Nov 15, 2022·edited Nov 15, 2022Liked by Med Mal Reviewer
Another frustrating case that illustrates the farce that is our medicolegal system. Many patients have baseline abnormal EKGs. The EKG being abnormal would not have stopped the surgery from proceeding if it was like that at baseline. Furthermore, if the patient did not have clinical anginal equivalents and had reasonable baseline performance status (greater or equal to 4 mets) then no pre-operative risk stratification would have been recommended - regardless of if the person doing the eval was an internist or a cardiologist. The standard of care would have been met. The problem is that shit happens. And shit can happen more if you are older with multiple cardiovascular risk factors. But by over-testing, you are exposing the patient to the risks of testing without necessarily making their operative risk lower. You could easily find a lesion, cath the patient, never have made a difference in their perioperative outcome, but put them at risk of a cath related adverse event like a hematoma or CIN. You can't work backwards from "something bad happened" to "something must have been missed" because in reality, shit happens. What would help the internist would be a well reasoned pre op note and ideally use of an evidence based risk calculator like NSQIP.
As for the cardiologist's opinion, I am honestly embarrassed for them. What are they even talking about? It's true that cutting into tissue can cause inflammation and certainly noninfectious systemic stress can cause SIRS. But SIRS is at least in part defined by abnormal vital signs, in contrary to what the cardiologist said. Post-op systemic inflammatory stress can certainly cause plenty of issues and likely contributes to delirium, sometimes low grade fevers, sometimes low grade leukocytosis, a-fib, other cardiovascular events, and other complications. And regardless of how SIRS is defined, it has absolutely nothing to do with the issue at hand, which is the pre-op eval. We aren't trying to prevent inflammation with the pre-op eval - that makes no sense as a goal. Systemic inflammation can certainly cause a coronary plaque to rupture but then the question goes back to: is finding and fixing every plaque considered the standard of care? Of course not. We know that fixing asymptomatic lesions does not improve outcomes generally. If the patient had good performance status and no active anginal symptoms (as well as an EKG unchanged from baseline), then finding and fixing lesions would not have been the standard of care and in fact may come across as unscrupulous. What happened to this man falls into the "shit happens" category. Shit happens to everyone. If shit didn't happen, we'd all live forever.
Thanks for the thoughtful response, I think you really hit the nail on the head. The system is terrible, but I did find it refreshing to see an attempt by the defense to point out the scientific literature doesn't support at least one of their claims. Probably going to steal your quote "You can't work backwards from 'something bad happened' to 'something must have been missed'"
Shit happens, and sadly we find doctors dumb enough to testify against us. It's a horrific system. It's also a shitty system that 10 year old guidelines aren't followed. Doctors come into work and think "hm i'll decided to just do this for every patient, that seems right" instead of "let me open my computer and use a few brain cells today and read up on what tests are indicated before and after surgery in 2022 instead of relying on intuition."
One thing that is not mentioned is the pts functional status. If he achieves >4 Mets at baseline without cardiac sx I think it could reasonably be argued the physician was following guidelines and standard of care.
Would you say that for such a low risk surgery, AHA/ACC guidelines wouldn't recommend further cardiac testing even for someone with unknown METS or < 4 METS?
In my preop note template I like this phrase in which I took from a cardiologist. I try to document like a porkypine.
"Per ACC/AHA peri-operative guidelines, moderate risk surgery and METS >=4 is low risk for MACE and no further cardiac testing is required. Pt has no active cardiac condition (ACS/USA, decompensated CHF, ventricular arrhythmias or severe valvular disease) and can easily achieve > 4 METS. Pt does not require further cardiac evaluation prior to undergoing surgical procedure. These recommendations follow the 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. (JACC Vol. 64 No. 22, Dec 9, 2014, pp e77-e137).
Evaluating Risk in Surgery is a combination of patient’s risk factors and surgical risk factors. Patient is being evaluated for medical optimization and not “surgical clearance”. MACE is the major adverse cardiovascular event risk, and can be assessed based on the Revised Cardiac Risk Index score."
