Did a stroke patient experience a bad outcome in the ED? If tissue plasminogen activator (tPA) wasn’t administered in the ED, without a good reason documented in the chart, a malpractice lawsuit is likely.
“The tPA question remains a prime opportunity for EPs to be second-guessed by plaintiff attorneys after an undesired outcome occurs,” says David S. Waxman, JD, an attorney in the Chicago office of Arnstein & Lehr.
A recent statement from the American Heart Association/American Stroke Association outlines several scenarios in which the eligibility criteria for alteplase (a type of tPA) in acute ischemic stroke could be relaxed.1
“The new statement certainly anticipates increased utilization of tPA for patients over 80,” Waxman notes. This could increase the number of patients who could benefit from the intervention significantly.
“It goes a long way toward challenging the orthodoxy of the three-hour post-symptom onset rule, with an eye toward extending treatment out to 4.5 hours,” Waxman says. This gives plaintiff attorneys an expanded ability to argue that a particular patient should have received tPA, but didn’t.
“When a damaging stroke occurs and tPA is not administered in the ED, counsel will immediately look for documented support for the decision not to intervene,” Waxman warns.
The opposite also is true. If administering tPA results in a damaging bleed, even though it is a well-known complication, “the ED practitioner is immediately subject to criticism for being too aggressive,” Waxman explains. There are now more patients for whom tPA is at least a potential intervention. “Simply as a matter of statistics, even if all of the other risk factors remained constant, there is now a greater population of potential patients who were tPA-eligible but not offered tPA therapy,” says David J. Ryan, JD, a partner at Lewis Brisbois in Portland, OR.
Additionally, there are now more higher-risk patients who potentially are eligible. These patients include the elderly; those suffering from diabetes, hyperglycemia, or hypoglycemia; and even those with prior intracranial hemorrhage as long as it wasn’t recent. “On paper, these patients might be eligible, in the sense that they are no longer subject to an absolute exclusion,” Ryan notes.
Nevertheless, EPs might conclude that the treatment is not justified by the risk-benefit analysis, or is contraindicated by the elevated risk of an adverse event. “A physician who uses discretion to withhold tPA under a risk-benefit analysis no longer can defend the decision by simply pointing to an ‘absolute’ exclusion,” Ryan says. EPs must be able to explain and defend their clinical decision-making.
The same is true for claims alleging that tPA was offered improperly to a high-risk patient who suffered a bad outcome as a result. “These claims also could become more difficult to defend, for the same reason,” Ryan says. The physician can no longer simply justify the decision by saying it complied with inclusion/exclusion criteria, but must explain the risk-benefit analysis. Ryan anticipates that the additional potential recipients will increase the number of potential plaintiffs. In addition, the relaxed eligibility for certain classifications of higher-risk patients could lead to an increase in patients who are not subject to absolute exclusion, but still may be subject to a discretionary exclusion based on the physicians’ risk-benefit analysis. “This leads to more second-guessing,” Ryan adds.
The fragility of the newly eligible population also could affect the potential damages. “In the event of an adverse outcome, the likelihood that the bad outcome could be of a catastrophic nature would seem to increase based on the overall poor health of the claimant,” Ryan offers.
Loss of Chance
Nathaniel Schlicher, MD, JD, MBA, FACEP, says that for EPs, “additional hours of eligibility means more vigilance to consider tPA in a larger pool of patients.”
Thus, EDs’ liability exposure increases for the “failure-to-treat” patient population. “While the data [are] modest for this group, with current loss of chance doctrine litigation in many states, the need for ongoing consideration in this expanded population is real,” says Schlicher, regional director of quality assurance and associate director of litigation support for TeamHealth in Tacoma, WA.
The loss of chance doctrine states that if the patient had already received a poor prognosis, the reduction in prognosis (such as a 15% reduction in survival going from stage 3 to stage 4 cancer) can be compensated for in the setting of negligence, Schlicher explains.
