Federal Preemption of Product Liability Federal Preemption of Product Liability Claims Claims

in the United Statesin the United States

British Institute for International & Comparative British Institute for International & Comparative LawLaw

Product Liability & Mass Torts in a Global Product Liability & Mass Torts in a Global MarketplaceMarketplace

London - June 2007London - June 2007

Tripp HastonTripp Haston

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Framework of Federal Preemption Framework of Federal Preemption Dual Legal Systems – State & Federal Dual Legal Systems – State & Federal

Which Legal System Has Priority? Which Legal System Has Priority? It DependsIt Depends

U.S. Constitution – Supremacy Clause provides that U.S. Constitution – Supremacy Clause provides that federal law can federal law can preempt preempt state law in certain state law in certain circumstancescircumstances

Consequence of Preemption?Consequence of Preemption?Nullifies applicable state law with regard to rights or Nullifies applicable state law with regard to rights or remedies provided and federal law controlsremedies provided and federal law controls

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Types of Federal Preemption:Types of Federal Preemption:

Express PreemptionExpress Preemption

Implied or Field PreemptionImplied or Field Preemption

Conflict PreemptionConflict PreemptionSometimes lines blurred between Sometimes lines blurred between Implied/Field & Conflict PremptionImplied/Field & Conflict Premption

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Express PreemptionExpress PreemptionInstances in which Constitution itself Instances in which Constitution itself or Congress declares a federal law or or Congress declares a federal law or federal agency’s decisions completely federal agency’s decisions completely preempt state law in a particular field.preempt state law in a particular field.

Examples:Examples: ConstitutionConstitution: Foreign Affairs, National : Foreign Affairs, National Defense & Immigration PolicyDefense & Immigration Policy

StatutoryStatutory: Airline Deregulation Act; : Airline Deregulation Act; Securities Litigation Uniform Standards Securities Litigation Uniform Standards ActAct

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Implied PreemptionImplied PreemptionInstances in which Congress’ Instances in which Congress’ legislative scheme or a federal legislative scheme or a federal agency’s regulatory scheme in a agency’s regulatory scheme in a particular field is particular field is sufficiently sufficiently comprehensive to make reasonable comprehensive to make reasonable inference that it “left no room” for inference that it “left no room” for state regulationstate regulation

Examples:Examples: Regulation of Airline Schedules – Regulation of Airline Schedules – FAA/NRA FAA/NRA City of Burbank v. Lockheed Air Terminal Inc.City of Burbank v. Lockheed Air Terminal Inc., 411 U.S. , 411 U.S. 624 (1973)624 (1973)

Regulation of Ports/Waterways – PWSA Regulation of Ports/Waterways – PWSA United States v. LockeUnited States v. Locke, 529 U.S. 89, 112-16 (2000), 529 U.S. 89, 112-16 (2000)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Conflict PreemptionConflict PreemptionInstances in which compliance with Instances in which compliance with both federal and state law is either both federal and state law is either “impossible” or “stands as an “impossible” or “stands as an obstacle” to full purposes and obstacle” to full purposes and objectives of federal law. Examplesobjectives of federal law. Examples

ExamplesExamples “ “Fraud on the FDA” claims Fraud on the FDA” claims Buckman Co. v. Plaintiffs' Legal Comm.Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 , 531 U.S. 341 (2001)(2001)

Certain Automobile Design Defect Certain Automobile Design Defect claims claims Geier v. American Honda Motor Co., Geier v. American Honda Motor Co.,

Inc.Inc., 529 U.S. 861 (2000), 529 U.S. 861 (2000)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Food & Drug AdministrationFood & Drug AdministrationNew Rule on Labeling Content & Format New Rule on Labeling Content & Format (21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)(21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)

Consumer Products Safety CommissionConsumer Products Safety Commission

New Rule Setting Mattress Flammability StandardsNew Rule Setting Mattress Flammability Standards(16 C.F.R.§ 1633 – eff. July 1, 2007)(16 C.F.R.§ 1633 – eff. July 1, 2007)

National Highway Traffic Safety National Highway Traffic Safety AdministrationAdministration

New Rule Setting Roof Auto Crush ResistanceNew Rule Setting Roof Auto Crush Resistance(70 Fed. Reg. 49223 (2005)(70 Fed. Reg. 49223 (2005)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

FDA Preemption of State Law Products ClaimsFDA Preemption of State Law Products ClaimsNew FDA Rule on Labeling Content & Format New FDA Rule on Labeling Content & Format (21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)(21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)

Background? Background? Major Overhaul of Labeling FormatMajor Overhaul of Labeling FormatJustifiable Industry Concern Justifiable Industry Concern

Significance?Significance? State Law Pharma Claims – “Failure to Warn”State Law Pharma Claims – “Failure to Warn”

FDA First Time Spoken Broadly on Preemption FDA First Time Spoken Broadly on Preemption

Its Labeling Decisions Both a “Ceiling” & a “Floor.”Its Labeling Decisions Both a “Ceiling” & a “Floor.”

