Pharmaceutical and Medical Device Safety

A Study in Public and Private Regulation

Nonfiction, Reference & Language, Law, Alternative Dispute Resolution, Arbitration, Negotiation, & Mediation
Cover of the book Pharmaceutical and Medical Device Safety by Sonia Macleod, Sweta Chakraborty, Bloomsbury Publishing
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Sonia Macleod, Sweta Chakraborty ISBN: 9781509916733
Publisher: Bloomsbury Publishing Publication: February 21, 2019
Imprint: Hart/Beck Language: English
Author: Sonia Macleod, Sweta Chakraborty
ISBN: 9781509916733
Publisher: Bloomsbury Publishing
Publication: February 21, 2019
Imprint: Hart/Beck
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Bloomsbury Publishing

Cover of the book Selections from Ovid Amores II by Sonia Macleod, Sweta Chakraborty
Cover of the book How to Resist by Sonia Macleod, Sweta Chakraborty
Cover of the book The Slow Philosophy of J. M. Coetzee by Sonia Macleod, Sweta Chakraborty
Cover of the book James Joyce and Absolute Music by Sonia Macleod, Sweta Chakraborty
Cover of the book Memento Mori by Sonia Macleod, Sweta Chakraborty
Cover of the book OCR Ancient History GCSE Component 2 by Sonia Macleod, Sweta Chakraborty
Cover of the book Understanding Children's Behaviour by Sonia Macleod, Sweta Chakraborty
Cover of the book The Gay Talese Reader by Sonia Macleod, Sweta Chakraborty
Cover of the book 50 Dates Worse Than Yours by Sonia Macleod, Sweta Chakraborty
Cover of the book Werewolf Stories to Tell in the Dark by Sonia Macleod, Sweta Chakraborty
Cover of the book Understanding Language by Sonia Macleod, Sweta Chakraborty
Cover of the book The Legitimacy of Family Rights in Strasbourg Case Law by Sonia Macleod, Sweta Chakraborty
Cover of the book Dancing with the Nation by Sonia Macleod, Sweta Chakraborty
Cover of the book The Pocket Book of Weather by Sonia Macleod, Sweta Chakraborty
Cover of the book British Imperial by Sonia Macleod, Sweta Chakraborty
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy