Download or read book Medicinal Product Liability and Regulation written by Richard Goldberg and published by A&C Black. This book was released on 2014-07-18 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug and Medical Device Product Liability Deskbook written by James Beck and published by Law Journal Press. This book was released on 2004 with total page 982 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-01-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Devices Law and Regulation Answer Book written by Suzan Onel and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Product Liability written by Duncan Fairgrieve and published by Oxford University Press. This book was released on 2020-05-20 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug and Device Product Liability Litigation Strategy written by Mark Herrmann and published by Oxford University Press. This book was released on 2011-12-21 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year, thousands of lawsuits are filed in federal and state courts seeking recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into multidistrict litigation, and class actions. The litigation occasionally becomes life-threatening for the defendant corporations, and may breed a public relations nightmare, as occurred with Vioxx, breast implants, and fen-phen. Drug and Device Product Liability Litigation Strategy, by Mark Herrmann and David B. Alden, offers assistance to lawyers who practice in this high-stakes, high-profile, and rapidly-evolving area. The book's primary focus is to provide useful practice pointers and overall strategic guidance for attorneys in product liability litigation involving prescription drugs and medical devices. It will serve as an indispensable guide to handling such a case from pre-litigation through trial. The legal landscape in this important area is expected to shift as the Supreme Court's decisions in Riegel v. Medtronic, Inc. and Wyeth v. Levine are applied, and as the President and Congress address tort reform and other health care issues. Practitioners will need thoughtful, expert advice to navigate these changes.
Download or read book Product Liability Insurance and the Pharmaceutical Industry written by Geraint G. Howells and published by Manchester University Press. This book was released on 1991 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug and Medical Device Product Liability Deskbook written by James Beck and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals written by Steven Garber and published by Rand Corporation. This book was released on 2013-02-15 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Download or read book Drug and Device Product Liability Litigation Strategy written by Mark Herrmann and published by Oxford University Press, USA. This book was released on 2012 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Drug and Device Product Liability Litigation Strategy, Mark Herrmann and David B. Alden provide useful practice pointers and overall strategic guidance for attorneys in product liability litigation involving prescription drugs and medical devices.
Download or read book Product Liability Standards written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness and published by . This book was released on 1994 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legal and Forensic Medicine written by Roy G. Beran and published by Springer. This book was released on 2013-09-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.
Download or read book Product Liability written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness and published by . This book was released on 1988 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Download or read book Drug Product Liability written by Frank C. Woodside and published by LexisNexis. This book was released on 1997-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 3 Volumes; Looseleaf; updated with supplements & revisions.
Download or read book Product Liability and Innovation written by National Academy of Engineering and published by National Academies Press. This book was released on 1994-02-01 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Product liability is a contentious issue. Proponents argue that American tort law promotes product safety. Manufacturers contend that lawsuits chill new product development. Product Liability and Innovation provides an overview and an engineering perspective on the product liability system. The volume offers studies of selected industries, exploring the effect of product liability on corporate product development decisions and on the creative opportunities and day-to-day work of engineers. The volume addresses the potential liability of the parts or materials supplier and discusses the impact of liability on the availability of insurance. It looks at "junk science" in the courtroom and analyzes opportunities to incorporate into product design what we know about human behavior and risk. The book also looks at current efforts at tort reform and compares U.S. injury claims handling with that of other countries. This volume will be important to policymakers, industrialists, attorneys, product engineers, and individuals concerned about the impact of product liability on the industrial future.
