Legally Speaking | Did this OB fail to timely diagnose uterine sarcoma?

Andrew I. Kaplan, Esq. is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City. This case was successfully tried to verdict by his partner, Neil F. Brenes, Esq.

Facts

On June 4, 2008, a 40-year-old white G0 presented to the defendant ob/gyn with complaints of hair loss, weight gain, and premenstrual dysphoric disorder (PMDD). She reported that her Pap smears were always normal (her most recent one had been in March 2008), but that she had tested positive for human papillomavirus (HPV) in April 2007. More recently, she had amenorrhea for 3 months at the beginning of the year and her follicle stimulating hormone (FSH) levels were consistent with menopause.

During this visit, an ultrasound (U/S) revealed a uterine fibroid measuring 6 x 8 cm, which the ob/gyn felt was possibly related to her Hashimoto’s disease. Because the patient had no symptoms related to the fibroid, the ob/gyn did not initiate estrogen therapy. The patient was directed to return to the office in 6 months. However, she called the office on June 24 and reported that she was having more hair loss and was interested in a hysterectomy and hormone therapy. 

The patient called the ob/gyn again on July 2 and reported that her last menstrual period was on May 31. She also reported moodiness and worsening depression. The doctor prescribed estradiol and Prometrium. The patient was seen in the ob/gyn’s office on December 17 and reported that her hair loss was still a problem. The doctor performed another U/S, which showed that the fibroid was stable and measured 6.2 x 7.6 cm.

The patient was next seen by the ob/gyn on March 22, 2010. The doctor documented that she had a long conversation with the patient about feeling unhappy on low-dose estrogen therapy. An U/S performed by the doctor revealed that the fibroid measured 9.0 x 7.0 cm. The patient’s preference for not getting another U/S at an outside facility was also documented. A Pap smear showed no intraepithelial lesion or malignancy. The ob/gyn increased the estrogen dose.

When the patient returned to the doctor on August 16, she reported firmness on her left side and frequent urination. U/S showed the fibroid was “significantly larger,” measuring 10.6 x 9.6 cm. The doctor encouraged her to have a laparoscopically assisted vaginal hysterectomy (LAVH) and removal of the cervix. She also advised her to have a bilateral salpingo-oopherectomy (BSO). The patient was to come back in 3 to 6 weeks to discuss surgical options.

The patient did not return to the doctor’s office until February 9, 2011. An U/S performed at that visit showed fluid in the uterus and that the fibroid was the same size as in August 2010. The doctor ordered another pelvic U/S, which showed a large central myoma of 8.2 x 6.7 x 6.8 cm and a fluid collection of 3.2 x 4.9 x 1.3 cm (~10 mL). The doctor noted that the patient needed to undergo a dilation, endometrial biopsy, and fluid drainage.

The patient was now thinking of undergoing the LAVH and was directed to return to the ob/gyn’s office in ≤ 6 months. But about 3 weeks later, she presented to the hospital emergency department with complaints of right flank pain and lower back pain. A computed tomography (CT) scan of the abdomen and pelvis performed on April 1 showed “few” very large uterine masses, the largest in the left anterior uterine body measuring 15.4 x 9.7 x 10.5 cm. Another mass on the right posterior uterine body was 8.9 x 8.3 x 6.4 cm. The impression was that these masses could represent hyaline degenerating-type fibroids. It was suggested that magnetic resonance imaging (MRI) be obtained. An endovaginal U/S performed the same day showed a large posterior body fibroid of 9.8 x 10.2 x 10.3 cm.

On April 20, the patient underwent an MRI out of state. It was highly suggestive of malignant degeneration of a fibroid in the right uterine body/lower uterine segment. There was no direct regional invasion of pelvic ascites such as would be expected with a leiomyosarcoma. However, metastatic lymphadenopathy was visualized in the pelvis, along with cystic/hemorrhagic degeneration of a fundal intramural fibroid and blood products of varying ages in the nondilated endometrium with probable internal debris.

The patient was referred to a gynecologic oncologist to discuss surgical options. The last note in the ob/gyn’s office chart is a summary of a phone conversation with the patient. The doctor documented that the patient was seen out of state and that an MRI showed a second fibroid that was suspicious for sarcoma. The plan was for the patient to see an oncologist and possibly undergo a total abdominal hysterectomy (TAH).

On May 2, the patient underwent an exploratory laparotomy, TAH with BSO and right pelvic node dissection, and right peri-aortic lymph node dissection at an outside hospital. The pathology report noted: “High-grade poorly differentiated malignant tumor associated with fibroadipose tissue in the lymph nodes; uterus with high-grade poorly differentiated malignant tumor, 15.5 cm, associated with marked lymphovascular space invasion, tumor necrosis.” The final diagnosis was high-grade poorly differentiated uterine sarcoma with mixed smooth muscle and endometrial stromal cell differentiation and lymph node metastasis.

The patient underwent a positron emission tomography scan on May 11, which revealed expected postoperative physiologic changes and no additional disease. She began chemotherapy and underwent radiation therapy until September 19. Chemotherapy was restarted on November 3 and ended December 20, 2011.

Allegations

The plaintiff alleged that the ob/gyn negligently attributed the plaintiff’s complaints to a fibroid and failed to suspect and timely diagnose cancer. It was alleged that the doctor failed to follow, monitor, and measure the size of the fibroid. It was alleged that there was a failure to make the proper referrals and consultations and a failure to order an MRI. It was also claimed that the ob/gyn negligently interpreted the various U/S that were performed while the patient was under her care and failed to advise the plaintiff of surgical options.