I also include the RCRI score in my note
RCRI = rate of major cardiac event
Six independent predictors of major cardiac complications:
(-) High-risk type of surgery (examples include vascular surgery and any open intraperitoneal or intrathoracic procedures)
(-) History of ischemic heart disease
(-) History of HF
(-) History of cerebrovascular disease
(-) Diabetes mellitus requiring treatment with insulin
I haven't seen any studies looking at association between quoting the exact literature in a note and favorable malpractice outcomes, but its a pretty compelling argument. I think you're about as protected as you can be with documentation like that.
Sep 24, 2023·edited Sep 24, 2023Liked by Med Mal Reviewer
In my opinion, this case demonstrates that patients cannot be "cleared" for surgery. The patient should have been seen by cardiology pre-op for peri-operative stratification since the patient had known CAD. Cardiology then would have stratified the patient into low, moderate, or high risk for a peri-operative cardiovascular event.
The stratification level should have been discussed with the patient during the informed consent process. If the patient came back as a high risk for a perioperative cardiovascular event, then the patient may not have consented to the procedure and/or the surgeon may not have even recommended surgery.
The patient likely died from global ischemia to the heart from the catecholamine release which is induced by surgery. The assumption that SIRS was involved in the cause of death by the expert is pure opinion testimony and the expert should have been Daubert challenged.
Agreed, the involvement of SIRS was pretty ridiculous. I've seen numerous Daubert hearings in federal malpractice cases but how this is managed in state courts seems to vary a lot, even when you take into consideration which states have adopted Daubert or a modified version.
No malpractice was committed here and I'm sad to see that this lawsuit was settled.
Even if a stress test was indicated prior to surgery, it would not be correct to assume that it would have shown ischemia. Most plaque-rupture mediated myocardial infarction comes from soft, non-obstructive plaque anyway, and would not have been picked up on a functional test.
I was somewhat surprised they settled because their case was relatively strong. I think they wanted to be spared the time, stress, and expense of trial... and the unknown risk of what a jury might decide.
There are very clear and evidence-based guidelines that could close these cases out in a snap. Instead we have this bloated system of "expert" dweebs and lawyers making up rules as they go along, using their "opinion" over easily attainable facts.
The 2014 AHA guidelines dictate that unless someone has signs of active myocardial ischemia (angina, accelerating DOE), exercise tolerance is sufficient evidence that a patient can survive an elective surgery. The evidence has shown that invasive cardiac workup does not yield a favorable risk/benefit ratio. This patient sadly lost out on that ratio, and that is unfortunate, but not reason for a lawsuit. So theoretically no EKG or stress test was warranted prior to this case.
His MI on postoperative day 3 is the classic time frame for a post-operative MI in at at-risk patient. There is a post surgical inflammatory state, but the witness is wrong to use the term SIRS, a highly outdate acronym that applies to sepsis with an infectious etiology. This expert witness is a quack, IMHO.
The catch here is the patient did have an EKG on file. If a test was done, you can't ignore it. An EKG with true ST changes should be investigated prior to elective surgery. Stress tests are almost never indicated prior to surgery (unless the procedure high risk and truly elective and the patient is non-ambulatory with very high risk factors). But in this case, it would have made sense to get one.
Who is responsible here? First, the orthopedist for ordering an EKG, and not following up on it themselves. This is shitty practice. But since we are obliged to clean up after our shitty colleagues, we cannot stop here. Perioperative medical optimization is the anesthesiologist's duty. And in this case, they ought to have reviewed the medical records, and thus reviewed the abnormal EKG. An argument in their favor would be that the EKG was not apparent or attainable. Another perfectly legitimate argument would be that they heard about the previously normal stress test, and were reassured by that.
In summ - standard of care was followed in terms of preop optimization *if* there had been no EKG ordered by the orthopedist. But because one was ordered, and it was reportedly quite abnormal, he should have gotten more workup. And this is ultimately the responsibility of the anesthesiologist, but medical record and history taking hygeine should have been better across the board.
