Was this a failure to diagnose ovarian failure?

Factual Summary

On March 24, 2014, a 26-year-old female patient began treatment with the defendants’ practice, when she was examined and evaluated by Defendant A. The patient completed a questionnaire, in which she documented the reason for the appointment as “irregular period/other symptoms having to do with that.” She did not specify any other symptoms.

The patient reported her last menstrual period (LMP) as occurring on Nov. 29 to Dec. 8, 2013, and again on Feb. 3, 2014. She had no past obstetrical history. Her gynecologic history was negative for sexually transmitted diseases (STD) and pelvic inflammatory disease. Her medical history was pertinent for anxiety, but she was no longer on fluoxetine.

Her mother had ovarian cancer but both parents were alive and well. The patient smoked ½ packs of cigarettes per day. She had no known drug allergies.

Defendant A referred her for lab work including a complete metabolic panel, complete blood count (CBC), and hormone levels. Bloodwork was performed on April 10, 2014 and reported to Defendant A on April 16.

The triiodothyronine (T3) uptake was high at 36. The luteinizing hormone (LH) was 1.8 with follicle-stimulating hormone (FSH) at 8.0. The prolactin was 12, dehydroepiandrosterone 235, and testosterone 17. The lab report contains the following reference ranges: follicular phase (2.5-10.2 mIU/mL); mid-cycle peak (3.1-17.7 mIU/mL); luteal phase (1.5-9.1 mIU/mL); and postmenopausal (23-116.3 mIU/mL).

Prolactin levels were reported as 12.0 ng/mL, with a reference range of post-menopausal (2-20 ng/mL); pregnant (10-209 ng/mL); non-pregnant (3-39 ng/mL).On April 16, the patient also presented to the codefendant’s perinatal services clinic for a pelvic sonogram due to amenorrhea “on and off for the past 6 months.”

Her LMP was documented as April 5. The impression was normal pelvic sonogram with no adnexal masses noted. There was no free fluid seen. The endometrial stripe was within normal limits. Clinical correlation and follow up was recommended.

A progesterone level was drawn on April 29. The result was .4 ng/mL, with reference ranges as follows: Follicular phase (.0-1.1 ng/mL), mid-follicular (0.0 – 1.0 ng/mL), mid-cycle (.5-1.7 ng/mL), luteal phase (1.0-21 ng/mL), mid-luteal (6.0-24 ng/mL), post-menopausal (0.0-1.0 ng/mL), oral contraceptives (.3-.9 ng/mL).

On Sept. 6, the patient presented to her primary care physician (PCP) with complaints of a pelvic infection that had been diagnosed by a walk-in clinic the day earlier. Her PCP advised her to follow up with her gynecologist and follow the antibiotics recommendations of the walk-in clinic. There was no discussion of amenorrhea documented in the records at this visit.

Approximately six weeks later, on Oct. 27, the patient returned to the defendants’ practice and was evaluated by Defendant A. The exam and findings were generally negative. Cultures were taken for gonorrhea and chlamydia, as well as urine culture and sensitivity tests.

Defendant A diagnosed a yeast infection and prescribed fluconazole. The cultures for gonorrhea, chlamydia and a urine culture were negative.

On Dec. 15, the patient presented to her PCP with complaints of missed periods, requesting a pregnancy test. Her PCP did a pregnancy test, which was negative.

He recommended follow up with her ob/gyn. On Feb. 3, 2015, she again returned to her PCP with complaints of not feeling well, including headache and anxiety. She was evaluated and the working plan included follow-up with her ob/gyn, diet, exercise, water intake, and to go to the ER if her symptoms persisted.

On May 11, she presented again to her PCP’s office for “routine gynecological treatment.” She reported she was “feeling well and with no complaints.”

Her LMP was documented as April 27. The plan was for blood work including CBC, a metabolic panel, STD screenings, thyroid levels, and to return to the office for routine care as needed.

On May 18, nearly six months after her PCP first advised her to return to her ob/gyn for follow-up care, the patient returned to Defendant A’s office, this time for a possible yeast infection with itchy discharge. Fluconazole 150 mg by mouth once a day was prescribed.

On June 1, the patient returned with concerns about a possible lost tampon. Defendant A performed an internal exam, found no lost tampon, and prescribed metronidazole 0.75 vaginally at bedtime for five days for bacterial vaginosis.

On Aug. 27, she returned to her PCP, for a sick visit due to an upper respiratory infection. Her last menstrual period was documented as Aug. 6.

On Nov. 5, the patient returned to the defendants’ practice and was seen by Defendant B. The chief complaint was bacterial vaginosis.

A vaginal culture and urine culture were obtained. Defendant B prescribed metronidazole, and nystatin and triamcinolone acetonide cream. Defendant B also discussed birth control options with the patient.

According to the plaintiff, she had bad experiences with birth control in the past, and was reluctant to go on them again. On Dec. 7, the patient saw Defendant A. According to the record, the plan was to check labs and birth control pills were prescribed.On Dec. 14, she went for blood work, which came back abnormal. The FSH was in the menopausal range at 25.1 IU/L.

On Dec. 21, the patient called the defendants’ clinic, stating that she had a repeat bacterial infection. A prescription for metronidazole was called to her pharmacy. This was the last contact that the plaintiff had with the defendants’ office.

On Feb. 1, 2016, the patient presented for the first time to the offices of non-party ob/gyn.She reported her last menstrual period started on Jan. 18, 2016. She reported frequent bacterial infections and amenorrhea. She was diagnosed with bacterial vaginosis and prescribed clindamycin. No further workup was performed at this time, despite the report of amenorrhea during this visit.