Additional jurisdictions recognize “loss of chance” theories of recovery. “This can be particularly daunting in the case of strokes, where proof of a particular outcome could be a difficult hurdle for a plaintiff,” Ryan explains.
In some jurisdictions, the reduced chance of an optimal outcome (whatever that might look like for any individual patient) may be recoverable. This may be true even if the overall chance of achieving that outcome was less than 50%.
“With scientific literature backing the efficacy of tPA in improving the likelihood of an optimal outcome, even a small-to-moderate improvement of the odds can be legally significant,” Ryan notes.
An EP who determines that a modest chance of benefiting from tPA is outweighed by the inherent risks to justify that conclusion clinically on a standard-of-care basis, Ryan adds. “The ‘no causation’ defense might no longer be available.”
Result: Delayed Diagnosis
Research suggests that EPs face higher risks for failure to administer tPA than if a bad outcome occurs as a result of giving it.2
Alan Lembitz, MD, chief medical officer at COPIC, a Denver-based medical professional liability insurance provider, agrees. “The data and our experience clearly show that litigation is now for failure to consider or to treat in acute neurologic compromise such as stroke.”
Particularly problematic, because of their difficult presentations, are posterior circulation events and posterior circulation dissections. “Sagittal venous thrombosis is also rare, difficult to diagnose, and devastating,” Lembitz notes. The lower threshold for advanced imaging studies such as MRI, magnetic resonance angiography, and magnetic resonance venography has made these diagnoses evident.
“This points to the original ED visit, or visits, as missed opportunities and resultant delayed diagnoses,” Lembitz adds.
Telemedicine with trained stroke neurologists can aid in decision-making and, ultimately, the defense of a malpractice claim against the EP. “Performance of, and documentation of, the neurologic examination is often a focal point in the litigated cases in which these diagnoses were delayed or missed,” Lembitz explains.
In a classic case, an ED patient presents with dizziness. The EP’s note states, “Neuro exam, non-focal,” or “Alert, moves all four extremities,” or something similar. The ED nurse’s note mentions headache or neck ache, but somehow this piece of information is not conveyed to the EP.
“My own experience, in reviewing dozens of such cases, unfortunately, is that either a detailed neuro exam, including elements assessing posterior circulation, was either not done, not documented, or both,” Lembitz says.
In the ED, suspected stroke patients generally don’t undergo a CT of the head, notes Lembitz, “but even if they do, it misses posterior circulation events as high as 30% of the time, per the literature.” Subsequent catastrophic dissection or enlargement of the posterior infarct and serious neurological compromise or death can occur as a result.
“We have been having a stroke neurologist do in-service training to emergency medicine physicians as to how to conduct and document a detailed ED neuro exam,” Lembitz says. A thorough exam usually takes five to seven minutes.
“Some have reported that while they certainly recognize each element of the examination, their skills have atrophied over time,” Lembitz adds.
EPs particularly appreciate the review on how to differentiate central vs. peripheral vertigo. “This is incredibly difficult, even in the most experienced clinician,” Lembitz notes.
Only about 5% of patients with acute ischemic stroke in the United States receive tPA. “The most common exclusion is failure to arrive at the ED in time,” Waxman says. Between 22-31% of patients arrive at an ED within three hours of symptom onset.
“In all instances, defensive charting can be of considerable assistance to the EP,” Waxman offers.
The ED chart should show how the EP determined whether an acute stroke patient was a candidate for tPA. These are some factors that Waxman likes to see documented:
- whether the patient demonstrates clinical improvement;
- whether disqualifying co-morbidities exist;
- the clarity of evidence on the timing of the onset of symptoms.
“Often times, there is no clear answer,” Waxman notes. These two factors can help the ED defense:
1. Good documentation of the EP’s thought process, supporting whichever decision he or she made.
“This can go a long way toward thwarting criticism of their decision,” Waxman explains.
2. Consultation with a neurologist.
When a plaintiff’s attorney is reviewing a post-stroke mishap, Waxman says “there is an enormous difference between a thinly documented decision by an EP faced with a difficult decision, and an EP charting their detailed consultation with a knowledgeable neurologist who was able to guide the EP on whether to pull the tPA trigger.”
