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

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Sonia Macleod Sweta Chakraborty

Pharmaceutical and Medical Device Safety

A Study in Public and Private Regulation

Sonia Macleod, Sweta Chakraborty

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Hardback

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English

Hart/Beck
21 February 2019

Arbitration, mediation & alternative dispute resolution; Consumer protection law

Series: Civil Justice Systems

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.

By: Sonia Macleod, Sweta Chakraborty
Imprint: Hart/Beck
Country of Publication: United Kingdom
Dimensions: Height: 244mm, Width: 169mm,
Weight: 712g
ISBN: 9781509916696
ISBN 10: 1509916695
Series: Civil Justice Systems
Pages: 320
Publication Date: 21 February 2019
Audience: Professional and scholarly , Professional and scholarly , Undergraduate , Undergraduate
Format: Hardback
Publisher's Status: Active

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.