Product liability and the economics of pharmaceuticals and medical devices:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | Undetermined |
| Veröffentlicht: |
Santa Monica, Calif.
Rand <<[u.a.]>>
1993
|
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXXIX, 227 S. graph. Darst. |
| ISBN: | 0833014501 |
Internformat
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| 245 | 1 | 0 | |a Product liability and the economics of pharmaceuticals and medical devices |c Steven Garber |
| 264 | 1 | |a Santa Monica, Calif. |b Rand <<[u.a.]>> |c 1993 | |
| 300 | |a XXXIX, 227 S. |b graph. Darst. | ||
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Datensatz im Suchindex
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| adam_text | R-4285-ICJ PRODUCT LIABILITY AND THE ECONOMICS OF PHARMACEUTICALS AND
MEDICAL DEVICES STEVEN GARBER RAND INSTITUTE FOR I X J ^ 1 ^ 1 ^ I CIVIL
JUSTICE CONTENTS FOREWORD V FIGURES XV TABLES XVII EXECUTIVE SUMMARY XIX
ACKNOWLEDGMENTS .. . . XXXVII ABBREVIATIONS XXXIX 1. INTRODUCTION 1
PARTI BACKGROUND: THE DECISIONMAKING CONTEXT 5 2. OUTCOMES, DECISIONS,
AND ANALYTIC FRAMEWORK . . 7 PRODUCT LIABILITY, INDUSTRIAL PERFORMANCE,
AND ECONOMIC EFFICIENCY. . 7 PROFITABILITY, DECISIONS, AND ECONOMIC
PERFORMANCE 8 INTERMEDIATE OUTCOMES 8 INNOVATION ; . . . . 8 PRODUCT
AVAILABILITY ... 10 SAFETY AND EFFECTIVENESS 10 COST 12 PRICE 12
COMPETITIVENESS 12 THE COMPLEXITY OF THE DECISION ENVIRONMENT . 13 THE
CENTRAL ROLE OF DECISIONMAKING 13 3. MARKETS, TECHNOLOGY, AND REGULATION
14 THE MARKET CONTEXT 14 INDUSTRY PROFILES 14 PHARMACEUTICALS 14 MEDICAL
DEVICES 15 ECONOMIC ASPECTS OF MARKETS FOR DRUGS AND DEVICES 16 MARKETS
AND SUBMARKETS 17 DRUG SALES PROFITS*DURATION AND VARIABILITY 17
SHORT-TERM COMPETITION 19 LONG-TERM COMPETITION 21 TECHNOLOGY AND THE
ECONOMICS OF DRUG DEVELOPMENT 22 TRIAL, ERROR, AND SURPRISES 23 VARIOUS
STRATEGIES OF DRUG DEVELOPMENT 24 STAGES OF DRUG DEVELOPMENT 25
REGULATION OF SAFETY AND EFFECTIVENESS IN THE UNITED STATES 27 PROFILE
OF REGULATIONS 28 ECONOMIC EFFECTS OF REGULATION 31 4. THE EFFECTS OF
PRODUCT LIABILITY ON THE PROFITABILITY OF ACTIONS 34 EFFECTS OF PRODUCT
LIABILITY ON COMPANY INCENTIVES*OVERVIEW .... 34 LEGAL DOCTRINE AND ITS
INTERPRETATION AND APPLICATION 37 PRODUCT LIABILITY DOCTRINE IN
PHARMACEUTICALS AND MEDICAL DEVICES 37 STRICT LIABILITY, NEGLIGENCE, AND
COMMENT K 37 THE PRIMARY IMPORTANCE OF WARNING DEFECTS 39 INJURY
CAUSATION 40 EXCEPTIONS TO THE LEARNED INTERMEDIARY RULE 41 FDA
REGULATION 43 PUNITIVE DAMAGES 43 STATUTES OF LIMITATION 44
PROPORTIONATE LIABILITY 44 FOREIGN PRODUCT USERS IN U.S. COURTS 45
INTERPRETATION AND APPLICATION OF DOCTRINE*SOURCES AND USES OF
DISCRETION 45 MAJOR SOURCES OF DISCRETION: SCIENTIFIC UNCERTAINTY AND
PUNITIVE DAMAGES 46 SOME EFFECTS OF DISCRETION 46 THE POTENTIAL FOR MASS
TORTS 51 A RECENT LEGISLATIVE REFORM 51 DETERMINANTS OF LIABILITY
EFFECTS ON PROFITABILITY 53 ASPECTS OF UNCERTAINTY AND RISK 56 UNLIMITED
POTENTIAL LIABILITY COSTS 57 THE TIME HORIZON AND THE DEGREE OF
UNCERTAINTY ; 58 DECISIONMAKERS INFORMATION ABOUT THE LIABILITY
ENVIRONMENT ... 59 DIFFERENCES IN LIABILITY POTENTIAL ACROSS PRODUCTS
AND PATIENTS 60 DOCTRINE 61 INTERPRETATION AND APPLICATION OF DOCTRINE
