http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Economic effects of product liability and other litigation involving the safety and effectiveness of pharmaceuticals
1 online resource (xx, 96 pages) : illustrations
Liability effects on the economic performance of the pharmaceutical industry play a prominent role in the debate about the economic effects of product liability in the United States. The author analyzes incentive effects on company decisions, implications for economic outcomes such as drug safety and effectiveness, and suggests how public policy changes could mitigate liability-based sources of inefficient decisions of pharmaceutical companies.
Cover; Title Page; Copyright; Preface; Contents; Figure and Tables; Summary; Acknowledgments; Abbreviations; CHAPTER ONE: Introduction; CHAPTER TWO: Conceptual Framework for the Analyses; Positive Analysis: Effects of Liability Exposure on Company Decisions and Economic Outcomes; Company Decisions and Economic Outcomes; Conceptualizing Company Decisionmaking; What Determines Whether Companies Respond to Liability Exposure?; What Kinds of Conclusions Are Possible from the Positive Analytic Approach?; Normative Analysis: Economic Efficiency of Effects of Liability Exposure; Economic Efficiency.
Identifying Sources of InefficiencyCHAPTER THREE: The Legal and Institutional Settings; Food and Drug Administration Regulation; Preapproval Regulations; Post-Market Regulations; Product-Liability Law for Prescription Drugs; Manufacturing Defects; Design Defects; Warnings Defects; Regulatory Compliance Defenses (RCDs); Other Legal Issues and Practices; Personal-Injury Causation; Class Actions Alleging Personal Injuries; Class Actions Alleging Financial Injuries; Judicial Gatekeeping of Expert Evidence; U.S. Supreme Court Decisions on Sizes of Punitive Damages; Medical Monitoring Claims.
Congregation and Coordination of Related LawsuitsSettlements of Mass Torts; CHAPTER FOUR: Pharmaceutical Mass Torts During the 1990s and 2000s; Mass Torts Resulting in Especially Large Payouts by Defendants; Fen-Phen Diet Pills; Baycol; Rezulin; Vioxx; Hormone Replacement Therapies-Premarin, Provera, and Prempro; Zyprexa; Mass Tort Attempts Resulting in Substantially Smaller Payouts by Defendants; Norplant; Childhood Vaccines and Autism; Other Mass Tort Attempts That Have Largely Failed for Plaintiffs; Summing Up; Mass Drug-Related Injuries; Mass Torts; Financial Incentives to Avoid Liability.
Roles of Punitive DamagesControversies About Injury Causation; Transaction Costs of Unsuccessful Mass Tort Attempts; CHAPTER FIVE: Preemption of Pharmaceutical Failure-to-Warn Claims; Federal Preemption Law; Purported Economic Effects of Failure-to-Warn Claims; Economic Arguments Supporting Preemption; Economic Arguments Opposing Preemption; Preemption of Failure-to-Warn Claims for Generic Drugs; Would Failure-to-Warn Litigation Pass a Social Cost-Benefit Test?; Sources of Confusion in the Preemption Debate; The Overall Economic Efficiency of FTW Litigation Is Unknown.
CHAPTER SIX: Incentives Stemming from Other Litigation Affecting Safety and EffectivenessActions Brought by the U.S. Department of Justice; State Consumer Protection Acts-Background and Controversies; Safety- and Effectiveness-Related Litigation Brought by State Attorneys General; Safety- and Effectiveness-Related Financial-Injury Litigation Brought by Private Parties; Shareholder Suits Pertaining to Pharmaceutical Safety and Effectiveness; Summing Up; CHAPTER SEVEN: In Conclusion; Major Legal Developments Since 1990; Product Liability for Personal Injury.