Is there a definitive standard?
A 42-year-old patient was unloading a truck when he developed sudden nausea and dizziness. He was found in a bathroom vomiting. When his co-worker approached him, he was unable to describe what happened to him. An ambulance was called 10-15 minutes later when the man complained of numbness in his right arm, his tongue, and the left side of his face.
The patient arrived in the ED approximately 40 minutes after his symptoms began. On arrival to the ED, the triage nurse noted that the patient had right-sided weakness and felt that his legs were “rubbery.” He vomited on more than one occasion and had persistent dizziness. The emergency physician evaluated the patient within 30 minutes and did not note any right–sided weakness, but did note that the patient remained nauseous, dizzy and generally weak.
A CT scan of the head was ordered approximately 35 minutes after the patient’s arrival. Shortly afterwards, a CT scan of the posterior fossa was also ordered. Two other patients were waiting for CT scans ahead of this patient, one patient waiting for a scan of the abdomen and pelvis, and one 74–year–old waiting for a CT of the head.
The patient’s CT scan was not completed for another hour and 17 minutes. By the time the “wet read” of the CT scan was available, the patient’s symptoms had been present for 3 hours. The EP elected not to give thrombolytic therapy and did not contact consulting services until four hours after the patient’s symptoms began. The patient was admitted to internal medicine and neurology services with a diagnosis of CVA. Ultimately, the patient was diagnosed with a cerebellar stroke and died during his hospital stay.
The Expert Testimony
In a deposition, the plaintiff’s expert, Frank Baker, MD, made the following statements:
1. He works single coverage in a hospital that sees approximately 19,000 patients per year. He works approximately eight 12–hour shifts per month, sees 10–12 stroke patients per month, and gives thrombolytic therapy 4–6 times per year.
2. Physicians should not administer tPA without speaking to a consultant because they need to have the agreement of someone who will care for the patient after the patient leaves the ER.
3. The symptom complex of dizziness, vomiting, and ataxia should not cause a physician to consider migraine headaches or inner ear problems in their differential diagnosis. Instead, this symptom complex is specific for a cerebellar stroke.
4. It is “rare” that a patient arrives and can get a CT of the head within 3 hours of symptom onset in a stroke.
5. The patient in this case would not have become neurologically worse if he had received tPA within three hours because the clot causing the stroke would have dissolved and would not have reformed.
6. A patient with improving or resolved weakness in the extremity but persistent facial numbness should still receive tPA because a focal finding was still present.
7. In 2002, no reasonably well–qualified emergency physicians would have disagreed as to whether this patient needed tPA.
8. In 2001, no reasonably well–qualified emergency physicians would have disagreed on whether the risks of giving tPA outweighed the potential benefits of giving tPA to this patient.
In a deposition, the plaintiff’s expert, Frank Baker, MD, made the following statements:
1. He works single coverage in a hospital that sees approximately 19,000 patients per year. He works approximately eight 12–hour shifts per month, sees 10–12 stroke patients per month, and gives thrombolytic therapy 4–6 times per year.
2. Physicians should not administer tPA without speaking to a consultant because they need to have the agreement of someone who will care for the patient after the patient leaves the ER.
3. The symptom complex of dizziness, vomiting, and ataxia should not cause a physician to consider migraine headaches or inner ear problems in their differential diagnosis. Instead, this symptom complex is specific for a cerebellar stroke.
4. It is “rare” that a patient arrives and can get a CT of the head within 3 hours of symptom onset in a stroke.
5. The patient in this case would not have become neurologically worse if he had received tPA within three hours because the clot causing the stroke would have dissolved and would not have reformed.
6. A patient with improving or resolved weakness in the extremity but persistent facial numbness should still receive tPA because a focal finding was still present.
7. In 2002, no reasonably well–qualified emergency physicians would have disagreed as to whether this patient needed tPA.
8. In 2001, no reasonably well–qualified emergency physicians would have disagreed on whether the risks of giving tPA outweighed the potential benefits of giving tPA to this patient.
The expert further stated that the emergency physician’s actions fell below the standard of care for the following reasons:
1. Failing to perform or failing to document a full physical examination including the patient’s coordination, cerebellar function, and gait.
2. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given.
3. Failing to expedite the CT scan of the patient’s head so that the results would have been available within 3 hours.
1. Failing to perform or failing to document a full physical examination including the patient’s coordination, cerebellar function, and gait.
2. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given.
3. Failing to expedite the CT scan of the patient’s head so that the results would have been available within 3 hours.
Specifically, the expert believed that other patients needing CT scans should have been made to wait and stated that “all things being equal,” a 42-year-old should receive preferential treatment over a 77-year-old when both need CT scans of the head.
Are the expert’s statements accurate? Did the emergency physician act within the standard of care?
{mospagebreak title=Final Analysis}
Final Analysis with William Sullivan, MD, JD
With many issues to discuss and limited space, this final opinion will address the statements most likely to affect the outcome of the patient’s treatment and the outcome of the underlying litigation.
With many issues to discuss and limited space, this final opinion will address the statements most likely to affect the outcome of the patient’s treatment and the outcome of the underlying litigation.
Expert experience
Medical experts describe their experiences treating a disease process to enhance their credibility with the judge and/or jury. In this case, several respondents questioned the expert’s claims regarding his experience with stroke management.