62 POTENTIAL FOR MASS TORTS 63 DIFFERENCES ACROSS PRODUCTS: SUMMARY 64
CONCLUSIONS 65 5. DECISIONMAKING IN THE PRESENCE OF LIABILITY POTENTIAL
66 MAXIMIZATION OF EXPECTED UTILITY 66 BEHAVIORAL DECISIONMAKING AND A
MODEL EMPHASIZING LIABILITY RISK 68 ASSESSING LIABILITY RISK 71
MITIGATING SUBSTANTIAL RISKS 74 COMPARING REMAINING RISK WITH POTENTIAL
PROFITS 75 CONCLUSION 76 XI PART II THE PREVAILING LIABILITY ENVIRONMENT
AND ECONOMIC OUTCOMES 77 6. PRODUCT LIABILITY AND THE AVAILABILITY OF
EXISTING PRODUCTS 81 PRODUCTS THAT HAVE BECOME UNAVAILABLE 81 OUTCOMES
WITHIN THE PREVAILING LIABILITY ENVIRONMENT 82 PRODUCT WITHDRAWALS 82
DELAY OR FAILURE TO INTRODUCE A PRODUCT 86 ATTRIBUTING OUTCOMES TO
LIABILITY 87 IMPLICATIONS FOR VIEWS OF DECISIONMAKING 90 THE STAKES:
DIRECT AND INDIRECT LIABILITY COSTS 90 DIFFERENCES ACROSS PRODUCTS 92
COULD LIABILITY HAVE CAUSED WITHDRAWALS ESCAPING PUBLIC ATTENTION? 95
COULD LIABILITY HAVE PREVENTED PRODUCT INTRODUCTIONS WITHOUT A PUBLIC
AWARENESS OF THIS EFFECT? 96 MARKETING DESPITE SUBSTANTIAL LIABILITY
POTENTIAL 97 BEHAVIOR WITHIN THE PREVAILING LIABILITY ENVIRONMENT 97
COMPANY ACTIONS TO MITIGATE LIABILITY POTENTIAL 97 WITHDRAWALS OF ONLY
SOME PRODUCERS 100 ENTRY INTO MARKETS WITH EARLIER WITHDRAWALS 102
IMPLICATIONS FOR DECISIONMAKING 103 CONCLUSION 103 7. PRODUCT LIABILITY
AND PRODUCT PRICING 105 PRICE EFFECTS OF SUBSTANTIAL LIABILITY POTENTIAL
105 WAYS IN WHICH SUBSTANTIAL LIABILITY POTENTIAL CAN AFFECT PRICE 110
EFFECTS MEDIATED THROUGH COSTS 110 THE IRRELEVANCE OF SUNK COSTS 110
PAST COSTS AND FUTURE PRICES ILL DEGREE OF COMPETITION AND THE EFFECTS
OF COSTS 113 PRICE EFFECTS MEDIATED THROUGH OTHER FACTORS 114 EFFECTS ON
PRICES OF OTHER PRODUCTS . 115 TORT REFORM AND PRICING 116 PRICE EFFECTS
OF INSUBSTANTIAL LIABILITY THREATS 118 SOCIAL FUNCTIONS OF
LIABILITY-RELATED PRICE INCREASES 119 PRICE PREMIUMS AND COMPENSATION
FUNDS 119 PRICE PREMIUMS AND PURCHASE DECISIONS 121 CONCLUSION 122 8.
PRODUCT LIABILITY AND THE SAFETY AND EFFECTIVENESS OF EXISTING DRUGS AND
DEVICES 123 PRODUCT LIABILITY INCENTIVES, FDA SAFETY STANDARDS, AND
COMPLIANCE WITH REGULATIONS 125 EFFECTS MEDIATED THROUGH DESIGN AND
TESTING 128 DOES LIABILITY CAUSE DESIGN CHANGES ENHANCING PRODUCT
SAFETY? . . 128 DOES LIABILITY CAUSE COMPANIES TO TEST PRODUCTS MORE
EXTENSIVELY? 131 EFFECTS MEDIATED THROUGH INFORMATION PROVISION TO
PHYSICIANS AND PATIENTS 132 HOW DOES PRODUCT LIABILITY AFFECT
INFORMATION PROVISION? 133 WHAT ARE THE IMPLICATIONS FOR SAFETY AND
EFFECTIVENESS? 136 EFFECTS MEDIATED THROUGH PRODUCT AVAILABILITY 138
CONCLUSIONS 139 DRUGS 140 STRICTLY REGULATED DEVICES 140 LESS-REGULATED
DEVICES 140 SUMMARY 141 9. PRODUCT LIABILITY AND INNOVATION 142 EFFECTS
ON INNOVATION ACROSS THE DRUG AND DEVICE INDUSTRIES 143 A VIEW OF
DECISIONMAKING BY AFFECTED COMPANIES ...... I 146 QUANTIFYING EFFECTS ON
COMPANY INCENTIVES: APPROACH 147 PROJECTED PROFIT PROFILES 150
ACCOUNTING FOR RISK 153 CHOOSING BASELINE DISCOUNT RATES 154 CHOOSING
LIABILITY RISK PREMIUMS FOR THE DISCOUNT RATE 155 ACCOUNTING FOR DELAY
157 EFFECTS ON COMPANY INCENTIVES: RESULTS 158 EFFECTS ON INNOVATION
DECISIONS 163 CONCLUSION 166 PART III IMPLICATIONS FOR POLICY 169 10.
