MEDICINAL PRODUCT LIABILITY AND REGULATION
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- Author: RICHARD GOLDBERG
- ISBN: 9781841132518
- Availability: In Stock
Buy MEDICINAL PRODUCT LIABILITY AND REGULATION | Law Books , FOREIGN BOOKS
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.