Commentary
Despite allegations that the defendant internist failed to properly monitor INR levels and appropriately manage medications, the jury returned a defense verdict.
Case Details
The patient, a 60 YOWF (5’3”, 203 lb), with a medical history of anxiety, depression, sleep apnea, and chronic back pain, was seen by the defendant internist for medication management related to her conditions. The defendant internist adjusted the patient’s medications over the next few months.
Eight months after the initial exam, the patient presented to the defendant internist reporting a history of 12 hours of abdominal pain and chills. The defendant internist elicited tenderness across the abdomen upon examination. An abdominal/pelvic CT scan with contrast was ordered, which revealed an occlusive thrombus in the superior mesenteric vein. The defendant internist referred the patient to the local hospital’s ED where she was admitted and eventually diagnosed with Factor V Leiden mutation heterozygosity. The patient was discharged five days later on warfarin 5 mg daily, Benicar, Ambien, and Tylenol (PRN).
The patient returned to the defendant internist after discharge and had an INR drawn. Since all INR testing analysis was completed offsite, there was a one day delay in the results. The patient’s INR result was 1.8 (target 2-3). The defendant internist instructed the patient to increase her warfarin to 7.5 mg for two days, then return to 5 mg daily. Additionally, a hematology appointment was made for the patient. The defendant internist informed the patient she needed her INR checked in one week at either the defendant’s office or the referred hematologist’s office.
The patient saw the hematologist nine days later. Her INR level was 1.25. The hematologist managed the anticoagulation therapy for four weeks using warfarin and a short-term Lovenox bridge. The patient’s plasminogen activator inhibitor (PAI) 4G/5G polymorphism was reported as heterozygous positive during this time. The hematologist sent the defendant internist a letter stating the patient was told the heterozygous Factor V Leiden mutation was a primary risk factor for hypercoagulability. The letter also noted the factor was associated with a four-to six-fold increased relative risk for thrombosis. The hematologist recommended the patient continue on warfarin 5 mg daily and discussed the need for long-term anticoagulation treatment.
The patient saw the hematologist over the next 19 months for INR monitoring and warfarin management. Documentation during this time showed her INR remained unstable and indicated that multiple discussions took place regarding medication compliance. Two prescriptions for an INR home self-testing machine were provided, and an additional letter was sent to the defendant internist stating the need for long-term anticoagulation therapy due to the patient’s Factor V Leiden mutation. The 19-month timeframe ended when the hematologist’s group ceased operation and the patient’s hematologist joined another group. The patient was then a “no show” for two additional appointments at the hematologist’s new office.
The patient returned to the defendant internist seeking a physical approximately six months after her last hematology appointment. Her INR was 1.2 and the defendant internist instructed the patient to increase the warfarin dosage to 7.5 mg daily and have her INR checked every two weeks. Approximately three months later, the defendant internist saw the patient for complaints of joint pain. Physician notes from this encounter show the patient received a prescription for a home INR machine—and the importance of follow-up with her previous hematologist or finding a new one was discussed.
Two months later, the patient asked the defendant internist to write long-term warfarin prescriptions because she would be traveling overseas to join her husband who had taken a job abroad. The defendant internist complied with the long-term prescription request. The patient had an appointment to see her previous hematologist prior to leaving on her trip, but did not show up for the appointment.
While overseas, the patient became confused while on a train with her husband. She was taken to the ED and a CT scan showed a hematoma in the left lentiform nucleus with a bleed into an underlying lesion. An MRI later suggested this was a cavernoma. The patient’s INR was 5.6 upon arrival, requiring Octaplex and vitamin K. A repeat CT scan showed clot expansion with increasing midline shift and obstructive hydrocephalus.
After a combined eight-month hospital and rehabilitation admission with diagnoses of hydrocephalus, post-left basal ganglia ICH, intraventricular extension, right-sided weakness, expressive and receptive dysphasia, and DVT, the patient returned to the United States and was admitted to a rehabilitation hospital.
Expert Testimony
The plaintiff named the internist but not the hematologist in a lawsuit. Plaintiff experts criticized the defendant internist’s lack of medication management and INR monitoring, especially when there was little follow-up testing before giving the long-term prescription.
Defense experts stated the patient’s anticoagulation treatment was being managed by the hematologist, as the defendant internist was not equipped to provide this care. The defense argued that the hemorrhage of the cavernous malformation would have occurred regardless of the INR level and led to the serious neurological deficits.
Resolution
The jury deliberated for approximately 30 minutes and returned with a unanimous defense verdict.
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