Unrealistic Expectations for tPA Can Lead to Litigation

Make your thought process clear

"It's too bad someone didn't give you thrombolytics, because you probably wouldn't be paralyzed now." Whether it's a nurse, doctor, or someone else making that statement to a stroke patient cared for in your ED, you could end up named in a lawsuit.

"There seems to be more and more litigation surrounding not giving thrombolytics," says Matthew Rice, MD, JD, FACEP, an ED physician with Northwest Emergency Physicians of TEAMHealth in Federal Way, WA. "People's expectation is that this is a magic drug. So, one of the risks for EDs is not giving it when people believe it should have been given."

Victoria L. Vance, JD, a health care attorney with Tucker, Ellis & West in Cleveland, OH, agrees that there is a public perception that tissue plasminogen activator (tPA) is a "magic bullet." Vance is former senior counsel and director of litigation for The Cleveland Clinic Foundation.

"The law lags science. Presently, the allure of the 'clot-busting' drug remains high," says Vance. "There are many reported settlements and verdicts arising out of the failure to give tPA to a stroke patient in the ED."

Evidence Against EDs

Jamison G. White, an attorney at Silverman, Thompson, Slutkin & White in Baltimore, says his firm has successfully handled several cases involving stroke patients who presented to the ED. Most of the lawsuits involved failing to administer tPA.

"It is well known that time is the enemy after any stroke," White says. "In our experience, one of the most powerful pieces of evidence in a case against an ED physician where the issue is failure to timely diagnose and treat a stroke patient, is the failure of the ED physician to order a stat blood draw and/or stat CT scan of the brain in a patient who presented within the 'golden window' of treatment with the recent onset of stroke symptoms."

This is particularly damaging when subsequent CT scans demonstrate that the patient suffered a non-hemorrhagic stroke. "In short, failing to treat a stroke patient with tPA within the golden window when no contraindications existed, runs contrary to the prevailing standard of care today," says White.

White says other strong evidence against EDs would be the failure of the ED staff to timely triage, and/or have a patient who presented with the acute onset of stroke symptoms be seen by a physician, within the golden window for treatment.  

"Common errors that we see in this setting appear to be a failure of ED personnel to appreciate the true nature of a patient's complaints, a mix-up with one patient temporarily confused with another which delays treatment, and overall over-crowding in the ED," notes White. 

The ED records may reveal the lag time between when a patient is triaged and when the appropriate stroke treatment is initiated has pushed a patient from inside to outside the treatment window.

"We have the ability to subpoena the ED's records to see how many patients were triaged and/or treated during the time period that the plaintiff was in the ED, to see if the ED was essentially overwhelmed and this particular patient fell through the cracks so to speak," says White. "What we allege in these lawsuits is a simple failure to timely diagnose and/or treat the patient."

John Burton, MD, chair of the Department of Emergency Medicine at Carilion Clinic in Roanoke, VA, notes that even with over-crowding, the ED must operate a successful triage function to identify patients with conditions that are "time dependent" with regards to therapy.

"Fortunately, there are not many truly time-dependent therapies. Acute myocardial infarction would of course be the classic example," says Burton. "Treatment of ischemic stroke with tPA has effectively evolved, and been represented, as another."

Don't Misuse tPA

Hartmut Gross, MD, a professor of emergency medicine at Medical College of Georgia in Augusta, says that the current legal atmosphere is clearly that you are more likely to be sued for failing to give tPA than giving the drug.

"This is much like after the cardiac tPA recommendations came out," says Gross. "The initial lawsuits were on losing the opportunity to treat, and are still the majority of cases—90% of so, based on what limited literature is out there."

A typical lawsuit involving damage after giving tPA might involve allegations that the patient's blood pressure was uncontrolled, the risks weren't explained, and there is a bad outcome.

Although a blood pressure documented in the patient's chart is difficult to dispute, medical decision making can be more of a grey area. "These cases always come up after several years and your memory is poor. You don't remember exactly what your thinking is," says Gross. "So if you don't give tPA, you need to describe very clearly why it's contraindicated."

