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Author: James Beck
Publisher: Law Journal Press
Published: 2004
Total Pages: 982
ISBN-13: 9781588521217
DOWNLOAD EBOOKThis timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Author: Mark Herrmann
Publisher: Oxford University Press
Published: 2011-12-21
Total Pages: 539
ISBN-13: 0199750246
DOWNLOAD EBOOKEach 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.
Author: Marden G. Dixon
Publisher:
Published: 1994
Total Pages:
ISBN-13:
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Publisher: DIANE Publishing
Published: 1993
Total Pages: 380
ISBN-13: 9780788104688
DOWNLOAD EBOOKAnalyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.
Author: Brian L. Strom
Publisher: John Wiley & Sons
Published: 2019-12-16
Total Pages: 1220
ISBN-13: 1119413419
DOWNLOAD EBOOKDieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.
Author: Roy G. Beran
Publisher: Springer
Published: 2013-09-05
Total Pages: 0
ISBN-13: 9783642323379
DOWNLOAD EBOOKThis 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.
Author: Eric Stallard
Publisher: Springer Science & Business Media
Published: 2005
Total Pages: 434
ISBN-13: 9780387949871
DOWNLOAD EBOOKThis selection of papers encompasses recent methodological advances in several important areas, such as multivariate failure time data and interval censored data, as well as innovative applications of the existing theory and methods. Using a rigorous account of statistical forecasting efforts that led to the successful resolution of the John-Manville asbestos litigation, the models in this volume can be adapted to forecast industry-wide asbestos liability. More generally, because the models are not overly dependent on the U.S. legal system and the role of asbestos, this volume will be of interest in other product liability cases, as well as similar forecasting situations for a range of insurable or compensational events. Throughout the text, the emphasis is on the iterative nature of model building and the uncertainty generated by lack of complete knowledge of the injury process. This uncertainty is balanced against the court's need for a definitive settlement, and how these opposing principles can be reconciled. A valuable reference for researchers and practitioners in the field of survival analysis.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1988-01-01
Total Pages: 203
ISBN-13: 0309038472
DOWNLOAD EBOOKIn 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.
Author: Richard Goldberg
Publisher: Bloomsbury Publishing
Published: 2013-10-10
Total Pages: 242
ISBN-13: 1782251537
DOWNLOAD EBOOKThe 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.
Author: Anna C. Mastroianni
Publisher:
Published: 1994
Total Pages: 268
ISBN-13:
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