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51 year old African American female with history of elevated factor VIII, hypercoagulable state of multiple thromboses in past, PE, CVA, MI and right-sided hemiplegia, which is mild to moderate.
On 03-08-23 there is a request to change her Eliquis over to Coumadin due to chronic kidney disease. The notes indicate the recommended INR for this patient is 2.5-3.5 per the physician. She is prescribed Coumadin 5 mg every evening and ordered to continue with Eliquis and ASA until INR is therapeutic. Her INR was to be checked twice a week. Until therapeutic.
INRs
03-14-23 – 1.6,
03-17-23 – 2.6,
03-21-23 – 4.4,
03-24-23 – 6.6,
03-28-23 – 4.3.
03-29-23 Visit – The Coumadin is changed to 5mg every Saturday and Sunday and 7.5mg Mon-Fri and that is continued.
INRs:
03-30-23 – 6.2
04-04-23 – 4.6,
04-07-23 – Expir,
04-11-23 – 4.4,
04-19-23 – 5.9,
04-21-23 – 6.1,
04-25-23 – 3.5,
04-28-23 – 4.2,
05-02-23 – 4.0,
05-05-23 – 3.8.
05-11-23 Visit- The note indicates she is now therapeutic and taking Coumadin as prescribed.
INRs:
05-12-23 – 4.8,
05-26-23 – 4.0.
On 06-07-23 She is admitted to hospital and INR found to be 6.3. The patient had CT angiogram of head and neck that was negative for vascular occlusion but there was significant tentorial and bilateral hemispheric subdural hemorrhages with mass effect including narrowing of the basilar cisterns. She undergoes bur hole placement 06-11-23 and is re-admitted 06-29-23 and undergoes craniotomy.
She subsequently dies on 08-13-23 due to late effect of CVA. No autopsy performed.
Files:
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Do you believe there might have been medical error?
We do not combine Eliquis and Coumadin. We combine Heparin and Coumadin for it to be therapeutic. This led to a CVA - bleeding with a hematoma and mass effect, which led to her death.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Using apixaban together with warfarin may increase the risk of bleeding, including severe and sometimes fatal hemorrhage. reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9556604/
What makes you a good expert for this case?
I have done trial work, testified on the trial, and done deposition.
How often do you encounter cases similar to this one in your practice?
Not often at all. I do not see physicians combing Eliquis with Coumadin
Do you believe there might have been medical error?
There is not enough information included to make a definitive statement about an error or about causation. Here are my questions that would have to be answered with a complete review of the records: 1) "She is prescribed Coumadin 5 mg every evening and ordered to continue with Eliquis and ASA until INR is therapeutic." If patient started warfarin on 3/8, then she had been taking it for 9 days by 3/17 when her INR was therapeutic at 2.6 and the Eliquis and ASA should have been stopped, at least per the plan. However, there is an odd quotation from the 5/11/23 visit: "05-11-23 Visit- The note indicates she is now therapeutic and taking Coumadin as prescribed." Does this mean she wasn't considered therapeutic before that, despite her INR running between 3.5 and 6.6, all clearly above there target range?. ***When exactly were the Eliquis and aspirin stopped?*** 2) Prescribing aspirin to someone who is fully anticoagulated with warfarin increases the risk of bleeding. However, it can be done successfully, and it may have been felt necessary for this patient given her severe hypercoagulable state. However, I have never seen a patient with such a long string of elevated INR levels, without downward adjustment in the dose so that some levels come down to the target range or lower. In fact, the INRs from 3/31 to 3/28 were 4.4, 6.6, and 4.3, all markedly above the target range, and yet her dose was increased on 3/29/23. This is so outlandish that I find it hard to believe anyone who manages patients on warfarin would do it intentionally, and it makes me wonder ***how the data presented here could be correct.*** 3) Moreover, keeping someone on aspirin who had and INR of 2.0 - 3.0 or 2.5 to 3.5 is one thing, but keeping someone on aspirin AND keeping their INR from 4.3 to 6.6 is something I can't imagine any clinician doing. ***Was the aspirin stopped or continued?*** 4) ***What happened between 6/11 and 6/29?*** She had a burr hole placed on 6/11 when her INR was 6.3. I assume she was given plasma and vitamin K to bring her INR down to normal and she was left off of warfarin and sent to rehab. **Was she discharged too soon?*** It is standard treatment to keep someone with such a life-threatening bleed off of anticoagulation for a period of time. How long of a period of time is not a question answered in the literature. ***What happened between 6/29 and. 8/23.?*** Why did she bleed again? ***Was she placed back on anticoagulation.?*** My guess is that she was off of anticoagulation from 6/29 to 8/23 and then had a thrombotic stroke, but this is unclear. One could argue that the breach was keeping her INR so high that she ended up having a severe bleed and had to come off blood thinner, and then she had a thrombotic stroke.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
This question is more difficult. Again, all of the information is not here. A thorough review of the records needs to be done. It appears that she died of a thrombotic stroke, caused by her underlying hypercoagulable state, which was not caused by a medical error. The argument that she was over anticoagulated and that error caused her anticoagulation to be stopped and that lead to a fatal stroke, while it may be true, is cumbersome to make and difficult to prove.
What makes you a good expert for this case?
I have been practicing hematology and oncology for over 30 years. I am board certified in both. I have reviewed 80 medical-legal cases in the past 5 years. I continue to practice 4 days a week. I have the breadth knowledge and the experience and the ability to carefully analyze the records that a case like this requires.
How often do you encounter cases similar to this one in your practice?
I adjust patient's warfarin daily. I decide what anticoagulation regimen a patient should get daily. Fortunately I have only seen such disasters a few times in my career. I have had several patients with subdural hematomas or retroperitoneal hematomas. I had a patient with a paraspinous hematoma that caused cord compression and paralysis. Why some patients bleed and others clot is not always clear. The question is should it have been avoided by a reasonably prudent and trained physician?
Do you believe there might have been medical error?
From the data given, it appears that she was not adequately monitored or at least may not have been given recommendations to lower dose while on Coumadin. It appears that she often had higher than recommended INR, which can lead to bleeding or hemorrhage. I am not sure of the communication between the patient and physician, which would be important to know.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
If there was not another explanation for SDH, such as obvious trauma, then the elevated INR alone may have caused the bleed.
What makes you a good expert for this case?
Heme/Onc for over 3 decades. I have monitored and managed anticoagulation for many patients with thrombophilia. I have managed Coumadin, Eliquis, etc. Please note, I am boarded in internal medicine and medical oncology, but not boarded in hematology. I do however practice both benign and malignant hematology.
How often do you encounter cases similar to this one in your practice?
A few times a year, we are called in consultation for over anticoagulation and complications.
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