ED physicians more often sued for not giving tPA for stroke
Controversy engenders "incredible amount of liability"
Emergency physicians are much more likely to be sued for not administering tissue plasminogen activator (tPA) to stroke patients, than for giving the drug, says a new study.1 Of 33 lawsuits involving tPA and ischemic stroke, 88% claimed that injury resulted from failing to treat with tPA, with emergency physicians named in 19 of the cases. While defendants prevailed in 21 (64%) of the cases, of the 12 who lost, 83% involved failure to treat, while two (17%) claimed injury from treatment with tPA.
Only five of the cases occurred during the five years after tPA was approved, with the other 28 cases occurring over the next five years. According to the researchers, these numbers suggest that patients and their attorneys are becoming more likely to hold EDs liable when tPA is not used.
ED physicians reluctant to treat
Diagnostic uncertainty combined with treatment that has the potential to harm the patient makes many ED physicians reluctant to give tPA, says Edward Jauch, MD, MS, assistant professor in the department of emergency medicine at the University of Cincinnati and a member of the Greater Cincinnati/Northern Kentucky Stroke Team.
"This is a therapy which has some perceived risk, and the risk is real," he says. "But the reality is, you are far more likely to be sued for failing to offer therapy than you are for inappropriately treating or having a complication."
In addition, tPA has a narrow therapeutic window, and neurology consultation and input often is not available in a timely manner. "One of my own personal crusades is to improve the general training of emergency physicians in neurologic emergencies," says Jauch. "Many emergency physicians are uncomfortable diagnosing a stroke solely based on their clinical examination, especially when there is often no confirmatory test for stroke available acutely."
Jauch says he has treated about 150 stroke patients with tPA in the past 12 years. "I'm a firm believer that in an appropriate patient, tPA has a role," he says. "I would want it for myself and for my family, if they were appropriate candidates."
The controversy over tPA is, in a way, "the perfect storm," says Jauch. "There really isn't anything that is comparable in terms of its divisiveness. It also exposes ED physicians to significant potential liability, which is only going to get worse. I think the legal community is starting to wake up to this."
Lack of treatment not surprising
It's true that fear of a lawsuit plays a role in the clinical decision-making of some ED physicians, but there are other clinical issues that explain why a patient may not be treated, according to Arthur Pancioli, MD, associate professor and vice chairman of the department of emergency medicine at the University of Cincinnati (OH).
"I believe that the most common reason that emergency physicians do not give tPA to stroke patients is that relatively few patients are truly candidates," he says.
Even in systems with very efficient stroke teams in place, less than 10% of ischemic stroke patients actually receive tPA.2
"This has significant implications," says Pancioli. "Even in very busy systems, an emergency physician will be involved in this treatment relatively rarely." Intracerebral hemorrhage, which generally leads to death or worsening disability, occurs in 5.2% to 6.4% of patients.3,4
This leaves ED physicians in a situation in which they are asked to make a high-stakes decision about a therapy with significant risk. They must make a clinical diagnosis of ischemic stroke quickly while ruling out other possibilities, while also considering that the clinical spectrum of ischemic stroke is "enormous," says Pancioli.
"They must also have available both rapid imaging and consultants to allow this type of care to be safely deliveredand do all of this really fast," he says. "Keep in mind that all of these things are being asked when the physician has likely provided this therapy only a handful of times."
To this, add in the deluge of controversy from a variety of voices that claim tPA does not have meaningful clinical benefit, largely coming from criticisms of the original National Institute of Neurological Disorders and Stroke study.3
Ultimately, the ED physician is asked to provide a therapy, which is potentially quite dangerous, often with limited information available, in a very short time window, without tolerance for clinical error. "Remember that you've only done it a few times if ever, and you have heard well-articulated arguments why the whole thing might be a bad idea," says Pancioli. "One might easily imagine why a given patient does not get treated."
Pancioli says he believes the data are clear that for appropriately treated patients there is potential for benefit. "I do believe in tPA, and have used it for acute ischemic stroke in well over 200 patients," he says.
Pancioli adds that his own experience reviewing cases involving tPA mirrors the above study's findingsthat ED physicians are most often sued for failing to treat a patient believed to have been an appropriate candidate.
"The best way to avoid getting sued for not giving tPA is to have a system that ensures that patients are offered treatment if they are candidates," he says. "The second element that is necessary is clear documentation of the clinical decision-making that occurred, so that there is no doubt as to why the clinician believed that a patient was indeed not a candidate. "
Are ED physicians being "strong-armed"?
Jerome Hoffman, MD, a professor of emergency medicine at the University of California-Los Angeles School of Medicine, says he finds the evidence for tPA's effectiveness unconvincing. "I believe this treatment is clearly unproven, and that there is good reason for ED physicians to make a choice not to use it, in the best interest of their patients," he says. "And before anyone could rationally claim that it is useful for patients, we would need a lot more evidence."
ED physicians are being "strong-armed" into using tPA, with the threat of litigation used as a scare tactic, argues Hoffman. "There is a lot of effort made to force us to act in a way based not on any new science, but based on legal risks'you're going to get sued if you don't do this.' That is really unfortunate, and we should all be offended and resent that," he says. "Regardless of what we think about tPA for stroke, sidestepping evidence is the wrong way to resolve controversy."
