Will published standards/guidelines protect you in a lawsuit?
A male in his 70’s presents to the ER with aphasia and hemiparesis. He is within the 3 hour window for tPA. However, he is on warfarin for atrial fibrillation. His NIHSS score is 27 and INR is 1.7. CT scan shows no evidence of hemorrhage. The board-certified EP believes that the patient does not meet criteria for tPA (based on the most recent 2005 stroke guidelines) and consults a neurologist by phone to confirm, which he does. The EP asks the neurologist to come evaluate the patient himself, but the neurologist says that’s unnecessary. tPA is not given and the patient is admitted and treated conservatively (no tPA or heparin). He is eventually discharged with life-changing disabilities files a lawsuit.
Lawyers argued that the standard of care was to receive tPA and that the neurologist should have personally examined the patient.
Defense argued that giving tPA would be a violation of the standard of care. It also would not have altered the patient’s disability (modified Rankin criteria at 60 days) due to his dense, hemispheric stroke . The risk of hemorrhage with tPA in a stroke like this is far greater than any possible benefit. tPA was clearly contraindicated (on warfarin, elevated INR, high NIHSS score). Even if tPA were appropriate, it was not the EP’s role to give it, especially when a neurologist confirms that it wasn’t indicated.
The outcome
The EP submitted his case to an arbitration panel who found that he had met the standard of care. However, the EP’s insurer paid a “nuisance amount” of $20,000 to dismiss the case and avoid a report to the National Practitioner Data Bank (NPDB). The neurologist paid an undisclosed amount, NOT for violating the standard of care but for not coming to the ED as requested by the EP.
Take-home points
The original NINDS study some 25 years ago remains the only major study that found tPA to be effective in stroke, and that came with only a roughly 2:1 ratio of benefit to risk. The use of tPA remains the standard of care but is surrounded by controversy.
Stroke cases require thorough documentation of medical decision making – including what steps you did or did not take.
One can follow all the guidelines and still be named in a malpractice lawsuit despite well-defined inclusion/exclusion criteria for a certain treatment.
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