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

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

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

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 agency’s 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

Federal Preemption of Product Liability Claims in the United States  Implied Preemption  Instances in which Congress’ legislative scheme or a federal agency’s 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, (2000)

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)

Federal Preemption of Product Liability Claims in the United States  Food & Drug Administration  New Rule on Labeling Content & Format (21 C.F.R.§§ & – 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 (2005)

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.§§ & – 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

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

Federal Preemption of Product Liability Claims in the United States  Judicial Interpretation of FDA’s 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 (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 (N.D. Ca. Aug. 16, 2006)

Federal Preemption of Product Liability Claims in the United States  Judicial Interpretation of FDA’s 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 (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 (S.D. Ala. April 28, 2007)

Federal Preemption of Product Liability Claims in the United States  Cases Finding Preemption Sykes v. GlaxoSmithKline, 2007 WL (E.D. Pa. 2007) In re Bextra, 2006 WL (N.D. Ca. 2006) Colacicco v. Apotex, 432 F.Supp.2d 514 (E.D. Pa. 2006) Conte v. Wyeth, 2006 WL (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 (S. Ct. Vt. 2006) Perry v. Novartis Pharma., 456 F.Supp.2d 678 (E.D. Pa. 2006) McNellis v. Pfizer, 2006 WL (D.N.J. 2006) Jackson v. Pfizer, 432 F.Supp.2d 964, 967 (D. Neb. 2006) Coutu v. Tracy, 2006 WL (Super. Ct. R.I. 2006) Laisure-Radke v. Par Pharma., 2006 WL (W.D. Wash. 2006) Peters v. Astrazeneca, et al., 417 F.Supp.2d 1051 (W.D. Wis. 2006) Barnhill v Teva, No (S.D. Ala. April 28, 2007)

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

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

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

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 agency’s 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

Federal Preemption of Product Liability Claims in the United States  Implied Preemption  Instances in which Congress’ legislative scheme or a federal agency’s 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, (2000)

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)

Federal Preemption of Product Liability Claims in the United States  Food & Drug Administration  New Rule on Labeling Content & Format (21 C.F.R.§§ & – 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 (2005)

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.§§ & – 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

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

Federal Preemption of Product Liability Claims in the United States  Judicial Interpretation of FDA’s 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 (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 (N.D. Ca. Aug. 16, 2006)