Pharmaceutical and medical device safety : a study in public and private regulation / Sonia Macleod and Sweta Chakraborty.

Format:

Book

Author/Creator:

Macleod, Sonia, author.

Chakraborty, Sweta, author.

Series:

Civil justice systems ; v. 8.

Civil justice systems ; volume 8

Language:

English

Subjects (All):

Medical laws and legislation.

Drugs--Law and legislation.

Drugs.

Medical instruments and apparatus--Safety regulations.

Medical instruments and apparatus.

Products liability--Drugs.

Products liability.

Products liability--Medical instruments and apparatus.

Medical laws and legislation--Great Britain.

Medical laws and legislation--European Union countries.

Medical laws and legislation--United States.

Physical Description:

1 online resource (298 pages).

Place of Publication:

München, Germany : C.H. Beck ; Oxford, UK ; Portland, Oregon : Hart Publishing, 2019.

Summary:

"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 that a product might be 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."--Bloomsbury Publishing.

Contents:

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.

Notes:

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Includes bibliographical references and index.