Weintraub Michael I
Department of Neurology and Internal Medicine, New York Medical College, Valhalla, NY, USA.
Stroke. 2006 Jul;37(7):1917-22. doi: 10.1161/01.STR.0000226651.04862.da. Epub 2006 May 25.
Despite the success of the 1995 National Institutes of Neurological Disorders and Stroke (NINDS) study using IV recombinant tissue plasminogen activator (tPA) within 3 hours in acute stroke and its subsequent FDA approval, there has been a reluctance to use tPA because of safety and efficacy issues with high incidence of intracerebral hemorrhage, and protocol violations.
The following cases will illustrate the increased number of malpractice lawsuits generated by the controversy of "standard of care" and illustrate and educate clinicians regarding specific issues and how to avoid: (A) Failure to use tPA (loss of chance) or to transfer, Reed versus Granbury Hospital (Texas): acute stroke victim taken to local hospital with tPA available only for cardiology. Wife subsequently transferred patient to nearby stroke center but no tPA given. Defendant verdict; (B) Stroke misdiagnosis (failure to diagnose, loss of chance), Mei versus Kaiser Permanente South (San Francisco, CA): acute stroke while driving with ambulance taking to local hospital. Symptoms were misdiagnosed and neurologist did not see her for 6 hours. Plaintiff verdict; (C) Bleeding complications of therapy/failure of informed consent, Harris versus Oak Valley Hospital (California): acute stroke and hypertension treated with tPA with subsequent development of intracerebral hemorrhage. Patient alleged that tPA should not have been given. Defense verdict; (D) Expert witness testimony, Wojcicki versus Caragher (Massachusetts): a prominent neurologist gave "false and misleading testimony" and the Court found that the neurologist perpetrated a "fraud on the Court" intentionally and deliberately misleading the Court and jury. Court sanctioned the neurologist 88,685 dollars; Ensink versus Mecosta County General Hospital (Michigan): neurological testimony (plaintiff expert) regarding potential benefit of using tPA during last available 1 hour of window was felt to be "speculative". Defendant verdict.
Neurologists, emergency room physicians and hospitals are at increased liability risk if they use or do not use tPA. Detailed documentation, informed consent or timely transfer should reduce threat of legal action.
尽管1995年美国国立神经疾病与中风研究所（NINDS）开展的研究成功证实，急性中风患者在3小时内静脉注射重组组织型纤溶酶原激活剂（tPA）有效，且随后获得了美国食品药品监督管理局（FDA）的批准，但由于脑出血发生率高、存在安全和有效性问题以及违反治疗方案等原因，tPA的使用一直存在阻力。
以下案例将说明因“治疗标准”争议引发的医疗事故诉讼数量增加，并向临床医生阐明具体问题及如何避免这些问题：（A）未使用tPA（机会丧失）或未进行转诊，里德诉格兰伯里医院（得克萨斯州）：急性中风患者被送往当地医院，该院仅有用于心脏病治疗的tPA。患者妻子随后将其转至附近的中风中心，但未给予tPA治疗。被告胜诉；（B）中风误诊（未能诊断、机会丧失），梅诉南加州凯撒医疗集团（加利福尼亚州旧金山）：患者在乘坐救护车前往当地医院途中突发急性中风。症状被误诊，神经科医生6小时后才对其进行诊治。原告胜诉；（C）治疗出血并发症/未获得知情同意，哈里斯诉橡树谷医院（加利福尼亚州）：急性中风和高血压患者接受tPA治疗后发生脑出血。患者称本不应给予tPA治疗。被告胜诉；（D）专家证人证言，沃伊契茨基诉卡拉赫（马萨诸塞州）：一位知名神经科医生提供了“虚假且具误导性的证言”，法院认定该神经科医生故意且蓄意误导法院和陪审团，对法院实施了“欺诈行为”。法院对该神经科医生处以88,685美元的罚款；恩辛克诉梅科斯塔县综合医院（密歇根州）：关于在最后1小时时间窗内使用tPA的潜在益处的神经学证言（原告专家）被认为“具有推测性”。被告胜诉。
神经科医生、急诊室医生和医院在使用或不使用tPA时面临的责任风险都会增加。详细的记录、知情同意或及时转诊应可降低法律诉讼的威胁。
