Availability: Pharmaceutical and medical device safety

Pharmaceutical and medical device safety: a study in public and private regulation

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Bibliographic Details
Main Authors:	Macleod, Sonia (Author), Chakraborty, Sweta (Author)
Format:	Book
Language:	English
Published:	Oxford Hart Publishing 2019 Baden-Baden Nomos 2019 München C.H.Beck 2019
Edition:	First published
Series:	Civil justice systems
Subjects:	Produzentenhaftung Arzneimittelüberwachung Internationales Wirtschaftsrecht Medizinprodukt USA Großbritannien Medizinprodukterecht Haftung Litigation Pharmaprodukte Produkthaftung medical device sector
Links:	http://deposit.dnb.de/cgi-bin/dokserv?id=9d728e4b6ae64a19a144864a7e29a9f8&prov=M&dok_var=1&dok_ext=htm http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030666384&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
Physical Description:	xxi, 298 Seiten Diagramme
ISBN:	9781509916696 9783848754632 9783406737145

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MARC


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Record in the Search Index

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adam_text	CONTENTS FOREWORD BY CHRISTOPHER HODGES ................................................................................................ V ACKNOWLEDGEMENTS ...................................................................................................................... IX ABBREVIATIONS ............................................................................................................................ XIX 1. INTRODUCTION .......................................................................................................................... 1 I. THE LEGAL CONTEXT ...................................................................................................... 1 A. BASIS OF LIABILITY ................................................................................................ 10 B. LITIGATION SYSTEMS ............................................................................................ 11 C. FUNDING AND COSTS ........................................................................................... 11 D. US: THE CLASS ACTION AND MDL ...................................................................... 12 E. EUROPE ............................................................................................................... 14 F. SETTLEMENT SCHEMES .......................................................................................... 16 2. THE REGULATION OF MEDICINES AND MEDICAL DEVICES ......................................................... 17 I. MEDICINAL PRODUCTS .................................................................................................. 18 A. HISTORICAL DRUG/PHARMACEUTICAL REGULATION IN THE UK ................................ 18 I. 1948-59: THE BIRTH OF THE NATIONAL HEALTH SERVICE .............................. 21 II. 1959-62: THALIDOMIDE ............................................................................ 22 III. 1963-71: VOLUNTARY SELF-REGULATION ....................................................... 23 IV. 1971 ONWARDS: STATUTORY REGULATION ..................................................... 24 B. EUROPEAN REGULATION OF MEDICINAL PRODUCTS ................................................. 25 I. A BRIEF HISTORY OF EUROPEAN MEDICINAL PRODUCTS REGULATION ............ 26 II. CURRENT EU STRUCTURES AND PROCEDURES FOR REGULATING MEDICINAL PRODUCTS ................................................................................. 30 C. EUROPEAN REGULATION OF MEDICAL DEVICES ...................................................... 42 I. CLASSIFICATION AND STANDARDS .................................................................. 46 D. GENERAL PRODUCT SAFETY REGULATION IN EUROPE ............................................... 50 E. MEDICINAL PRODUCT REGULATION IN THE US ....................................................... 50 I. HISTORIC REGULATION OF MEDICINAL PRODUCTS IN THE US ......................... 51 II. CURRENT REGULATION OF MEDICINAL PRODUCTS IN THE US .......................... 56 III. MARKETING AUTHORISATIONS WITHIN THE US ............................................. 58 IV. REQUIREMENTS FOR DEVELOPING AND MARKETING MEDICINAL PRODUCTS IN THE US .................................................................................. 60 F. US REGULATION OF MEDICAL DEVICES ................................................................. 73 I. US CLASSIFICATION AND STANDARDS ............................................................ 73 3. DETAILED CASE DESCRIPTIONS AND REGULATORY HISTORIES .................................................... 82 I. TERATOGENS AND FOETAL DAMAGE ............................................................................... 82 A. THALIDOMIDE (ALPHA-PHTHALIMIDO-GLUTARIMIDE) ............................................. 82 I. DESCRIPTION ............................................................................................. 82 XII CONTENTS II. SAFETY ISSUE .............................................................................................. 82 III. MARKETING AND REGULATORY HISTORY ........................................................ 83 IV. LITIGATION ................................................................................................. 85 V. CONCLUSION .............................................................................................. 87 B. HORMONAL PREGNANCY TESTS - INCLUDING PRIMODOS ...................................... 88 I. DESCRIPTION ............................................................................................. 88 II. SAFETY ISSUE .............................................................................................. 88 III. MARKETING AND REGULATORY HISTORY ........................................................ 89 IV. LITIGATION ................................................................................................. 91 V. CONCLUSION .............................................................................................. 91 C. DIETHYLSTILBOESTROL (DES) ................................................................................ 92 I. DESCRIPTION ............................................................................................. 92 II. SAFETY ISSUE .............................................................................................. 92 III. MARKETING AND REGULATORY HISTORY ........................................................ 92 IV. LITIGATION ................................................................................................. 