Medicolegal Considerations with Intravenous Tissue Plasminogen Activator in Stroke: A Systematic Review

Hindawi Publishing Corporation Stroke Research and Treatment Volume 2013, Article ID 562564, 6 pages http://dx.doi.org/10.1155/2013/562564 Review Article Medicolegal Considerations with Intravenous Tissue Plasminogen Activator in Stroke: A Systematic Review Archit Bhatt, Adnan Safdar, Dhara Chaudhari, Diane Clark, Amber Pollak, Arshad Majid, and Mounzer Kassab Providence Brain and Spine Institute, Portland, OR 97225, USA Correspondence should be addressed to Archit Bhatt; Received 6 January 2013; Revised 30 April 2013; Accepted 17 June 2013 Academic Editor: Thilo Hölscher Copyright © 2013 Archit Bhatt et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Intravenous tPA (tissue plasminogen activator) therapy remains underutilized in patients with Acute Ischemic Stroke (AIS). Anecdotal data indicates that physicians are increasingly liable for administering and for failure to administer tPA. Methods. An extensive search of Medline, Embase, Westlaw, LexisNexis Legal, and Google Scholar databases was performed. Case studies that involved malpractice litigation in ischemic stroke and thrombolytic therapy were analyzed systematically. Results. We identified 789 ischemic stroke litigation cases, of which 46 cases were related to intravenous tPA and stroke litigation. Case descriptions of 40 cases were available. Data for verdicts were available for 38 patients. The most frequent plaintiff claim was related to failure to administer intravenous tPA (38, 95%). Only 2 (5.0%) claim involved complications of treatment with tPA. Hospitals were defendants in majority of the 36 cases. Physicians were involved in 33 cases. While ED physicians were involved in 25 (60.52%) cases, neurologists were involved in 8 (20.0%) cases. There were 26 (65%) defendant-favored and 12 (30%) plaintiff-favored verdicts. Conclusion. Physicians and hospitals are at an increased risk of litigation in patients with AIS when in IV-tPA is being considered for treatment. While majority of the cases litigated were cases where tPA was not administered, only about 1 in 20 cases was litigated when complications occurred. 1. Introduction Acute Ischemic Strokes (AIS) is the number one cause of morbidity and third leading cause of mortality in the developed world behind heart disease and cancer. Approximately 795,000 cases of strokes occur annually in the United States, of which 610,000 are first ever strokes. Prior to 1995, there was no FDA-approved thrombolytic treatment available for AIS. Between 1991 and 1995, a NINDS sponsored randomized trial [1] was conducted to assess the safety and efficacy of recombinant tissue plasminogen activator (tPA) in patients with AIS, within 3 hours of stroke onset. The results showed that tPAtreated stroke patients were 32 percent more likely to show minimum or no disability at 3 months (odds ratio 1.7, CI 1.2– 2.6, NNT 8, NNH 16, and ARR 12%), compared to patients who did not get tPA. Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred not only in 6.4 percent of patients given tPA but also 0.6 percent of patients given placebo (𝑃 < 0.001). Mortality at three months was 17 percent in the tPA group and 21 percent in the placebo group (𝑃 = 0.30). Over subsequent years, two trials [2, 3] evaluated tPA within 0–6 hours, showing that tPA isnot efficacious in the expanded time window. However, tPA has recently been shown to be effective in a selected group of stroke patients between 0 and 4.5 hours [4]. A joint report by AHA stroke council and AAN quality standards committee states that tPA should be considered in patients with ischemic stroke within 3 hours [5]. In 2002, the American Academy of Emergency Medicine [6] position statement raised concerns about the risk and benefit ratio of tPA in stroke and debate over whether tPA should be considered standard of care. The statement argued that the National Institute of Neurological Disorders and Stroke (NINDS) study suggested that 8 out of 18 (44%) stroke patients who receive tPA according to a strict protocol recover by three months after the event without significant disability. 2 Whereas, 6 out of 18 (33%) stroke patients (one-third) recover substantially, regardless of treatment, they also indicated that 1 out of 18 patients have a symptomatic bleeding complication. Malpractice is defined as “the failure to meet a standard of care or standard of conduct that is recognized by a profession reaches the level of malpractice when a client or patient is injured or damaged because of error.” The burden of the proof or preponderance of evidence is on the plaintiff, in any medical malpractice litigation. In other words, if a jury believes there is at least 51 percent likelihood that a defendant was negligent or liable, the plaintiff has met its burden of proof and will prevail. This is particularly helpful when juries cannot decide between the testimonies of two expert witnesses presenting opposite opinions or views. In the United States, AIS is the number one cause of disability and morbidity thus attracting medical litigation. A study reviewing malpractice cases in New York State showed that severity of the patient’s disability, not the occurrence of an adverse event due to medical negligence, was predictive of payment to the plaintiff [7]. Frivolous medical malpractice lawsuits are common; consequently, exorbitant amount of human and financial resources is utilized, even if the case eventually is ruled in favor of the defendant [8]. According to the 2009 PIAA Risk Management Review: Neurology Edition (available at http://www.piaa.us) [9], for the year 2008, neurology and neurosurgery had the highest average indemnity of the 28 specialties included in the PIAA review. In the case of tPA and stroke, medical litigation works as a double-edged sword. Frequently reasons cited for litigation in the court of law include lost opportunity to give tPA or adverse events related to tPA. Recent reviews [10, 11] have emphasized that physicians are at risk for malpractice suits both when administering and not administering tPA to AIS patients. Disinclination to use tPA by physicians for legal or clinical reasons may potentially lead to medical malpractice litigation. To date, no systematic reviews have been performed, which evaluate malpractice and thrombolytic therapy in ischemic stroke patients. The objective of this review is to do a systematic evaluation of malpractice cases published in major medical and legal databases. Stroke Research and Treatment Table 1: Malpractice claims. Claim Cases (𝑛, %) Failure to treat with tPA 28, 70% Complication as a result of giving tPA 2, 5% Failure to diagnose 10, 25% Total claims 40 Verdict in favor of (𝑛, %) Of 28 Defendant: 19, 67.9% Plaintiff: 7, 25% NA: 2, 7.1% Of 2 Defendant: 1, (...truncated)