In this legal climate, an ED physician may be tempted to err on the side of giving tPA, especially when family members or the patient are demanding it. "But there are risks with tPA treatment, to be sure," says Vance. "These can also have adverse legal, as well as medical, consequences."

For instance, if the stroke is caused by a hemorrhage, rather than a blood clot, tPA is generally contraindicated. "This is because of the high risk that it could cause internal bleeding into the brain, with devastating consequences," says Vance.

Likewise, patients with a history of intracranial hemorrhage or head trauma would be at risk for uncontrolled, and potentially fatal, bleeding if tPA is given, she adds. Pregnancy is a relative contraindication to using tPA because of the potential risks to mother and baby from placental abruption, retroplacental hemorrhage, abortion, or postpartum hemorrhage.

"Misuse of tPA in any of these scenarios is an invitation for claims and litigation," says Vance. She recommends the following to reduce risks:

Follow your ED's stroke and/or tPA protocol.

"Educate your staff on the protocol," says Vance. "Remember, protocols are not inflexible. These must be written as a guide to clinical judgment. Protocols should not be mandatory, or so prescriptive as to foreclose case-by-case decision making."

Remember that even if tPA is given, lawsuits still can arise from the perceived failure to administer the drug quickly enough.

The window of opportunity to administer tPA recently has been expanded from 3 hours to 4.5 hours. Guidelines state that "delays in evaluation and initiation of therapy should be avoided, because the opportunity for improvement is greater with earlier treatment."1 A recent analysis of pooled data from eight clinical trials showed significantly elevated mortality risk among patients who received tPA from 4.5-6 hours after stroke.2

"In a tPA-related claim, the legal retrospective will focus on time," says Vance. "It is advisable to document the timeline of your workup."

Vance says to note the time when the neurologist consult was called, when labs were drawn and results returned, when the patient was sent for and received CT imaging, all nursing interventions, and all physician orders and actions.

Gross notes that while some institutions wait for all laboratory results to come back before giving tPA, this is not his practice. "Unless I suspect an abnormality, I don't wait for the lab results—we just move on to tPA," he says. "The big emergency medicine policymakers generally suggest leaving it up to the individual institutions. However they make their protocols, that will be the standard they'll be held to."

Retain your ED's census records, trauma logs, and duty rosters.

"If a patient-plaintiff ever asks about staffing and acuity levels while questioning the speed of treatment of a particular patient, you will be prepared to respond," says Vance.

Obtain and document an accurate history as to the time of onset of symptoms, to determine if the therapeutic window is still available.

A patient may tell you upon arrival at 3:00 p.m. that their symptoms began at noon, which is carefully documented in the chart. Minutes later, an ED staff member finds out from a family member that the patient's symptoms in fact began hours earlier, so tPA cannot be given. If the time of onset is not corrected in the chart, says Gross, you might later have a hard time defending your decision not to offer the drug.

"Seek out family members, knowledgeable witnesses, or a foreign language translator, as necessary, to get the most accurate and complete history and timeline of pertinent events," says Vance. These may include onset and progression of symptoms, recent head injuries, bleeding problems, bleeding ulcers, trauma, hypertension, and pregnancy.

Carefully document the patient's clinical course in the emergency department.

"If patients are improving, they often do not qualify for tPA," adds Vance.

However, this is not always the case. "Some folks will make the argument 'the symptoms are improving,' so tPA was not given, but that is kind of a vague point," says Gross. "If you have a patient who is rapidly improving, but still seems to park at a fairly high number, most of those folks we will continue to treat. If the patient still has a pretty bad deficit, I would proceed on giving it, and document exactly that."

References

1. del Zoppo GJ, et al. Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator. A science advisory from the American Heart Association/American Stroke Association. Stroke 2009;40:2945-2948.

2. Lees KR, et al. Time to treatment with intravenous alteplase and outcome in stroke: An updated pooled analysis of ECASS, ATLANTIS, NINDS, & EPITHET Trials. Lancet 2010;375:1695-1703.