Medicinal Product Liability and Regulation

Medicinal Product Liability and Regulation

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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.
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Product details

  • Hardback | 242 pages
  • 172 x 246 x 28mm | 599.99g
  • Hart Publishing
  • Oxford, United Kingdom
  • English
  • 1841132519
  • 9781841132518
  • 1,128,959

Table of contents

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 Overview
I. 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
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Review quote

...the book can be strongly recommended to everyone interested in this important and rapidly evolving compartment of the law. -- Ken Oliphant * Yearbook of European Tort Law *
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About Richard Goldberg

Richard Goldberg is Professor of Law at Durham University.
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