The alleged injuries were: Stage III C2 uterine sarcoma; tumor measuring 15.5 x 9.2 x 7.8 cm with marked lymphovascular space invasion and tumor necrosis; positive lymph nodes; lobectomy revealing metastatic high-grade sarcoma with necrosis and lymphovascular invasion in the right lung; TAH; BSO; peri-aortic and retroperitoneal lymph node dissection; chemotherapy; radiation; alopecia; anxiety; headaches; weakness; dizziness; weight loss; fatigue; bloating; nausea/vomiting; pelvic discomfort; loss of enjoyment of life; and lost earnings.

Trial

At trial, the defendant ob/gyn testified that she had never considered that the plaintiff had a uterine sarcoma at any time that she was treating her up to and including the office visit of August 16, 2010. She confirmed that she never visualized (on U/S) 2 masses in the plaintiff’s uterus or suspected she had 2 masses in the uterus during that period.

The plaintiff’s counsel established that the fibroid size was stable when the plaintiff began hormone therapy. He then established that the fibroid was noted to grow significantly from March 2010 to August 2010, although the patient had been on a relatively lower dose of hormone therapy. (His strategy was to establish that the growth of the fibroid could not be attributed to the hormone therapy and therefore should have been suspicious.) He also argued that the growth was “significant” enough to warrant further testing, including CT or MRI.

The ob/gyn testified that the plaintiff was perimenopausal, so she was still making estrogen. Therefore, the fibroid growth was not suspicious. She testified that the plaintiff’s clinical picture was consistent with a growing fibroid and not suspicious for cancer.

The plaintiff’s obstetrical expert testified that the fibroid growth was significant. He testified to a “rule” that when a mass such as this grows by 1 cm in any one direction, or more than .4 cm in 2 directions, the growth should be considered suspicious and testing is warranted. He testified that the growth was significant here in light of the fact that the patient was postmenopausal and not making any estrogen. In his opinion, the hormone therapy was not responsible for the fibroid growth, because the patient had been on a higher dose previously with no corresponding growth. In his opinion, the ob/gyn departed from accepted medical practice by failing to consider that the fibroid growth was suspicious for cancer and by failing to order additional testing, including CT or MRI. On cross examination, the plaintiff’s expert agreed that uterine sarcomas are extremely rare and difficult to diagnose. Most importantly, he conceded that the fibroid growth was not caused by the uterine sarcoma, assuming that it was present in March and August 2010.

The plaintiff’s radiology expert conceded during direct examination that a uterine sarcoma cannot be distinguished from a fibroid on any type of imaging study, including U/S, CT, and MRI. He testified that the only way the diagnosis can be confirmed is by pathology after a hysterectomy. On cross examination he agreed that the uterine sarcoma was suspected by the radiologist who performed the MRI at the outside hospital in April 2011 because enlarged lymph nodes were seen. The radiologist would not have been able to distinguish the fibroid from the sarcoma by merely looking at the 2 masses in the uterus. Rather, the second mass was suspicious for uterine sarcoma because of enlarged lymph nodes. The expert conceded that unless enlarged lymph nodes were present and seen on CT or MRI (had either been performed in March or August 2010) nothing on the scans would have been suspicious for sarcoma.

The patient testified that when she saw the defendant on March 22, 2010, she complained that her abdomen was swollen. The plaintiff’s experts relied upon this testimony in an attempt to document that the patient’s clinical picture was consistent with an abnormally large, rapidly growing fibroid. On cross-examination, however, the plaintiff testified that she was not certain that she made the same complaint to the defendant in August 2010, and this complaint is not documented for either the March or August visit. The plaintiff admitted that she did not make any complaints to any other physicians she saw during the same period.

The plaintiff’s oncology expert utilized a “doubling time” analysis to support his opinion that the uterine sarcoma was both present and detectible in March and August 2010. Using that analysis, he calculated that the tumor would have been at least 1 cm3 (the size a mass must be to be detected on CT or MRI). He also testified that had the diagnosis been made in March or August of 2010, the plaintiff’s cancer would have been Stage I with a 74% chance of 5-year survival.

On cross-examination, we pointed out that the measurements of the tumor in the surgical pathology report were incorrect and much larger than the size measured on the MRI performed just 3 weeks earlier. So, if he started with a smaller mass than what he initially calculated, that meant that the tumor might have been smaller than the 1 cm³ he said would have been likely in March or August 2010, and thus may not have been detectable. He further agreed that this type of cancer often spreads in patients who are diagnosed at Stage I, therefore, patients with uterine sarcoma have a poor prognosis at any disease stage.

Our radiology expert refuted the “4-mm rule,” which he stated was “ridiculous.” He testified that this particular mass could not be visualized on U/S in March or August 2010 and that imaging studies cannot distinguish a fibroid from a uterine sarcoma. He testified it was not incumbent upon the ob/gyn to investigate the fibroid growth in March and August 2010, as it was not unusual or suspicious for cancer.

Our final witness, a gynecologic oncology expert, also refuted the “4 mm rule” and said that there was nothing suspicious about the fibroid growth as documented in March and August 2010. He testified that the patient’s clinical picture fit perfectly with a growing fibroid and was not suspicious for cancer.

He also testified that because the patient was perimenopausal and on hormone replacement therapy, it was reasonable to conclude that the fibroid growth was related to the hormone therapy.

The “doubling time” theory, he said, was flawed and not based upon accepted science. He pointed out that the plaintiff’s statistics concerning the survival rate for Stage I uterine sarcoma patients were incorrect because they included patients with low-grade sarcomas, which have a much higher cure rate than high-grade sarcomas.

The verdict

The verdict sheet asked whether it was a departure for the ob/gyn not to have suspected cancer and/or order further testing on March 22 and August 16, 2010. The jury unanimously answered “no.” A verdict was rendered in favor of the defendant.