ECONOMIC ANALYSIS OF LIABILITY POLICY REFORM 171 ECONOMIC EFFECTS OF THE
PREVAILING LIABILITY ENVIRONMENT: SUMMARY 172 WHAT CAN WE SAY ABOUT
ECONOMIC EFFECTS? 172 PRODUCT AVAILABILITY 172 PRICING : . . . . 173
SAFETY AND EFFECTIVENESS 173 INNOVATION 174 UNRESOLVED ISSUES 174
THEORIES OF EFFICIENT LIABILITY SYSTEMS 175 DETERMINANTS OF EFFICIENCY
OF THE ACTUAL LIABILITY SYSTEM 178 INCENTIVES CREATED BY THE ACTUAL
LIABILITY SYSTEM 180 DISTORTIONS RELEVANT TO BOTH THE STRICT LIABILITY
AND NEGLIGENCE BENCHMARKS 181 DISTORTIONS SPECIFIC TO STRICT LIABILITY
182 NEGLIGENCE: ARE THE STANDARDS EFFICIENT? 182 INFORMATION,
PERCEPTION, AND PERCEIVED LIABILITY COST POTENTIAL . . . 184 ECONOMIC
DECISIONMAKING, UNCERTAINTY, AND RISK 185 OTHER INCENTIVES FOR SAFETY
185 DIRECT COSTS OF THE LIABILITY SYSTEM 186 ECONOMIC PERSPECTIVES ON
POLICY REFORM 186 REFORMS SHOULD AIM TO STRENGTHEN DETERRENCE OF SOME
ACTIVITIES AND TO WEAKEN DETERRENCE OF OTHER ACTIVITIES 186 XM LIABILITY
POLICY SHOULD TARGET SAFETY, EFFECTIVENESS, AND THE MIX OF INNOVATION
187 EFFICIENCY RATIONALES FOR LIABILITY ARE DIFFERENT FOR DRUGS AND
EXTENSIVELY REGULATED DEVICES THAN FOR OTHER DEVICES 188 LIABILITY
POLICY CAN AFFECT INCENTIVES, PREDICTABILITY, AND INFORMATION, BUT NOT
THE PSYCHOLOGY OR ATTITUDES OF DECISIONMAKERS 188 SUBSTANTIAL DETERRENCE
OF INEFFICIENT BEHAVIOR IMPLIES SOME DETERRENCE OF EFFICIENT BEHAVIOR
189 LIABILITY POLICY MIGHT BEST VARY OVER PRODUCTS 189 IMPLICATIONS FOR
SOME MAJOR POLICY ISSUES 190 DOES STRICT LIABILITY OR NEGLIGENCE SEEM
MORE ECONOMICALLY PROMISING? 191 WOULD A REGULATORY COMPLIANCE DEFENSE
PROMOTE ECONOMIC EFFICIENCY? 192 COULD REFORMS OF HOW SCIENCE IS USED IN
COURT BE ECONOMICALLY ADVANTAGEOUS? 194 WHAT MIGHT BE DONE TO IMPROVE
THE EFFICIENCY OF WARNINGS? 194 HOW COULD THE EFFICIENCY EFFECTS OF
PUNITIVE DAMAGES BE IMPROVED? 196 WHAT EFFICIENCY ISSUES ARE PECULIAR TO
MASS TORTS? 198 HOW MUCH MIGHT EFFICIENCY BE ENHANCED BY IMPROVEMENTS IN
INFORMATION ABOUT THE LIABILITY SYSTEM? 199 IN CONCLUSION 200 REFERENCES
201 ICJ PUBLICATIONS 219
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| illustrated | Illustrated |
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| institution | BVB |
| isbn | 0833014501 |
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| physical | XXXIX, 227 S. graph. Darst. |
| publishDate | 1993 |
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| publisher | Rand <<[u.a.]>> |
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| spelling | Garber, Steven Verfasser aut Product liability and the economics of pharmaceuticals and medical devices Steven Garber Santa Monica, Calif. Rand <<[u.a.]>> 1993 XXXIX, 227 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018367959&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Garber, Steven Product liability and the economics of pharmaceuticals and medical devices |
| title | Product liability and the economics of pharmaceuticals and medical devices |
| title_auth | Product liability and the economics of pharmaceuticals and medical devices |
| title_exact_search | Product liability and the economics of pharmaceuticals and medical devices |
| title_full | Product liability and the economics of pharmaceuticals and medical devices Steven Garber |
| title_fullStr | Product liability and the economics of pharmaceuticals and medical devices Steven Garber |
| title_full_unstemmed | Product liability and the economics of pharmaceuticals and medical devices Steven Garber |
| title_short | Product liability and the economics of pharmaceuticals and medical devices |
| title_sort | product liability and the economics of pharmaceuticals and medical devices |
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