Should this ectopic pregnancy have been diagnosed earlier?

The facts

On October 24, 2011, a 29-year-old patient presented to the defendant hospital’s emergency department complaining of a 4-day history of vaginal bleeding and lower abdominal pain. She was in no acute distress, and had no vomiting, diarrhea, dysuria, or headache. Her complaints were of dizziness and mild shortness of breath. An ultrasound had been performed and blood samples had been drawn when the patient was seen at the codefendant hospital 2 days earlier.

The woman was told that the imaging showed no intrauterine pregnancy. Her blood sample, however, revealed a beta-human chorionic gonadotropin (β-hCG) level of 313 and rising, which correlated with her last menstrual period (LMP) on September 9, 2011. A basic metabolic panel, coagulation study, and urinalysis were normal, and testing for gonorrhea and chlamydia was negative. Urinalysis did show many bacteria. The patient’s hematocrit (HCT) was 33.2 and her hemoglobin (Hgb) was 11.1. Physical examination by the emergency medicine attending physician found that the patient’s abdomen was soft with mild left quadrant tenderness but no guarding or rebound. The attending noted mild vaginal bleeding and that the cervical OS was closed. Abdominal and transvaginal pelvic ultrasound were performed and revealed no evidence of an intrauterine pregnancy, no focal uterine masses, a small amount of free fluid in the cul de sac, a small right ovarian cyst, and a normal left ovary. The impression was ectopic pregnancy rather than spontaneous abortion.

Because the patient had no pain or active vaginal bleeding she was discharged home with information about ectopic pregnancies. She was also told to follow up in the women’s health center (WHC) in 48 hours. On October 26, 2011, the plaintiff presented to the WHC as directed and was seen by co-defendant Dr A, who noted that her ultrasound was negative for intrauterine pregnancy. The plaintiff had no pain but was having a small amount of vaginal bleeding. Dr A’s impression was likely complete abortion but he noted that an ectopic pregnancy could not be ruled out. Blood was drawn for an hCG level and the patient was to be called with the result. The β-hCG blood level was to be followed until it was down to 0. Instructions regarding ectopic pregnancy were given to the patient. No complete blood count was ordered.

On October 28, 2011, the plaintiff came back to the WHC for follow-up to evaluate a rising hCG level. She was again seen by Dr A, who had noticed that the β-hCG level drawn on October 26 was 421.4 and more elevated than 2 days earlier. Additional blood samples were drawn for another β-hCG level and the result was 447.1, another increase. The woman’s HCT was 32.9 and her Hgb was 11.4. The risk of a possible ectopic pregnancy was discussed with the patient, who expressed that she understood. The treatment plan that day included dilation with suction and curettage and the risks of the procedure-including bleeding, infection, uterine perforation, and damage to the bowel and bladder-were discussed with the patient. The need for possible methotrexate therapy versus a laparoscopic procedure in the future was also discussed.

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The plaintiff was admitted that day to the ambulatory surgical unit (ASU) and signed a consent form for a possible salpingectomy. She underwent a diagnostic laparoscopy and dilation and curettage (D&C) and excision of a right ovarian mass. The surgery was performed by Dr A, assisted by defendant PGY-1 ob/gyn Dr B. Intraoperative findings are partially noted in the operative report dictated by Dr B and signed by Dr A, which fails to mention the intraoperative appearance of the fallopian tubes despite the patient being consented for a possible salpingectomy.

Laparoscopy showed an 8-week-size anteverted uterus, 50 cc of hemoperitoneum, 1- to 2-cm right ovarian mass, normal left ovary and left adnexa, and a grossly normal upper abdomen. Pathology specimens included endometrial curettings and a right ovarian mass.

NEXT:  More on the case

The surgical pathology report revealed that the endometrial fragments contained decidua tissue only and no chorionic villi, indicating that no intrauterine pregnancy was removed. The right ovarian mass was a pregnancy luteoma, a benign tumor that usually regresses after pregnancy. The patient appeared stable postoperatively and was discharged home with follow-up at the WHC scheduled on November 9, 2011.

On November 2, 2011 the plaintiff was recalled to the WHC to check her hCG levels, which had been steadily rising. She was seen by Dr A, who had noted that the hCG had increased to 884.9, which was suggestive of an ectopic pregnancy rather than an abnormal intrauterine pregnancy. The patient had no pain or appearance of an acute abdomen and so she was told to return to the WHC for possible methotrexate therapy.

On November 4, 2011 the plaintiff returned to the WHC and was seen by non-party Dr C. Her hCG level had risen further to 916.2. The risks, benefits, and adverse effects of methotrexate therapy were explained to the patient and she agreed to try it and was given 85 mg without any adverse effects. Ectopic pregnancy precautions were reviewed and the plaintiff was told to return to the clinic on Day 4 and on Day 7 and then weekly until her hCG levels had dropped to 0. If her hCG levels had decreased less than 15% between Day 4 and Day 7 and there were no other complications, she was to receive a second dose of methotrexate.

