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首页> 外文期刊>Georgetown Journal of International Law >BIG PHARMA'S HEART OF DARKNESS: THE ALIEN TORT STATUTE AND PREVENTING CLINICAL TRIAL COLONIALISM
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BIG PHARMA'S HEART OF DARKNESS: THE ALIEN TORT STATUTE AND PREVENTING CLINICAL TRIAL COLONIALISM

机译：大药房的黑心：外来侵权行为规约和预防临床审判殖民主义

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摘要

In recent years, U.S. pharmaceutical companies have begun to export clinical trial drug research to foreign countries at an alarmingly high rate in an effort to cut costs and quickly introduce new drugs into the market. Alongside this overall numerical increase has been a rise in the documented instances of unethical research practices as well as reported patient injury and death. Because FDA guidelines fail to effectively oversee foreign clinical trials as they happen, foreign participants harmed during the course of clinical trial research must resort to post hoc judicial recourse for protection. The Alien Tort Statute provides for the most effective avenue of recovery for harm resulting from unethical practices "in violation of the law of nations." Abdullahi v. Pfizer set the stage for holding drug companies liable for failure to obtain informed consent from patients during foreign clinical trials. The Second Circuit's recent decision in Kiobel v. Royal Dutch Petroleum Co. to immunize corporations from liability under the ATS, however, has added to the growing body of overall uncertainty surrounding liability under the ATS. Because the economic deterrence model of tort liability demands certainty in the law in order to adequately deter harmful behavior, the Supreme Court must clearly articulate the perimeters of corporate liability under the ATS when deciding Kiobel. Since limiting corporate liability will not deter pharmaceutical companies from employing unethical practices in foreign clinical trials, the Supreme Court, then, must allow for corporate civil liability under the ATS.
机译：近年来，美国制药公司已开始以惊人的高速度向国外出口临床试验药物研究，以努力降低成本并迅速将新药引入市场。伴随着总体数字的增长，记录在案的不道德研究实践以及报告的患者受伤和死亡也有所增加。由于FDA指南未能有效监督外国临床试验的发生，因此在临床试验研究过程中受到伤害的外国参与者必须诉诸事后司法手段寻求保护。 《外国人侵权法》为因“违反国家法律”的不道德行为而造成的损害提供了最有效的赔偿途径。 Abdullahi诉Pfizer为在外国临床试验中未能获得患者知情同意的药物公司承担责任。然而，第二巡回法院最近在Kiobel诉荷兰皇家石油公司一案中裁定，免除ATS项下的责任的公司，这增加了围绕ATS项下责任的总体不确定性。由于侵权责任的经济威慑模型要求法律具有确定性才能充分阻止有害行为，因此，最高法院在决定Kiobel时必须明确阐明ATS规定的公司责任范围。由于限制公司责任不会阻止制药公司在国外临床试验中采用不道德的做法，因此，最高法院必须允许根据ATS承担公司民事责任。

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