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

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

Author: Sonia Macleod; Sweta Chakraborty
Publisher: Hart Publishing
ISBN: 9781509916696
Published In: February 2019
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

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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.

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

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