Medicinal Product Liability And Regulation
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Medicinal Product Liability And Regulation
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Author : Richard Goldberg
language : en
Publisher: A&C Black
Release Date : 2014-07-18
Medicinal Product Liability And Regulation written by Richard Goldberg and has been published by A&C Black this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-18 with Law categories.
The piecemeal developments in product liability reform in Europe have their origins in the tragic association of phocomelia in children with thalidomide in 1962. In many ways these events have continued to generate pressure for reform of product liability, especially for the victims of drug-induced injury. This monograph attempts to address the major problems that typify claims for drug-induced injury, as well as highlighting the complex interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability under the product liability directive, the claimant may have considerable difficulty in establishing that the relevant product is defective and that it caused the damage. It may also be necessary to overcome the development risk defence where this is pleaded. The monograph addresses these problems on a comparative jurisprudential basis, and seeks to determine whether medicinal products should be treated as a special case in the field of product liability. It examines the role of epidemiological evidence in assessing causation in product liability cases concerning medicinal products in the light of recent developments in the UK Supreme Court, the United States, Canada and France. In particular, it addresses the difficulties in reconciling the standards of proof in law and science, including the theory that causation can be proved on the balance of probabilities by reference to the doubling of risk of injury. An important case study compares and contrasts the approaches of the UK and the US to the measles, mumps, rubella Litigation. The book also examines the question as to whether compliance with regulatory standards should protect pharmaceutical manufacturers from product liability suits. It seeks to support a via media whereby the victims of drug induced injury can receive justice, while at the same time encouraging drug safety and innovation in drug development.
Product Liability Insurance And The Pharmaceutical Industry
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Author : Geraint G. Howells
language : en
Publisher: Manchester University Press
Release Date : 1991
Product Liability Insurance And The Pharmaceutical Industry written by Geraint G. Howells and has been published by Manchester University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991 with Insurance, Products liability categories.
A collection of papers from the ninth Fulbright Colloquium held in September 1989. The papers compare legal practices and procedures in North America and Europe and the barriers to drug development caused by increased litigation in cases involving pharmaceutical products.
Product Liability
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Author : Duncan Fairgrieve
language : en
Publisher: Oxford University Press
Release Date : 2020-05-20
Product Liability written by Duncan Fairgrieve and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-20 with Law categories.
Product Liability is a recognised authority in the field and covers the product liability laws through which manufacturers, retailers, and others may be held liable to compensate persons who are injured, or who incur financial loss, when the products which they manufacture or sell are defective or not fit for their purpose. Product defects may originate in the production process, be one of design, or be grounded in a failure to issue an adequate warning or directions for safe use and practitioners advising business clients or claimants will find this book provides all the necessary information for practitioners to manage a product liability claim. This new edition has been fully updated to take account of 10 years of development in case law and regulation, and the increasing impact of cross-border and transnational sale of goods. The Court of Justice of the European Union handed down major rulings concerning the Product Liability Directive which affect the application of the Directive and national arrangements and Fairgrieve and Goldberg examines this in detail. For any legal practitioner operating in areas which require knowledge of European product liability law, an understanding of the impact of recent developments is essential and this work is an essential resource for practitioners working on product liability, sale of goods, personal injury and negligence. The work provides comprehensive coverage of the law of negligence as it applies to product liability, of the strict liability provisions of the Consumer Protection Act 1987, and of the EU's Product Liability Directive on which the Act is based. Although the majority of cases involve pharmaceuticals and medical devices, in recent English cases the allegedly defective products have been as diverse as a child's buggy, an All Terrain Vehicle, and even a coffee cup. Many cases are brought as group actions, and the book examines the rights of those who are injured by defective products. As well as considering the perspective of the law as it has developed in the UK, this edition contains detailed discussion of case law from other jurisdictions including the USA, Australia, New Zealand, Canada, France and Germany. The coverage in the work is complemented by a full analysis of issues which arise in transnational litigation involving problems of jurisdiction and the choice of laws.
The Law And Regulation Of Medicines
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Author : Peter Feldschreiber
language : en
Publisher: Oxford University Press, USA
Release Date : 2008
The Law And Regulation Of Medicines written by Peter Feldschreiber and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Law categories.
