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of warranty arises where persons are damaged because of a product's failure to live up to an express or implied representation of the manufacturer. It is distinguished from negligence liability in that it is not based on fault or failure of a manufacturer to exercise reasonable care. |
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Negligence is a failure to exercise that degree of care that a person of ordinary prudence would exercise under the same circumstances. Liability for negligence in pharmaceutical product cases is most likely to involve a failure to warn, or to warn adequately, of foreseeable harm. Since most theories of liability are based on the negligent failure of the manufacturer to test, discover, or warn, these are discussed in more detail here. |
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The manufacturer has a duty to use reasonable care in the design of the product. According to the Restatement (Second) of Torts, a product is defective if it is in an unreasonably dangerous condition [9]. Proof that a safer alternative design exists or could have been utilized is an important factor [12]. In Brouchu v. Ortho Pharmaceutical Corp., the court allowed the use of the design defect theory because a lower does oral contraceptive was equally as effective in preventing contraception as the higher does pill with less risk of stroke [13]. |
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During the product development phase, a manufacturer is under a legal duty to anticipate both intended and unintended but foreseeable uses of a product. Expensive lawsuits follow when a new drug is removed from the market for adverse experiences (AEs) (e.g., temafloxacin). Building safety into a product is less costly than recalling a product that causes injuries and ensuing litigation [5]. |
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The manufacturer has a duty to ensure that the product is manufactured with reasonably safe materials and materials that are proper for its intended and foreseeable uses [5]. For example, plaintiffs have alleged they contracted polio because a killed virus polio vaccine was contaminated with live polio virus. Recently a settlement was reached in a class action suit brought by hemophiliacs infected with the AIDS virus in the early 1980s when they used anti-hemophiliac blood-clotting factors [14]. |
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The manufacturer has a duty to ensure sound laboratory, clinical trial, and manufacturing processes. Cases have been brought against manufacturers for failure to follow good laboratory practices (GLPs) or good manufacturing practices (GMPs). Appropriate tests and inspections are needed to ensure freedom from manufacturing defects. The manufacturer cannot escape liability by shifting responsibility for product inspection or testing to another (e.g., |
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