Future stroke-related litigation against emergency departments (EDs) is likely to be fueled by greater numbers of possible plaintiffs, due to updated recommendations for expanded treatment time windows.1
“New guidelines do create risk. Our pool of potential candidates is larger, and we are moving faster,” says Bryan E. Baskin, DO, FACEP, associate quality improvement officer at the Cleveland Clinic Emergency Services Institute and an attending emergency physician (EP) at Fairview Hospital.
The guidelines are relevant to ED litigation that alleges missed stroke or a delayed diagnosis of such. “It’s good medically, for better outcomes. But it also creates higher expectations from patients,” says Renée Bernard, JD, vice president of patient safety at The Mutual Risk Retention Group in Walnut Creek, CA.
Outdated practices in EDs are legally problematic. “ED providers may be hindered by hospital systems and processes that are typically slow to change. This leaves them in a vulnerable position,” Bernard explains.
The earliest possible administration of tissue plasminogen activator (tPA) is recommended, assuming patients meet criteria. “This can be used to support plaintiff arguments that the EP should have given tPA without consulting neurology,” Bernard offers.
If there is no time to wait for neurology, perhaps because the treatment window is closing fast, it is an easy decision to make. “But if there’s more time to wait, emergency providers may choose to do so, and limit their legal risk,” Bernard counters.
The problem is that every minute the EP waits for neurology, this delays possible life-saving treatment interventions and could lead to worse patient outcomes. Malpractice claims often center on the fact that a stroke patient came to the ED within the treatment time frame, but treatment was administered too late. “The argument is that had it been offered, the outcome would have been better,” Baskin notes.
More patients are candidates for both intravenous (IV) and intra-arterial tPA, as well as endovascular therapy, due to expanded time frames. This means more potential plaintiffs if ED delays happen. Baskin has seen malpractice cases center on these recommendations:
- IV tPA is indicated within three to 4.5 hours (for select patients) from the last known well time;
- For certain strokes, endovascular therapy is indicated for time frames even beyond 4.5 hours.
Baskin says to limit legal risks, EPs should “make sure to consider therapies beyond IV tPA when the patient is a candidate.” This might call for vascular imaging and/or transfer of the patient to a primary stroke center. “Stroke is missed more often in subtle presentations,” Baskin adds.
An example would be a patient presenting with dizziness and subtle neurological changes. Other tricky cases are patients with profound changes such as lethargy and aphasia, who are treated as altered mental status cases instead of acute stroke cases. “When strokes are missed or undertreated, attorneys make the case that acute intervention was not considered due to lack of a thorough history and physical,” Baskin observes.
The plaintiff expert looks for these things in the ED chart: Identification of risk factors, efforts to establish the last known well time, a thorough neurological exam, and a National Institutes of Health Stroke Scale Score. If any of that is missing, it helps the plaintiff attorney to demonstrate that poor care was given. On the other hand, good documentation on these points could discourage the attorney from pursuing a lawsuit in the first place. “Even under tort reforms where non-economic caps exist, these cases hold high indemnity, as long-term care for stroke is costly,” Baskin notes. These are a few issues that arise repeatedly in stroke-related ED malpractice claims:
• ED charts include incorrect time frames for important events. “Time is everything in these cases,” Bernard stresses.
The appearance of any kind of delay (in transfer, treatment, or referral) is problematic for the defense. The precise time of an initial exam, a repeat exam, or when someone noted a change in the patient’s condition can make or break the outcome of a lawsuit.
Time-stamping in the electronic health record (EHR) appears to be exact, but can be misleading. “Providers should not rely on the EHR technology to time their entries for them. This can lead to inaccuracies,” Bernard cautions.
One reason is that EPs often start their documentation at the time of the case, but finalize it hours later. Based on that final timestamp, an egregious delay in care seems to have happened. “Later, when deposed, the provider will recall that there was not a delay in the exam. But there is no evidence in the medical record to support that testimony,” Bernard says.
Each individual keystroke is not timestamped, only the time the note was completed. Judges or juries must decide what to believe: the EP’s version of events, or what the ED medical record shows. Bernard offers two simple options to clear up the situation: “Providers should be aware of how their EHR timestamps [are entered], or — even better — enter the time themselves as part of their note.”
• Family members change their recollection of the last known normal time during their depositions. “We have seen a cluster of these cases,” Bernard says.
Stroke malpractice cases often hinge on the exact time the patient was last seen normal. Plaintiff attorneys use it to prove that the treatment window for tPA ran out during the ED visit.
