Description
Bloomsbury Publishing PLC Medicinal Product Liability and Regulation by Richard Goldberg
The development of product liability law in Europe has its origins in the tragic appearance of the thalidomide drug in 1962. What happened as a result has shaped product liability law ever since especially for victims of drug-induced injury. This work addresses the complex problems arising in claims for drug-induced injury highlighting the interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability claimants may have great difficulty in showing that the relevant product is defective and that it caused the damage. The development risk defence may also need to be overcome. These problems are addressed comparatively and the question asked whether medicinal products should be treated as a special case in the field of product liability. The book also examines the role of epidemiological evidence in causation in the light of developments in the UK USA and France - in particular the difficulty of 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. The MMR litigation is examined as an important case study comparing and contrasting experiences in the UK and USA.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.