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use data and ensure pediatric testing during new drug development for products that have potentially widespread use in children. |
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While manufacturers have not faced substantial litigation by clinical trial participants, inclusion of women or pediatric patients in early clinical trials may change that. There is a potential risk that any birth defect that occurs in the child of a woman who conceives while on an investigational drug could result in a lawsuit against the manufacturer by the offspring. Under current law, the offspring of women participating in clinical trials have the right to sue if health problems result. Additionally, approximately forty states allow suits on behalf of the fetus. This might be a problem in Phase I if healthy volunteers are involved or if reproductive/teratology animal studies have not been completed. Changes in federal law would be required to decrease any sponsor liability [25]. |
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In addition to regulatory actions, other trends that are shifting liability to pharmaceutical manufacturers include media sensationalization; extremely large settlements and judgments by juries; and contingency fees for plaintiffs' lawyers [1]. Companies are disrupted by the discovery process and the costs for defense are high. |
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The media coverage of AEs can lead to class action suits. In high media profile litigation, the costs to a company's reputation with the financial markets and the public may be astronomical. This has encouraged pharmaceutical product manufacturers to settle instead of defending their products. In the case of Bendectin, the company took the drug off the market in 1983 after 1800 lawsuits had been filed and the company faced increasingly burdensome product liability insurance costs. In Havner v Merrell Dow Pharmaceuticals, a jury ordered the manufacturer to pay $19.2 million to a couple who blamed the drug for their son's club feet [26]. In March 1994, the verdict was thrown out entirely by the Court of Appeals, which found there was no scientific evidence to support the jury's conclusions. The plaintiffs have appealed [27]. |
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The widely prescribed sleeping pill, Halcion demonstrates the potential damage of media coverage. A recurring allegation accuses the company of relying on falsified clinical studies and bribing researchers to hide the truth about Halcion. The FDA was swept into a RICO (Racketeer Influenced and Corrupt Organization) suit, with plaintiffs contending the FDA improperly approved the drug [28]. The RICO Act describes punishable racketeering offenses. Questions were raised over the accuracy of an early Halcion clinical trial in the 1970s, known as protocol 321. The results of this trial were used in the product's NDA [29]. In 1992, an FDA panel found that Halcion was still safe and effective, but told the company to lower initial recommended dosages. Recently, a Federal Tort Claims Act action for $7.5 million was filed by a |
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