I found it interesting that the orthopedist and anesthesiologist didn't get sued. Usually plaintiffs are fond of suing anyone even remotely involved. Not sure what to say about the quack expert but the defense attorney got him to back himself into a corner on the SIRS issue, then nuked his argument. Kind of satisfying to see.
All adults I see with any CV risks get an ekg as a part of their preop clearance. This case just reaffirms my decision. The plaintiff’s expert witness was stretching far with the SIRS hypothesis. Thank you for posting these. I learn so much!
(From a physicians perspective:) This case should NEVER have been settled.
- old EKG findings
- no reported anginal symptoms (supposedly)
- angiography within last 5 years
Agree with Jason that the defense deposition is embarrassing. The differential diagnosis for cardiac arrest post orthopedic surgery is wide and unaddressed. The whole idea of blaming SIRS is totally out of left field. The pathology from the post mortem should be scrutinized: the mere presence of partially obstructive CAD does not necessarily mean that there was myocardial infarction. Was there a discussion of the myocardial tissue pathology? Any findings of PE, bone marrow embolism, severe GI bleed (as many orthopedic cases require post-op anticoagulation)? Finally, the patient may have had a plain old PEA/EMD arrest.
Both parties agreed that the cause of death was acute MI. It appears the autopsy was truly indicative of an actual MI, not just simple identification of coronary lesions. No mention of any other contributing factors.
I agree that this doesn’t read like malpractice. I’m surprised this case settled.
Just thinking out loud:
In theory, a heart attack a day after surgery could have been pure coincidence. Does the burden of proof lie in proving the heart attack was caused by the surgery, or in proving the heart attack has nothing to with the surgery?
Regardless and more importantly, I’m not sure why the argument was framed in arguing the cause of the heart attack. The PCP followed the standard of care and made the best decision with the information they had during the preop eval. And it would be unreasonable for a primary care doc to look for any and all tests that may have been done by some other doctor for every preoperative eval.
Some other questions I have:
Even if the EKG was abnormal, what would have been done differently for an asymptomatic patient? A stress test to look for a stentable lesion? A stress test so that the patient can be put on GDMT prior to surgery?
Why not put everyone through a stress test prior to any surgery then?
There is no evidence to support doing either would improve peri and post op CV complications in an asymptomatic patient.
If this case was taken seriously, the take away would be: all preoperative evaluation needs to include a cardiologist’s input and a stress test. And, perhaps facetiously, the cardiologist shouldn’t clear anyone with CV risk factors for elective surgery.
As I understand it, the burden of proof in a civil case like this requires a plaintiff to show that its more like than not (>50% certainty) that the defendant was negligent. As opposed to a criminal case in which there is a burden for the prosecutor to show that they're guilty beyond a shadow of a doubt (100% certainty). I'm not a lawyer so my interpretation of this may be somewhat off, if any attorneys read this and want to chime in I'd be curious to see what they say.
Agree that there's a lot of very perverse and inappropriate downstream implications for medical care if the plaintiff's allegations are accurate or represent the standard of care. Based on the feedback I've gotten from practicing PCPs, the plaintiff's claims have been thoroughly debunked.
Hi, out of curiosity, do attorneys ever reach out to you asking for expert witness recommendations? Subscribing to your substack has inspired me to give it a try.
I am board certified in Internal Medicine and practice outpatient primary care. I'd love to help out in cases that could use my expertise.
Every now and then. I think most of the referrals happen by word of mouth. There's hundreds of "expert witness referral" companies that would love to charge you $500/year to have a listing, with reportedly varying levels of success.
