply Congressional intent in
  Preamble
• FDA change in position re preemptive effect of
  its Preamble
• 2000 Proposed Rule regulations will not preempt
  state claims
• 2006 Final Rule regulations preempt state
  claims
• Cases
• McNellis v. Pfizer, 2006 WL 2819046 (D.N.J. Sept.
  29, 2006)
• Perry v. Novartis, 456 F. Supp. 2d 678 (E.D. Pa.
  Oct. 16, 2006)
• Barnhill v Teva Pharmaceuticals, No. 06-282 (S.D.
  Ala. April 28, 2007)

13
Federal Preemption of Product Liability Claims in
the United States

• Cases Finding Preemption
• Sykes v. GlaxoSmithKline, 2007 WL 957337 (E.D.
  Pa. 2007)
• In re Bextra, 2006 WL 2374742 (N.D. Ca. 2006)
• Colacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa.
  2006)
• Conte v. Wyeth, 2006 WL 2692469 (Cal. Sup. Ct.
  2006)
• In re Vioxx, Texas State Court Opinion (April
  2007)
• Cases Against Preemption
• Weiss v. Fujisawa Pharma. Co., 464 F.Supp.2d 666
  (E.D. Ky. 2006)
• Levine v. Wyeth, 2006 WL 3041078 (S. Ct. Vt.
  2006)
• Perry v. Novartis Pharma., 456 F.Supp.2d 678
  (E.D. Pa. 2006)
• McNellis v. Pfizer, 2006 WL 2819046 (D.N.J. 2006)
• Jackson v. Pfizer, 432 F.Supp.2d 964, 967 (D.
  Neb. 2006)
• Coutu v. Tracy, 2006 WL 1314261 (Super. Ct. R.I.
  2006)
• Laisure-Radke v. Par Pharma., 2006 WL 901657
  (W.D. Wash. 2006)
• Peters v. Astrazeneca, et al., 417 F.Supp.2d 1051
  (W.D. Wis. 2006)
• Barnhill v Teva, No. 06-282 (S.D. Ala. April 28,
  2007)

14
Federal Preemption of Product Liability Claims
in the United States

• British Institute for International Comparative
  Law
• Product Liability Mass Torts in a Global
  Marketplace
• London - June 2007

Tripp Haston
15
Federal Preemption of Product Liability Claims in
the United States

• Framework of Federal Preemption
• Dual Legal Systems State Federal
• Which Legal System Has Priority?
• It Depends
• U.S. Constitution Supremacy Clause provides
  that federal law can preempt state law in certain
  circumstances
• Consequence of Preemption?
• Nullifies applicable state law with regard to
  rights or remedies provided and federal law
  controls

16
Federal Preemption of Product Liability Claims in
the United States

• Types of Federal Preemption
• Express Preemption
• Implied or Field Preemption
• Conflict Preemption
• Sometimes lines blurred between Implied/Field
  Conflict Premption

17
Federal Preemption of Product Liability Claims in
the United States

• Express Preemption
• Instances in which Constitution itself or
  Congress declares a federal law or federal
  agencys decisions completely preempt state law
  in a particular field.
• Examples
• Constitution Foreign Affairs, National Defense
  Immigration Policy
• Statutory Airline Deregulation Act
  Securities Litigation Uniform Standards Act

18
Federal Preemption of Product Liability Claims in
the United States

• Implied Preemption
• Instances in which Congress legislative scheme
  or a federal agencys regulatory scheme in a
  particular field is sufficiently comprehensive to
  make reasonable inference that it left no room
  for state regulation
• Examples
• Regulation of Airline Schedules FAA/NRA
• City of Burbank v. Lockheed Air Terminal Inc.,
  411 U.S. 624 (1973)
• Regulation of Ports/Waterways PWSA
• United States v. Locke, 529 U.S. 89, 112-16
  (2000)

19
Federal Preemption of Product Liability Claims in
the United States

• Conflict Preemption
• Instances in which compliance with both federal
  and state law is either impossible or stands
  as an obstacle to full purposes and objectives
  of federal law. Examples
• Examples
• Fraud on the FDA claims
• Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S.
  341 (2001)
• Certain Automobile Design Defect claims
  Geier v. American Honda Motor Co., Inc., 529
  U.S. 861 (2000)

20
Federal Preemption of Product Liability Claims in
the United States

• Food Drug Administration
• New Rule on Labeling Content Format
• (21 C.F.R. 201.56 201.57 eff. June 30,
  2006)
• Consumer Products Safety Commission
• New Rule Setting Mattress Flammability Standards
• (16 C.F.R. 1633 eff. July 1, 2007)
• National Highway Traffic Safety Administration
• New Rule Setting Roof Auto Crush Resistance
• (70 Fed. Reg. 49223 (2005)

21
Federal Preemption of Product Liability Claims in
the United States

• FDA Preemption of State Law Products Claims
• New FDA Rule on Labeling Content Format
• (21 C.F.R. 201.56 201.57 eff. June 30,
  2006)
• Background?
• Major Overhaul of Labeling Format
• Justifiable Industry Concern
• Significance?
• State Law Pharma Claims Failure to Warn
• FDA First Time Spoken Broadly on Preemption
• Its Labeling Decisions Both a Ceiling a
  Floor.
• Specifically Described Broad Categories of
  Preempted Claims

22
Federal Preemption of Product Liability Claims in
the United States

• Significant Illustrative Preempted Claims
• Failing to include contraindication or warning
  for information that fails to meet FDA rules for
  inclusion of such information
• Failing to include timely warnings that
  Sponsor submitted to FDA, if that information was
  not required by FDA, unless proven Sponsor
  intentionally withheld information from the FDA
• Failing to include information or warnings which
  the FDA had prohibited Sponsor from including
• Including information in Label or Advertising
  which FDA approved

23
Federal Preemption of Product Liability Claims in
the United States

• Judicial Interpretation of FDAs Position
• Issue Does Chevron deference apply?
• Chevron U.S.A., Inc. v. National Resources
  Defense Counsel, Inc., 467 U.S. 837 (1984)
• Courts affording substantial deference do so
  because
• Absence of clearly expressed Congressional
  intent
• FDA is uniquely qualified to administer complex
  regulatory scheme involving technical subject
  matter, and/or
• FDA is final authority over labeling revisions
• Cases
• Sykes v. GSK, 2007 WL 957337 (E.D. Pa. Mar. 28,
  2007)
• Colacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa.
  May 25, 2006)
• In re Bextra, 2006 WL 2374742 (N.D. Ca. Aug. 16,
  2006)