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Vol 23 No 10 Oct/Nov 2018

Book of the Month

Cover of Civil Fraud: Law, Practice and Procedure

Civil Fraud: Law, Practice and Procedure

Edited by: Thomas Grant, David Mumford
Price: £219.00

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


ISBN13: 9781509916696
To be Published: February 2019
Publisher: Hart Publishing
Country of Publication: UK
Format: Hardback
Price: £55.00



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.

Subjects:
Medical Law

Series: Civil Justice Systems

Regulatory Delivery ISBN 9781509918584
To be published May 2019
Hart Publishing
£75.00
Delivering Collective Redress: New Technologies ISBN 9781509918546
Published May 2018
Hart Publishing
£60.00
£54.00 + £10.80 VAT
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Redress Schemes for Personal Injuries (eBook) ISBN 9781509916634
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Hart Publishing
£76.50 + £15.30 VAT
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Redress Schemes for Personal Injuries ISBN 9781509916610
Published November 2017
Hart Publishing
£85.00
£54.00 + £10.80 VAT
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£85.50 + £17.10 VAT
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Consumer ADR in Europe (eBook) ISBN 9781847319425
Published May 2012
Hart Publishing
£76.50 + £15.30 VAT
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Consumer ADR in Europe ISBN 9781849463485
Published May 2012
Hart Publishing
£85.00
£100.00