A Survey of Lawsuits Filed for the Complaint of Tardive Dyskinesia Following Treatment with Metoclopramide

E. Ehrenpreis, A. K. Bs, A. Bsa, Smith Bsd, W. Bas
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引用次数: 12

Abstract

Background: Tardive dyskinesia (TD) is a severe neurologic adverse reaction occurring with long-term use of metoclopramide. Aim: To examine all reported legal cases involving metoclopramide-induced TD prior to June 16, 2014 in an effort to inform physicians and practitioners of the current legal risks associated with the prescription of metoclopramide. Methods: A search of the Westlaw database for cases that contained the terms metoclopramide and tardive dyskinesia was performed. This dataset was then queried for cases brought against physicians or practitioners. Full length reports were obtained and information was pulled regarding plaintiff demographics, medical specialty of the defendant, plaintiff’s TD symptoms, lawsuit claims, and case outcome. Results: There were ninety-six cases in which patients filed a claim that met our search criteria. Eighty-five cases (88.5%) were brought against the brand name and/or generic medicine manufacturers as failure to warn claims. There were eleven cases brought against physicians or practitioners. Eight of eleven lawsuits (72%), of cases were either dismissed, settled or were in the process of settlement. There has also been an increase in the number of malpractice cases filed related to metoclopramide induced TD since the FDA issued its black box warning in February, 2009. Conclusions: There have been a small number of cases directed at physicians related to the prescription of metoclopramide and the development of TD, most of which were either dismissed or settled.
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甲氧氯普胺治疗后迟发性运动障碍的诉讼调查
背景:迟发性运动障碍(TD)是长期使用甲氧氯普胺引起的严重神经系统不良反应。目的:对2014年6月16日前报告的所有涉及甲氧氯普胺致TD的法律案例进行分析,以告知医生和从业人员目前与甲氧氯普胺处方相关的法律风险。方法:对Westlaw数据库中包含甲氧氯普胺和迟发性运动障碍的病例进行检索。然后对该数据集进行查询,查找针对医生或从业人员的案件。获得了完整的报告,并提取了有关原告人口统计数据、被告的医学专业、原告的TD症状、诉讼索赔和案件结果的信息。结果:有96例患者提出的索赔符合我们的搜索标准。85起(88.5%)案件是针对品牌和/或仿制药制造商未能警告索赔而提起的。针对医生或从业人员的案件有11起。11件诉讼中,有8件(72%)被驳回、和解或正在和解中。自2009年2月FDA发布黑框警告以来,与甲氧氯普胺致TD相关的医疗事故案件数量也有所增加。结论:有少数针对医生的病例与甲氧氯普胺的处方和TD的发展有关,其中大多数被驳回或解决。
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