Documentation of legitimate reasons for not administering tPA to a stroke patient is helpful to the EP’s defense, though the EP still may be held liable by a jury. To reduce risks, EPs can:
- Explicitly document the exact reason why tPA is not administered.
- Clearly explain the reasons to the family.
- Bear in mind that contraindications to tPA are evolving rapidly.
The EP failed to diagnose a stroke. The EP diagnoses stroke, but the neurology consult does not recommend tissue plasminogen activator (tPA) use. The EP diagnoses stroke but does not obtain a neurology consult, and decides not to administer tPA. These are typical fact patterns in cases alleging that EPs failed to administer tPA to a stroke patient, says Jonathan A. Edlow, MD, vice chairman of the Department of Emergency Medicine at Beth Israel Deaconess Medical Center in Boston.
In one malpractice case, the EP correctly suspected a stroke and implemented the hospital’s “stroke activation.” This included ordering an immediate CT scan and neurology consultation.
“The neurologist made a determination not to give tPA, but the EP was included in the legal action — although she was ultimately dropped,” Edlow says.
In some cases, the EP has a valid reason for not administering the drug: The patient improves rapidly and is close to normal, or there is ambiguity about the last time the patient was normal. These legitimate reasons are sometimes documented poorly in the ED chart.
“One crucial point is that for every stroke patient, the EP should explicitly document the exact reason why tPA is not being given, even if the EP thinks it is obvious,” Edlow says, noting he has been consulted on multiple malpractice cases in which the ED chart included good documentation of the EP’s reasoning. “There were lots of good reasons for not giving tPA, so the lawyers did not pursue the case.”
Here are some possible defenses to allegations that the EP failed to give tPA:
- The CT showed a hypodensity, which led the EP to question the time of onset.
Normally, the CT takes several hours to become positive.
“If a patient is telling you that the stroke started one hour ago and the CT already shows a significant hypodensity that fits with the clinical deficit, that would make me pause and ask enough questions of the right people so that I am absolutely sure about last time known normal,” Edlow says.
Often, resolving this issue becomes a judgment call.
“As with any high-stakes decision, it’s always best practice to document your medical decision making in the chart,” Edlow says. “Explain your thought process to the patient or family, and document that too.”
- The patient became normal.
“The EP must do a careful neurological exam, and document that it is normal,” Edlow says. “Note that it is also possible to have a stroke with an NIHSS [National Institutes of Health Stroke Scale] of 0, usually in the posterior fossa.”
Edlow says an NIHSS in every stroke patient is “a good idea for the sake of completeness, but also to better communicate with the neurologist and to quantify improvement or worsening.” This means performing a second or third NIHSS test.
Edlow notes that contraindications to tPA are evolving rapidly.
“Some that were contraindications a few years ago are either not now, or have become ‘relative’ ones,” he says.1
EPs sometimes use a patient’s rapidly improving symptoms as a reason not to treat.
“But many of these patients do quite poorly,” Edlow says. “It’s one thing for a NIHSS to go from 15 to 10 — improving but still a big stroke — another to go from 10 to 5 — improving but still a moderate stroke — and quite another to go from 6 to 1 or 5 to 0.”
Plaintiff attorneys often exploit the fact that information becomes available to EPs incrementally.
“It is quite common that the EP is not privy to information that might become available in 30 minutes or in an hour,” Edlow says. By that time, the timeframe for tPA could be over.
“Every EP has had the experience of getting one story from EMS and then a very different story from eyewitnesses,” Edlow says.
The EMS crew might state that the stroke started at 11:30, but when the family arrives, it becomes clear that the patient was found with a deficit at 11:30, but the last time known normal was actually 9:50. Depending on when the patient arrived, that 100-minute change could make the patient ineligible for tPA.
“One trick is to ask the EMS crew to radio the EP with the cell phone number of an eyewitness so that the information can be acquired while the patient is en route,” Edlow says.
Edlow urges staff to presume stroke in every patient presenting with an abrupt onset of a neurological symptom until proven otherwise. For every stroke patient, Edlow says staff should document the following:
- Last time known normal;
- Results of a neurological exam, preferably including an NIHSS;
- Results of a brain imaging study (usually CT) and read by a radiologist or equivalent;
- The reason(s) why tPA was not administered, even if the EP thinks it’s obvious.
