medicinal product liability and regulation

Download Book Medicinal Product Liability And Regulation in PDF format. You can Read Online Medicinal Product Liability And Regulation here in PDF, EPUB, Mobi or Docx formats.

Medicinal Product Liability And Regulation

Author : Richard Goldberg
ISBN : 9781782251545
Genre : Law
File Size : 38. 69 MB
Format : PDF, Mobi
Download : 980
Read : 346

Get This Book


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.

Drug And Medical Device Product Liability Deskbook

Author : James Beck
ISBN : 1588521214
Genre : Medical
File Size : 66. 85 MB
Format : PDF, ePub, Mobi
Download : 718
Read : 782

Get This Book


This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.

Drug And Device Product Liability Litigation Strategy

Author : Mark Herrmann
ISBN : 9780199750245
Genre : Law
File Size : 55. 99 MB
Format : PDF, Docs
Download : 204
Read : 161

Get This Book


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.

Product Liability And Innovation

Author : Steering Committee on Product Liability and Innovation
ISBN : 9780309051309
Genre : Technology & Engineering
File Size : 35. 32 MB
Format : PDF, ePub
Download : 755
Read : 1276

Get This Book


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.

New Medical Devices

Author : Karen B. Ekelman
ISBN : NAP:13522
Genre : Medical
File Size : 45. 22 MB
Format : PDF
Download : 834
Read : 665

Get This Book


As in other areas of technological advance, the benefits of new medical devices are not without cost and raise many issues for study. We know that certain medical devices, such as the computed tomographic scanner, have reduced the net cost of treating som diseases. But how are other new technologies related to the rising cost of health care, and how can we ensure the most cost-effective use of new equipment? How can we promote innovation in medical technologies when the trends in the judical application of tort law have made industries hesitant to develop products for which profits may be modest and liabilities severe? The symposium considered topics in three general areas, which make up the three major devisions of this volume. These topics are 1) innovation and use of new medical devices; 2) current trends in federal and private support of technological innovation, medical device regulation, product liability, and health care reimbursement; and 3) several perspectives on how these trends interact to influence the availability and appropriate use of new medical devices.

Drug And Medical Device Product Liability Deskbook

Author : James Beck
ISBN : 1588521214
Genre : Medical
File Size : 42. 64 MB
Format : PDF, ePub, Mobi
Download : 763
Read : 150

Get This Book


This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.

Developing New Contraceptives

Author : Committee on Contraceptive Development
ISBN : 9780309564526
Genre : Medical
File Size : 37. 51 MB
Format : PDF, Kindle
Download : 781
Read : 949

Get This Book


There are numerous reasons to hasten the introduction of new and improved contraceptives--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 contraceptives--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 States--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 researchers--everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.

Law And The Regulation Of Medicines

Author : Emily Jackson
ISBN : 9781847319098
Genre : Law
File Size : 85. 12 MB
Format : PDF, Kindle
Download : 413
Read : 1315

Get This Book


The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

The Law And Ethics Of The Pharmaceutical Industry

Author : M.N.G. Dukes
ISBN : 0080459366
Genre : Medical
File Size : 31. 98 MB
Format : PDF, Docs
Download : 720
Read : 1294

Get This Book


As 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

Perspectives On Causation

Author : Richard Goldberg
ISBN : 9781847318268
Genre : Law
File Size : 85. 69 MB
Format : PDF, ePub, Mobi
Download : 105
Read : 382

Get This Book


The chapters in this volume arise from a conference held at the University of Aberdeen concerning the law of causation in the UK, Commonwealth countries, France and the USA. The distinguished group of international experts who have contributed to this book examine the ways in which legal doctrine in causation is developing, and how British law should seek to influence and be influenced by developments in other countries. As such, the book will serve as a focal point for the study of this important area of law. The book is organised around three themes - the black letter law, scientific evidence, and legal theory. In black letter law scholarship, major arguments have emerged about how legal doctrine will develop in cases involving indeterminate defendants and evidential gaps in causation. Various chapters examine the ways in which legal doctrine should develop over the next few years, in particular in England, Scotland, Canada and the USA, including the problem of causation in asbestos cases. In the area of scientific evidence, its role in the assessment of causation in civil litigation has never been greater. The extent to which such evidence can be admitted and used in causation disputes is controversial. This section of the book is therefore devoted to exploring the role of statistical evidence in resolving causation problems, including recent trends in litigation in the UK, USA, Australia and in France and the question of liability for future harm. In the legal theory area, the so-called NESS (necessary element in a sufficient set) test of causation is discussed and defended. The importance of tort law responding to developing science and observations from the perspective of precaution and indeterminate causation are also explored. The book will be of interest to legal academics, policy makers in the field, specialist legal practitioners, those in the pharmaceutical and bioscience sectors, physicians and scientists.

Top Download:

Best Books