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In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
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.
Mark Geistfeld, the author of the leading textbook on products liability, an important text on tort law and dozens of scholarly articles, has class-tested the material in Products Liability Law for more than five years at NYU. He has made the study of products liability an advanced torts class that cements knowledge of fundamental tort principles while developing both specialized expertise and a deeper understanding of the torts process. Illuminating textual discussion follows a wide range of riveting cases. Unlike many casebooks that simply pose the question, Products Liability Law provides the analyses needed to address each challenging problem. Unifying the two competing conceptions of products liability, students become familiar with both approaches and develop a balanced perspective. Features: Stellar authorship: Mark Geistfeld leading textbook on products liability important tort law textbook dozens of scholarly articles. Classroom-tested for five years Makes the study of products liability an advanced tortsclass cements knowledge of fundamental tort principles develops both specialized expertise and a deeper understanding of the torts process Wide range of interesting cases followed by extended textual discussion Provides analysis needed to address challenging questions, missing from most casebooks Unifies the two competing conceptions of products liability
This work provides comprehensive analysis of product liability under the common law of negligence, the strict liability provisions of the Consumer Protection Act 1987, and the EU's Product Liability Directive, placed in the context of the international and transnational legal framework.--
Featuring chapters from Uría Menéndez, Deneys Reitz Inc and Minter Ellison, this first edition covers key issues that can arise in relation to product regulation, recall, liability and insurance coverage in a number of jurisdictions in Europe, North America, South America and Asia.
The efficacy of various political institutions is the subject of intense debate between proponents of broad legislative standards enforced through litigation and those who prefer regulation by administrative agencies. This book explores the trade-offs between litigation and regulation, the circumstances in which one approach may outperform the other, and the principles that affect the choice between addressing particular economic activities with one system or the other. Combining theoretical analysis with empirical investigation in a range of industries, including public health, financial markets, medical care, and workplace safety, Regulation versus Litigation sheds light on the costs and benefits of two important instruments of economic policy.
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.
Thirty years after the entry into force of the Directive on liability for defective products (Council Directive 85/374/EEC), and in the light of the threat to user safety posed by consumer goods that make use of new technologies, it is essential to assess and determine whether the Directive remains an adequate legal response to the phenomenon of products brought to market that fail to ensure appropriate levels of safety for their users. This book is the result of an extensive international research project funded by the Polish National Science Centre. Individual country reports analyze the implementation of the Directive in the domestic law of several EU and EEA Member States (namely Austria, Czech Republic, Denmark, England, France, Germany, Italy, Netherlands, Norway, Poland, Spain, and Switzerland) and the relationship of the implemented rules with the already existing rules of tort law. The country reports show that the practical significance of product liability differs widely in the various Member States. Also taking into account non-EU countries (Canada, Israel, South Africa and the USA), this book examines whether EU law will ensure sufficient safety for individuals using goods that have been produced using new technologies that are currently under development. This, as well as an economic analysis of product liability, makes the book valuable for academics, practitioners, policy makers, and all those interested in the subject. (Series: Principles of European Tort Law) Subject: Tort Law, Private Law]