ED physicians always should do what they believe is best for their patients, regardless of the risk of lawsuits, says Hoffman. "Physicians who feel that they shouldn't be using this drug can at least take some solace in the fact that almost all the physicians that have been sued for not giving it have won the suits," he says.
When ED physicians did lose the lawsuits, the real issue often had to do with other egregious errors that had nothing to do with tPA, such as failing to recognize the stroke, get a computerized tomography (CT) scan, or contact a neurologist, adds Hoffman. "In most of the cases when the ED physician gave good care, the physician has been successful in defending the lawsuit," he says. "If you combine doing the right thing for the patient with empathetic care, your chance of being sued remains very low."
However, even if you believe that tPA should not be offered because it is harmful, discuss this with the patient and get informed consent or refusal, instead of simply not offering the treatment, says Hoffman. "Even though I personally feel sympathy for such an argumentI agree that the treatment is not helpful and is more likely to do harm than goodI don't think you do yourself a favor if you ignore it," he says. "That is not the wisest thing."
Instead, give patients adequate information to make their own informed decision, advises Hoffman. "I explain to patients that they may have heard about this therapy, and seen it described as 'clot busting' or even lifesaving, but that the truth is far more complex, and they really need to know a reasonable and fair summary of the evidence," he says. "In my experience, most of them, when told what that evidence actually shows, are not eager to have the medicine given."
Communication is key
Jauch says that one of the biggest mistakes ED physicians can make is failing to explain their rationale for not treating to the patient's family. If you make the decision but don't tell the family why, it can be for all the right reasons, but their perception is, you didn't do something.
"If you are not using tPA even though the patient meets the eligibility criteria, you better explain your decision-making process," says Jauch. "The more quantitative data you have for them about the risk, the better off you will be."
Explain the risks as published in the literaturenot your own perception of risk or your opinion that tPA is not a proven drug, adds Jauch. "As physicians in an authoritative position at a very stressful time, we have incredible powers of persuasion," says Jauch. "You don't want to be coercive."
It may be helpful for patients to hear an explanation from the neurologist directly. "A lot of times, a neurologist is called who says no, for X, Y, and Z reasons, and the ED physician just goes back and says no. Then the family is kind of left saying, 'Well, why not?'" says Jauch. "Hearing it from the 'expert' and understanding the issues that went into the decision can soothe their concerns."
If it is the family's wish not to have the patient treated because they don't want to take the risk, document this carefully. However, if the patient is a candidate for tPA and has the risks and benefits clearly explained to them, Jauch says it's infrequent that they refuse treatment. "I have been doing this for 12 years and it has only happened twice," he says.
In one case, a young woman had a fairly mild but clinically significant stroke and told Jauch that she wanted to take absolutely no chance of dying from the treatment. "She was a great candidate, but we ended up not treating her," he says. "She had a minimal chance of having a hemorrhagemaybe 3%but I couldn't say there was absolutely no risk."
Jauch documented that the decision was made at the bedside in the presence of the daughter, son, and husband, and gave their names. "Otherwise, retrospectively one could argue that the patient was not of sound mind and body or had language issues because of the stroke which impaired their ability to make a sound decision," he says.
The other patient was so severely disabled at baseline, that the family didn't want her to survive only to return to the nursing home in a debilitated state.
Inappropriate use of tPA by failing to adhere to the inclusion/exclusion criteria is another legal landmine. "Some doctors may feel compelled to push the boundaries, but if you deviate from the approved use of the drug, you better have a really good conversation with the patient and family as to why you are deviating from the standard of care," says Jauch.
The bottom line is that you can make great clinical decisions, but if your reasoning is not conveyed to the family, lawsuits could ensue. "Sometimes you do all the right things and there is a bad outcome. But if you had good communication with the family, you are much less likely to be sued," says Jauch.
References
1. Liang BA, Zivin JA. Empirical characteristics of litigation involving tissue plasminogen activator and ischemic stroke. Ann Emerg Med 2008 Feb 28 [Epub ahead of print].
2. Hills NK, Johnston SC. Why are eligible thrombolysis candidates left untreated? Am J Prev Med 2006;31(6 Suppl 2):S210-216.
3. 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;333:1581-1587.
4. Graham GD. Tissue plasminogen activator for acute ischemic stroke in clinical practice: A meta-analysis of safety data. Stroke 2003;34:2847-2850.
Sources
For more information, contact:
- Jerome R. Hoffman, MD, Professor of Clinical Medicine, Department of Emergency Medicine, University of California-Los Angeles, Box 951777, 924 Westward Blvd, Suite 300, Los Angeles, CA 90095-1777. Phone: (310) 794-0573. E-mail: [email protected]
- Edward Jauch, MD, MS, Assistant Professor, Department of Emergency Medicine, University of Cincinnati, 231 Albert Sabin Way, PO Box 670769, Cincinnati, OH 45267-0769. Phone: (513) 558-5281. E-mail: [email protected]
- Arthur Pancioli, MD, Associate Professor and Vice Chairman, Department of Emergency Medicine, University of Cincinnati, 2600 Clifton Avenue, Cincinnati, OH 45221. Phone: (513) 558-8087. E-mail: [email protected]
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