Medicinal Product Liability and Regulation
Autor Richard Goldbergen Limba Engleză Hardback – 9 oct 2013
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Specificații
ISBN-13: 9781841132518
ISBN-10: 1841132519
Pagini: 242
Dimensiuni: 171 x 244 x 23 mm
Greutate: 0.61 kg
Ediția:New.
Editura: Bloomsbury Publishing
Colecția Hart Publishing
Locul publicării:London, United Kingdom
ISBN-10: 1841132519
Pagini: 242
Dimensiuni: 171 x 244 x 23 mm
Greutate: 0.61 kg
Ediția:New.
Editura: Bloomsbury Publishing
Colecția Hart Publishing
Locul publicării:London, United Kingdom
Caracteristici
This monograph seeks to determine whether medicinal products should be treated as a special case in the field of product liability.The author 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 and France.An interesting and useful analysis for all those working in the field of medical law.
Notă biografică
Richard Goldberg is Professor of Law at Durham University.
Cuprins
Introduction 1. Medicinal Product Liability in Context I. Introduction II. Historical Background: A Special Case? The Unique Characteristics of Medicinal Products III. Position Under the Product Liability Directive and the Consumer Protection Act 1987 IV. Vaccine Damage V. European Pharmaceutical Product Liability Regimes VI. Reform VII. Conclusion 2. Defective Medicinal Products in the US and UK: An OverviewI. Introduction II. Defective Medicinal Products in the US III. Defective Medicinal Products in the UK IV. Conclusion 3. Design Defects and Medicinal Products I. Introduction II. Design Defects and Pharmaceutical Products: The US Experience III. Design Defects and Pharmaceutical Products Under the Product Liability Directive IV. Reform: A Net Benefit Approach to Drug Design Defects or Combined Consumer-Expectations Risk-Utility V. Conclusion 4. Warning and Instruction Defects and Medicinal Products I. Introduction II. Warning and Instruction Defects and Pharmaceutical Products: The US Experience III. Warning and Instruction Defects and Pharmaceutical Products Under the Product Liability Directive IV. Conclusions 5. Causation, Risk and Epidemiological Evidence in Medicinal Product Liability Litigation: Law's Coming of Age I. Introduction II. Reconciling the Standards of Proof in Law and Science in the UK III. Conclusions 6. The Rise and Fall of the MMR Litigation: A Comparative Perspective I. Introduction II. Background: The Vaccines and Autism Controversy III. UK MMR Litigation IV. The US Omnibus Autism Proceeding Test Cases V. A French Comparison: The Liberal French Approach to Hepatitis B Vaccine and Demyelinating Diseases Using Presumptions of Causation VI. MMR and the General Medical Council VII. Conclusion 7. Regulatory Compliance and Medicinal Product Liability I. Introduction II. Compliance with Common Practice Regulatory and Statutory Standards III. Defect Attributable to Mandatory Statutory or Community Requirements IV. Federal Preemption and Prescription Drugs V. A Regulatory Compliance Defence for Medicinal Products VI. Conclusion 8. The Development Risk Defence and Medicinal Products I. Nature and Scope of the Defence II. Infringement Proceedings in the European Court of Justice: Commission v United Kingdom III. European Commission Reform Proposals IV. Defects Which Might be Expected to be Discovered V. The Meaning and Implications of Scientific and Technical Knowledge VI. Defects Which are Known of, but Undetectable in any Particular Case VII. Conclusion 9. Conclusion
Recenzii
...the book can be strongly recommended to everyone interested in this important and rapidly evolving compartment of the law.
Descriere
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.