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Pharmaceutical and medical device safety : a study in public and private regulation

Author: Sonia Macleod; Sweta Chakraborty
Publisher: Oxford, UK : Hart Publishing, 2019. ©2019
Series: Civil justice systems.
Edition/Format:   Print book : EnglishView all editions and formats
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  Read more...
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Additional Physical Format: Online version:
Macleod, Sonia, author.
Pharmaceutical and medical device safety
Oxford, UK ; Chicago, Illinois : Hart Publishing, 2019
(DLC) 2018057920
Document Type: Book
All Authors / Contributors: Sonia Macleod; Sweta Chakraborty
ISBN: 9781509916696 1509916695
OCLC Number: 1077482060
Description: xxi, 298 pages : illustrations ; 25 cm.
Contents: Introduction --
Medical instruments and apparatus --
Detailed Case Descriptions and Regulatory Histories --
Conclusions.
Series Title: Civil justice systems.
Responsibility: Sonia Macleod and Sweta Chakraborty.

Abstract:

"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"--

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