Medical experts describe their experiences treating a disease process to enhance their credibility with the judge and/or jury. In this case, several respondents questioned the expert’s claims regarding his experience with stroke management.
“I work 13 10-hour shifts a month in a high acuity, high volume ED and see a certifiable CVA only every other shift,” wrote one respondent.
“First, no way (the expert) sees that many strokes and uses lytics with that frequency in a small ER,” wrote another reader. “My ER sees 100,000 pts per year and as a whole we deliver lytics once every 1-2 months.”
The actual incidence of strokes in the United States is between 250 and 411 strokes per 100,000 patients per year. This expert works roughly 1152 hours per year (13% of the total hours available each year) and sees 120 to 144 strokes per year. On average, then, the hospital at which he works would see between 923 and 1107 strokes per year for a volume of 19,000 patients. This equates to 4857 to 5826 stroke patients per 100,000 patient visits which is ten to twenty times the national average.
Differential diagnosis
While less likely to affect the outcome of the case, several respondents disagreed with the expert’s statement that dizziness, vomiting, and ataxia are specific for a cerebellar stroke, noting that various other medical problems including alcohol intoxication, basilar migraine, viral neuronitis, vertebral artery dissection, and Meniere’s disease may cause this same symptom complex.
While less likely to affect the outcome of the case, several respondents disagreed with the expert’s statement that dizziness, vomiting, and ataxia are specific for a cerebellar stroke, noting that various other medical problems including alcohol intoxication, basilar migraine, viral neuronitis, vertebral artery dissection, and Meniere’s disease may cause this same symptom complex.
“The ‘expert’ is not correct,” wrote one reader, “the symptom complex of dizziness, ataxia and vomiting are not specific for cellebellar stroke. Hasn’t he ever taken care of an intoxicated person? Or should we administer thrombolytics to drunks?”
Were thrombolytics indicated?
It is unlikely that reasonable emergency physicians will ever universally agree that thrombolytics are the standard of care in acute ischemic strokes. A 2005 survey by Brown et al. showed that 40% of emergency physicians are unwilling to use tPA in an acute stroke (note that this case took place in 2004). While the NINDS study showed a relative benefit of tPA use in acute strokes, subsequent studies such as ECASS and ATLANTIS showed little benefit, and ATLANTIS demonstrated an increase in symptomatic intracerebral hemorrhage with tPA use. AAEM’s policy statement on tPA use in stroke specifically states that available data are insufficient to deem thrombolytics as a standard of care. ACEP’s thrombolytic policy states that further studies are needed to define the patients most likely to benefit from tPA use in acute strokes, noting that there is insufficient evidence to endorse tPA use when NINDS guidelines cannot be followed. Both organizations note that no subsequent randomized double-blinded study has been able to replicate the NINDS findings. Regardless of which position an expert takes, ethical testimony should acknowledge that there is much conflicting data regarding the efficacy of tPA in acute stroke. While tPA may improve outcomes in certain patient populations under certain conditions, as the answers to this scenario demonstrate, it is likely that there is no universal “standard of care” for use of tPA in acute strokes.
It is unlikely that reasonable emergency physicians will ever universally agree that thrombolytics are the standard of care in acute ischemic strokes. A 2005 survey by Brown et al. showed that 40% of emergency physicians are unwilling to use tPA in an acute stroke (note that this case took place in 2004). While the NINDS study showed a relative benefit of tPA use in acute strokes, subsequent studies such as ECASS and ATLANTIS showed little benefit, and ATLANTIS demonstrated an increase in symptomatic intracerebral hemorrhage with tPA use. AAEM’s policy statement on tPA use in stroke specifically states that available data are insufficient to deem thrombolytics as a standard of care. ACEP’s thrombolytic policy states that further studies are needed to define the patients most likely to benefit from tPA use in acute strokes, noting that there is insufficient evidence to endorse tPA use when NINDS guidelines cannot be followed. Both organizations note that no subsequent randomized double-blinded study has been able to replicate the NINDS findings. Regardless of which position an expert takes, ethical testimony should acknowledge that there is much conflicting data regarding the efficacy of tPA in acute stroke. While tPA may improve outcomes in certain patient populations under certain conditions, as the answers to this scenario demonstrate, it is likely that there is no universal “standard of care” for use of tPA in acute strokes.
If we assume that thrombolytics should have been given, several respondents noted that the patient had rapidly improving symptoms. Weakness was present on the patient’s arrival, but was not present on the physician’s exam 30 minutes later. Rapidly improving symptoms are one of the exclusion criteria for thrombolytics in acute stroke, and many respondents believed that a reasonable physician would have been justified in withholding tPA based on this criterion alone.
“Key words are ‘no right-sided weakness’,” wrote one respondent. “It means that the patient’s condition was improving compared to the triage finding earlier.”
Would the patient have become worse with tPA?
In any malpractice case, a plaintiff must prove duty, breach of duty, causation and damages. The expert’s statement that the patient would not have become worse had he received tPA establishes the “causation” element in this malpractice case. In effect, the expert was stating that “but for” the physician’s failure to give tPA, the patient would not have suffered damages. Several respondents disagreed with this assertion. The expert’s statement seems to ignore the significant number of patients who experience symptomatic intracranial bleeding after tPA use—6.4% in the NINDS study and up to 15.7% in subsequent studies. While thrombolytics may improve functional outcomesin some patients, they are not as harmless as the expert implies.
