Legally Speaking: Did contraindicated hysterectomy lead to HIT and limb loss?

On Sept. 22, 2015, the patient underwent a supracervical hysterectomy, right salpingectomy, lysis of adhesions, and control of massive pelvic hemorrhage. By way of indications for the surgery, Defendant OB documented that the patient was a 45-year-old para-I with a history of a symptomatic fibroid uterus who desired definitive treatment with hysterectomy.

Intraoperatively, he described that the uterus was 7-8 weeks in size and there was a large pedunculated fibroid on the fundus, which measured 10x12x8 cm with necrosis.

Intraoperatively, Defendant OB noted that when attempting to remove the lap pad that had been packed into the right pelvis, there was noted to be “massive amounts of venous bleeding.” The source of bleeding was not well visualized and an intraoperative vascular consult was obtained from Defendant Vascular Surgeon.

Defendant Vascular Surgeon noted that the patient was bleeding “profusely from pelvic veins” and that “the patient was hypotensive, lost several liters of blood, there was bleeding from the deep pelvic veins as well as uterine veins on the right side. This was very difficult to control.”

Eventually, hemostasis was achieved. The patient was hypotensive, received pressors, and had an estimated blood loss of 4.5 liters. At deposition, Defendant OB explained that the Ligasur “slipped” off the uterine vein as he was ligating.

Upon arrival to the SICU, the patient was hemodynamically unstable and, as such, it was decided to administer PRBCs and FFP and to continue with aggressive resuscitation. The resident described that the patient was stable and was to receive Fentanyl for pain control and sub-q Heparin for DVT prophylaxis.

This was held until the afternoon of Sept. 23, secondary to “massive bleeding.” The patient’s platelet count on Sept. 22 was 196k and hemoglobin and hematocrit were 10.4/31.4.

On Sept. 23, 2015, the gyn service noted that the patient was stable. Heparin was given at 2:27 p.m. on Sept. 24, the patient was described as critically ill and she was undergoing resuscitation with volume and products.

The resident noted that the patient denied chest pain, shortness of breath, nausea, vomiting, lower extremity pain, or calf tenderness.

The resident’s plan included re-starting sub-q Heparin for DVT prophylaxis as the patient was high risk for DVT. The patient was seen by Defendant OB who agreed with the resident’s plan of care. DVT prophylaxis included 5000 units of sub-q Heparin, SCDs, and having the patient out of bed and ambulating as tolerated.

Heparin was given at 6:34 a.m.; 2 p.m.; and 10 p.m. On Sept. 23, the patient’s platelet count dropped to 128 and then to 100 (HGB/HCT 9.5/27.3), and on the Sept. 24 the platelet count dropped to 82 and the HGB/HCT to 8.5/24.5.

On Sept. 25, 2015, the SICU resident noted no acute events overnight and that the patient was in no apparent distress.

The patient’s sub-q Heparin was to be 7500 units every 8 hours and she was to undergo a DVT sonogram. The study was interpreted as being negative for any evidence of acute deep venous thrombosis.

The patient was transferred to the floor. Defendant OB noted that the patient would be discharged home on Lovenox for up to 6 weeks. The patient’s morning dose of Heparin was held, and doses were given at 3:08 p.m. and 10:54 p.m. Her platelet count dropped to 79k and HGB/HCT was 7.3/21.3 (as of 11:00 p.m. on Sept. 24).

On Sept. 26, gyn resident noted that the patient denied lightheadedness, shortness of breath, and/or chest pain. No labs were repeated on this day. On Sept. 27, 2015, the resident examined the patient and noted that she was doing well and ready to be discharged later that evening.

The patient denied chest pain, shortness of breath, and was ambulating without difficulty. Platelet count that evening was 133k and H/H was down to 6.4/18.5. A Lovenox injection was given at 1:00 p.m.

On Sept. 28, 2015, the patient reported swelling in her legs and that they felt tight and sore with walking. At 12:21 a.m., the patient was seen by Defendant OB who noted that the patient felt lightheaded at times, however, she denied chest pain and/or shortness of breath and was able to ambulate well. H/H was 6.5/19 (critical values) and platelet count was 169k. Lovenox injection was given at 9:30 a.m.

The patient failed to appear for her Sept. 30, 2015, follow-up visit in the gyn clinic. The patient testified that she did not present for her follow-up appointment because she was in too much pain and unable to walk. On Oct. 7, 2015, the resident called the patient regarding her missed post-operative appointment. The patient did not answer the phone and a voice mail message was left.

The resident called the patient on Oct. 9 and, again, a message was left asking that the patient call back. On Oct. 14, 2015, the resident spoke to the patient in the presence of Defendant OB.

The patient advised that she had been admitted to another hospital with bilateral DVTs and had undergone an above-the-knee amputation of the left lower extremity. She stated that she had continued to take the Lovenox daily after discharge.

Codefendant Hospital Admission

On Oct. 3, 2015, patient presented to codefendant hospital and was admitted due to bilateral leg swelling and pain. In the E.D., she was found to be anemic (HGB 6.4) and thrombocytopenic (PLT 16).

A hematology consult noted the patient’s clinical findings were concerning for HIT (Heparin Induced Thrombocytopenia) and that she was in need of Argatroban. A CT Scan came back and showed multiple DVTs in the femoral vein and lower left leg. Thereafter, an infusion of Argatroban was started.

