Medicinal Product Liability and Regulation

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