Does the standard of care require that a consultant be called prior to tPA administration?
Alleging that a physician’s actions fell below the standard of care is another way of saying that a physician was negligent. While a discussion with a consultant prior to tPA administration would be optimal, is an emergency physician negligent for administering tPA before speaking with a consultant?
Consultation is certainly not the standard of care when administering tPA to an acute myocardial infraction and I am unable to find any literature supporting this notion when administering tPA to a patient with an acute stroke. What if the consultant does not answer his pages? Should the emergency physician allow the “therapeutic window” for administering tPA to expire? What if there is no neurologist on staff at the hospital and the emergency physician has difficulty finding a hospital willing to accept transfer? What if, as with this patient, the symptoms are rapidly improving? What if the emergency physician disagrees with the consultant’s recommendations? These hypothetical situations underscore the need to evaluate a physician’s actions on a case-by-case basis rather than to describe the standard of care in broad generalities.
In summary, most physicians responding to this scenario believed that the physician in the underlying case behaved appropriately under the circumstances. Many questioned the veracity of the expert’s statements. The thoughtful responses to this scenario are much appreciated.
Bill Sullivan is the Director of Emergency Services at St. Mary’s Hospital in Streator, IL and is a Clinical Assistant Professor of Emergency Medicine at both the University of Illinois and Midwestern University. He has a private law practice specializing in legal issues related to healthcare professionals and regularly consults and lectures on medicolegal issues.
See next page for all responses to this SOC analysis.
{mospagebreak title=Reader responses}
November 07
Standard of Care verdict
“Does this patient need Thrombolytics?”
Standard of Care verdict
“Does this patient need Thrombolytics?”
This patient should have received tPA stat. This patient needed a FAST CT scan. The ED has preference.
–Ira Grove, MD
–Ira Grove, MD
Academically speaking, this patient did not qualify for the thrombolytics because “…the EP evaluated the patient within 30 minutes and did not note any right-sided weakness, but did note that the patient remained nauseous, dizzy and generally weak.” Key words are “no right-sided weakness.” It means that the patient’s condition was improving compares to the triage finding earlier; which could be a relative contra-indication to the use of thrombolytics. In the real world, always always try to make an effort to involve the patient, and if at all possible, their immediate families on making significant medical decisions. Let them decide what is best for them. I have given thrombolytics to patients more than three hours after a thrombotic CVA. Some do want to take the risk, while some don’t. But it’ll reduce any potential future dispute for a bad outcome when the patients and or their families had taken part in the decision-making process.
–J. Ting, DO
–J. Ting, DO
Sounds like patient may have had lateral medullary syndrome with numbess. PICA infract. These are difficult to diagnose and it is highly questionable whether they should get tPA. Typically patients get better on their own after cerebellar infract. Why did this patient die? I would not expect it to be directly related to stroke. I would say no malpractice.
–David G. Srour, Md
–David G. Srour, Md
I disagree with some of the expert’s testimony. It’s quite easy to “Monday morning quarterback” when you know, after the fact, that the scan did not show a bleed. Also, we don’t know about this expert’s hospital but not every emergency physician has the authority and power to pull other patients out of the scanner so his can go first. However, once the scan was done, an expeditious consult and probable tPA treatment would have been appropriate
–Mike McCormack, Md
–Mike McCormack, Md
I do not think the physician fell below the standard of care. The triage nurse noted right-sided weakness which resolved on the physician’s exam. This suggests neurological improvement and a contraindication to thrombolytics. The “expert” is not correct: the symptom complex of dizziness, ataxia and vomiting are not specific for cerebellar stroke. Hasn’t he ever taken care of an intoxicated person? Or should we administer thrombolytics to drunks?
–Ned Magen, DO
–Ned Magen, DO
If it is true that these parts of the physical examination were not done, then yes, it is below the standard of care. Any patient with a suspicion of inner ear vs. cerebellar (posterior circulation) problems must have those parts of the physical examination done.
Further, if the patient was suspected of having a posterior circulation CVA, the failure to contact a neurologist (I’m not sure a neurosurgeon is the right person) is below the standard of care. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given. The EP should have expedited the CT, certainly ahead of non-emergent patients. Specifically, the expert believed that other patients needing CT scans should have been made to wait and stated that “all things being equal,” a 42-year-old should receive preferential treatment over a 77-year-old when both need CT scans of the head. For my opinion, it depends on the nature of the clinical picture of the 77-year-old’s problem. Having said all this, I don’t think that the current knowledge of thrombolysis in CVA would allow us to say that the expeditious administration of tPA would have resulted in a wonderful and remarkable recovery and complete resolution of the patient’s symptoms. However, since there is some evidence (regardless of how weak) that the administration of tPA may help, the patient has the right to know about that therapy and make an informed decision on whether to accept the therapy or not. If I were in this poor man’s position and was told the risks, I think I would opt for the tPA. However, that is my opinion and not what all patients would do, although all EPs should discuss the pros and cons of this therapy with their patients and consult with an expert (neurologist) in these cases.
Regarding his assertions:
1. Seems a bit on the high side.
2. Agree
3. It is a difficult diagnosis to make and should be considered, but I don’t think you can say it is specific for a posterior circulation stroke.
4. Probably true for a hospital that only sees 19,000 patients a year. If there is not a regularly scheduled CT tech on duty, then this is true.
5. Who knows! This is pure speculation and not more likely than not. The best spin on the NINDS trial is a small average improvement in all patients.
6. If the only residua is facial numbness, I for one would not agree to tPA. The benefits (uncertain) are not worth the risk of a bleed.
7. Lots of reasonably well-qualified EPs would disagree with this statement.
8. Ditto
–Dan Mayer, Md
1. Seems a bit on the high side.
2. Agree
3. It is a difficult diagnosis to make and should be considered, but I don’t think you can say it is specific for a posterior circulation stroke.
4. Probably true for a hospital that only sees 19,000 patients a year. If there is not a regularly scheduled CT tech on duty, then this is true.
5. Who knows! This is pure speculation and not more likely than not. The best spin on the NINDS trial is a small average improvement in all patients.
6. If the only residua is facial numbness, I for one would not agree to tPA. The benefits (uncertain) are not worth the risk of a bleed.
7. Lots of reasonably well-qualified EPs would disagree with this statement.
8. Ditto
–Dan Mayer, Md
This is too easy. Of course the EP acted well within the standard of care. Plaintiff expert in this case says some things that are reasonable such as sicker patients sould be moved ahead of less ill patients for CT etc. That said, the literature is very clear here. First and most notable, this patient was not having an MCA stroke or symptoms of an MCA stroke. As per the outcome, there was indeed a posterior circulation CVA. The NINDS study was for MCA infracts only. The literature for post circulation infracts is suspect to non-existent at best.
Further, I do not have an exact NIH stroke score on this patient but it seems low, thus taking him out as a candidate for TPS.
Next, if he were not a TPA candidate as far as the EP felt for reasons above, a Neuro consult is not emergent.
Finally and perhaps more convincingly, his documented symptoms and signs were improoving also removing him as a TPA candidate.
If this EP was found negligent in a jury trial, it just goes to show you how OJ got off.
Sorry for my editorial. This plaintiff expert is the reason many EPs want out of EM. I will look forward to your comments.
–Thomas Rebbecchi, Md
Cooper University Hospital
Camden NJ
–Thomas Rebbecchi, Md
Cooper University Hospital
Camden NJ
Several problems:
1. The whole point of giving tPA in any stroke to begin with is a point of contention.
2. The expert’s demographics are most suspicious. I work 13 10-hour shifts a month in a high acuity, high volume ED and see a certifiable CVA only every other shift. I have never given tPA directly nor in consultation with a specialist, and where I work where there is a stroke team. I can pick up the phone on patient arrival and have the scan done and the specialist at the bedside ready to give tPA within 30 minutes of the patient hitting the door. I agree with the expert that having the patient arrive to the ED in a timely enough manner to even qualify for tPA is uncommon.
3. If the EP didn’t do a good job documenting that doesn’t constitute bad care, just sloppy admin.
4. Any EP worth their salt would not only consider migraine and inner ear pathology for dizziness, vomiting, and ataxia, but in addition would never overlook the consideration of vertebral dissection and definately not any toxicology (suggests the EP wasn’t residency trained to not consider tox).
5. No mention was made about the initial complaint of variable RUE weakness, which does not seem to suggest isolated posterior circulation pathology as the expert claimed was so straight-forward.
–Anonymous
1. The whole point of giving tPA in any stroke to begin with is a point of contention.
2. The expert’s demographics are most suspicious. I work 13 10-hour shifts a month in a high acuity, high volume ED and see a certifiable CVA only every other shift. I have never given tPA directly nor in consultation with a specialist, and where I work where there is a stroke team. I can pick up the phone on patient arrival and have the scan done and the specialist at the bedside ready to give tPA within 30 minutes of the patient hitting the door. I agree with the expert that having the patient arrive to the ED in a timely enough manner to even qualify for tPA is uncommon.
3. If the EP didn’t do a good job documenting that doesn’t constitute bad care, just sloppy admin.
4. Any EP worth their salt would not only consider migraine and inner ear pathology for dizziness, vomiting, and ataxia, but in addition would never overlook the consideration of vertebral dissection and definately not any toxicology (suggests the EP wasn’t residency trained to not consider tox).
5. No mention was made about the initial complaint of variable RUE weakness, which does not seem to suggest isolated posterior circulation pathology as the expert claimed was so straight-forward.
–Anonymous
The expert witness’ testimony is ridiculous. The patient’s symptoms were extremely nonspecific and he did not have unilateral weakness at the time of exam. This emergency physician would not have given tPA for resolving symptoms even if the rest of the story were classic for a CVA. I would also be more concerned with the possibility of a cerebellar hemmorhage or vertebral artery dissection in which tPA would be contraindicated.
–M. Abe, MD
NY, NY
–M. Abe, MD
NY, NY
1. No way (the expert) sees that many strokes and uses lytics with that frequncy in a small ER. My ER sees 100,000 pts per year and as a whole we deliver lytics once every 1-2 months.
2. Regarding the claim that physicians should not administer tPA without speaking to a consultant: Not close to the standard. EM providers can do so if the local systems supports this, which it often will since neurologist are not running in 24 hrs per day.
3. Expert says: The symptom complex of dizziness, vomiting, and ataxia should not cause a physician to consider migraine headaches or inner ear problems in their differential diagnosis. Instead, this symptom complex is specific for a cerebellar stroke. I say the differential is wide; however, a cerebellar stroke is high on the differential.