Defense attorneys use it to show the opposite, that the time frame already ran out by the time the patient arrived at the ED. “Getting a definitive answer is often difficult,” Bernard admits.
Stroke patients’ cognition may be abnormal, or family members may be unsure when symptoms first started. To be sure nothing is missed on this crucial point, EPs can consult with colleagues to see if anything relevant was stated or charted at any time during the ED visit.
“Not only is it better clinical care, it is also a stronger malpractice defense to have a medical record documentation in alignment with other providers,” Bernard explains.
In one malpractice case, a family member at the bedside gave the last known normal time as 8:00 p.m. The ED nurse documented that time. “At the time of deposition, the family member testified to a different time, which helped the plaintiff’s case,” Bernard recalls.
No other providers documented the 8:00 p.m. time. At deposition, the family member claimed that onset of symptoms occurred hours later. The new time put the patient squarely in the treatment window for tPA during the ED visit. The case was resolved with a confidential settlement. “It would have helped our provider to have corroborating documentation from the bedside nurse or another provider,” Bernard adds.
• Some missed stroke claims have involved younger patients who also were intoxicated at the time of the ED visit. “These cases are less common, but they can have devastating outcomes,” Bernard says.
An intoxicated patient makes obtaining an initial neurological exam difficult. “Physicians can miss pertinent findings that would create suspicion for a head bleed,” Bernard says.
• Delays happen because the ED has limited access to imaging or neurology consults. The problem is the EP cannot determine if a stroke patient is a candidate for tPA or surgical interventions. “Rural treating areas are obvious for these hurdles,” Bernard reports.
However, malpractice cases alleging delayed transfer can happen in any ED. “We also see this in systems if the hospital has outsourced neurology consultation services that may not be as responsive in off-hours or on weekends,” Bernard says.
• Charts lack any kind of answers on why a particular test was not obtained. One recent malpractice case involved a patient discharged from an ED with a diagnosis of vertigo. The patient reported blurry vision, eye pain, and dizziness. A head CT revealed no acute abnormalities. The EP noted some mild ataxia with slight unsteady gait, but the neurological exam was otherwise normal.
The next day, the patient collapsed and was brought to another ED. There, staff performed an MRI; stroke was diagnosed. In subsequent litigation, the plaintiff alleged some neurologic deficits, including problems with gait and cognitive function, occurred.
“Ultimately, the patient’s condition stabilized. It was vigorously disputed as to what injury and/or loss of cognitive function, if any, was truly suffered by the patient,” says David A. Depolo, Esq., an attorney with Walnut Creek, CA-based Donnelly Nelson Depolo Murray & Efremsky.
One of the main issues in the case was whether an MRI should have been ordered at the first ED visit, in addition to the CT scan. At the first ED, the ED resident did order an MRI but never was performed because the neurology service deemed the procedure unnecessary. The defense team said it would not have mattered anyway.
“The defense argued that there was no treatment option that would have arrested the further development of problems that occurred,” says Depolo, who represented both the EP and hospital.
The plaintiff attorney contended the standard of care required the MRI to be performed at the first ED visit, based on the patient’s history and clinical findings. The defense countered that the patient was outside the treatment window for tPA, and that the poor outcome could not have been stopped regardless.
Initially, the EP was the main focus of the litigation. “It morphed into a case against the neurological team, because they made the decision to cancel the MRI,” Depolo reports.
The plaintiff’s expert, a well-respected neurologist, testified that the MRI should not have been canceled because it would have showed signs of stroke. Also, the neurologist testified that immediate treatment would have minimized the bad outcome. Finally, had the stroke been diagnosed, the neurologist said blood pressure medications (which the ED team decreased) would have been kept at the same level to maintain adequate perfusion, thereby preventing further injury.
“Ultimately, the case settled for an amount substantially below the plaintiff’s original demand, and consistent with the costs that would have been incurred had the matter been taken to trial,” Depolo says.
The lawsuit focused on why the ordered MRI was canceled. The ED chart was silent on this point, with no documentation of the conversation between the EP and neurologist. “There was no recall of the discussion, and poor documentation to support the reasoning behind the discontinuation of the MRI order. This would have been immensely beneficial to the case,” Depolo explains.
Even a minimal statement such as “Discontinued MRI order, Clinical exam does not warrant study” could have helped the defense. From the EP’s perspective, it points to the importance of explaining why a test that was considered never happened.
“If you are going to make an important decision on a study, the reason for your decision-making is always a good thing to document if you can,” Depolo says.
- Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2019;50:e344-e418.