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excipient manufacturer) [5]. Similarly, releasing a product for commercial distribution in the face of certain danger signs emanating from the test results could lead to product liability. |
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In addition to quality control testing, there is also a duty to test for safety during the preclinical and clinical product development phases. The manufacturer must test not only for apparent dangers of an investigational product but also for those dangers it should have discovered. In Barson v. ER Squibb & Sons, the company was liable for failure to conduct teratology tests that were not required by the Food and Drug Administration (FDA) at that time [15]. In Tinnerholm v Parke-Davis & Co., the manufacturer was liable for negligent failure to test a drug under foreseeable market conditions [16]. Inadequate preclinical testing, failure to monitor AEs, failure to keep abreast of relevant scientific literature may all lead to a failure to test causation. |
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Satisfaction of the FDA requirements regarding testing will not protect the manufacturer from liability for failure to test [12]. Further, New Drug Application (NDA) test results are available to plaintiffs through discovery and the Freedom of Information Act (FOIA). |
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4. Inadequate Directions for Use, Labeling, and Advertisements |
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Most pharmaceutical product liability cases are based on a failure to adequately warn theory. Inadequate, outdated, or nonexistent product instructions or warnings may lead to liability. Under strict liability, even if a product is perfectly manufactured, it can be considered defective and unreasonably dangerous if not accompanied by adequate warnings. Some products are considered unavoidably unsafe and warning labels on these products eliminate or significantly reduce strict liability [5,9]. Manufacturers are exempt from failure to warn liability for unknown risks, as in those not yet detected for an investigational new drug (IND). However, in a number of court cases, product overpromotion (e.g., lack of fair balance) has been found to nullify the effect of adequate warnings. |
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B. Factors Shifting Liability to the Manufacturer |
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1. Adverse Experience Reporting Regulations |
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A number of factors are shifting product liability to the manufacturer. In general, failure of a pharmaceutical company to properly state the results of clinical trials constitutes fraud. Cases of mysterious vandalism of clinical investigator offices on the eve of FDA audits on the quality of data collected in support of NDAs have occurred [17]. Fraudulent data were recently associated with the National Surgical Adjuvant Breast and Bowel Cancer Project. Although safety testing fraud remains a problem, a company may inadvertently fail to link an investigational drug with an AE, as in the recent case of deaths |
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