By TMLT Risk Management Department
On July 8, a 41-year-old woman was referred by her ob-gyn for a screening mammogram. This was the patient’s first mammogram. The radiologist interpreted this study as showing “dense fibroglandular tissue in both upper outer quadrants with no discrete mass or architectural distortion seen.” He did note a “small isolated calcification in the right upper outer quadrant.” His final impression was no mammographic evidence of malignancy. The ob-gyn told the patient to return for a mammogram in two years.
One month later, the patient was performing a breast examination on herself when she noted a lump in her left breast. Since she had just received negative results from a mammogram, she did not mention the lump to her ob-gyn. On September 10, the patient noted that the lump in her left breast seemed bigger and more defined. She went to her ob-gyn, who referred her for an ultrasound of the breast. On September 27, the radiologist interpreted this ultrasound as showing a “heterogenous 3.6 cm mass at the 2 o’clock position.” He also noted in his report that “this mass is not seen with certainty on the mammogram study ... though it could be obscured by dense parenchyma.” The radiologist recommended a biopsy.
The biopsy was completed on October 8. Results from the biopsy indicated that the patient had a sarcoma. She was referred to an oncologist and underwent a repeat biopsy. That biopsy revealed a high-grade sarcomatoid malignancy. The patient was treated with chemotherapy. In February, the patient under-went a left segmental mastectomy and sentinel node biopsy.
She was treated with radiation and an additional course of chemotherapy. However, the chemotherapy had to be stopped because the patient developed a reaction to the treatment. Nineteen months later, the patient underwent breast reconstruction.
A lawsuit was filed against the radiologist. The allegations included failure to properly interpret the July 8 mammogram, resulting in an 11-week delay in diagnosing breast sarcoma.
The plaintiff’s treating oncologist testified that the patient’s lesion was less than 5 cm when the radiologist read the initial mammogram. By the time the patient’s diagnosis was made, her lesion was greater than 5 cm, thus reducing her survival rate from 75 percent to 35 percent. He also testified that since the lesion was greater than 5 cm, she required chemotherapy. A patient with a lesion less than 5 cm would only require surgery and radiation. This expert also claimed the patient now has a less than 50 percent chance of survival based on the delay.
Two radiologists who reviewed this case for the defense stated there was evidence on the July 8th mammogram that required further work up with either additional magnification compression views or ultrasound since the lesion was only apparent on the MLO view. However, a radiologist who specializes in mammogram interpretation supported the defendant’s interpretation. He testified that while he agreed the patient’s sarcoma was likely present in July, the standard of care required that the lesion be present on both views in order to support the plaintiff’s claims. According to this expert, sarcomas are very difficult to diagnose because they present with different findings compared to other breast cancers.
A defense oncology expert stated the patient’s chance of survival was greater than 50 percent and perhaps as high as 80 percent. This expert agreed that tumor size is an important factor in prognosticating survival statistics in sarcomas, but it is not the only factor.
Based on the potential damages, sympathetic nature of the case, and the uncertainty of how the testimony of the patient’s treating oncologist would affect a jury, this case was settled on behalf of the radiologist.
It is known that the interpretation of mammography studies carries a high degree of risk for radiologists. There are many factors that can obstruct the view and make it difficult to detect minor abnormalities. Of course those abnormalities are often apparent in hindsight, making the radiologist particularly vulnerable if a malpractice suit is filed.
Physicians should consider biopsy in patients with suspicious or palpable abnormalities, regardless of negative mammogram. Because a negative result does not always exclude cancer, it is also prudent to tell the patient that if a lump develops she should seek medical attention as soon as possible. Additionally, radiologists can reduce their risks by reading films in an area with as few distractions as possible. _
The information and opinions in this article should not be used or referred to as primary legal sources nor construed as establishing medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the particular facts and circumstances of each individual case and no generalization can be made that would apply to all cases. The information presented should be used as a resource, selected and adapted with the advice of your attorney. It is distributed with the understanding that neither Texas Medical Liability Trust nor Texas Medical Insurance Company is engaged in rendering legal services. © Copyright 2008 TMLT