EPs often are frustrated when hospitals don’t do more to ensure the availability of neurology consults within the tPA decision-making period. “EPs should be strongly encouraged to raise this issue through their administrative channels,” Waxman underscores.
Not only is the expertise of a consulting neurologist a benefit to the patient, says Waxman, “it clearly has the potential to assist the EP and the hospital, should tPA second-guessing become an issue.”
Patients and juries are more familiar with telemedicine, particularly telestroke consultations with vascular neurologists, Ryan notes. There is a growing expectation that EPs should have access to specialists via this technology.
“Physician documentation also should include a description of whether telestroke consult was considered and if not requested, an explanation for why not,” Ryan adds.
Three Important Things
Schlicher says documenting these three events can be particularly helpful to the ED defense team:
1. Onset of symptoms.
“Failure to document time of onset of symptoms leaves it to recollection and factual arguments that are unlikely to go in the provider’s favor,” Schlicher warns.
Clearly documenting that symptoms started 10 hours prior to arrival at the ED effectively shuts down the plaintiff attorney’s ability to argue tPA should have been administered. “In the opening line of your history of present illness, it indicates that the patient does not qualify,” Schlicher explains.
2. The reason that a patient did not receive tPA.
“Documenting in the medical decision-making with a clear statement of exclusion or in a protocolized checklist can further secure your defense,” Schlicher says.
3. A National Institutes of Health (NIH) Stroke Scale.
Failure to document an NIH Stroke Scale on all patients with possible stroke makes it “pretty easy” for the plaintiff’s counsel to prevail, Schlicher notes. “It’s all in the name. Far too many providers still do not do it, and this is a shame.”
The NIH Stroke Scale helps communicate the extent of the patient’s injury. “It can help defend you in low- and high-score cases where tPA is contraindicated,” Schlicher notes.
Schlicher says that in his experience, a merely catastrophic outcome generally will not result in a settlement, if these items are documented properly.
“These three steps make it harder for a plaintiff’s attorney to want to accept a case where a clinician considered the diagnosis and made a clinical judgment on appropriate treatment,” he adds.
In Ryan’s experience, most “failure to give tPA” cases eventually settle. “In fact, cases with defensible care but catastrophic injuries and potentially significant damage awards are sometimes the best candidates for settlement,” he notes. This is because each side faces massive risks if the case proceeds to trial.
“In such circumstances, one of the important but sometimes forgotten roles of good documentation is to position the case for a favorable settlement,” Ryan offers.
Strong documentation in these cases is a powerful tool for the EP defendant. “It allows defense counsel, a mediator, or the court to create pressure on plaintiff’s counsel to negotiate reasonably because of the risk of a defense verdict at trial,” Ryan adds.
- Demaerschalk BM, Kleindorfer DO, Adeoye OM, et al. Scientific rationale for the inclusion and exclusion criteria for intravenous alteplase in acute ischemic stroke: A statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2016;47:581-641.
- Liang BA, Zivin JA. Empirical characteristics of litigation involving tissue plasminogen activator and ischemic stroke. Ann Emerg Med 2008;52:160-164.
- Alan Lembitz, MD, Chief Medical Officer, COPIC. Phone: (720) 858-6133. Fax: (720) 858-6003. Email: firstname.lastname@example.org.
- David J. Ryan, JD, Partner, Lewis Brisbois, Portland, OR. Phone: (971) 712-2804. Fax: (971) 712-2801. Email: David.Ryan@lewisbrisbois.com.
- Nathaniel Schlicher, MD, JD, MBA, FACEP, Regional Director, Quality Assurance, Associate Director, Litigation Support, SWAT Review Program, TeamHealth, Tacoma, WA. Fax: (865) 560-7100. Email: email@example.com.
- David S. Waxman, JD, Arnstein & Lehr, Chicago. Phone: (312) 876-7867. Email: DSWaxman@arnstein.com.