Medicinal Product Liability and Regulation

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.

Auteur

Richard Goldberg is Professor of Law at Durham University.

Contenu

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. 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