Specifically Described Broad Categories of Preempted ClaimsSpecifically Described Broad Categories of Preempted Claims

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Significant Illustrative Preempted ClaimsSignificant Illustrative Preempted Claims Failing to include contraindication or warning for Failing to include contraindication or warning for information that fails to meet FDA rules for inclusion of information that fails to meet FDA rules for inclusion of such informationsuch information

Failing to include “timely” warnings that Sponsor Failing to include “timely” warnings that Sponsor submitted to FDA, if that information was not required by submitted to FDA, if that information was not required by FDA, unless proven Sponsor intentionally withheld FDA, unless proven Sponsor intentionally withheld information from the FDAinformation from the FDA

Failing to include information or warnings which the FDA Failing to include information or warnings which the FDA had prohibited Sponsor from includinghad prohibited Sponsor from including

Including information in Label or Advertising which FDA Including information in Label or Advertising which FDA approvedapproved

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Judicial Interpretation of FDA’s PositionJudicial Interpretation of FDA’s PositionIssue: Does Issue: Does Chevron Chevron deference apply?deference apply?

Chevron U.S.A., Inc. v. National Resources Defense Counsel, Inc.Chevron U.S.A., Inc. v. National Resources Defense Counsel, Inc., 467 U.S. , 467 U.S. 837 (1984)837 (1984)

Courts affording Courts affording substantial deferencesubstantial deference do so because: do so because:

Absence of clearly expressed Congressional intentAbsence of clearly expressed Congressional intent

FDA is uniquely qualified to administer complex regulatory scheme FDA is uniquely qualified to administer complex regulatory scheme involving technical subject matter, and/orinvolving technical subject matter, and/or

FDA is final authority over labeling revisionsFDA is final authority over labeling revisions

Cases:Cases:Sykes v. GSKSykes v. GSK, 2007 WL 957337 (E.D. Pa. Mar. 28, 2007) , 2007 WL 957337 (E.D. Pa. Mar. 28, 2007) Colacicco v. ApotexColacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa. May 25, 2006), 432 F.Supp.2d 514 (E.D. Pa. May 25, 2006)In re BextraIn re Bextra, 2006 WL 2374742 (N.D. Ca. Aug. 16, 2006), 2006 WL 2374742 (N.D. Ca. Aug. 16, 2006)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Judicial Interpretation of FDA’s PositionJudicial Interpretation of FDA’s PositionIssue: Does Issue: Does Chevron Chevron deference apply?deference apply?

Chevron U.S.A., Inc. v. National Resources Defense Counsel, Inc.Chevron U.S.A., Inc. v. National Resources Defense Counsel, Inc., 467 U.S. 837 , 467 U.S. 837 (1984)(1984)

Courts affording Courts affording little to no little to no deference do so because:deference do so because:FDA attempts to supply Congressional intent in PreambleFDA attempts to supply Congressional intent in Preamble

FDA change in position re: preemptive effect of its PreambleFDA change in position re: preemptive effect of its Preamble

2000 Proposed Rule – regulations will not preempt state claims2000 Proposed Rule – regulations will not preempt state claims

2006 Final Rule – regulations preempt state claims2006 Final Rule – regulations preempt state claims

Cases:Cases:

McNellis v. PfizerMcNellis v. Pfizer, 2006 WL 2819046 (D.N.J. Sept. 29, 2006), 2006 WL 2819046 (D.N.J. Sept. 29, 2006)

Perry v. NovartisPerry v. Novartis, 456 F. Supp. 2d 678 (E.D. Pa. Oct. 16, 2006), 456 F. Supp. 2d 678 (E.D. Pa. Oct. 16, 2006)

Barnhill v Teva Pharmaceuticals, Barnhill v Teva Pharmaceuticals, No. 06-282 (S.D. Ala. April 28, 2007)No. 06-282 (S.D. Ala. April 28, 2007)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Cases Finding PreemptionCases Finding PreemptionSykes v. GlaxoSmithKlineSykes v. GlaxoSmithKline, 2007 WL 957337 (E.D. Pa. 2007) , 2007 WL 957337 (E.D. Pa. 2007)

In re BextraIn re Bextra, 2006 WL 2374742 (N.D. Ca. 2006), 2006 WL 2374742 (N.D. Ca. 2006)

Colacicco v. ApotexColacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa. 2006), 432 F.Supp.2d 514 (E.D. Pa. 2006)

Conte v. WyethConte v. Wyeth, 2006 WL 2692469 (Cal. Sup. Ct. 2006), 2006 WL 2692469 (Cal. Sup. Ct. 2006)

