INR Neglect: A Case of Preventable Tragedy

Facts of the Case

In 2003, a MLMIC-insured cardiologist treated a 65-year-old male who had severe mitral valve regurgitation with normal LV function, as well as hypertension. Over the course of the next two years, the patient’s ejection fraction decreased to 30-40%.

In 2005, the patient underwent mechanical mitral valve replacement surgery. He then experienced several episodes of congestive heart failure and atrial fibrillation, requiring two admissions to the hospital. When his ejection fraction dropped to 15%, an automatic implantable cardioverter-defibrillator was inserted. Because of the valve replacement, the patient was placed on long-term anticoagulation (Coumadin) by his cardiovascular surgeon. One month later, the cardiologist took over the maintenance of the anticoagulation. He monitored the patient’s international normalized ratio (INR) level monthly.

The results of the INR levels enabled the cardiologist to determine whether to adjust the dosage of Coumadin. After he reviewed the results, he had his staff contact the patient to tell him whether to increase, decrease, discontinue or maintain the Coumadin dosage at the same level. Because the patient primarily spoke Spanish,  a staff member fluent in Spanish called him with these instructions. If the patient’s INR was too high, he was advised to not take the Coumadin for a defined period of time and then restart it. After he resumed the medication, he was to repeat the INR. Unfortunately, the cardiologist’s office records failed to document both the current Coumadin dosage and any adjustments made after reviewing the patient’s blood work. Until 2011, the patient’s INR levels remained therapeutic.

In November of 2011, the now 73-year-old patient’s INR was 3.87. He was seen one week later for a routine checkup by the cardiologist and had no complaints of chest pain or shortness of breath. The examination of his heart and lungs was normal, however, once again, the physician failed to document the patient’s current dosage of Coumadin, the results of the patient’s most recent INR level or whether he had prescribed any other medications for this patient.

The following day, the patient’s prescription for Coumadin was renewed by a covering physician. One week later, the patient’s INR was 4.65. When this test result was received and reviewed, the designated staff member was told to promptly call the patient and advise him to discontinue the Coumadin for three to four days and then have another INR performed. These instructions were not documented in the patient’s medical record.

Shortly thereafter, the patient experienced hematuria and went to a nearby hospital emergency department, where his cardiologist was not an attending. Thus, his cardiologist was neither informed of the patient’s visit nor contacted by the emergency department physician. The patient claimed he was advised to stop taking his Coumadin, which he did. By December 13, 2011, the patient’s INR level was 1.56. The cardiologist was promptly informed of this. Allegedly, the patient was told to promptly resume the Couma din. However, once again, these instructions and the telephone call by the staff were not documented.

One week later, the patient’s INR was 1.10. The cardiologist was not advised of these results and  was gone on vacation until the end of December. The covering physician also was not informed of this critical test result by the cardiologist’s office staff. When the cardiologist returned to the office on December 27, he, too, was not informed of this INR.

On January 3, 2012, the patient was taken to the ED of a local hospital. He had slurred speech and left-sided weakness/paralysis. A brain CT scan confirmed that he had an infarct, and he was admitted to the stroke unit. His INR was found to be 1.5. A subsequent CT scan revealed an acute ischemic infarct in the right MCA and ACA distribution, with a 7 mm midline shift but no intracranial hemorrhage. The patient had left-sided paralysis and could not open his eyes, eat or drink. He mumbled and tapped his head to indicate pain. Because he could not eat solid food, the placement of a feeding tube was recommended. . The family refused to consent to this procedure. A Do Not Resuscitate order was then issued. Over the next 24 hours, the patient developed pulmonary congestion, renal insufficiency and hyperkalemia. Three days later, he  expired.

Lawsuit Filed

The daughter of the deceased commenced a lawsuit against the cardiologist. She alleged that from November 2011 on, he negligently failed to properly monitor and respond to the decedent’s INR levels, mismanaged his anticoag ulation and failed to act promptly to review the test results and inform the patient that he had a dangerously low INR. Thus, the patient had a sub-therapeutic INR for a prolonged period of time, which led to the stroke. The daughter also alleged that the cardiologist failed to timely reinstate the patient’s Coumadin, thereby permitting the decedent’s condition to deteriorate, resulting in a fatal embolic stroke. The complaint demanded monetary damages for the decedent’s pain and suffering, the loss of services to his wife of seven years and the loss of guidance, counseling and companionship on behalf of his three adult children.

