Rachel Forman, MD
When I read the title of this article, the first thing that came to mind was the bleeding risk associated with tPA. After all, we carefully read through the tPA contraindications checklist making sure we will not cause harm to our patients. It turns out that there is a lot more to worry about!
In the article “Systematic Review of Malpractice Litigation in the Diagnosis and Treatment of Acute Stroke,” Haslett et al. discuss characteristics of malpractice cases related to acute stroke management.
It was helpful that the authors first defined some legal terms, specifically that “to prove medical malpractice occurred, a plaintiff must show that during the course of treatment, the physician deviated from the standard of care as defined by the medical community, and that caused injury to the patient.”
The authors queried a variety of online legal databases for jury verdicts and settlements related to medical malpractice and stroke in the United States. Cases included allegations of failure to timely diagnose, timely treat, timely refer to an appropriate doctor, timely transfer, and inappropriate treatment. Only cases in the acute stroke setting were included. Cases related to malpractice leading to a stroke (i.e., chiropractic maneuvers causing dissection) were excluded. They included both ischemic and hemorrhagic strokes, and excluded subarachnoid hemorrhage.
After the screening process, 272 cases were available for analysis (246 related to ischemic stroke and 26 related to intracranial hemorrhage, ranging from 1987 to 2017). Thirty-eight states were represented, with the highest number coming from New York (37 cases), California (34 cases), and Florida (32 cases). The majority of cases (171) occurred at community hospitals. A number of cases were related to a recent procedure (14.7%) such as a carotid endarterectomy or cardiac catheterization. In 36% of cases, the patient had been discharged home and subsequently was discovered to have had a stroke. This last point can open up an entire new discussion on which patients warrant an MRI prior to discharge.
The most common allegation was failure to diagnose and treat. The overall results for ischemic stroke were: 56% in favor of the defendant where no payout was made, 27% settlement outside of court, and 17% trial with a plaintiff verdict. The mean payout for these cases was $1,802,693. The results for hemorrhagic stroke: 46%, 27%, and 27% respectively with median $3,250,000 for payout. Of note, the most common physician defendants were emergency department (33%), primary care (27%), and neurologists (17%). One interesting point was that having a neurologist named as the defendant was more likely to result in a verdict favoring the defendant (63%).
The authors discuss that it will be interesting to observe these trends now that thrombectomy is the standard of care since the positive 2015 trials. There were seven cases related to this (2009-2012): 3 defense verdicts with no payout, 1 case settled, and 3 resulted in plaintiff verdicts (>$3 million). Another interesting statistic was that only 13% of hospitals have the capability to deliver thrombectomy on their own. The concept of failure to timely transfer will likely become a bigger phenomenon; 12% of the cases were related to this.
This article is a good reminder on the importance to clearly document the reasoning for NOT recommending treatment with tPA or thrombectomy in an acute stroke case. It turns out only 1 case in this study was related to tPA complications, and that case was dismissed. It will be interesting to revisit this topic a few years down the road as the thrombectomy landscape continues to change.