Ob/gyn neglects to monitor patient on HRT

Mr. Kaplan is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP, specializing in medical malpractice defense and healthcare litigation. He welcomes feedback on this column via email to aikaplan@arfdlaw.com.

Facts

In February 2005, Dr. A first saw a 49-year-old patient with a history of heavy menstruation and fibroids who had undergone a dilation and curettage by a different physician in July 204. performed by a different physician. During the visit, the woman told Dr. A that she had bled the entire month of January 2005. He subsequently performed a vaginal hysterectomy and bilateral salpingo-oophorectomy on the woman, after which, she later testified, Dr. A suggested that she start taking hormone replacement therapy (HRT).

The plaintiff’s post-op follow up with Dr. A was on March 14, 2005. Documentation from that visit indicated that the woman was taking Premarin 5 days per week and the dosage was reduced from 1.25 mg to .625 me, and that Provera was to be taken 5 days per month. Dr. A did not see the plaintiff for another 13 months, for a routine check-up with no abnormal findings. Dr. A examined the patient’s breasts and noted that there were no masses. He advised the plaintiff to continue taking Premarin and Provera at the same dosages and to have a mammogram in about a year. In July 2007, the patient had a mammogram at the radiology group, which was normal. A copy of the mammography report was forwarded to Dr. A.

Dr. A saw the plaintiff again on November 18, 2007 for a routine check-up, during which there were no abnormal findings and  no changes in the woman’s breasts were documented. He recommended that she continue taking hormones and changed the Provera dose to 10 mg, 7 days per month; the Premarin dose and schedule remained un changed. Although Dr. A did not see the plaintiff between November 18, 2007, and July 9, 2010, the radiology group sent him annual reports concerning bilateral mammograms, which were consistently negative for any malignancy. Although it is not documented in Dr. A’s office record, the doctor maintains and testified at his deposition that he would have advised the patient at each visit that she should have an annual gynecologic check-up and mammogram. Furthermore, American Congress of Obstetricians and Gynecologists guidelines specifically state, “physicians who prescribe hormone replacement should be diligent in assessing the possibility of breast disease and should perform regular examinations and mammograms… ”

The patient testified that she first felt a lump in her left breast during a self-examination in August 2008 and presented to the radiology group for a mammogram. According to a report that was forwarded to Dr. A by radiologist Dr. C, the radiology group interpreted a bilateral mammogram and ultrasound of the left breast on August 24, 2008. Ultrasonography of the left breast did not reveal any solid or cystic nodules. Three small cysts were discernible in the right breast, the largest being 5 mm. There were no solid nodules and Dr. C reported “no masses with a dominant characteristic to suggest malignancy.” However, it is clear that both Dr. C and the plaintiff felt a nodule in the areola region of the left breast, and Dr. C stated the following: “There are no changes on either modality [mammography or ultrasound] to correlate with the suggested palpable nodule in the left breast. Management should be based on clinical grounds.”

On September 14, 2008, Dr. A’s office renewed the plaintiff’s prescription for Premarin .625 mg but there was no office visit and no documentation of a discussion about the mammogram results from August 2008. On January 5, 2009, the plaintiff presented to a different radiology group. A bilateral mammogram taken that day revealed a 1-cm region of subtle architectural distortion that corresponded with the palpable lump. The distortion was further demonstrated on a tangential spot compression view in the craniocaudal projection.

Ultrasound examination revealed a 1-cm irregular hypechoic mass at the 2 o’clock axis of the left breast, 3 cm from the nipple. A .4-cm cyst was identified at the 4 o’clock axis of the left breast, 1 cm from the nipple. The impression was a palpable mass in the upper outer quadrant of the left breast that was an invasive carcinoma with features of infiltrating lobular carcinoma and focal in situ component. There were also bilateral cysts. The plaintiff testified that the radiologist told her to stop HRT immediately because the hormones would feed a tumor.

The patient had 2 segmental excisions before she was admitted to a hospital center on April 6, 2009, for a left total mastectomy. In October 2009, the plaintiff underwent left breast reconstruction at the same hospital center. The operative report noted that she had completed a course of chemotherapy.

Allegations

The plaintiff alleged that the defendants failed to diagnose breast cancer on or about August 24, 2008. Furthermore, she alleged that Dr. A was negligent in continuing to prescribe HRT without seeing her. In particular, a prescription was renewed on September 14, 2008, after the mammogram at issue. The plaintiff alleged that at that point, HRT was contraindicated. The plaintiff also alleged that Dr. A failed to order needle biopsies in a timely manner and failed to contact her after receiving the August 24, 2008, radiology report. It was alleged that the codefendant radiologists failed to properly interpret these mammograms and ultrasound studies.