97 V. CONCLUSION .............................................................................................. 99 D. EPILIM/DEPAKOTE/DEPAKENE (SODIUM VALPROATE, VALPROIC ACID, MAGNESIUM VALPROATE, VALPROATE SEMISODIUM OR VALPROMIDE) .................. 100 I. DESCRIPTION ........................................................................................... 100 II. SAFETY ISSUE ............................................................................................ 100 III. MARKETING AND REGULATORY HISTORY ...................................................... 101 IV. LITIGATION ............................................................................................... 105 V. CONCLUSION ............................................................................................ 107 E. ACCUTANE/ROACCUTANE (ISOTRETINOIN) ........................................................... 108 I. DESCRIPTION ........................................................................................... 108 II. SAFETY ISSUE ............................................................................................ 108 III. MARKETING AND REGULATORY HISTORY ...................................................... 108 IV. LITIGATION ............................................................................................... 116 V. CONCLUSION ................................... 118 II. CONTRACEPTIVES AND HORMONE REPLACEMENT THERAPY .......................................... 119 A. GRAVIGARD OR COPPER 7 INTRAUTERINE DEVICE ................................................. 119 I. DESCRIPTION .............................................................................. 119 II. SAFETY ISSUE ............................................................................................ 119 III. MARKETING AND REGULATORY HISTORY ...................................................... 120 IV. LITIGATION ......................................... 121 V. CONCLUSION ............................................................................................ 124 B. THIRD-GENERATION ORAL CONTRACEPTIVES ........................................................ 125 I. DESCRIPTION ........................................................................................... 125 II. SAFETY ISSUE ............................................................................................ 125 III. MARKETING AND REGULATORY HISTORY ...................................................... 125 IV. LITIGATION ............................................................................................... 128 V. CONCLUSION ............................................................................................ 128 C. NORPLANT (LEVONORGESTREL) .............................................................................. 129 I. DESCRIPTION ........................................................................................... 129 II. SAFETY ISSUE ............................................................................................ 129 III. MARKETING AND REGULATORY HISTORY ...................................................... 129 CONTENTS XIII IV. LITIGATION ................................................................................................ 130 V. CONCLUSION ............................................................................................. 131 D. HORMONE REPLACEMENT THERAPY ................................................................... 132 I. DESCRIPTION ............................................................................................ 132 II. SAFETY ISSUE ............................................................................................. 132 III. MARKETING AND REGULATORY HISTORY ...................................................... 132 IV. LITIGATION ................................................................................................ 136 V. CONCLUSION ............................................................................................. 137 III. VACCINES ................................................................................................................... 138 A. DTP VACCINE ................................................................................................... 138 I. DESCRIPTION ............................................................................................ 138 II. SAFETY ISSUE ............................................................................................. 138 III. MARKETING AND REGULATORY HISTORY ...................................................... 139 IV. LITIGATION ................................................................................................ 142 V. CONCLUSION ............................................................................................. 144 B. MMR VACCINE ................................................................................................ 145 I. DESCRIPTION ............................................................................................ 145 II. SAFETY ISSUE ............................................................................................. 147 III. MARKETING AND REGULATORY HISTORY ...................................................... 147 IV. LITIGATION ............................................................................................... 148 V. CONCLUSION ............................................................................................ 149 IV. NEUROMODULATORS ................................................................................................... 150 A. BENZODIAZEPINES ............................................................................................ 150 I. DESCRIPTION ........................................................................................... 150 II. SAFETY ISSUE ............................................................................................ 150 III. MARKETING AND REGULATORY HISTORY ...................................................... 150 IV. LITIGATION ............................................................................................... 151 V. CONCLUSION ............................................................................................ 153 B. MERITAL (NOMIFENSINE) .................................................................................... 154 I. DESCRIPTION ........................................................................................... 154 II. SAFETY ISSUE ............................................................................................ 