4. It is “rare” that a patient arrives and can get a CT of the head within 3 hours of symptom onset in a stroke. [Agree…very few pts arrive early enough for this to be a consideration]
5. The patient in this case would not have become neurologically worse if he had received tPA within three hours because the clot causing the stroke would have dissolved and would not have reformed. [A conjecture at best…no data]
6. A patient with improving or resolved weakness in the extremity but persistent facial numbness should still receive tPA because a focal finding was still present. [Very debatable]
7. In 2002, no reasonably well-qualified emergency physicians would have disagreed as to whether this patient needed tPA
8. In 2001, no reasonably well-qualified emergency physicians would have disagreed on whether the risks of giving tPA outweighed the potential benefits of giving tPA to this patient. [For 7 & 8 …disagreements were huge then and continue to be now]
2. Regarding the claim that physicians should not administer tPA without speaking to a consultant: Not close to the standard. EM providers can do so if the local systems supports this, which it often will since neurologist are not running in 24 hrs per day.
3. Expert says: The symptom complex of dizziness, vomiting, and ataxia should not cause a physician to consider migraine headaches or inner ear problems in their differential diagnosis. Instead, this symptom complex is specific for a cerebellar stroke. I say the differential is wide; however, a cerebellar stroke is high on the differential.
4. It is “rare” that a patient arrives and can get a CT of the head within 3 hours of symptom onset in a stroke. [Agree…very few pts arrive early enough for this to be a consideration]
5. The patient in this case would not have become neurologically worse if he had received tPA within three hours because the clot causing the stroke would have dissolved and would not have reformed. [A conjecture at best…no data]
6. A patient with improving or resolved weakness in the extremity but persistent facial numbness should still receive tPA because a focal finding was still present. [Very debatable]
7. In 2002, no reasonably well-qualified emergency physicians would have disagreed as to whether this patient needed tPA
8. In 2001, no reasonably well-qualified emergency physicians would have disagreed on whether the risks of giving tPA outweighed the potential benefits of giving tPA to this patient. [For 7 & 8 …disagreements were huge then and continue to be now]
The expert further stated that the emergency physician’s actions fell below the standard of care for the following reasons:
1. Failing to perform or failing to document a full physical examination including the patient’s coordination, cerebellar function, and gait. [a cerebellar exam is very appropriate for this patient; lack of FTN or heel-shin is a problem. Would likely not have tried gait on him…sounds quite dizzy and sense it to be a fall risk] 2. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given. [as above…not standard of care…and consult a neurosurgeon…must be pulling my arm] 3. Failing to expedite the CT scan of the patient’s head so that the results would have been available within 3 hours. [Tough one…local institutional ppolicy must address this one. The doc may need to prioritize. There is not enough info on the other patients for me to do this prioritization]
1. Failing to perform or failing to document a full physical examination including the patient’s coordination, cerebellar function, and gait. [a cerebellar exam is very appropriate for this patient; lack of FTN or heel-shin is a problem. Would likely not have tried gait on him…sounds quite dizzy and sense it to be a fall risk] 2. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given. [as above…not standard of care…and consult a neurosurgeon…must be pulling my arm] 3. Failing to expedite the CT scan of the patient’s head so that the results would have been available within 3 hours. [Tough one…local institutional ppolicy must address this one. The doc may need to prioritize. There is not enough info on the other patients for me to do this prioritization]
Specifically, the expert believed that other patients needing CT scans should have been made to wait and stated that “all things being equal,” a 42-year-old should receive preferential treatment over a 77-year-old when both need CT scans of the head.
Have a great day
–Kurt K
–Kurt K
I believe that the standard of care was not met here in this 42-year-old with a stroke. First, this patient should have a thorough neurologic exam done and documented. Also, serial exams must be done and documented as well. The history provided was not complete. The risks for strokes (any significant PMH) were not stated. But, given the information that you have, if there were any weakness, yes, thrombolytics should be given after all risks and benefits were discussed and understood. Numbness is not necessarily an indication for thrombolytics. Most often, cerebellar or posterior cerebral infarcts are not seen on CT. A MRI is necessary. Yes, if a stroke is suspected, then the head CT should have been made a priority over the other CTs to meet the window for thrombolytics. A neurologist should have been consulted and the discussion documented.
–Marcus Ma, Md
–Marcus Ma, Md
I have to disagree with the “expert” on many points.
1. Evidence for TPA has never been good. Personally I would never order it for stroke. I keep a couple of Emergency Medicine Abstracts in my desk that show TPA intracranial hemorrhagic complications and mortality are much higher than for stroke treatment without TPA. Bukata and Hoffman have been strong opponents of TPA for stroke from the beginning and they have a wide audience in the emergency medicine community.
2. Stroke symptoms accompanied by vomiting point quite often to the stroke being hemorrhagic which would exclude TPA but may require neurosurgical intervention, so the quicker the CT can be done the better. We should do all we can to expedite the CT. However, we all know that though we want things to be done quickly we can’t always make it happen. I would try to get them to scan this patient before less emergent problems.
3. The scenario doesn’t say if any findings are already visible on CT scan. That would make hemorrhage due to TPA even more likely and be an exclusion criterion. With such a severe cerebellar stroke that it caused death so quickly, TPA would have a low probability for success. The original articles show a small percent were improved a small amount at 3 months. I am skeptical of the anecdotal cases of rapid improvement with TPA. These are likely to be the same ones that would rapidly improve without TPA.
