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胚胎植入前遗传学诊断:新技术面临的诉讼系统性回顾。

Preimplantation genetic diagnosis: a systematic review of litigation in the face of new technology.

机构信息

School of Medicine, The University of Texas Medical Branch at Galveston, Galveston, Texas 77555-0587, USA.

出版信息

Fertil Steril. 2012 Nov;98(5):1277-82. doi: 10.1016/j.fertnstert.2012.07.1100. Epub 2012 Aug 14.

Abstract

OBJECTIVE

To study legal cases against IVF facilities pertaining to preimplantation genetic diagnosis (PGD) misdiagnosis.

DESIGN

Systematic case law review.

SETTING

University medical center using US legal databases.

PATIENT(S): The IVF recipients using PGD services.

INTERVENTION(S): Lawsuits pertaining to PGD against IVF facilities.

MAIN OUTCOME MEASURE(S): Lawsuits, court rulings, damage awards, and settlements pertaining to PGD after the birth of a child with a genetic defect.

RESULT(S): Causes of action pertaining to PGD arise from negligence in performing the procedure as well as failure to properly inform patients of key information, such as inherent errors associated with the PGD process, a facility's minimal experience in performing PGD, and the option of obtaining PGD. Courts have sympathized with the financial burden involved in caring for children with disabilities. Monetary damage awards are based on the costs of caring for children with debilitating defects, including lifetime medical and custodial care.

CONCLUSION(S): Facilities offering PGD services expose themselves to a new realm of liability in which damage awards can easily exceed the limits of a facility's insurance policy. Competent laboratory personnel and proper informed consent--with particular care to inform patients of the inherent inaccuracies of PGD--are crucial in helping deter liability.

摘要

目的

研究涉及植入前遗传学诊断(PGD)误诊的体外受精(IVF)机构的法律案件。

设计

系统的案例法审查。

地点

使用美国法律数据库的大学医疗中心。

患者(s):使用 PGD 服务的 IVF 受者。

干预措施(s):针对 IVF 机构的与 PGD 相关的诉讼。

主要观察指标(s):与出生后具有遗传缺陷的儿童有关的 PGD 后法律诉讼、法院裁决、损害赔偿和和解。

结果(s):与 PGD 相关的诉讼理由源于程序执行中的疏忽以及未能向患者提供关键信息,例如与 PGD 过程相关的固有错误、机构执行 PGD 的经验有限以及获取 PGD 的选择。法院同情照顾残疾儿童所涉及的经济负担。金钱损害赔偿是基于照顾患有致残缺陷的儿童的费用,包括终身医疗和监护护理。

结论(s):提供 PGD 服务的机构使自己面临新的责任领域,损害赔偿很容易超过机构保险政策的限制。合格的实验室人员和适当的知情同意——特别要告知患者 PGD 的固有不准确性——对于帮助阻止责任至关重要。

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