This is a comprehensive textbook on the science, regulatory policy and law surrounding the discovery, development and marketing of new medicines. It is a reference work and source of expertise for legal, medical, and pharmaceutical professionals working in the fields of medicine regulation, medical law and product liability. Written by an author team comprising specialists in pharmaceutical medicine, pharmacology and therapeutics, and lawyers specializing in product liability law and intellectual property, this book reviews all the areas of science, regulatory policy and legislation, together with the consumer protection and intellectual property law as applicable to the development and commercialization of medicinal products. Serving as a practical introduction for practitioners wishing to undertake work in this highly complex area of law, this book is specifically designed to facilitate deeper mutual understanding of the scientific and technical issues for the lawyer, and the legal issues for those involved with regulatory policy and decision making and senior executives in the pharmaceutical industry. The work covers the European and UK legislation on medicines and healthcare products, including the principal directives and regulations, together with UK implementing legislation and instruments, and the key case law. It covers the structure and function of the regulatory authorities, applications to carry out clinical trials, intellectual property issues, product liability issues and litigation. This book provides practical guidance on drafting regulatory submissions, preparing litigation against decisions of the regulatory authorities; determining appropriate regulatory submission strategies throughout the European Community, and preparing litigation relating to medicinal products liability under the Product Liability Directive and the Consumer Protection Act 1987.
Drug Product Liability
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Author : Frank C. Woodside
language : en
Publisher: LexisNexis
Release Date : 1997-01-01
Drug Product Liability written by Frank C. Woodside and has been published by LexisNexis this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-01-01 with Drugs categories.
3 Volumes; Looseleaf; updated with supplements & revisions.
Economic Effects Of Product Liability And Other Litigation Involving The Safety And Effectiveness Of Pharmaceuticals
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Author : Steven Garber
language : en
Publisher: Rand Corporation
Release Date : 2013-02-15
Economic Effects Of Product Liability And Other Litigation Involving The Safety And Effectiveness Of Pharmaceuticals written by Steven Garber and has been published by Rand Corporation this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-15 with Law categories.
Liability effects on the economic performance of the pharmaceutical industry play a prominent role in the debate about the economic effects of product liability in the United States. The author analyzes incentive effects on company decisions, implications for economic outcomes such as drug safety and effectiveness, and suggests how public policy changes could mitigate liability-based sources of inefficient decisions of pharmaceutical companies.
Pharmaceutical And Medical Device Safety
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Author : Sonia Macleod
language : en
Publisher:
Release Date : 2019
Pharmaceutical And Medical Device Safety written by Sonia Macleod and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with categories.
"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."--Bloomsbury Publishing.
Drug And Medical Device Product Liability Deskbook
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Author : James Beck
language : en
Publisher:
Release Date :
Drug And Medical Device Product Liability Deskbook written by James Beck and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with Actions and defenses categories.
Comparative Product Liability
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Author : Geraint G. Howells
language : en
Publisher: Aldershot, England : Dartmouth
Release Date : 1993
Comparative Product Liability written by Geraint G. Howells and has been published by Aldershot, England : Dartmouth this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with Law categories.
This book provides a grounding in the principles of product liability and examines how they have been tackled by different legal systems. In particular the author looks at European developments against the background of, for example, the United States, where the concern to protect consumers of defective products has led to something of a products liability crisis - large damage awards plus strict liability have meant that it is difficult for some industries to obtain insurance - and New Zealand, where a no fault compensation scheme operates. The book provides an understanding of the process by which European laws are harmonized, by analyzing the European Directive on Product Liability - and assesses how effective the measures taken have been in the European Community and elsewhere.
Product Liability And The Economics Of Pharmaceuticals And Medical Devices
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Author : Steven Garber
language : en
Publisher: RAND Corporation
Release Date : 1993
Product Liability And The Economics Of Pharmaceuticals And Medical Devices written by Steven Garber and has been published by RAND Corporation this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993 with Business & Economics categories.
This study examined the economic effects of product liability on firms producing drugs and medical devices. The study found that the liability system enhances the economic contributions of the industries in some ways.