4. I work single coverage 19,000 volume, many more hours per month than the expert and don’t see nearly that many acute strokes per month. In a year maybe there is about one patient who would actually meet TPA criteria. The expert inflates his numbers I think.
5. If an ED doc believes TPA will help and the patient meets criteria, he doesn’t need a consultant’s permission; no more than we do with TPA for MIs (when PTCA isn’t an option).
6. The symptoms complex of dizziness, vomiting and ataxia could be cerebellar CVA, tumor, SAH, benign positional vertigo, meningitis, subdural, otitis media, etc. The expert shouldn’t claim it to be specific for stroke only.
7. It’s true that it is rare for a patient to make it inside the 3 hour window, usually because of delay in presentation rather than delay in obtaining the CT.
8. The claim that the patient would not get worse with TPA is patently false as the literature clearly shows higher intracranial bleeds and higher death rates with TPA.
9. If the ED doc is correct that there was no focal extremity weakness, it is likely that the stroke score would not be high enough for the patient to meet criteria to be a TPA candidate. If he had focal weakness initially and that had resolved by the time of the ED physician exam, that would exclude TPA. Rapid improvement is an exclusion criterion.
10. I believe the ED doc met the standard of care in not giving the TPA. If I see a patient that actually does meet TPA criteria, I would pull out the EMA articles showing about double the brain bleeds and mortality and give it to patient and family and say that personally I could not advocate with a clear conscience a medicine that I know is twice as likely to make them worse or kill them. If after that informed consent they still want it, then I’d let the neurologist order it.
–Dwayne Bernard, Md
1. Evidence for TPA has never been good. Personally I would never order it for stroke. I keep a couple of Emergency Medicine Abstracts in my desk that show TPA intracranial hemorrhagic complications and mortality are much higher than for stroke treatment without TPA. Bukata and Hoffman have been strong opponents of TPA for stroke from the beginning and they have a wide audience in the emergency medicine community.
2. Stroke symptoms accompanied by vomiting point quite often to the stroke being hemorrhagic which would exclude TPA but may require neurosurgical intervention, so the quicker the CT can be done the better. We should do all we can to expedite the CT. However, we all know that though we want things to be done quickly we can’t always make it happen. I would try to get them to scan this patient before less emergent problems.
3. The scenario doesn’t say if any findings are already visible on CT scan. That would make hemorrhage due to TPA even more likely and be an exclusion criterion. With such a severe cerebellar stroke that it caused death so quickly, TPA would have a low probability for success. The original articles show a small percent were improved a small amount at 3 months. I am skeptical of the anecdotal cases of rapid improvement with TPA. These are likely to be the same ones that would rapidly improve without TPA.
4. I work single coverage 19,000 volume, many more hours per month than the expert and don’t see nearly that many acute strokes per month. In a year maybe there is about one patient who would actually meet TPA criteria. The expert inflates his numbers I think.
5. If an ED doc believes TPA will help and the patient meets criteria, he doesn’t need a consultant’s permission; no more than we do with TPA for MIs (when PTCA isn’t an option).
6. The symptoms complex of dizziness, vomiting and ataxia could be cerebellar CVA, tumor, SAH, benign positional vertigo, meningitis, subdural, otitis media, etc. The expert shouldn’t claim it to be specific for stroke only.
7. It’s true that it is rare for a patient to make it inside the 3 hour window, usually because of delay in presentation rather than delay in obtaining the CT.
8. The claim that the patient would not get worse with TPA is patently false as the literature clearly shows higher intracranial bleeds and higher death rates with TPA.
9. If the ED doc is correct that there was no focal extremity weakness, it is likely that the stroke score would not be high enough for the patient to meet criteria to be a TPA candidate. If he had focal weakness initially and that had resolved by the time of the ED physician exam, that would exclude TPA. Rapid improvement is an exclusion criterion.
10. I believe the ED doc met the standard of care in not giving the TPA. If I see a patient that actually does meet TPA criteria, I would pull out the EMA articles showing about double the brain bleeds and mortality and give it to patient and family and say that personally I could not advocate with a clear conscience a medicine that I know is twice as likely to make them worse or kill them. If after that informed consent they still want it, then I’d let the neurologist order it.
–Dwayne Bernard, Md
Regarding Dr. Baker’s assertions of tPA frequency: I work single coverage in a rural ED that sees approximately 17,000 patients per year. The patient population we serve is predominantly elderly. We see nowhere near 10-12 stroke patients per month, and in the past two years I can think of only two patients that met the criteria for tPA. One was far outside the three hour window and the other actually received tPA and improved dramatically. In my estimation the statistics quoted by the expert may be somewhat exaggerated, however I have no knowledge of the patient population that he serves.
I agree completely with the assertion (that EPs should not administer tPA without speaking to a consultant because they need to have the agreement of someone who will care for the patient after the patient leaves the ER). The input of a neurologist that has actually looked at the CT is the optimal situation.
I completely disagree that the symptom complex of dizziness, vomiting, and ataxia should not cause a physician to consider migraine headaches or inner ear problems in their differential diagnosis and that this symptom complex is specific for a cerebellar stroke. Rather, the differential diagnosis in a patient of this age with these symptoms is fairly long, including stroke, electrolyte abnormality, hypoglycemia, vertigo, cerebellar bleed, mass lesion, etc, etc, etc… To state unequivocally that a patient with the above noted symptoms is specific for a stroke is like saying that a patient with abdominal pain should have no other diagnoses considered except appendicitis and should be taken to the operating room at once. It just isn’t true.
