A CT scan revealed stroke in a 60-year-old man found unresponsive in his truck.
“Because his downtime was unknown, we did not give tPA, and ended up getting sued,” says Rhamin Ligon, MD, director of quality and risk management at Maryland Emergency Medicine Network in Baltimore.
The plaintiff attorney challenged the ED’s assumption about the time frame being outside the treatment window for tPA. When the EP was asked if the patient’s wife or employer was called, the answer was no. According to the plaintiff attorney, there was a timeline that perhaps could have been verified putting the patient inside the treatment window for the drug. The ED disagreed, based on the fact that the man’s symptoms started in the morning, and he was found hours later.
Nonetheless, the fact that no one attempted to verify the timeline made the case more difficult to defend. “The lesson for us is: do due diligence, and try to verify the timeline if you can,” Ligon offers.
Most lawsuits involving tPA allege the EP failed to give the drug, or that the drug wasn’t given quickly enough.1
“A big issue we have with strokes is the public perception that tPA cures strokes. The expectation is that people are going to receive the drug and be cured,” says Mark Spiro, MD, chief medical officer of the Walnut Creek, CA-based The Mutual Risk Retention Group.
In reality, a minority of stroke patients receive tPA. Almost all are outside the treatment window or don’t meet the criteria for another reason. “About 80% of our stroke cases are for failure to give tPA, rather than for giving it inappropriately,” Spiro says.
EPs also get sued for giving the drug, too. One such claim involved a woman who was very clear that she understood the risks and wanted to take a chance on tPA. “She went on to bleed and sued us, with a six-figure settlement,” Ligon reports. The time frame became a key issue in this particular case. The patient was expected to barely meet the 4.5-hour time frame, which poses somewhat higher risks for intracerebral hemorrhage than the three-hour timeframe. The orders were written in a timely manner, but by the time the drug was actually given, it was 15 minutes outside the time frame. The plaintiff alleged that this contributed to the patient’s bad outcome.
Ligon says the lesson for EPs is: “Be cognizant that you may write the order at a certain time, but that’s not the time the drug is hung.” Another issue was that the written consent could not be located. The ED chart continued good documentation of the verbal discussion with the patient, and the plaintiff didn’t link the lost consent to causation. Still, the ED is considering some process changes. “We’ve talked about doing an electronic consent, or having another party document in the chart that the consent was obtained,” Ligon says.
Inadequate discussions can trigger malpractice litigation involving tPA and stroke. It’s not enough to simply tell patients or family members that they don’t meet the criteria.
“You need to help them understand why. I don’t know that we always do a good job of that,” says Ligon, who chairs a risk management forum for his health system’s 17 EDs. The group often discusses tPA-related litigation. “Everybody had at least one case where they did give tPA and it was tough to decide to give it, or a case where they didn’t give it and it was a tough decision not to give it,” she recalls.
Visual aids can help convey the realities of the drug to patients and families. Ligon says this is the best way to show that the vast majority of patients don’t exhibit any improvement at all, some are worse off, and some people die after taking the drug. “In my experience, most patients actually decline the drug after learning that,” Ligon notes.
Ligon says clinical decision aids make it less likely the EP will make a mistake. If there is a lawsuit, the EP has good justification for whatever decision they made, one that is backed up by institutional policy. An aid could build in a question such as, “Can you attempt to verify the timeline for this particular patient?”
“It’s not, ‘Did this start within the last three hours?’ ‘No. OK, done.’ It’s asking how was it verified,” Ligon stresses.
If the patient is incapacitated, identifying the surrogate decision-maker can be problematic in the ED. “tPA is considered to be standard of care, at least according to some neurologists, so should I give it if I can’t obtain consent? A faction of folks is starting to say yes,” Ligon says. Some neurologists argue that tPA should be given without consent because it’s the standard of care for stroke, just as an appendectomy would be performed without consent if a patient experienced appendicitis. “Our neurology colleagues are really pushing getting this drug. But they don’t necessarily want to come to the bedside to help us out,” Ligon adds.
Ligon consults with neurology on almost every stroke patient.
“Often, there is nothing else to do, but I just want to make them aware, and see if they would do anything differently.”
- Bruce NT, Neil WP, Zivin JA. Medico-legal aspects of using tissue plasminogen activator in acute ischemic stroke. Curr Treat Options Cardiovasc Med 2011;13:233-239.