Expert Review

The care was reviewed by an expert in internal medicine who concluded that there were serious issues in this case due to the lack of documentation of the decedent’s INR levels, the dosages of Coumadin he prescribed and the specific instructions relayed to the patient. These deficiencies in documentation made it difficult to determine whether and when the cardiologist became aware of the dece dent’s INR of 4.65, which resulted in hematuria and a visit to the emergency department. Further, the medical record did not reflect when or whether the patient was advised to resume the Coumadin. Because of his failure to document these critical values and his instructions to the patient during the pivotal time period in mid to late December 2011, the standard of care was not met. Further, the expert concluded that because there was no documentation of the physician’s awareness of an INR of 1.10 nor documentation that the decedent had resumed the Coumadin, inaction resulted in a CVA and the death of this patient.

At the plaintiff’s (daughter’s)deposition, she testified that she had accompanied the decedent to the defendant phy sician’s office seven or eight times. She also testified that, although his office staff had called her several times to relay instructions to the decedent to stop taking Coumadin, she was never told when he was to resume this medication. She further testified that, while the family was together for the Christmas holidays, her stepmother informed her that the decedent had been instructed to discontinue the Coumadin but was not told when to resume it.

Settlement

Because there was an apparent deviation from the standard of care, settlement negotiations were undertaken prior to the deposition of the defendant cardiologist. Counsel for the defendant had reported to the MLMIC claims staff that a probable jury verdict would likely approach the limits of his $1.3M policy. The settlement value of this lawsuit was estimated to be in the mid-six figures. Because of the decedent’s age and co-morbidities, defense counsel was able to settle this lawsuit on behalf of the insured cardiologist within his policy limits.

There was a global failure to properly and consistently communicate with the decedent and fully document his care. The failure to respond to his INRs and timely adjust his dosages of Coumadin resulted in the decedent’s demise.

Over the 11-year period of care by the cardiologist, the INR laboratory results were contained in the decedent’s medical record, confirming that his INR was regularly monitored. However, there was little to no documentation about any advice the decedent was given about how and when to adjust his Coumadin dosage, nor was there confirmation that he understood the significance of changes to his INR.

Legal Perspective

If this case had proceeded to deposition or trial, plaintiff’s counsel likely would have established a deviation where the unlicensed staff member was used to translate and convey critical medical information. Merely speaking Spanish does not qualify a staff member to provide medical advice and critical information to a patient of limited English proficiency (LEP). In this case, it was crucial that the decedent understand the importance of the relevant medical issues, yet there was no written confirmation that the decedent understood the directions that were given. LEP patients who receive federal funding for healthcare, i.e., Medicare, must have access to a translator who is competent in medical terminology and information. Therefore, translation of the risks of Coumadin and confirmation that the decedent understood that information could easily be challenged. The decedent and his daughter needed to understand that after his INR was checked, the physician must advise him of any adjustments to his Coumadin dosage. If not contacted, the patient should have been advised to promptly contact the cardiologist.

When the patient’s INR reached 3.87, there was no documentation that a call was made to the decedent to adjust his Coumadin dosage, nor was there evidence that the defendant was even made aware of this elevated INR by his staff. This lapse was compounded by the renewal of the decedent’s Coumadin prescription by another physician without first checking the most recent INR. Finally, when the decedent’s INR continued to rise, the defendant apparently did adjust the Coumadin dosage, however, again, there was no documentation of this communication. It appeared that the decedent was not told for how long his Coumadin should be decreased nor was he told when to have his INR re-checked.

From this point on, there were a series of disastrous events. The decedent experienced hematuria and went to an emergency department where he was advised to completely discontinue Coumadin. The defendant claimed that he was not advised of this emergency department visit. The decedent’s next INR was 1.56. There was no documentation that the defendant provided any instructions to the decedent nor that he was notified both before and after his vacation that the decedent’s INR was 1.10. Further, he apparently failed to review any test results he received or contact the decedent or his daughter. Thereafter, the decedent had a terminal CVA and expired.

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This document is for general purposes only and should not be construed as medical or legal advice. This document is not comprehensive and does not cover all possible factual circumstances. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors for any questions related to legal, medical or professional obligations, the applicable state or federal laws or other professional questions.