Medicinal Product Liability And Regulation

Medicinal Product Liability and Regulation PDF
Author: Richard Goldberg
Publisher: A&C Black
ISBN: 1782251545
Size: 55.20 MB
Format: PDF, ePub
Category : Law
Languages : en
Pages : 242
View: 3376

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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.

Product Liability

Product Liability PDF
Author: Duncan Fairgrieve
Publisher: Oxford University Press
ISBN: 0191669946
Size: 49.71 MB
Format: PDF, Mobi
Category : Law
Languages : en
Pages : 1112
View: 1652

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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.

Perspectives On Causation

Perspectives on Causation PDF
Author: Richard Goldberg
Publisher: Bloomsbury Publishing
ISBN: 1847318266
Size: 70.89 MB
Format: PDF, Kindle
Category : Law
Languages : en
Pages : 478
View: 5203

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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.

Medicine Patients And The Law

Medicine  patients and the law PDF
Author: Margaret Brazier
Publisher: Manchester University Press
ISBN: 1526100517
Size: 41.64 MB
Format: PDF, ePub
Category : Law
Languages : en
Pages : 856
View: 5991

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Embryo research, cloning, assisted conception, neonatal care, saviour siblings, organ transplants, drug trials - modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book, now in its sixth edition, Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The book has been fully revised and updated to cover the latest cases, from assisted dying to informed consent; legislative reform of the NHS, professional regulation and redress; European regulations on data protection and clinical trials; and legislation and policy reforms on organ donation, assisted conception and mental capacity. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.

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: 18.22 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 366
View: 3219

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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.

Private Law In The External Relations Of The Eu

Private Law in the External Relations of the EU PDF
Author: Marise Cremona
Publisher: Oxford University Press
ISBN: 0191062006
Size: 26.13 MB
Format: PDF, ePub, Docs
Category : Law
Languages : en
Pages : 350
View: 4990

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Private Law in the External Relations of the EU is an innovative study of the interactions between EU external relations law and private law, two unrelated fields of law, inverted if private law is understood as regulatory private law - the space where regulatory law intersects with private economic activity. Here the link between the Internal Market and the global market - and thereby international law - is much more prominent. In this book, key questions about the relationship between EU external relations law and private law are answered, including: in what ways might European private law act as a tool to achieve EU external policy objectives, particularly in regulatory fields? How might the quickly developing EU external competence over the procedural dimensions of private law, including private international law, impact on substantive law, both externally and internally? And how is the legal position of private parties affected by EU external relations? In asking these questions, this edited collection opens up a field of enquiry into the so far underexplored relationship between these two fields of law. In doing so, it addresses three different aspects of the relationship: (i) the evolution of the EU competence, (ii) the ways in which EU private law extends its reach beyond the boundaries of the internal market, and (iii) the ways in which the EU contributes to the formation of private regulation at the international level.

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: 66.94 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 1640
View: 1967

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

The Oxford Handbook Of Law Regulation And Technology

The Oxford Handbook of Law  Regulation and Technology PDF
Author: Roger Brownsword
Publisher: Oxford University Press
ISBN: 0191502235
Size: 45.62 MB
Format: PDF, ePub, Mobi
Category : Law
Languages : en
Pages : 1216
View: 5846

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The variety, pace, and power of technological innovations that have emerged in the 21st Century have been breathtaking. These technological developments, which include advances in networked information and communications, biotechnology, neurotechnology, nanotechnology, robotics, and environmental engineering technology, have raised a number of vital and complex questions. Although these technologies have the potential to generate positive transformation and help address 'grand societal challenges', the novelty associated with technological innovation has also been accompanied by anxieties about their risks and destabilizing effects. Is there a potential harm to human health or the environment? What are the ethical implications? Do this innovations erode of antagonize values such as human dignity, privacy, democracy, or other norms underpinning existing bodies of law and regulation? These technological developments have therefore spawned a nascent but growing body of 'law and technology' scholarship, broadly concerned with exploring the legal, social and ethical dimensions of technological innovation. This handbook collates the many and varied strands of this scholarship, focusing broadly across a range of new and emerging technology and a vast array of social and policy sectors, through which leading scholars in the field interrogate the interfaces between law, emerging technology, and regulation. Structured in five parts, the handbook (I) establishes the collection of essays within existing scholarship concerned with law and technology as well as regulatory governance; (II) explores the relationship between technology development by focusing on core concepts and values which technological developments implicate; (III) studies the challenges for law in responding to the emergence of new technologies, examining how legal norms, doctrine and institutions have been shaped, challenged and destabilized by technology, and even how technologies have been shaped by legal regimes; (IV) provides a critical exploration of the implications of technological innovation, examining the ways in which technological innovation has generated challenges for regulators in the governance of technological development, and the implications of employing new technologies as an instrument of regulatory governance; (V) explores various interfaces between law, regulatory governance, and new technologies across a range of key social domains.

Law And Corporate Behaviour

Law and Corporate Behaviour PDF
Author: Christopher Hodges
Publisher: Bloomsbury Publishing
ISBN: 1782255834
Size: 28.65 MB
Format: PDF
Category : Law
Languages : en
Pages : 704
View: 455

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This book examines the theories and practice of how to control corporate behaviour through legal techniques. The principal theories examined are deterrence, economic rational acting, responsive regulation, and the findings of behavioural psychology. Leading examples of the various approaches are given in order to illustrate the models: private enforcement of law through litigation in the USA, public enforcement of competition law by the European Commission, and the recent reform of policies on public enforcement of regulatory law in the United Kingdom. Noting that behavioural psychology has as yet had only limited application in legal and regulatory theory, the book then analyses various European regulatory structures where behavioural techniques can be seen or could be applied. Sectors examined include financial services, civil aviation, pharmaceuticals, and workplace health & safety. Key findings are that 'enforcement' has to focus on identifying the causes of non-compliance, so as to be able to support improved performance, rather than be based on fear motivating complete compliance. Systems in which reporting is essential for safety only function with a no-blame culture. The book concludes by proposing an holistic model for maximising compliance within large organisations, combining public regulatory and criminal controls with internal corporate systems and external influences by stakeholders, held together by a unified core of ethical principles. Hence, the book proposes a new theory of ethical regulation.

Product Liability And Innovation

Product Liability and Innovation PDF
Author: National Academy of Engineering
Publisher: National Academies Press
ISBN: 0309051304
Size: 73.41 MB
Format: PDF
Category : Technology & Engineering
Languages : en
Pages : 216
View: 6434

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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.

Regulation Versus Litigation

Regulation versus Litigation PDF
Author: Daniel P. Kessler
Publisher: University of Chicago Press
ISBN: 0226432211
Size: 60.26 MB
Format: PDF, Kindle
Category : Business & Economics
Languages : en
Pages : 344
View: 1363

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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.

Regulating Patient Safety

Regulating Patient Safety PDF
Author: Oliver Quick
Publisher: Cambridge University Press
ISBN: 0521190991
Size: 53.65 MB
Format: PDF, ePub, Mobi
Category : Law
Languages : en
Pages : 198
View: 5780

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This illuminating study explores the role of professionals, patients, regulation and law in improving patient safety.

Economic Effects Of Product Liability And Other Litigation Involving The Safety And Effectiveness Of Pharmaceuticals

Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals PDF
Author: Steven Garber
Publisher: Rand Corporation
ISBN: 0833079913
Size: 45.13 MB
Format: PDF, Mobi
Category : BUSINESS & ECONOMICS
Languages : en
Pages : 116
View: 2510

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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.