In re Vioxx, In re Vioxx, Texas State Court Opinion (April 2007)Texas State Court Opinion (April 2007)

Cases Against Preemption Cases Against Preemption

Weiss v. Fujisawa Pharma. Co.Weiss v. Fujisawa Pharma. Co., 464 F.Supp.2d 666 (E.D. Ky. 2006) , 464 F.Supp.2d 666 (E.D. Ky. 2006)

Levine v. WyethLevine v. Wyeth, 2006 WL 3041078 (S. Ct. Vt. 2006) , 2006 WL 3041078 (S. Ct. Vt. 2006)

Perry v. Novartis Pharma.Perry v. Novartis Pharma., 456 F.Supp.2d 678 (E.D. Pa. 2006), 456 F.Supp.2d 678 (E.D. Pa. 2006)

McNellis v. PfizerMcNellis v. Pfizer, 2006 WL 2819046 (D.N.J. 2006), 2006 WL 2819046 (D.N.J. 2006)

Jackson v. PfizerJackson v. Pfizer,, 432 F.Supp.2d 964, 967 (D. Neb. 2006) 432 F.Supp.2d 964, 967 (D. Neb. 2006)

Coutu v. TracyCoutu v. Tracy, 2006 WL 1314261 (Super. Ct. R.I. 2006) , 2006 WL 1314261 (Super. Ct. R.I. 2006)

Laisure-Radke v. Par Pharma.Laisure-Radke v. Par Pharma., 2006 WL 901657 (W.D. Wash. 2006) , 2006 WL 901657 (W.D. Wash. 2006)

Peters v. Astrazeneca, et al.Peters v. Astrazeneca, et al., 417 F.Supp.2d 1051 (W.D. Wis. 2006) , 417 F.Supp.2d 1051 (W.D. Wis. 2006)

Barnhill v Teva, Barnhill v Teva, No. 06-282 (S.D. Ala. April 28, 2007)No. 06-282 (S.D. Ala. April 28, 2007)

Federal Preemption of Product Liability Federal Preemption of Product Liability Claims Claims

in the United Statesin the United States

British Institute for International & Comparative British Institute for International & Comparative LawLaw

Product Liability & Mass Torts in a Global Product Liability & Mass Torts in a Global MarketplaceMarketplace

London - June 2007London - June 2007

Tripp HastonTripp Haston

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Framework of Federal Preemption Framework of Federal Preemption Dual Legal Systems – State & Federal Dual Legal Systems – State & Federal

Which Legal System Has Priority? Which Legal System Has Priority? It DependsIt Depends

U.S. Constitution – Supremacy Clause provides that U.S. Constitution – Supremacy Clause provides that federal law can federal law can preempt preempt state law in certain state law in certain circumstancescircumstances

Consequence of Preemption?Consequence of Preemption?Nullifies applicable state law with regard to rights or Nullifies applicable state law with regard to rights or remedies provided and federal law controlsremedies provided and federal law controls

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Types of Federal Preemption:Types of Federal Preemption:

Express PreemptionExpress Preemption

Implied or Field PreemptionImplied or Field Preemption

Conflict PreemptionConflict PreemptionSometimes lines blurred between Sometimes lines blurred between Implied/Field & Conflict PremptionImplied/Field & Conflict Premption

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Express PreemptionExpress PreemptionInstances in which Constitution itself Instances in which Constitution itself or Congress declares a federal law or or Congress declares a federal law or federal agency’s decisions completely federal agency’s decisions completely preempt state law in a particular field.preempt state law in a particular field.

Examples:Examples: ConstitutionConstitution: Foreign Affairs, National : Foreign Affairs, National Defense & Immigration PolicyDefense & Immigration Policy

StatutoryStatutory: Airline Deregulation Act; : Airline Deregulation Act; Securities Litigation Uniform Standards Securities Litigation Uniform Standards ActAct

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Implied PreemptionImplied PreemptionInstances in which Congress’ Instances in which Congress’ legislative scheme or a federal legislative scheme or a federal agency’s regulatory scheme in a agency’s regulatory scheme in a particular field is particular field is sufficiently sufficiently comprehensive to make reasonable comprehensive to make reasonable inference that it “left no room” for inference that it “left no room” for state regulationstate regulation

Examples:Examples: Regulation of Airline Schedules – Regulation of Airline Schedules – FAA/NRA FAA/NRA City of Burbank v. Lockheed Air Terminal Inc.City of Burbank v. Lockheed Air Terminal Inc., 411 U.S. , 411 U.S. 624 (1973)624 (1973)