The expert says that the patient in this case would not have become neurologically worse if he had received tPA within three hours, but there’s no way to tell that. The patient also might have bled and if so had a much higher chance of permanent disability or death.
The expert claims that a patient with improving or resolved weakness in the extremity but persistent facial numbness should still receive tPA because a focal finding was still present. This is wrong. Part of the exclusion criteria for tPA is improvement of neurologic function. If they are getting better they are not a tPA candidate.
I also disagree with the assertion that in 2001 and 2002, no reasonably well–qualified emergency physicians would have disagreed as to whether this patient needed tPA. ACEP does not recommend tPA as a standard of care since the data does not strongly support its use in terms of long term improvements.
The expert further stated that the emergency physician’s actions fell below the standard of care for the following reasons:
1. Failing to perform or failing to document a full physical examination including the patient’s coordination, cerebellar function, and gait.
Certainly a neurologic exam and determination of a stroke score, preferably via the NIH stroke scale, is mandatory in any patient that is being considered as a tPA candidate in the face of CVA.
2. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given.
This would depend upon whether or not this patient is felt to be a thrombolytic patient or not. If not, then its OK to take your time. If so, then time is of the essence.
3. Failing to expedite the CT scan of the patient’s head so that the results would have been available within 3 hours.
Again. if the patient is felt to be a tPA candidate, then time is of the essence and yes, they should get top priority. A non contrast CT scan of the head can be done quickly, and should be done in preference to others if they are not in a time-critical situation.
1. Failing to perform or failing to document a full physical examination including the patient’s coordination, cerebellar function, and gait.
Certainly a neurologic exam and determination of a stroke score, preferably via the NIH stroke scale, is mandatory in any patient that is being considered as a tPA candidate in the face of CVA.
2. Failing to consult the neurologist or neurosurgeon within three hours of the patient’s symptoms to discuss whether tPA should have been given.
This would depend upon whether or not this patient is felt to be a thrombolytic patient or not. If not, then its OK to take your time. If so, then time is of the essence.
3. Failing to expedite the CT scan of the patient’s head so that the results would have been available within 3 hours.
Again. if the patient is felt to be a tPA candidate, then time is of the essence and yes, they should get top priority. A non contrast CT scan of the head can be done quickly, and should be done in preference to others if they are not in a time-critical situation.
Sad case but probably unsalvageable. It is unfortunate when so-called “experts” need such public rebuking, but Dr Frank Baker has an unfortunate “clue deficit.” A tiny embolus must have taken out that part of his cerebrum that supported rational thought. His laughable testimony is easily dismissed after a cursory review of any “thrombolytics in stroke” literature. I will respond to his initial 8 statements in order:
I’m very skeptical about that claim and it could easily be verified by the defendant’s attorney. If this claim is true, he is either giving way too much tPA or has a very different universe of patients than the rest of us.
Good idea, maybe it is possible in the land of Oz, but that pipe dream remains wishful thinking in many locations.
If that syndrome is specific for a cerebeller stroke, then abdominal pain is specific for AIP, Dr Baker needs to do some homework
Well at least that is true—does not really jive with his claim of frequent tPA administration for CVA. Delay of course is symptom to presentation time, not door to CT time.
Very speculative and unsubstantiated statement. History reveals no anecdotal alternatives and full series reported in the literature do not support this with any great certainty, thus his point can not be made emphatically at all. Patient might have gotten worse at a faster rate had he received tPA earlier.
Untrue—I wonder if he would have testified against an EP who gave tPA in this situation and caused a fatal hemorrhage.
He’s killing me
I’m laughing so hard at this “expert” that I’m gonna rupture a berry aneurysm (Don’t let Dr Baker give me tPA please).
From the information given, I do not see where the physician departed from the standard of care, but I’d have to review the entire case before concluding that. Certainly Dr Baker needs to review the literature before testifying against a defendant. He is an easily impeachable witness based on competency, character, bias, inconsistency and contradiction (to name a few).
–John Ogle, Md, MPH, FACEP
President, Boulder County Medical Society
President, Boulder County Medical Society
This case is not very clear.
First, for a patient with an embolic/thrombotic CVA to be considered a candidate for lytics, their NIHSS score needs to be 3 or worse. Although the story here focuses more on the time delays in getting this patient a head CT, having “rubbery legs and nausea” does not appear to fit the devastating neuro deficit bill. There is no mention of speech deficits or aphasia/dysarthria. And a cerebellar exam is not documented. Even if the patient had his wet read within 3 hours, I’m not sure he would have qualified based on sx for lytics
First, for a patient with an embolic/thrombotic CVA to be considered a candidate for lytics, their NIHSS score needs to be 3 or worse. Although the story here focuses more on the time delays in getting this patient a head CT, having “rubbery legs and nausea” does not appear to fit the devastating neuro deficit bill. There is no mention of speech deficits or aphasia/dysarthria. And a cerebellar exam is not documented. Even if the patient had his wet read within 3 hours, I’m not sure he would have qualified based on sx for lytics
Second, a posterior fossa CT seems redundant. CVA protocol CT’s go through the post fossa. The fact that CT is not a great modality to evaluate that part of the brain is a limitation of the study. In our institution, cerebellar CVA would be ultimately dx’d c MRI (unless there was a bleed and its huge).
