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
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
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
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
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
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
VI. Compensation or Redress?... 274
VII. Public Regulation v Private Regulation... 278
A. Compensation - Redress... 278
B. Deterrence... 280
VIII. Conclusions... 280
Index...283
