Drug And Device Product Liability Litigation Strategy
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Author : Mark Herrmann,David B. Alden Publisher : Oxford University Press, USA Page : 539 pages File Size : 41,5 Mb Release : 2011-12-21 Category : LAW ISBN : 9780199734948
Drug and Device Product Liability Litigation Strategy by Mark Herrmann,David B. Alden Pdf
Drug & Device Product Liability Litigation Strategy provides useful practice pointers and overall strategic guidance for attorneys involved in product liability litigation for prescription drugs and medical devices.
Product Liability by Richard J. Heafey,Don M. Kennedy Pdf
From the initial client interview through every step in building the case, this book provides hundreds of valuable ideas and tactics from the perspective of both plaintiffs' and defendants' counsel.
Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals by Steven Garber Pdf
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.
Product Liability and the Economics of Pharmaceuticals and Medical Devices by Steven Garber Pdf
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.
National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development
Author : National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development Publisher : National Academies Press Page : 206 pages File Size : 51,8 Mb Release : 1990-01-01 Category : Medical ISBN : 9780309041478
Developing New Contraceptives by National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development Pdf
There are numerous reasons to hasten the introduction of new and improved contraceptivesâ€"from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptivesâ€"in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United Statesâ€"covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchersâ€"everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.
Product Liability by Duncan Fairgrieve,Richard S Goldberg Pdf
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.
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Publisher : National Academies Press Page : 304 pages File Size : 46,6 Mb Release : 2015-04-20 Category : Medical ISBN : 9780309316323
Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association)
Author : American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association) Publisher : American Bar Association Page : 216 pages File Size : 44,5 Mb Release : 2007 Category : Law ISBN : 1590318730
Model Rules of Professional Conduct by American Bar Association. House of Delegates,Center for Professional Responsibility (American Bar Association) Pdf
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Institute of Medicine,Board on Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Author : Institute of Medicine,Board on Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Publisher : National Academies Press Page : 112 pages File Size : 46,5 Mb Release : 2001-10-31 Category : Medical ISBN : 9780309183208
Innovation and Invention in Medical Devices by Institute of Medicine,Board on Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Pdf
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.
Medicinal Product Liability and Regulation by Richard Goldberg Pdf
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.