154 III. MARKETING AND REGULATORY HISTORY ...................................................... 154 IV. LITIGATION ............................................................................................... 156 V. CONCLUSION ............................................................................................ 156 C. SELECTIVE SEROTONIN REUPTAKE INHIBITORS ...................................................... 157 I. DESCRIPTION ........................................................................................... 157 II. SAFETY ISSUES .......................................................................................... 157 III. MARKETING AND REGULATORY HISTORY ...................................................... 159 IV. LITIGATION ............................................................................................... 161 V. CONCLUSION ............................................................................................ 163 D. SABRIL (VIGABATRIN) .......................................................................................... 164 I. DESCRIPTION ........................................................................................... 164 II. SAFETY ISSUE ............................................................................................ 164 III. MARKETING AND REGULATORY HISTORY ...................................................... 164 IV. LITIGATION ............................................................................................... 165 V. CONCLUSION .................................................... 165 XIV CONTENTS E. MIRAPEXIN/SIFROL/DAQUIRAN (PRAMIPEXOLE) .................................................. 166 I. DESCRIPTION ............................................................................................ 166 II. SAFETY ISSUE ............................................................................................. 166 III. MARKETING AND REGULATORY HISTORY ...................................................... 167 IV. LITIGATION ............................................................................................... 168 V. CONCLUSION ............................................................................................ 169 V. NON-STEROIDAL ANTI-INFLAMMATORIES ...................................................................... 170 A. OPREN (BENOXAPROFEN) ................................................................................... 170 I. DESCRIPTION ............................................................................................ 170 II. SAFETY ISSUE ............................................................................................. 170 III. MARKETING AND REGULATORY HISTORY ...................................................... 170 IV. LITIGATION ............................................................................................... 171 V. CONCLUSION ............................................................................................ 172 B. VIOXX (ROFECOXIB) ............................................................................................ 173 I. DESCRIPTION ........................................................................................... 173 II. SAFETY ISSUE ............................................................................................ 173 III. MARKETING AND REGULATORY HISTORY ...................................................... 174 IV. LITIGATION ............................................................................................... 175 V. CONCLUSION ............................................................................................ 176 VI. PANCREATIC FUNCTION (ENDOCRINE AND EXOCRINE) AND OBESITY TREATMENTS ......................................................................................... 177 A. ADIFAX/ISOMERIDE/REDUX (DEXFENFLURAMINE) AND PONDERAX (FENFLURAMINE) ................................................................................................ 177 I. DESCRIPTION ........................................................................................... 177 II. SAFETY ISSUE ............................................................................................ 177 III. MARKETING AND REGULATORY HISTORY ...................................................... 178 IV. LITIGATION ............................................................................................... 179 V. CONCLUSION ............................................................................................ 180 B. MEDIATOR (BENFLUOREX) ................................................................................... 181 I. DESCRIPTION ........................................................................................... 181 II. SAFETY ISSUE ............................................................................................ 181 III. MARKETING AND REGULATORY HISTORY ...................................................... 181 IV. LITIGATION ............................................................................................... 184 V. CONCLUSION ............................................................................................ 184 C. HUMAN INSULIN ............................................................................................... 185 I. DESCRIPTION ........................................................................................... 185 II. ALLEGED SAFETY ISSUE .............................................................................. 185 III. MARKETING AND REGULATORY HISTORY ...................................................... 187 IV. LITIGATION ............................................................................................... 188 V. CONCLUSION ............................................................................................ 189 D. PANCREATIC ENZYMES ....................................................................................... 190 I. DESCRIPTION ........................................................................................... 190 II. SAFETY ISSUE ............................................................................................ 190 III. MARKETING AND REGULATORY HISTORY ...................................................... 190 IV. LITIGATION ............................................................................................... 192 V. CONCLUSION ............................................................................................ 192 CONTENTS XV VII. CONTAMINATED HUMAN-TISSUE-DERIVED PRODUCTS .............................................. 