LEADER 05275nam 2200577 a 450 001 9910220156803321 005 20230803020707.0 035 $a(CKB)2550000001039444 035 $a(EBL)1365205 035 $a(OCoLC)857365412 035 $a(SSID)ssj0000949383 035 $a(PQKBManifestationID)11596464 035 $a(PQKBTitleCode)TC0000949383 035 $a(PQKBWorkID)11014317 035 $a(PQKB)10897110 035 $a(MiAaPQ)EBC1365205 035 $a(Au-PeEL)EBL1365205 035 $a(CaPaEBR)ebr10678757 035 $a(EXLCZ)992550000001039444 100 $a20130607d2013 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aEconomic effects of product liability and other litigation involving the safety and effectiveness of pharmaceuticals$b[electronic resource] /$fSteven Garber 210 $aSanta Monica, Calif. $cRAND Institute for Civil Justice$d2013 215 $a1 online resource (117 p.) 300 $aDescription based upon print version of record. 311 $a0-8330-7991-3 320 $aIncludes bibliographical references. 327 $aCover; 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 Decision making; 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 327 $aIdentifying Sources of Inefficiency CHAPTER 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 327 $aCongregation and Coordination of Related Lawsuits Settlements of Mass Torts; CHAPTER FOUR: Pharmaceutical Mass Torts During the 1990's and 2000's; 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 327 $aRoles of Punitive Damages Controversies 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 327 $aCHAPTER SIX: Incentives Stemming from Other Litigation Affecting Safety and Effectiveness Actions 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 327 $aOther Litigation Pertaining to Drug Safety and Effectiveness 330 $aLiability 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. 606 $aProducts liability$xDrugs$xEconomic aspects$zUnited States 606 $aPharmaceutical industry$zUnited States 615 0$aProducts liability$xDrugs$xEconomic aspects 615 0$aPharmaceutical industry 676 $a338.4761510973 700 $aGarber$b Steven$0914434 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910220156803321 996 $aEconomic effects of product liability and other litigation involving the safety and effectiveness of pharmaceuticals$92256795 997 $aUNINA