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

Sonia Macleod and Sweta Chakraborty

ISBN 10: 1509916695 / ISBN 13: 9781509916696

Published by Hart Publishing, Great Britain, 2019

About this Item

Y2 - A first British edition hardcover book in very good condition in very good dust jacket that is mylar protected. Dust jacket has some wrinkling on the edges and corners, some scratches, dust jacket and book have some bumped corners, some wrinkling on the spine edges, light discoloration and shelf wear. Civil Justice Systerms, Series General Editor Christopher Hodges. 9.75"x6.75", 298 pages. Satisfaction Guaranteed. 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. Size: 8vo - over 7¾" - 9¾" tall.

Seller Inventory # 2511ec1592

Bibliographic Details

• Title: Pharmaceutical and Medical Device Safety: A Study in Public and Private Regulation
• Publisher: Hart Publishing, Great Britain
• Publication Date: 2019
• Language: English
• ISBN 10: 1509916695
• ISBN 13: 9781509916696
• Binding: Hardcover
• Edition: First British Edition.
• Condition: Very Good
• Dust Jacket Condition: Very Good

About this title

Synopsis

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.

About the Author

Sonia Macleod is a researcher with the Research Programme on Civil Justice Systems at the Centre for Socio-Legal Studies, Oxford.
Sweta Chakraborty is a risk and behavioural scientist based in Washington DC. She is a former researcher with the Research Programme on Civil Justice Systems at the Centre for Socio-Legal Studies, Oxford, and an adjunct assistant professor at Columbia University.