Another frustrating case that illustrates the farce that is our medicolegal system. Many patients have baseline abnormal EKGs. The EKG being abnormal would not have stopped the surgery from proceeding if it was like that at baseline. Furthermore, if the patient did not have clinical anginal equivalents and had reasonable baseline performance status (greater or equal to 4 mets) then no pre-operative risk stratification would have been recommended - regardless of if the person doing the eval was an internist or a cardiologist. The standard of care would have been met. The problem is that shit happens. And shit can happen more if you are older with multiple cardiovascular risk factors. But by over-testing, you are exposing the patient to the risks of testing without necessarily making their operative risk lower. You could easily find a lesion, cath the patient, never have made a difference in their perioperative outcome, but put them at risk of a cath related adverse event like a hematoma or CIN. You can't work backwards from "something bad happened" to "something must have been missed" because in reality, shit happens. What would help the internist would be a well reasoned pre op note and ideally use of an evidence based risk calculator like NSQIP.
As for the cardiologist's opinion, I am honestly embarrassed for them. What are they even talking about? It's true that cutting into tissue can cause inflammation and certainly noninfectious systemic stress can cause SIRS. But SIRS is at least in part defined by abnormal vital signs, in contrary to what the cardiologist said. Post-op systemic inflammatory stress can certainly cause plenty of issues and likely contributes to delirium, sometimes low grade fevers, sometimes low grade leukocytosis, a-fib, other cardiovascular events, and other complications. And regardless of how SIRS is defined, it has absolutely nothing to do with the issue at hand, which is the pre-op eval. We aren't trying to prevent inflammation with the pre-op eval - that makes no sense as a goal. Systemic inflammation can certainly cause a coronary plaque to rupture but then the question goes back to: is finding and fixing every plaque considered the standard of care? Of course not. We know that fixing asymptomatic lesions does not improve outcomes generally. If the patient had good performance status and no active anginal symptoms (as well as an EKG unchanged from baseline), then finding and fixing lesions would not have been the standard of care and in fact may come across as unscrupulous. What happened to this man falls into the "shit happens" category. Shit happens to everyone. If shit didn't happen, we'd all live forever.
I hate our medical system. What is wrong with us?
-an annoyed hospitalist
Thanks for the thoughtful response, I think you really hit the nail on the head. The system is terrible, but I did find it refreshing to see an attempt by the defense to point out the scientific literature doesn't support at least one of their claims. Probably going to steal your quote "You can't work backwards from 'something bad happened' to 'something must have been missed'"
We are our own enemies!!
Experts witness have to be held accountable. This is a horrible case where yes SHIT happen. Risk stratification is is that risk
Stratification. Sad
Shit happens, and sadly we find doctors dumb enough to testify against us. It's a horrific system. It's also a shitty system that 10 year old guidelines aren't followed. Doctors come into work and think "hm i'll decided to just do this for every patient, that seems right" instead of "let me open my computer and use a few brain cells today and read up on what tests are indicated before and after surgery in 2022 instead of relying on intuition."
One thing that is not mentioned is the pts functional status. If he achieves >4 Mets at baseline without cardiac sx I think it could reasonably be argued the physician was following guidelines and standard of care.
Would you say that for such a low risk surgery, AHA/ACC guidelines wouldn't recommend further cardiac testing even for someone with unknown METS or < 4 METS?
In my preop note template I like this phrase in which I took from a cardiologist. I try to document like a porkypine.
"Per ACC/AHA peri-operative guidelines, moderate risk surgery and METS >=4 is low risk for MACE and no further cardiac testing is required. Pt has no active cardiac condition (ACS/USA, decompensated CHF, ventricular arrhythmias or severe valvular disease) and can easily achieve > 4 METS. Pt does not require further cardiac evaluation prior to undergoing surgical procedure. These recommendations follow the 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. (JACC Vol. 64 No. 22, Dec 9, 2014, pp e77-e137).
Evaluating Risk in Surgery is a combination of patient’s risk factors and surgical risk factors. Patient is being evaluated for medical optimization and not “surgical clearance”. MACE is the major adverse cardiovascular event risk, and can be assessed based on the Revised Cardiac Risk Index score."
