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Can civil lawsuits stem the tide of direct-to-consumer marketing of unproven stem cell interventions
npj Regenerative Medicine ( IF 6.4 ) Pub Date : 2018-02-19 , DOI: 10.1038/s41536-018-0043-6
Claire Horner , Evelyn Tenenbaum , Douglas Sipp , Zubin Master

The sale of unproven stem cell interventions (SCIs) by commercial entities has proliferated in highly developed countries, most notably in the USA. Yet, there have been few criminal prosecutions and regulatory enforcement actions against providers who have violated laws and best practice standards due to the lack of resources and legal ambiguity. While the stem cell research community has invested much in protecting patients and preventing the growth of this industry, some patients are seeking remedies under civil law to hold stem cell clinics responsible for fraudulent practices. Several patients have filed lawsuits against providers demanding compensation for physical injuries caused by unproven treatments and financial losses due to fraud and false advertising. Lawsuits can be used as a tool not only to compensate plaintiffs but also to achieve positive public health and policy outcomes. In this paper, we explore the value of a public health litigation strategy as a countermeasure against the exploitative practices of the unproven SCI industry by analyzing stem cell lawsuits and comparing them with other major public health litigation efforts. We argue that stem cell lawsuits complement other approaches to reining in unsafe practices. In particular, stem cell lawsuits could intensify publicity and raise awareness of the harms of unproven treatments, set legal precedent, reshape the media narrative from one focused on the right to try or practice to one highlighting the need for adequate safety and efficacy standards, and encourage authorities to turn their attention to policy reform and enforcement.



中文翻译:

民事诉讼能否阻止未经证实的干细胞干预措施直接面向消费者推销

商业实体对未经证实的干细胞干预措施(SCI)的销售在高度发达国家(尤其是在美国)激增。然而,由于缺乏资源和法律模棱两可,几乎没有针对违反法律和最佳实践标准的提供者提起刑事诉讼和监管行动。尽管干细胞研究界在保护患者和阻止该行业的发展方面投入了大量资金,但一些患者正在根据民法寻求补救措施,要求干细胞诊所对欺诈行为负责。有几例患者提起诉讼,要求提供者赔偿因未经证实的治疗方法造成的人身伤害,以及由于欺诈和虚假广告造成的经济损失。诉讼不仅可以用作赔偿原告的工具,而且可以用作实现积极的公共卫生和政策成果的工具。在本文中,我们通过分析干细胞诉讼并将其与其他主要的公共卫生诉讼努力进行比较,探讨了公共卫生诉讼策略的价值,作为对未经证实的SCI行业的剥削实践的对策。我们认为,干细胞诉讼是对控制不安全做法的其他方法的补充。特别是,干细胞诉讼可能会加强宣传并提高人们对未经证实的治疗方法的危害的认识,树立法律先例,将媒体的叙述从侧重于尝试权或实践权重塑为强调适当安全性和有效性标准的必要性,以及鼓励当局将注意力转移到政策改革和执行上。

更新日期:2018-02-19
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