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Author: Geraint G. Howells
Publisher: Manchester University Press
Published: 1991
Total Pages: 240
ISBN-13: 9780719033742
DOWNLOAD EBOOKA 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.
Author: Marden G. Dixon
Publisher:
Published: 1994
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: 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: 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:
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: M.N.G. Dukes
Publisher: Elsevier
Published: 2005-11-04
Total Pages: 429
ISBN-13: 0080459366
DOWNLOAD EBOOKAs one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.*Provides a balanced picture of the current role of the pharmaceutical industry in society*Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases*This is the only book addressing the legal implications of big pharma activities and ethical standards
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2011-04-03
Total Pages: 442
ISBN-13: 0309158060
DOWNLOAD EBOOKRare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: MORTON F. DALLER
Publisher: Wolters Kluwer Law & Business
Published: 2021-10-21
Total Pages: 1186
ISBN-13: 1543837344
DOWNLOAD EBOOKProduct Liability Desk Reference: A Fifty-State Compendium, 2022 Edition
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1991-02-01
Total Pages: 225
ISBN-13: 030904491X
DOWNLOAD EBOOKAmericans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