I also include the RCRI score in my note
RCRI = rate of major cardiac event
Six independent predictors of major cardiac complications:
(-) High-risk type of surgery (examples include vascular surgery and any open intraperitoneal or intrathoracic procedures)
(-) History of ischemic heart disease
(-) History of HF
(-) History of cerebrovascular disease
(-) Diabetes mellitus requiring treatment with insulin
(-) Preoperative serum creatinine >2.0 mg/dL (177 micromol/L)
Rate of cardiac death, nonfatal myocardial infarction, and nonfatal cardiac arrest according to the number of predictors:
0 = 0.4 percent (95% CI: 0.1-0.8)
1 = 0.9 percent (95% CI: 0.5-1.4)
2 = 6.6 percent (95% CI: 1.3-3.5) .
3+ = 11 percent (95% CI: 2.8-7.9)
I haven't seen any studies looking at association between quoting the exact literature in a note and favorable malpractice outcomes, but its a pretty compelling argument. I think you're about as protected as you can be with documentation like that.
In my opinion, this case demonstrates that patients cannot be "cleared" for surgery. The patient should have been seen by cardiology pre-op for peri-operative stratification since the patient had known CAD. Cardiology then would have stratified the patient into low, moderate, or high risk for a peri-operative cardiovascular event.
The stratification level should have been discussed with the patient during the informed consent process. If the patient came back as a high risk for a perioperative cardiovascular event, then the patient may not have consented to the procedure and/or the surgeon may not have even recommended surgery.
The patient likely died from global ischemia to the heart from the catecholamine release which is induced by surgery. The assumption that SIRS was involved in the cause of death by the expert is pure opinion testimony and the expert should have been Daubert challenged.
Agreed, the involvement of SIRS was pretty ridiculous. I've seen numerous Daubert hearings in federal malpractice cases but how this is managed in state courts seems to vary a lot, even when you take into consideration which states have adopted Daubert or a modified version.
I handle med mal cases in both federal and state courts. Florida recognizes Daubert.
No malpractice was committed here and I'm sad to see that this lawsuit was settled.
Even if a stress test was indicated prior to surgery, it would not be correct to assume that it would have shown ischemia. Most plaque-rupture mediated myocardial infarction comes from soft, non-obstructive plaque anyway, and would not have been picked up on a functional test.
I was somewhat surprised they settled because their case was relatively strong. I think they wanted to be spared the time, stress, and expense of trial... and the unknown risk of what a jury might decide.
There are very clear and evidence-based guidelines that could close these cases out in a snap. Instead we have this bloated system of "expert" dweebs and lawyers making up rules as they go along, using their "opinion" over easily attainable facts.
The 2014 AHA guidelines dictate that unless someone has signs of active myocardial ischemia (angina, accelerating DOE), exercise tolerance is sufficient evidence that a patient can survive an elective surgery. The evidence has shown that invasive cardiac workup does not yield a favorable risk/benefit ratio. This patient sadly lost out on that ratio, and that is unfortunate, but not reason for a lawsuit. So theoretically no EKG or stress test was warranted prior to this case.
His MI on postoperative day 3 is the classic time frame for a post-operative MI in at at-risk patient. There is a post surgical inflammatory state, but the witness is wrong to use the term SIRS, a highly outdate acronym that applies to sepsis with an infectious etiology. This expert witness is a quack, IMHO.
The catch here is the patient did have an EKG on file. If a test was done, you can't ignore it. An EKG with true ST changes should be investigated prior to elective surgery. Stress tests are almost never indicated prior to surgery (unless the procedure high risk and truly elective and the patient is non-ambulatory with very high risk factors). But in this case, it would have made sense to get one.
Who is responsible here? First, the orthopedist for ordering an EKG, and not following up on it themselves. This is shitty practice. But since we are obliged to clean up after our shitty colleagues, we cannot stop here. Perioperative medical optimization is the anesthesiologist's duty. And in this case, they ought to have reviewed the medical records, and thus reviewed the abnormal EKG. An argument in their favor would be that the EKG was not apparent or attainable. Another perfectly legitimate argument would be that they heard about the previously normal stress test, and were reassured by that.
