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aged manufacturers from developing these litogens. Product liability has also slowed other areas of research such as vaccines, Acquired Immune Deficiency Syndrome (AIDS), maternal drugs, and chemotherapy and has driven other products from the market (e.g., Bendectin). A February 1990 report by the National Research Council concluded that U.S. manufacturers might be unwilling to develop new contraceptive products for fear of product liability suits [6]. In fact, since 1970, the number of major U.S. pharmaceutical companies involved in contraceptive R & D has dropped from 20 to just two [7]. |
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A. Basis of Liability in Drug Development |
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Pharmaceutical product liability lawsuits may be brought under a variety of theories including negligence in the design, testing, and manufacture of the product; strict liability for defective design or failure to warn; breach of express or implied warranty; fraud; and deceit and misrepresentation for a misbranded or deceptively advertised product. Defenses vary by jurisdiction but may include lack of appropriate proof of causation; assumption of the risk or contributory negligence; statute of limitations; and inability to identify a tortfeasor (e.g., multisource product). In some cases manufacturers have been relieved of liability by statute (e.g., Swine Flu Act) [8]. |
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Strict liability in tort, as outlined by Restatement (Second) of Torts Section 402A, states that the seller of a defective and unreasonably dangerous product is liable for injury caused by the product [9]. The idea behind strict liability was to make the manufacturer carry the liability risk because the manufacturer was in the best position to allocate the risk more broadlyby increasing the price of the product and buying insurance [10]. A significant exception applying to pharmaceuticals is found in Comment K following Section 402A. Comment K exempts manufacturers of prescription drugs from strict liability for design defect, provided their products are properly prepared and contain appropriate directions and warnings of any known or knowable dangers that reasonably might be expected from their use. Comment K describes such products as unavoidably unsafe [11]. |
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Manufacturers have affirmative duties to convey accurate information about their products. Fraud, deceit, misrepresentation of a material fact can occur via the product literature, sales personnel or other company representatives, advertisements and other product promotion. One of the major advantages of filing suit on the basis of intentional torts such as these is the possibility of obtaining an award of punitive damages. |
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In drug product liability litigation, the breach of warranty theory is generally asserted along with other theories. In warranty liability, no proof of negligence is necessary. The claimant does not have to prove that a manufacturer was aware of the product defect or should have discovered it. Liability for breach |
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