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A tale of six implants: The Perez v. Wyeth Laboratories norplant case and the applicability of the learned intermediary doctrine to direct-to-consumer drug promotion

机译:六个植入物的故事:Perez诉Wyeth实验室norplant案,以及所学的中介理论对直接面向消费者的药物推广的适用性

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The issue in the Perez case of"whether the learned intermediary doctrine should bc modified with respect to the direct-to-consumer (DTC) advertising of prescription drugs" remains an issue of "general public importance that affects the health and well being of the consuming public." The suit started in May 1995 when plaintiffs filed suit against Wyeth-Ayerst in New Jersey alleging failure to warn about the side effects of Norplant. By 1999, 25 cases involving 46 plaintiffs had been consolidated in Middlesex County, New Jersey. The plaintiffs insisted that when manufacturers such as Wyeth-Ayerst engage in DTC advertising they must warn patients, as well as physicians, of potential side effects (see below). Traditionally, under the learned intermediary rule, a drug manufacturer is not liable for injury to a patient, provided that the company has provided adequate warning to that patient's physician. Citing In re Norplant Products Liability Litigation the plaintiffs asked the court to decide whether the learned intermediary rule applied to Norplant. The Texas court had ruled that the learned intermediary doctrine did apply and granted summary judgment to Wyeth-Ayerst; the plaintiffs did not wish to proceed further if the courts in New Jersey concurred. With Wyeth-Ayerst's consent, the court selected five "bellwether" plaintiffs, including Saray Perez, as test cases to decide whether the learned intermediary doctrine should apply to Norplant directly advertised to consumers.
机译:在Perez案中,“是否应就处方药的直接面向消费者(DTC)的广告对学到的中介学说进行修改”的问题仍然是“影响公众健康和福祉的一般公共重要性问题”。消费大众。”该诉讼始于1995年5月,当时原告在新泽西州对惠氏(Wyeth-Ayerst)提起诉讼,称未能警告Norplant的副作用。到1999年,新泽西州米德尔塞克斯县已巩固了25起涉及46个原告的案件。原告坚持认为,当惠氏(Wyeth-Ayerst)等制造商从事DTC广告时,必须警告患者以及医生潜在的副作用(请参阅下文)。传统上,根据习得的中介规则,药品制造商对患者的伤害不承担任何责任,只要该公司已向该患者的医生提供了足够的警告。以Norplant产品责任诉讼为例,原告要求法院决定所学的中介规则是否适用于Norplant。得克萨斯州法院裁定,确实适用所学的中介理论,并向惠氏-亚耶斯特(Wyeth-Ayerst)做出了简易判决;如果新泽西州的法院同意,原告不希望进一步进行诉讼。在惠氏公司的同意下,法院选择了包括莎莉·佩雷斯(Saray Perez)在内的五名“领头羊”原告作为测试案例,以决定所学的中介理论是否应适用于直接广告给消费者的Norplant。

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