In summ - standard of care was followed in terms of preop optimization *if* there had been no EKG ordered by the orthopedist. But because one was ordered, and it was reportedly quite abnormal, he should have gotten more workup. And this is ultimately the responsibility of the anesthesiologist, but medical record and history taking hygeine should have been better across the board.
I found it interesting that the orthopedist and anesthesiologist didn't get sued. Usually plaintiffs are fond of suing anyone even remotely involved. Not sure what to say about the quack expert but the defense attorney got him to back himself into a corner on the SIRS issue, then nuked his argument. Kind of satisfying to see.
All adults I see with any CV risks get an ekg as a part of their preop clearance. This case just reaffirms my decision. The plaintiff’s expert witness was stretching far with the SIRS hypothesis. Thank you for posting these. I learn so much!
(From a physicians perspective:) This case should NEVER have been settled.
- old EKG findings
- no reported anginal symptoms (supposedly)
- angiography within last 5 years
Agree with Jason that the defense deposition is embarrassing. The differential diagnosis for cardiac arrest post orthopedic surgery is wide and unaddressed. The whole idea of blaming SIRS is totally out of left field. The pathology from the post mortem should be scrutinized: the mere presence of partially obstructive CAD does not necessarily mean that there was myocardial infarction. Was there a discussion of the myocardial tissue pathology? Any findings of PE, bone marrow embolism, severe GI bleed (as many orthopedic cases require post-op anticoagulation)? Finally, the patient may have had a plain old PEA/EMD arrest.
Both parties agreed that the cause of death was acute MI. It appears the autopsy was truly indicative of an actual MI, not just simple identification of coronary lesions. No mention of any other contributing factors.
No need to explore: 1. Autopsy showed an MI, not myocarditis. 2. This was 2015, way before COVID or any mRNA vaccine.
I agree that this doesn’t read like malpractice. I’m surprised this case settled.
Just thinking out loud:
In theory, a heart attack a day after surgery could have been pure coincidence. Does the burden of proof lie in proving the heart attack was caused by the surgery, or in proving the heart attack has nothing to with the surgery?
Regardless and more importantly, I’m not sure why the argument was framed in arguing the cause of the heart attack. The PCP followed the standard of care and made the best decision with the information they had during the preop eval. And it would be unreasonable for a primary care doc to look for any and all tests that may have been done by some other doctor for every preoperative eval.
Some other questions I have:
Even if the EKG was abnormal, what would have been done differently for an asymptomatic patient? A stress test to look for a stentable lesion? A stress test so that the patient can be put on GDMT prior to surgery?
Why not put everyone through a stress test prior to any surgery then?
There is no evidence to support doing either would improve peri and post op CV complications in an asymptomatic patient.
If this case was taken seriously, the take away would be: all preoperative evaluation needs to include a cardiologist’s input and a stress test. And, perhaps facetiously, the cardiologist shouldn’t clear anyone with CV risk factors for elective surgery.
As I understand it, the burden of proof in a civil case like this requires a plaintiff to show that its more like than not (>50% certainty) that the defendant was negligent. As opposed to a criminal case in which there is a burden for the prosecutor to show that they're guilty beyond a shadow of a doubt (100% certainty). I'm not a lawyer so my interpretation of this may be somewhat off, if any attorneys read this and want to chime in I'd be curious to see what they say.
Agree that there's a lot of very perverse and inappropriate downstream implications for medical care if the plaintiff's allegations are accurate or represent the standard of care. Based on the feedback I've gotten from practicing PCPs, the plaintiff's claims have been thoroughly debunked.
This is very educational. What great reading.
Hi, out of curiosity, do attorneys ever reach out to you asking for expert witness recommendations? Subscribing to your substack has inspired me to give it a try.
I am board certified in Internal Medicine and practice outpatient primary care. I'd love to help out in cases that could use my expertise.
Thanks again for sharing all these cases !
Every now and then. I think most of the referrals happen by word of mouth. There's hundreds of "expert witness referral" companies that would love to charge you $500/year to have a listing, with reportedly varying levels of success.
Thanks this is great. I will sink my teeth into it tomorrow