Six months later, on Aug. 11, she returned to non-party ob/gyn’s office for further evaluation and treatment of a yeast infection.

At this visit, she was sent for further blood work. FSH was reported as 70.9 mIU/mL. The lab report contained the following reference ranges: follicular phase (3.5-12.5 mIU/mL); mid-cycle peak (4.7 – 21.5 mIU/mL); luteal phase (1.7-7.7 mIU/mL); and postmenopausal (25.8-134.8 mIU/mL).

On Aug. 21, the patient returned to non-party ob/gyn’s office. Her last menstrual cycle had been 3 months earlier. The plan was to repeat labs in one month and then start birth control pills. On Aug. 22, the patient had a sonogram with non-party ob/gyn that was interpreted to be within normal limits. That was the last contact the plaintiff had with non-party ob/gyn’s office.

On Sept. 1, the patient presented to a non-party specialist for a fertility evaluation. She reported her last menstrual period as June 10, 2016. On Sept. 7, her ovaries were “quiet.”

On Sept. 21, her right and left ovaries showed 2-3 follicles each. In 2017, she went to see a new ob/gyn, who treated her symptoms with an estradiol transdermal system and progesterone. She last had her period in the summer of 2018.

Allegations

The plaintiff alleged that from March 2014 through December 2015, the defendants failed to timeline and properly consider lab and sonogram results, failed to order further studies, failed to refer the plaintiff to a fertility specialist, and failed to consider her complaints and concerns. As a result, she claimed she was put into early ovarian failure and rendered infertile.

Discovery

The plaintiff testified that prior to her treatment with Defendant B she had some “weird body issues” including body aches, joint pains as well as headaches, fatigue, and anxiety.

The symptoms began to snowball into one another; and she reported that hot flashes and dizziness started around July of 2016. She reported that from about 2010 to 2013 her periods were regular on a 28-31 day cycle lasting 4-6 days, and she would have some typical symptoms of PMS such as cramping, but no other complaints of abnormal periods.

In 2014, she started noticing abnormal periods. This is when she started treatment with the defendants. She defined abnormal as “not as frequent and not on a schedule.” She also started suffering from frequent bacterial infections. 

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She also testified that during one visit Defendant A stated that she should “consider yourself lucky. No girl wants her period. Come back and see me when you want kids.”

She recalled a discussion over being put on birth control, but she did not want to go on it because of past experiences. She was told by subsequent physicians that she had the FSH level of a “menopausal woman.” She also testified that had she known earlier she could have used fertility-preserving treatment such as freezing her eggs. 

The fertility specialist advised her that it was too late for egg retrieval; however, she was a good candidate for in vitro fertilization.

Unfortunately, Defendant A passed away shortly after the commencement of the litigation. Defendant B had no recollection of this patient, having only treated her on one occasion during the time period in question. He felt strongly that the appropriate workup was done, there was no reason to repeat the testing after April 2014, and when it was repeated in late 2015 and came back suspicious, the patient never returned to the office.

Our expert felt the care was defensible. He explained that irregular periods in patients of this age are very common and ovarian failure is “last on the list” within the differential. He said that stress is the primary reason for irregular periods and they may also be the result of weight loss, exercise, and a host of other factors.

For that reason, the standard of care does not call for automatic lab testing when patients present with these complaints. The lab results consisted of an FSH of 8.0 and an LH of 1.8. The patient also had low progesterone and Defendant A put her on medication for that reason.

An FSH of 8.0 was perfectly normal and no further workup was required at that point. While the plaintiff took the position that further lab work should have been done when the patient returned on several occasions up through December 2015 (which is the next time her FSH was tested), our expert maintained that no additional testing was needed.

There was evidence that the patient did continue to have periods.For example, when a sonogram was done on April 14, the LMP was listed as April 5, 2014, and there was a June 1, 2015, visit for a possible lost tampon.

Additionally, after the patient left the defendants’ care in December 2015, there was an LMP listed as Jan. 18, 2016, at her subsequent treater’s office. Once the initial labs came back within normal limits and once the sonogram on April 14 showed normal ovaries with a left-side ovary that was ovulating, there was no reason to suspect the patient was going into ovarian failure.

He felt the patient should have been advised of her elevated FSH in August 2015, but that at that point the die was cast and it would not have altered the outcome.

Result

After all depositions were concluded, we moved for summary judgment dismissal of the case. While the motion was pending, but prior to opposing, the patient’s attorney contacted our office seeking a reasonable settlement as to the estate of Defendant A. Ultimately the case settled for $25,000.

Analysis

Putting aside the opportunity to resolve this case for less than the cost of trying it, the matter settled primarily for two reasons.

The first reason was the absence of any documentation by the defendants of awareness or follow-up with the patient for the elevated FSH in November 2015. Whether or not the die was cast, as it were, documenting acknowledgment of the abnormal results and discussion with the patient still was required.

This became even more necessary here, where Defendant A passed before he could testify in response to the patient’s assertion that he downplayed her complaints and test results to her detriment.

Absent an opportunity to produce a witness to rebut those assertions, and given the reasonable demand, the decision was made to resolve the matter rather than risk a sympathetic verdict, despite the defensibility of the care.

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About the Author

Andrew I. Kaplan, Esq. is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City, specializing in medical malpractice defense and healthcare litigation. This case was handled by one of his partners.