The issue in this scenario is that a patient with potential lytic window lost that opportunity by prolonged radiographic clearance. If the patients stroke score was sufficiently hi to warrant lyrics, then the Md should have pushed for the CT a bit quicker. However, if the stroke score was < 3 (which it appears based on the descriptors) then the time is a non issue.
–Sandy Sineff
–Sandy Sineff
Opinions, Statements
1) His yearly experience even though greater than mine is limited. He does not state if he works at a stroke center with a protocol for stroke codes. That is not stated in the legal fact pattern either.
2) Consultation with radiology and neurology is the standard at stroke centers. Having said that, there is a difficult choice to make. The choice of thrombolytics is in part driven by the bed availability in the ICU for a stroke code patient and also by the availability of neurology and an intensivist. These may not be available in many smaller hospitals. Smaller hospital would benefit from a transfer plan to a stoke center. These protocols did not exist in 2001.
3) The statement that the symptom complex is specific for a cerebellar CVA is a bit of stretch. The history does not clearly state Ataxia in the ED exam. More concerning for CVA is the history of the unilateral focal deficits. These did improve or were improving however. No statement of normal blood glucose either. Assume this to be the case given the outcome.
4) Not true in my practice. Large city EMS aware of stoke codes.
5) Not true. Small but significant risk of bleeding as outcome of TPA. His statement implies that it is a benign procedure without complications.
6) Not true. Improving examination is a relative contraindication to TPA given the risk of fatal bleed.
7) Not true. I would have been resistant to TPA in a patient with an improving neurological examination.
8) Absolutely not true. Minimizes or ignores the real risk of bleed from the TPA.
1) His yearly experience even though greater than mine is limited. He does not state if he works at a stroke center with a protocol for stroke codes. That is not stated in the legal fact pattern either.
2) Consultation with radiology and neurology is the standard at stroke centers. Having said that, there is a difficult choice to make. The choice of thrombolytics is in part driven by the bed availability in the ICU for a stroke code patient and also by the availability of neurology and an intensivist. These may not be available in many smaller hospitals. Smaller hospital would benefit from a transfer plan to a stoke center. These protocols did not exist in 2001.
3) The statement that the symptom complex is specific for a cerebellar CVA is a bit of stretch. The history does not clearly state Ataxia in the ED exam. More concerning for CVA is the history of the unilateral focal deficits. These did improve or were improving however. No statement of normal blood glucose either. Assume this to be the case given the outcome.
4) Not true in my practice. Large city EMS aware of stoke codes.
5) Not true. Small but significant risk of bleeding as outcome of TPA. His statement implies that it is a benign procedure without complications.
6) Not true. Improving examination is a relative contraindication to TPA given the risk of fatal bleed.
7) Not true. I would have been resistant to TPA in a patient with an improving neurological examination.
8) Absolutely not true. Minimizes or ignores the real risk of bleed from the TPA.
Second opinion set
1) Documentation of a good baseline neurological exam in a possible stroke patient is very important to allow for decisions based on progression of symptoms. The other important point is that the information is necessary for your discussion with the neurologist and will to a lesser extent help the radiologist.
2) This is more difficult but, EDs should have protocols for emergent evaluation of possible CVA’s . This is the answer for 2007. The answer for 2001 is that it was not the standard of care then. Stroke codes and stroke centers were not the standard of care.
3) This statement is on the edge of being offensive. We do not have enough information about the condition of the 77 year old to make a triage decision. The MDM should have documented that the triage decision was made based on medical condition. The “experts” apparent age bias is offensive and not the standard of care. It is not his place to see a 39 year old as having more value than 77 year old. The 77 yr old could have had a neurosurgical emergency (bleed with or without blowing pupil, a CVA more clear cut than this patient and needing TPA). Having said that the time of 1 hour 17 minutes for CT is a bit long given only one other patient. That should be tempered by the technology of that year and not judged by our new scanners. The fault in my mind is not showing the necessary urgency and due diligence and documenting it.
–Steven Portouw Md, CDR MC USN FAAEM
Senior Medical Officer
Fallujah Surgical
In this case, I believe the patient presented with atypical symptoms for a stroke and depending on the NIH stroke scale, many physicians would not even consider administering tPA if the symptoms were relatively non-specific. Several of the plantiffs’ expert comments are valid including documentation of a complete neurologic examination and administration of tPA in consultation with a neurologist. His point that most patients cannot get CT head within 3 hours of symptom onset is valid because most patients DO NOT present within that time period. Time of onset is the most common cause of exclusion from tPA. I find it hard to believe that a physician in a 19,000 volume ED administers tPA 4-6 times per year. The national average is less than 1% and this physician sees an average of 1 to 1.5 stroke patients per shift, an incredibly high number for his ED volume.
In the NINDS study, 6.4% of patients given tPA suffered intracerebral hemorrhage compared to 0.6% of patients who were not given tPA therefore, there is a definite risk to tPA and patients can become neurologically worse. Enough today, tPA is an extremely controversial issue which many emergency physicians do not feel comfortable administering.
–Tony Kanluen, Md
1 Comment
Frank Baker is a charlatan. He exagerates his experience, and will testify to anything if it results in a hefty fee for himself.