On Oct. 6, 2015, the patient was seen by surgery. Bilateral leg swelling was noted, left greater than right, with tenderness to palpitation. The patient was experiencing severe pain on passive extension of her left foot. The recommendation was for venous mechanical thrombectomy as soon as possible.

On this date the HIT assay came back positive as did the SRA assay. On Oct. 7, 2015, a resident was called as the patient was having severe pain to her left lower extremity with burning.

Surgery advised that pain with burning sensation after thrombectomy was common due to re-perfusion. The Vascular Service was called to evaluate the patient’s left foot. The service opined that the patient had phlegmasia cerulea and needed an emergency amputation.

The patient underwent left AKA on Oct. 7, 2015. On Oct. 14, 2015, the patient underwent an open right iliofemoral popliteal venous thrombectomy and IVC venogram, placement of four wall stents and primary repair of the right femoral vein. On Oct. 21, 2015, the patient was returned to surgery and underwent secondary closure of her left above-the-knee amputation. The patient remained hospitalized until Nov. 3, 2015.

ALLEGATIONS:

Plaintiff alleged she suffered left above-the-knee amputation; multiple surgeries to both legs; wheelchair dependence; physical and occupational therapy; psychological therapy; emotional distress; and an inability to perform activities of daily living.

She asserted that defendants were negligent in performing unnecessary hysterectomy as the patient was asymptomatic at the time of surgery; that the patient was at high risk for clot formation given prior DVT and her BMI, further contraindicating surgery; they alleged defendant OB failed to properly control bleeding during the surgery, resulting in massive hemorrhage and significantly increasing the risk of clot burden postoperatively; that defendants failed to consider, diagnose or treat HIT during the patients admission; failing to consult vascular surgery before or after the surgery; and that the patient was negligently discharged from defendant Hospital with undiagnosed and untreated critical anemia and DVTs, despite complaints of leg pain and swelling on the date of discharge.

DISCOVERY:

At his deposition, defendant OB pointed out the patient had confirmed dilated vessels preoperatively and was at increased risk for bleeding, which was discussed as part of her consent.

He disagreed that she was asymptomatic preoperatively and refuted the suggestion that menopause or medical management were acceptable alternatives to surgery. The “slip” of the Ligasur was unfortunate but unpreventable and properly managed with tamponade and consult of a vascular surgeon.

He disagreed that the patient was suffering from HIT during her admission, testifying that her initial diminution in platelet count was secondary to her significant intraoperative bleeding, and pointing to her escalating Platelet count in the two days prior to discharge. The patients leg swelling and edema at the time of discharge was secondary to third-spacing and hemodilution, and there was no complaint or evidence of pain at that time.

The patient failed to appear for her outpatient visit or call, at a time when they may have been able to intervene and save her leg. He conceded he was not an expert on coagulopathy but did not consult Vascular Surgery before the surgery or with regard to the patient’s post-operative anticoagulation.

Our OB expert felt that, pre-operatively, there was little documentation regarding plaintiff’s history of having had a DVT in 2008 including what, if any, work-up plaintiff underwent. He opined that plaintiff was an appropriate surgical candidate for the hysterectomy.

He further noted that other medications were not good alternatives to surgery as they would not have addressed plaintiff’s complaint of pain and/or could have caused early menopause. The intra-operative bleeding encountered was a known and accepted risk of surgery.

He did not believe that there was strong evidence of HIT prior to plaintiff’s discharge and indicated that plaintiffs low platelet count was reasonably attributable to the blood loss that occurred intra-operatively. Further, plaintiff’s platelet count was trending upward by the time she was discharged. He was critical however of discharging the patient with critical anemia and complaints of leg swelling and discomfort without further evaluation.

Our hematology expert opined that it generally takes 5-10 days for a Heparin sensitivity reaction to reveal itself. With a credible alternate explanation and rising platelet count on the 27th and 28th, he would not have considered HIT.

He felt it was appropriate to discharge the patient on Sept. 28 despite her anemic labs as they were stable, to be expected after her blood loss and resuscitation, and she was to follow up in the clinic in a few days. He felt her HIT started after she was discharged.

RESULT:

We moved for dismissal of the matter, primarily on the basis that the patient did not have HIT during the defendant hospital admission and it developed only after her discharge. Plaintiff opposed with experts of her own in ob/gyn and hematology.

Given the high-exposure nature of the case, the decision was made to mediate the matter while the motions were pending and we were able to resolve it for less than half of plaintiff’s initial settlement demand.

ANALYSIS:

This case presented a number of challenges that would have made it difficult to defend before a lay jury. First and foremost, the defense begins “behind the eight ball” in having to explain how a young woman could present for hysterectomy and wind up losing her leg. If there were one or two focused issues to defend medically, that might have made it more tenable.

However, the constellation of decisions and issues to defend – pre-op workup, consent, intra-op complication, anticoagulation management, decision to discharge, follow-up – made it increasingly risky to put in the hands of a lay jury when the known outcome was limb loss. Ultimately, defendant OB preferred to resolve the case if the opportunity arose to do so reasonably, and once it did, we acted.

Andrew Kaplan, Esq is a Partner at Aaronson, Rappaport, Feinstein Deutsch, LLP and a regular contributor to this column.