193 A. BLOOD PRODUCTS ............................................................................................. 193 I. DESCRIPTION ........................................................................................... 193 II. SAFETY ISSUE ........................................................................................... 193 III. MARKETING AND REGULATORY HISTORY .................................................... 194 IV. LITIGATION .............................................................................................. 194 V. CONCLUSION ........................................................................................... 196 B. HUMAN GROWTH HORMONE ........................................................................... 197 I. DESCRIPTION ........................................................................................... 197 II. SAFETY ISSUE ........................................................................................... 197 III. MARKETING AND REGULATORY HISTORY .................................................... 197 IV. LITIGATION .............................................................................................. 197 V. CONCLUSION ........................................................................................... 197 VIII. CARDIOVASCULAR PHARMACEUTICALS ......................................................................... 198 A. ERALDIN (PRACTOLOL) ........................................................................................ 198 I. DESCRIPTION ........................................................................................... 198 II. SAFETY ISSUE ........................................................................................... 198 III. MARKETING AND REGULATORY HISTORY .................................................... 198 IV. LITIGATION ............................................................................................. 199 V. CONCLUSION .......................................................................................... 200 B. MANOPLAX (FLOSEQUINAN) ............................................................................... 201 I. DESCRIPTION .......................................................................................... 201 II. SAFETY ISSUE .......................................................................................... 201 III. MARKETING AND REGULATORY HISTORY .................................................... 201 IV. LITIGATION ............................................................................................. 203 V. CONCLUSION .......................................................................................... 203 C. LIPOBAY (CERIVASTATIN) .................................................................................. 204 I. DESCRIPTION .......................................................................................... 204 II. SAFETY ISSUE .......................................................................................... 204 III. MARKETING AND REGULATORY HISTORY .................................................... 205 IV. LITIGATION ............................................................................................. 207 V. CONCLUSION .......................................................................................... 207 IX. ANTI-PROTOZOAN MEDICATIONS .............................................................................. 208 A. EMAFORM, ENTERO-FORM OR CHINOFORM (CLIOQUINOL) ................................. 208 I. DESCRIPTION .......................................................................................... 208 II. SAFETY ISSUE .......................................................................................... 208 III. MARKETING AND REGULATORY HISTORY .................................................... 209 IV. LITIGATION ............................................................................................. 210 V. CONCLUSION .......................................................................................... 211 B. LARIAM (MEFLOQUINE) ................................................................................... 212 I. DESCRIPTION .......................................................................................... 212 II. SAFETY ISSUE .......................................................................................... 212 III. MARKETING AND REGULATORY HISTORY .................................................... 212 IV. LITIGATION ............................................................................................. 215 V. CONCLUSION .......................................................................................... 216 XVI CONTENTS X. BREAST AND OTHER COSMETIC IMPLANTS ................................................................... 217 A. DOW-CORNING SILICONE IMPLANTS ................................................................. 217 I. DESCRIPTION ........................................................................................... 217 II. SAFETY ISSUE ............................................................................................ 217 III. MARKETING AND REGULATORY HISTORY ...................................................... 218 IV. LITIGATION ............................................................................................... 219 V. CONCLUSION ............................................................................................ 220 B. TRILUCENT BREAST IMPLANTS ............................................................................. 221 I. DESCRIPTION ........................................................................................... 221 II. SAFETY ISSUE ............................................................................................ 221 III. MARKETING AND REGULATORY HISTORY ...................................................... 221 IV. LITIGATION ............................................................................................... 222 V. CONCLUSION ............................................................................................ 223 C. POLY IMPLANT PROTHESE (PIP) HYDROGEL BREAST IMPLANTS ............................. 224 I. DESCRIPTION ........................................................................................... 224 II. SAFETY ISSUE ............................................................................................ 224 III. MARKETING AND REGULATORY HISTORY ...................................................... 225 IV. LITIGATION ............................................................................................... 