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Books > Law > Laws of other jurisdictions & general law > Social law
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Medicinal Product Liability and Regulation (Hardcover, New)
Loot Price: R4,142
Discovery Miles 41 420
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Medicinal Product Liability and Regulation (Hardcover, New)
Expected to ship within 10 - 15 working days
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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.
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