On November 8, 2011 the plaintiff returned to the WHC and was seen by Dr B and nonparty Dr D. On that day, her hCG level was noted to have risen to 1385; however, because she was purportedly asymptomatic she was told to return to have her hCG test repeated 3 days later on November 11, 2011. On that day, she returned to the WHC and was seen by a Dr E. Her β-hCG level was noted to be 1051.0, only a slight decrease from the prior level. The plaintiff complained of bilateral lower abdominal tenderness, and guarding and rebound was noted upon examination.

A transvaginal pelvic ultrasound revealed no evidence of a viable intrauterine pregnancy, but there was a large amount of complex fluid in the pelvis. Also noted was a left ovarian cyst and a normal right ovary and a large mass-like area in the cul-de-sac extending to the right adnexa, which was a new finding since the October 24, 2011 study. The report also revealed the suggestion of a ring-like tubal structure. Dr E’s impression was a ruptured ectopic pregnancy despite the decline of the β-hCG following methotrexate therapy. The case was discussed with Dr A and the plaintiff was admitted immediately for ambulatory surgery.

The plaintiff underwent an emergent laparoscopic right salpingectomy and a left ovarian cyst aspiration for a right ectopic pregnancy. The surgery was performed by Dr A. Intraoperative findings revealed a right fallopian tube ectopic pregnancy, 2 simple left ovarian cysts, no pelvic adhesions, and a uterus that was small, mobile, and grossly normal.

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The pathology report revealed that a segment of the right fallopian tube contained chorionic villi consistent with a fallopian tube pregnancy. The plaintiff was discharged home that day and told to return on November 23, 2011 for a postoperative check. When she came back to the WHC on November 23, 2011 and was seen by Dr A, she was noted to be ambulating, voiding, and passing gas, and that her pain was well controlled with pain medication, which was not needed on that day. She had no fever and her incision was healing well. The result of the ectopic pregnancy in the right tube was noted.

Dr A prescribed a contraceptive vaginal ring and Ms A was to return to the clinic for routine gynecologic care. However, she chose not to follow-up at the defendant hospital.

NEXT: Allegations and verdict

Allegations

The plaintiff asserted that during the diagnostic laparoscopy, Dr A and Dr B should have detected the ectopic pregnancy in the right fallopian tube. Her attorneys claimed that based upon the plaintiff’s abdominal pain, vaginal bleeding, and β- hCG levels, and absent evidence of intrauterine pregnancy on ultrasound, the defendants should have presumed ectopic pregnancy and adequately evaluated the fallopian tube before discharging the patient, thus avoiding rupture.

Discovery

At the deposition, the patient claimed that once her tube ruptured she was told by a physician at the defendant hospital that she would never again get pregnant but “could adopt.” She then revealed that she in fact became pregnant a year after the incidents at issue and suffered another ectopic pregnancy. She claimed no knowledge of discussions regarding the possibility of extrauterine pregnancy before the rupture was diagnosed, despite defendants’ testimony and hospital record entries regarding such discussions.

Our obstetric expert opined that the patient’s symptoms of lower back pain and blood in her urine with a positive pregnancy test could have been indicative of an early intrauterine pregnancy, a spontaneous abortion, or an ectopic pregnancy. A β-hCG level of 351 miu/mL correlates to a 4-week pregnancy from a woman’s LMP and at that early stage it is impossible to see it on ultrasound due to the minuscule size of the fetal sac, they pointed out. The “discriminatory zone” of β-hCG is the level above which an imaging scan should reliably visualize a gestational sac within the uterus in a normal intrauterine pregnancy. It is not until a β-hCG level reaches 1500–1800 mIU/mL that a gestational sac would expect to be visible with transvaginal ultrasonography (TVUS).

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The plaintiff ’s β-hCG levels remained well below the “discriminatory zone,” making it impossible to see a fetal gestational sac using TVUS. Because it was too early to see a fetal gestational sac, it was impossible to make the diagnosis of an intrauterine pregnancy or spontaneous abortion, so the physicians appropriately decided to monitor the patient’s β-hCG levels, stressing the signs and symptoms of ectopic rupture that could herald a potentially life-threatening complication and advising the patient of the need to return for medical follow-up.

When the patient returned on October 28, Dr A examined all of the adnexal structures, carefully inspecting both fallopian tubes, but the ectopic pregnancy was too small to discriminate in the fallopian tubes at that level of development and β-hCG level. Postoperatively, when plaintiff ’s β-hCG levels continued to rise, methotrexate was appropriately administered according to protocol.

When the patient subsequently returned her levels had risen and she properly underwent exploration, at which time the ectopic pregnancy was identified.

Resolution

Armed with expert support, the defendants moved for dismissal prior to trial. While the plaintiff contended that her symptoms should have raised the defendants’ index of suspicion for ectopic pregnancy, their expert could not refute the defendants’ contention through expert affidavit that the β-hCG levels on initial presentation were too low to support anything other than a nonviable pregnancy, whether ectopic or intrauterine.

In other words, even if the fallopian tube had been explored no viable pregnancy would have been located and thus plaintiff ’s result would have been the same.

The verdict

After oral argument before the court, the case was dismissed. The court agreed with the defendants’ experts that given the facts the patient’s result would not have been altered by earlier intervention.