The plaintiff also alleged that the codefendants failed to order a needle biopsy and failed to appreciate the significance of the fact that the plaintiff was taking HRT. Furthermore, the plaintiff alleged that the codefendants failed to order additional mammogram views and failed to order spot compressions. As a result of the alleged malpractice, the plaintiff claimed to have suffered a lumpectomy of the left breast, a mastectomy of the left breast, metastasis to one lymph node, advancement in the stage of cancer, tumor growth to 1.2 cm, scarring, increased risk of metastasis, and decreased chance of survival.

Discovery

According to the plaintiff’s deposition, Dr. A had not referred her for the mammogram at issue. The plaintiff also testified that she requested that a copy of the radiology report be forwarded to Dr. A.

Although the plaintiff testified that she felt the lump in her left breast increase in size between the time of her visit to the radiology group on August 24, 2008, and when she presented on January 5, 2009, she did not contact Dr. A regarding the lump because Dr. C had told her that she was fine. The plaintiff testified that she relied upon the radiology group to perform her breast examinations and that she had not had any breast examinations performed by Dr. A since 2004.

The plaintiff testified that she had learned from a telephone discussion with Dr. C that he had forwarded the mammogram report at issue to Dr. A and that “Dr. A should have followed up on the lump.” She believed that Dr. A should have notified her regarding his receipt of the report, because she still considered him to be her gynecologist because he was prescribing her HRT. She testified that she questioned Dr. A about why he did not call her for a follow-up appointment regarding the mammogram report at issue. Dr. A testified that he saw no need to contact the plaintiff because he had not seen her since 2004 and, at that point, there was no need for clinical follow-up by a physician. At his deposition, Dr. A testified that he did in fact see the plaintiff in his office on October 7, 2009. However, the doctor made no reference to being questioned by the plaintiff about why he did not follow up with her.

At his deposition, codefendant Dr. C testified that his comment that the “management should be based on clinical grounds” meant that the referring physician would take charge of the patient after the mammogram and that Dr. C would not be responsible for the further management of the patient. Dr. C also testified that his only basis for the “referral” was the patient’s statement that Dr. A was the referring physician. Dr. C’s office never obtained any written or oral referral from Dr. A or his office. Dr. C testified that he never spoke with Dr. A regarding the patient or the need for follow-up.

Dr. A testified that it was not his custom to telephone patients with results, but rather, to discuss results at the next follow-up office visit. Dr. A further testified that if a significant abnormality were present, he would contact the patient. Specifically, Dr. A said, if a report noted a palpable nodule, he would check whether the radiologic findings differed from previous studies. If there were no radiologic changes, he would discuss the results at the next office visit. In regard to the plaintiff, Dr. A noted that the left breast nodule was not significant because there was no radiographic change noted in the mammogram report and no change on the ultrasound.

Regarding the renewal of the Premarin prescription over the phone for years without regular check-ups, Dr. A explained that for patients who had undergone hysterectomies and been on HRT for many years without problems, he renewed Premarin by telephone indefinitely. Dr. A took the position that a causal relationship between Premarin and breast cancer has not been established.

Our experts felt that Dr. A should not have continued to prescribe HRT without having the patient come in for regular physical examinations, which would include breast examinations. At a minimum, he should have been seeing the patient once a year. Moreover, when he received the mammogram report from August 24, 2008, he should have immediately stopped the HRT and had the patient come in for a physical examination. They felt that the 4-month delay may have made a difference because the patient was receiving estrogen during that time, which would have enhanced tumor growth. They also found problems with the radiologist, who should have done additional views of the breast and had an obligation to recommend clinical correlation to the patient.

NEXT: THE VERDICT AND ANALYSIS >>

The verdict

The case settled prior to trial for $475,000. Half was paid by Dr. A and the other half by the codefendant radiologist, Dr. C.

Analysis

Based upon expert reviews and our analysis of the case, we felt Dr. A was liable in 2 areas. First, he failed to contact the patient after he read the August 2008 mammogram report that noted that there was a nodule and that recommended clinical management. He had not seen the patient in years and this was a change from previous reports. It was incumbent upon him to make attempts to see the patient so he could evaluate the nodule and determine whether further work-up was necessary. Second, Dr. A (or his office staff) continued refilling prescriptions for Premarin without having the patient come in to be evaluated and in the presence of a possible breast tumor.

Our experts were very critical of these aspects of the case. While one could certainly expect the radiologist to read the film appropriately and not give the patient a false sense of security, it was obvious that at trial the radiologist would take the position that he instructed the patient to follow up with her clinician (contrary to the patient’s testimony). In turn, despite the fact that the radiograph was read as negative, Dr. A. could not safely assume that it ruled out any type of malignancy, because approximately 10% to 15% of mammograms are “false negatives.” The plaintiff’s initial settlement demand was $900,000, and once negotiations brought it down to almost half that, both defendants agreed it would be prudent to resolve the case equitably rather than engage in protracted “finger-pointing” before a jury.

Even if it is only for once- or twice-yearly exams and prescriptions for continuing medication, ob/gyns should keep in mind that they often are a patient’s treating physician, and thus responsible for follow-up on any concerning findings.