Product Liability and the Economics of Pharmaceuticals and Medical Devices PDF Download

Author: Steven Garber
Publisher: RAND Corporation
ISBN:
Category : Business & Economics
Languages : en
Pages : 272

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Book Description
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.

Author: Steven Garber
Publisher: Rand Corporation
ISBN: 0833079913
Category : Business & Economics
Languages : en
Pages : 117

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Book Description
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.

Author: Frank A. Sloan
Publisher: Now Publishers Inc
ISBN: 1601980744
Category : Business & Economics
Languages : en
Pages : 174

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Book Description
The Law and Economics of Public Health synthesizes the empirical research findings on the relationship between law and the public's health that are found scattered in different literature ranging from economic journals to medical journals, journals on addictive behaviors, law reviews, and books. This is the only study to date that has assembled the empirical evidence from many areas ranging from motor vehicle liability and dram shop liability to medical malpractice, products liability as it applies to pharmaceutical products, and medical devices. The Law and Economics of Public Health addresses the fundamental question as to whether or not and the extent to which imposing tort liability on potential injurers improves the public's health. Does the threat of litigation on potential injurers make them exercise more caution? Does insurance coverage counter incentives to be careful? Does the tort system operate as perfectly as the theory would have it? This monograph answers these questions on the basis of empirical evidence. The Law and Economics of Public Health discusses both theory and empirical evidence in several areas of personal injury to which tort liability has been applied. The monograph starts by describing the general law and economics framework used to assess both positive and normative issues relating to tort liability. It then presents the rationale for and empirical evidence on particular applications of tort liability as it applies to personal injury.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225

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Book Description
Americans 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.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038472
Category : Medical
Languages : en
Pages : 203

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Book Description
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.

Author: H. Tristram Engelhardt
Publisher: M & M Scrivener Press
ISBN: 0980209471
Category : Business & Economics
Languages : en
Pages : 253

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Book Description
Innovation and the Pharmaceutical Industry: Critical Reflections on the Virtues of Profit examines the central role of profit in the development of pharmaceuticals, medical devices, and health care generally. Recent efforts to understand this role have often underestimated and even dismissed its importance, arguing for its replacement by other means and mechanisms. However, as the essays in this volume attest, it would be impossible to account adequately for the range of pharmaceuticals and medical devices that have become part of everyday medicine without recognizing that the depth and scope of innovations are tied not simply to altruism, a concern for the common good, or the pursuit of knowledge for its own sake, but crucially to the pursuit of private good and of individual profit. Balancing a concern for theory and practice, the analyses and evaluations provided in these essays touch directly on many of the most heated and important debates in pharmaceutical ethics, such as profit margins, corporate social responsibility, drug advertising, litigation, patents, and parallel trade. Reflecting critically on the problems and prospects of medical innovation, they invite a rethinking of the foundations of the bioethics and business ethics of the pharmaceutical and medical device industries by focusing on the long-term impact of policy decisions for human health and well-being.

Author: Sonia Macleod
Publisher:
ISBN: 9781509916764
Category :
Languages : en
Pages : 298

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Book Description
"This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control."--Bloomsbury Publishing.

Author: Tomas J. Philipson
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 31

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Book Description
The NBER Bulletin on Aging and Health provides summaries of publications like this. You can sign up to receive the NBER Bulletin on Aging and Health by email. In the United States, drugs are jointly regulated by the US Food and Drug Administration, which oversees premarket clinical trials designed to ensure drug safety and efficacy, and the liability system, which allows patients to sue manufacturers for unsafe drugs. In this paper, we examine the potential welfare effects of this dual system to ensure the safety of medical products, and conclude that product liability exemptions for FDA regulated activities could raise economic efficiency. When the safety level mandated by the FDA is binding-in the sense that manufacturers will not conduct additional clinical testing beyond what is mandated by FDA-then product liability may reduce efficiency by raising prices without pushing firms, who are already bound by the FDA's requirements, to invest further in product safety. We consider as a case study the National Vaccine Injury Compensation Program, which sharply reduced vaccine manufacturer's liability in 1988. We find evidence that the program reduced prices without affecting vaccine safety, suggest that liability limits can enhance economic efficiency in the presence of the FDA.

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 510

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Book Description

Author: Daniel P. Kessler
Publisher: University of Chicago Press
ISBN: 0226432181
Category : Business & Economics
Languages : en
Pages : 344

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Book Description
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.