Medicinal Product Liability And Regulation

Medicinal Product Liability and Regulation PDF
Author: Richard Goldberg
Publisher: A&C Black
ISBN: 1782251545
Size: 61.93 MB
Format: PDF
Category : Law
Languages : en
Pages : 242
View: 810

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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

Drug and Medical Device Product Liability Deskbook PDF
Author: James Beck
Publisher: Law Journal Press
ISBN: 9781588521217
Size: 66.65 MB
Format: PDF, ePub
Category : Medical
Languages : en
Pages : 1640
View: 4190

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

Product Liability

Product Liability PDF
Author: Duncan Fairgrieve
Publisher: Oxford University Press
ISBN: 0191669946
Size: 38.92 MB
Format: PDF, Mobi
Category : Law
Languages : en
Pages : 1112
View: 4174

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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.

Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad PDF
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030922408X
Size: 73.59 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 366
View: 4091

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A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

Product Liability And The Economics Of Pharmaceuticals And Medical Devices

Product Liability and the Economics of Pharmaceuticals and Medical Devices PDF
Author: Steven Garber
Publisher: Rand Corporation
ISBN:
Size: 75.70 MB
Format: PDF, Mobi
Category : Business & Economics
Languages : en
Pages : 227
View: 118

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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.

Medicines Medical Devices And The Law

Medicines  Medical Devices and the Law PDF
Author: John O'Grady
Publisher: Cambridge University Press
ISBN: 0521292514
Size: 80.84 MB
Format: PDF, ePub, Docs
Category : Law
Languages : en
Pages : 428
View: 2154

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The need for specialist knowledge of the laws governing the regulation of medicines has become apparent. This is the case among not only lawyers but also hospitals, researchers, prescribers and many others involved in the provision of healthcare. Such a need has been precipitated by a number of factors, including the changing structure of healthcare in the UK and Europe and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. However, the information available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book aims to address this situation by bringing together the knowledge of the laws governing the regulation of medicines ranging across the field from the ethics of the use of medicines in treatment and research, through to drug-induced injury, civil liability and no-fault compensation schemes.

The Medical Device Industry

The Medical Device Industry PDF
Author: Norman F. Estrin
Publisher: CRC Press
ISBN: 9780824782689
Size: 33.77 MB
Format: PDF, Kindle
Category : Medical
Languages : en
Pages : 976
View: 269

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Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach

Product Liability And Innovation

Product Liability and Innovation PDF
Author: National Academy of Engineering
Publisher: National Academies Press
ISBN: 0309051304
Size: 52.80 MB
Format: PDF
Category : Technology & Engineering
Languages : en
Pages : 216
View: 1949

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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.

Medicolegal Essentials In Healthcare

Medicolegal Essentials in Healthcare PDF
Author: Jason Payne-James
Publisher: Cambridge University Press
ISBN: 9781841101705
Size: 23.34 MB
Format: PDF, ePub
Category : Law
Languages : en
Pages : 260
View: 222

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Medicolegal Essentials in Healthcare provides a concise overview of the most clinically relevant medicolegal issues for healthcare groups in England and Wales, and is a valuable resource for medical, dental and nursing students in training as well as being a useful quick reference for practitioners in these fields. Each chapter is written by a leading expert on the subject, and as such provides up-to-date, concise, and comprehensive coverage, identifying key areas of controversy and enabling readers to put contemporary medicolegal issues into their appropriate clinical context. Key features include: Focuses on issues of immediate relevance to healthcare professionals Chapters written by leading experts in the field A knowledge of medicolegal issues is of increasing importance to all healthcare professionals, as society generally becomes more litigious, and practitioners face the threat of legal claims against them

Drug And Device Product Liability Litigation Strategy

Drug and Device Product Liability Litigation Strategy PDF
Author: Mark Herrmann
Publisher: Oxford University Press
ISBN: 0199750246
Size: 78.55 MB
Format: PDF, ePub, Mobi
Category : Law
Languages : en
Pages : 544
View: 1498

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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.

Drug Injury

Drug Injury PDF
Author: James O'Donnell (Pharm. D.)
Publisher: Lawyers & Judges Publishing Company
ISBN: 0913875279
Size: 67.17 MB
Format: PDF, ePub, Docs
Category : Law
Languages : en
Pages : 894
View: 2091

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If you have an involvement with the health care system, you know that drug-induced injury cases are as complex as they are common. While the injury to the patient might seem obvious, in reality that has very little effect on the course that the litigation will take. This makes it especially important to accurately evaluate the case. You'll want to be sure that the case you take on has merit and will prove economically sound for both you and your client. To successfully accomplish this, you need the knowledge of pharmacy and the drug manufacturing industry that the authors have carefully detailed in this book.Easy for the nonmedical professional to follow, the book is divided into three useful sections. The first section deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. The second section examines high-risk drug therapies that result in pharmaceutical litigation. You'll read about important litigation regarding drugs like Prozac, Accutane and Rezulin, as well as anabolic steroids, insulin and oral diabetic drugs, and more. Whether or not your case involves the drug cited you'll find that the theories applicable to one pharmaceutical case are often applicable to another. The third section of the book looks at the professional pharmacist and malpractice claims. It also includes appendices of FDA regulations relating to drug product liability, guidance for industry, use of risk minimization plans, and FDA pregnancy classifications.You'll find this text indispensable because it provides comprehensive information for all those affiliated with the pharmaceutical industry.New chapters: The failed system of drug warnings in America Clinical research: Testing treatments in humans FDA regulation of clinical investigations Identification of regulated solid dosage forms Evaluation of Causation in drug injury cases The role of pharmacoepidemiology and expert testimony in drug injury E-ferol disaster Drugs for asthma, allerfies and anaphylaxis: Harm from use, misuse and non-use Nephrotoxic drugs Statins and Baycol-Questionable cholesterol The Rezulin litigation Drug-induced movement disorders Ephedra The emergency department pharmacist Drug testing in the workplace

The Eu Environmental Liability Directive

The EU Environmental Liability Directive PDF
Author: Lucas Bergkamp
Publisher: Oxford University Press
ISBN: 0199670013
Size: 26.34 MB
Format: PDF
Category : Law
Languages : en
Pages : 371
View: 713

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The 2004 Environmental Liability Directive (ELD) created a legal regime for the restoration of environmental damage that was novel to all EU Member States. The first volume to provide guidance on interpreting and applying the ELD, this book presents a comprehensive commentary on legal issues arising under the ELD and an overview of administrative, technical, and legal practices in applying the ELD regimes in cases of actual or threatened environmental damage.