Explain Why tPA Can’t Be Administered
Andy Walker, MD, FAAEM, a Nashville, TN-based EP and legal consultant for EPs, says if EPs are not administering tPA, they should communicate the reason why to the patient and the family — and chart the discussion properly when it happens.
“When something is documented in real time, that carries a lot of weight with the jury,” he says. “They take that very seriously.”
Regardless of whether tPA is administered or not, Walker says EPs must prepare the patient and family for the possibility of a bad outcome.
“Make sure they don’t look at tPA like it’s a miracle drug, because it’s not,” he says.
Walker typically tells patients that without tPA the odds of a full recovery are just under 30%, and with tPA, that increases to just over 40%.
“The odds of a good recovery increase by about 12%. Of course, along with that comes the risk of bleeding, which can be devastating,” Walker adds.
Most patients presented with the option of tPA ask Walker what he would do.
“I tell them I would rather be dead than disabled, so I would take tPA thinking that if it didn’t help me, it just might finish me off,” he says. “That puts things in stark terms that they can understand.”
If the patient doesn’t meet eligibility criteria for tPA, “you’ve got to explain why,” Walker says. “Document that you’re aware of it, you’ve thought of it, and that they don’t qualify.”
Walker says this type of clear communication is the best way to avoid lawsuits involving tPA.
“Thoroughly explain your reasoning in the chart, because any bad outcome can get you sued,” he says. “And with a stroke patient, odds of a bad outcome are better than 50% no matter what you do.”
One EP chose not to offer tPA because the patient was rapidly improving and appeared to be making a full recovery. However, once hospitalized, the patient got worse and had a bad outcome; the family sued the EP.
“Nowhere on the chart did the EP specifically state, ‘I chose not to offer tPA because of the patient’s rapid and dramatic improvement,’” Walker explains. Lack of serial neurological exams complicated the EP’s defense.
“To understand what was going on, you had to cobble it together from a combination of brief doctor examinations and nursing notes,” Walker says. “It made the case much harder to defend.”
Damaging Expert Testimony
Even a well-documented, valid reason for not administering tPA is no guarantee a jury won’t rule against an EP. Walker says this is especially true “in the face of a living but permanently disabled patient and a plaintiff’s expert who will say anything for money.”
Walker has seen multiple plaintiff’s experts blatantly misrepresent the data on tPA.
“Some make unjustified statements about what the outcome would have been, had tPA been given,” he says.
While some studies show no benefit from tPA, others do. The original National Institute of Neurological Disorders and Stroke study showed an improvement in outcome from about 26% of stroke patients making a full or good recovery to about 39%.2
“Proponents of tPA, especially expert witnesses for plaintiffs, emphasize tPA’s relative improvement over placebo of 33% rather than the much more modest-sounding absolute improvement of just 13%,” Walker notes. In addition, he says, plaintiff experts “completely ignore the fact that even with tPA, the odds of a bad outcome — failure to make a good or full recovery — are greater than 50%.”
Some neurologists testify that a stroke patient probably would have gone home without a deficit if the EP had just given tPA.
“Unfortunately, in most states, neurologists and other people who aren’t EPs can testify as to the standard of care in emergency medicine,” Walker says. “They show up in court saying more or less if the EP had only given tPA, this patient would have walked out of the hospital as good as new.”
The expert might say, for instance, “Just last week I gave it to a stroke patient who was completely paralyzed on the right side and couldn’t speak a word. That patient walked out of the hospital completely fine.”
“They tell stories that are isolated bits of truth, but don’t really reflect reality,” Walker explains. “It’s hard to keep that kind of expert testimony out of trial.”
The defense’s experts can only counter such testimony by “telling the statistical truth,” Walker says. “They explain that tPA does provide some net benefit.”
Defense experts point out that there are significant risks and many exclusions with tPA; in fact, most people aren’t eligible.
“The problem is that now the jury has experts from each side saying completely different things,” Walker says. “You never know what they are going to do in that situation.”
- 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.
- [No authors listed].Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 1995;333:1581-1588.