225 V. CONCLUSION ............................................................................................ 227 D. POLY IMPLANT PROTHESE (PIP) IMGHC SILICONE BREAST IMPLANTS ................ 228 I. DESCRIPTION ........................................................................................... 228 II. SAFETY ISSUE ............................................................................................ 228 III. MARKETING AND REGULATORY HISTORY ..................................................... 230 IV. LITIGATION..... .......................................................................................... 232 V. CONCLUSION ............................................................................................ 234 XI. URINARY INCONTINENCE AND PELVIC PROLAPSE TREATMENTS ...................................... 235 A. MICTURIN (TERODILINE) ..................................................................................... 235 I. DESCRIPTION ........................................................................................... 235 II. SAFETY ISSUE ............................................................................................ 235 III. MARKETING AND REGULATORY HISTORY ..................................................... 235 IV. LITIGATION ............................................................................................... 236 V. CONCLUSION ............................................................................................ 236 B. UROGYNAECOLOGICAL MESH ............................................................................... 237 I. DESCRIPTION ............................................................................................ 237 II. SAFETY ISSUE ............................................................................................ 238 III. MARKETING AND REGULATORY HISTORY ..................................................... 239 IV. LITIGATION ............................................................................................... 259 V. CONCLUSION ............................................................................................ 264 4. CONCLUSIONS ...................................................................................................................... 265 I. PREVENTION IS BETTER THAN A CURE ............................................................................ 266 II. ADVERSE EVENT REPORTING ....................................................................................... 266 III. CORRELATION OR CAUSATION? ..................................................................................... 269 IV. THRESHOLDS .............................................................................................................. 269 V. PRODUCT WITHDRAWALS .......................................... 272 CONTENTS XVII VI. COMPENSATION OR REDRESS? ................................................................................. 274 VII. PUBLIC REGULATION V PRIVATE REGULATION .............................................................. 278 A. COMPENSATION - REDRESS ............................................................................. 278 B. DETERRENCE .................................................................................................... 280 VIII. CONCLUSIONS .......................................................................................................... 280 INDEX ......................................................................................................................................... 283
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author	Macleod, Sonia Chakraborty, Sweta
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geographic	USA (DE-588)4078704-7 gnd Großbritannien (DE-588)4022153-2 gnd
geographic_facet	USA Großbritannien
id	DE-604.BV045278756
illustrated	Not Illustrated
indexdate	2024-12-20T18:22:53Z
institution	BVB
institution_GND	(DE-588)117513-0 (DE-588)1023902869
isbn	9781509916696 9783848754632 9783406737145
language	English
oai_aleph_id	oai:aleph.bib-bvb.de:BVB01-030666384
open_access_boolean
owner	DE-M382
owner_facet	DE-M382
physical	xxi, 298 Seiten Diagramme
publishDate	2019
publishDateSearch	2019
publishDateSort	2019
publisher	Hart Publishing Nomos C.H.Beck
record_format	marc
series2	Civil justice systems
spellingShingle	Macleod, Sonia Chakraborty, Sweta Pharmaceutical and medical device safety a study in public and private regulation Produzentenhaftung (DE-588)4047375-2 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd Internationales Wirtschaftsrecht (DE-588)4027461-5 gnd Medizinprodukt (DE-588)4024018-6 gnd
subject_GND	(DE-588)4047375-2 (DE-588)4437717-4 (DE-588)4027461-5 (DE-588)4024018-6 (DE-588)4078704-7 (DE-588)4022153-2
title	Pharmaceutical and medical device safety a study in public and private regulation
title_auth	Pharmaceutical and medical device safety a study in public and private regulation
title_exact_search	Pharmaceutical and medical device safety a study in public and private regulation
title_full	Pharmaceutical and medical device safety a study in public and private regulation Sonia Macleod and Sweta Chakraborty
title_fullStr	Pharmaceutical and medical device safety a study in public and private regulation Sonia Macleod and Sweta Chakraborty
title_full_unstemmed	Pharmaceutical and medical device safety a study in public and private regulation Sonia Macleod and Sweta Chakraborty
title_short	Pharmaceutical and medical device safety
title_sort	pharmaceutical and medical device safety a study in public and private regulation
title_sub	a study in public and private regulation
topic	Produzentenhaftung (DE-588)4047375-2 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd Internationales Wirtschaftsrecht (DE-588)4027461-5 gnd Medizinprodukt (DE-588)4024018-6 gnd
topic_facet	Produzentenhaftung Arzneimittelüberwachung Internationales Wirtschaftsrecht Medizinprodukt USA Großbritannien
url	http://deposit.dnb.de/cgi-bin/dokserv?id=9d728e4b6ae64a19a144864a7e29a9f8&prov=M&dok_var=1&dok_ext=htm http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030666384&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
work_keys_str_mv	AT macleodsonia pharmaceuticalandmedicaldevicesafetyastudyinpublicandprivateregulation AT chakrabortysweta pharmaceuticalandmedicaldevicesafetyastudyinpublicandprivateregulation AT nomosverlagsgesellschaft pharmaceuticalandmedicaldevicesafetyastudyinpublicandprivateregulation AT verlagchbeck pharmaceuticalandmedicaldevicesafetyastudyinpublicandprivateregulation

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