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Pharmaceutical and Medical Device Safety: A Study in Public and Private Regulation

ISBN13: 9781509916696
Published: February 2019
Publisher: Hart Publishing
Country of Publication: UK
Format: Hardback
Price: £75.00

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This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.

As litigation normally post-dates regulatory implementation, the ‘private enforcement’ of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.

Medical Law and Bioethics
1. Introduction
I. The Legal Context
A. Basis of Liability
B. Litigation Systems
C. Funding and Costs
D. US: The Class Action and MDL
E. Europe
F. Settlement Schemes

2. The Regulation of Medicines and Medical Devices
I. Medicinal Products
A. Historical Drug/Pharmaceutical Regulation in the UK
B. European Regulation of Medicinal Products
C. European Regulation of Medical Devices
D. General Product Safety Regulation in Europe
E. Medicinal Product Regulation in the US
F. US Regulation of Medical Devices

3. Detailed Case Descriptions and Regulatory Histories
I. Teratogens and Foetal Damage
A. Thalidomide (alpha-phthalimido-glutarimide)
B. Hormonal Pregnancy Tests – Including Primodos
C. Diethylstilboestrol (DES)
D. Epilim/Depakote/Depakene (sodium valproate, valproic acid, magnesium valproate, valproate semisodium or valpromide)
E. Accutane/Roaccutane (isotretinoin)
II. Contraceptives and Hormone Replacement Therapy
A. Gravigard or Copper 7 Intrauterine Device
B. Third-Generation Oral Contraceptives
C. Norplant (levonorgestrel)
D. Hormone Replacement Therapy
III. Vaccines
A. DTP Vaccine
B. MMR Vaccine
IV. Neuromodulators
A. Benzodiazepines
B. Merital (nomifensine)
C. Selective Serotonin Reuptake Inhibitors
D. Sabril (vigabatrin)
E. Mirapexin/Sifrol/Daquiran (pramipexole)
V. Non-Steroidal Anti-Inflammatories
A. Opren (benoxaprofen)
B. Vioxx (rofecoxib)
VI. Pancreatic Function (Endocrine and Exocrine) and Obesity Treatments
A. Adifax/Isomeride/Redux (dexfenfluramine) and Ponderax (fenfluramine)
B. Mediator (benfluorex)
C. Human Insulin
D. Pancreatic Enzymes
VII. Contaminated Human-Tissue-Derived Products
A. Blood Products
B. Human Growth Hormone
VIII. Cardiovascular Pharmaceuticals
A. Eraldin (practolol)
B. Manoplax (flosequinan)
C. Lipobay (cerivastatin)
IX. Anti-Protozoan Medications
A. Emaform, Entero-Form or Chinoform (clioquinol)
B. Lariam (mefloquine)
X. Breast and Other Cosmetic Implants
A. Dow-Corning Silicone Implants
B. Trilucent Breast Implants
C. Poly Implant Prothese (PIP) Hydrogel Breast Implants
D. Poly Implant Prothese (PIP) IMGHC Silicone Breast Implants
XI. Urinary Incontinence and Pelvic Prolapse Treatments
A. Micturin (terodiline)
B. Urogynaecological Mesh

4. Conclusions
I. Prevention is Better than a Cure
II. Adverse Event Reporting
III. Correlation or Causation?
IV. Thresholds
V. Product Withdrawals
VI. Compensation or Redress?
VII. Public Regulation v Private Regulation
A. Compensation – Redress
B. Deterrence
VIII. Conclusions

Series: Civil Justice Systems

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Hart Publishing
Regulatory Delivery ISBN 9781509918584
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Delivering Collective Redress: New Technologies ISBN 9781509918546
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Redress Schemes for Personal Injuries (eBook) ISBN 9781509916634
Published November 2017
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Redress Schemes for Personal Injuries ISBN 9781509916610
Published November 2017
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Consumer ADR in Europe (eBook) ISBN 9781847319425
Published May 2012
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Consumer ADR in Europe ISBN 9781849463485
Published May 2012
Hart Publishing