Medicinal Product Liability and Regulation

Richard Goldberg

• Publisher: Hart Publishing
• Year: 2013
• Print ISBN: 9781841132518
• eBook ISBN: 9781782251538
• Edition: 1
• Topic: Law
• Subtopic: Tort Law
• Index: Law

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.

Table of contents

• Preliminary pages
• Preface
• Contents
• Table of Cases
• Table of Statutes
• 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 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. Deform: 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 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
• Index