Medicinal Product Liability and Regulation

Medicinal Product Liability and Regulation

Author: Richard Goldberg

Publisher: A&C Black

Published: 2014-07-18

Total Pages: 421

ISBN-13: 1782251545

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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

PRODUCT LIABILITY

Author: Helmut Koziol

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2017-11-07

Total Pages: 630

ISBN-13: 3110545810

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Where products develop ever more rapidly, the law may face difficulties in responding accordingly to new security threats which may arise. In the field of product liability, an extraordinary need for legal development has thus been perceived, with legislators and judges feeling compelled to find new solutions and to look across borders for these. In the detailed reports in this book, the World Tort Law Society proves that it is in an ideal position to examine the most significant concepts. The report on North America studies the special regime for product liability from its origin in the case law of the US; the European report is centred around the EU Product Liability Directive with its merits and faults; and the influence of these two systems as well as new answers are shown in the reports on Asia, Russia and four key jurisdictions in the rest of the world. Similar questions are discussed worldwide: How can a strict liability regime for products be justified, and can it be justified in all cases? How does the special regime relate to general rules of tort law? Should services be subject to a similar regime? The Members of the Society seek to provoke thought for solutions to these pervasive problems. In this spirit, the volume’s comparative conclusions invite discussion, and the book includes four responses to that call from eminent tort lawyers from different legal backgrounds.


Exploring Tort Law

Exploring Tort Law

Author: M. Stuart Madden

Publisher: Cambridge University Press

Published: 2005-09-26

Total Pages: 508

ISBN-13: 9780521851367

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This is a collection of scholarship from the most influential contributors regarding Torts law.


Handbook of Warnings

Handbook of Warnings

Author: Michael S. Wogalter

Publisher: CRC Press

Published: 2006-01-20

Total Pages: 872

ISBN-13: 1482289687

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A technical discussion that includes theory, research, and application, this book describes warning design standards and guidelines; aspects of law relevant to warnings such as government regulations, case/trial litigation, and the role of expert testimony in these cases; and international, health/medical, and marketing issues. Broken into thirteen


Principles of Products Liability

Principles of Products Liability

Author: Mark Geistfeld

Publisher:

Published: 2006

Total Pages: 304

ISBN-13:

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The varied doctrines, disputes, competing conceptions of liability and responsibility, and leading cases in this area are all discussed in this book. Unlike other books in this subject area, this title fully develops the underlying concepts and then repeatedly shows how the important doctrines can be understood in terms of a few basic principles. The book also provides insights into the processes of the common law, while locating products liability within tort law more generally. The book will be of interest both for the specialized study of products liability and the more general study of tort law.


Handbook on Law, Innovation and Growth

Handbook on Law, Innovation and Growth

Author: Robert E. Litan

Publisher: Edward Elgar Publishing

Published: 2011-01-01

Total Pages: 349

ISBN-13: 0857930540

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This Handbook provides breakthrough analyses on an important, cutting-edge topic: the connections between the legal system, both in substance and process, and innovation and growth. Arguably the most important intellectual development in legal scholarship and judicial decision-making over the past four decades has been the increasing use of economic modes of analysis in legal reasoning. The Handbook on Law, Innovation and Growth sheds new light on the linkages between innovation, growth and the legal system, answering questions that will help policymakers better understand and implement the law in an effort to advance economic welfare. This Handbook brings together many prominent scholars to examine the features of the legal infrastructure that affect both innovation and growth. Individual chapters explore different legal subject areas, in most cases offering recommendations for rule changes that could accelerate growth, primarily in the context of the US economy. The introductory chapter cohesively ties all of the contributions together and explains why it is time for legal scholarship and research to move in a new direction. Surpassing other literature on the subject, this landmark Handbook is certainly a critical volume for any student or scholar of law and economics.


Product Liability

Product Liability

Author: Duncan Fairgrieve

Publisher: Oxford University Press

Published: 2020-05-20

Total Pages: 1041

ISBN-13: 0191669946

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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.


Tort Law in Focus

Tort Law in Focus

Author: Geoffrey Rapp

Publisher: Aspen Publishing

Published: 2020-02-02

Total Pages: 746

ISBN-13: 1543807828

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Tort doctrine is complex and nuanced on its own; a torts casebook that mystifies first year students will not help them develop the core skill of legal analysis. Tort Law in Focus presents concepts in a way that students can understand and apply. Rather than hide the ball, Geoffrey Rapp explains new terms clearly, and guides students in the specific techniques of applying tort law to practice-based problems. Along with concrete examples, Tort Law in Focus provides clear and thorough introductions to those areas of tort law (such as proximate cause under the dominant and new Restatement approaches; res ipsa; factual cause, including but-for cause and alternatives in special cases like indivisible injuries and alternative causes; the duty of owners and occupiers of land; and comparative negligence) that are especially challenging for first-year law students. Professors and Students Will Benefit From: Clear introductions and transitional text that frame key rules, concepts, and cases A wide selection of modern, high-interest cases that apply dominant legal rules, and which, where possible, interpret and apply the Restatement (Third) Summaries and discussion of canonical cases that convey the history and context of modern tort law Examples, flow charts and maps that illustrate concepts, rules, and the relationships among parties and interests Consistent use of problems that encourage students to implement “IRAC” (or equivalent) strategies for structuring their analysis Samples of documents commonly used in tort law practice, such as demand letters and complaints