Regulation of Ports/Waterways – PWSA Regulation of Ports/Waterways – PWSA United States v. LockeUnited States v. Locke, 529 U.S. 89, 112-16 (2000), 529 U.S. 89, 112-16 (2000)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Conflict PreemptionConflict PreemptionInstances in which compliance with Instances in which compliance with both federal and state law is either both federal and state law is either “impossible” or “stands as an “impossible” or “stands as an obstacle” to full purposes and obstacle” to full purposes and objectives of federal law. Examplesobjectives of federal law. Examples

ExamplesExamples “ “Fraud on the FDA” claims Fraud on the FDA” claims Buckman Co. v. Plaintiffs' Legal Comm.Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 , 531 U.S. 341 (2001)(2001)

Certain Automobile Design Defect Certain Automobile Design Defect claims claims Geier v. American Honda Motor Co., Geier v. American Honda Motor Co.,

Inc.Inc., 529 U.S. 861 (2000), 529 U.S. 861 (2000)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Food & Drug AdministrationFood & Drug AdministrationNew Rule on Labeling Content & Format New Rule on Labeling Content & Format (21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)(21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)

Consumer Products Safety CommissionConsumer Products Safety Commission

New Rule Setting Mattress Flammability StandardsNew Rule Setting Mattress Flammability Standards(16 C.F.R.§ 1633 – eff. July 1, 2007)(16 C.F.R.§ 1633 – eff. July 1, 2007)

National Highway Traffic Safety National Highway Traffic Safety AdministrationAdministration

New Rule Setting Roof Auto Crush ResistanceNew Rule Setting Roof Auto Crush Resistance(70 Fed. Reg. 49223 (2005)(70 Fed. Reg. 49223 (2005)

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

FDA Preemption of State Law Products ClaimsFDA Preemption of State Law Products ClaimsNew FDA Rule on Labeling Content & Format New FDA Rule on Labeling Content & Format (21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)(21 C.F.R.§§ 201.56 & 201.57 – eff. June 30, 2006)

Background? Background? Major Overhaul of Labeling FormatMajor Overhaul of Labeling FormatJustifiable Industry Concern Justifiable Industry Concern

Significance?Significance? State Law Pharma Claims – “Failure to Warn”State Law Pharma Claims – “Failure to Warn”

FDA First Time Spoken Broadly on Preemption FDA First Time Spoken Broadly on Preemption

Its Labeling Decisions Both a “Ceiling” & a “Floor.”Its Labeling Decisions Both a “Ceiling” & a “Floor.”

Specifically Described Broad Categories of Preempted ClaimsSpecifically Described Broad Categories of Preempted Claims

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Significant Illustrative Preempted ClaimsSignificant Illustrative Preempted Claims Failing to include contraindication or warning for Failing to include contraindication or warning for information that fails to meet FDA rules for inclusion of information that fails to meet FDA rules for inclusion of such informationsuch information

Failing to include “timely” warnings that Sponsor Failing to include “timely” warnings that Sponsor submitted to FDA, if that information was not required by submitted to FDA, if that information was not required by FDA, unless proven Sponsor intentionally withheld FDA, unless proven Sponsor intentionally withheld information from the FDAinformation from the FDA

Failing to include information or warnings which the FDA Failing to include information or warnings which the FDA had prohibited Sponsor from includinghad prohibited Sponsor from including

Including information in Label or Advertising which FDA Including information in Label or Advertising which FDA approvedapproved

Federal Preemption of Product Liability Claims in the Federal Preemption of Product Liability Claims in the United StatesUnited States

Judicial Interpretation of FDA’s PositionJudicial Interpretation of FDA’s PositionIssue: Does Issue: Does Chevron Chevron deference apply?deference apply?

Chevron U.S.A., Inc. v. National Resources Defense Counsel, Inc.Chevron U.S.A., Inc. v. National Resources Defense Counsel, Inc., 467 U.S. , 467 U.S. 837 (1984)837 (1984)

Courts affording Courts affording substantial deferencesubstantial deference do so because: do so because:

Absence of clearly expressed Congressional intentAbsence of clearly expressed Congressional intent

FDA is uniquely qualified to administer complex regulatory scheme FDA is uniquely qualified to administer complex regulatory scheme involving technical subject matter, and/orinvolving technical subject matter, and/or

FDA is final authority over labeling revisionsFDA is final authority over labeling revisions

Cases:Cases:Sykes v. GSKSykes v. GSK, 2007 WL 957337 (E.D. Pa. Mar. 28, 2007) , 2007 WL 957337 (E.D. Pa. Mar. 28, 2007) Colacicco v. ApotexColacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa. May 25, 2006), 432 F.Supp.2d 514 (E.D. Pa. May 25, 2006)In re BextraIn re Bextra, 2006 WL 2374742 (N.D. Ca. Aug. 16, 2006), 2006 WL 2374742 (N.D. Ca. Aug. 16, 2006)