Failure to diagnose breast cancer

Presentation 
A 49-year-old African-American woman came to an internal medicine physician in August 2001. She continued to see this physician and his physician’s assistant for several years. The patient weighed 260 pounds and had a history of hypertension, diabetes, neuropathy, and hypothyroidism. Her surgical history included a hysterectomy and knee replacement. The patient reported that her mother had a history of breast cancer.
 

Physician action
The patient returned in January 2002 and the internal medicine physician recommended that she undergo a mammogram. There was no breast exam documented at this visit. The mammogram was completed and reported as negative or BI-RADs 1. The patient continued to follow up with the physician in 2002 and 2003 for her diabetes, hypothyroidism, hypertension as well as various complaints of knee, chest and arthritic pain.

In January 2004, the internal medicine physician recommended another mammogram. Again, no breast exam was documented in the chart. The mammogram was completed in February 2004 and interpreted as showing two new densities — one in each breast — that were not present on the prior study.

A diagnostic mammogram with ultrasound was performed in March 2004 and interpreted as a BI-RADs 3 showing a cyst in the right breast with the left breast having a 2- to 5-mm nodular density. Follow-up mammography was recommended in six months. The patient returned to the internal medicine physician’s office later that month. She was seen by the nurse practitioner who discussed the mammogram results and the need for a follow-up mammogram. The nurse practitioner noted the patient was complaining of a burning sensation in both breasts. A breast exam revealed a small palpable lesion in the right breast.

The patient failed to obtain the follow-up mammogram in late 2004. She was seen several times at the internal medicine physician’s office in 2005, yet no breast exam was documented. A mammogram was ordered in December 2005. The mammogram report indicated “no interval change.” There was no evidence of a dominant mass or suspicious clusters in either breast. The study was reported as a BI-RADs 2.

The patient did not return to the internal medicine physician’s office until March 2006, at which time they discussed the recent mammogram results. The physician did not order another mammogram until February 2007. This study was compared to the prior imaging studies and interpreted as a BI-RADs 3 due to increased micro-calcifications in the left breast and a nodule in the right breast. Again, the radiologist recommended follow-up mammography in six months. The patient and her husband were told by both the nurse practitioner and the internal medicine physician of the need for a follow-up mammogram in the next six months. A breast exam was not performed during this office visit.

The patient returned four months later with complaints of difficulty walking. The medical record indicated that the patient was to undergo a mammogram in two months. She never obtained the mammogram. The patient returned to the internal medicine physician’s office multiple times for treatment of her hypothyroidism, osteoarthritis, and hypertension. She was referred for a mammogram in April 2008, which was interpreted as showing a slightly more prominent nodule in the left breast. An ultrasound was recommended and completed in May 2008. It suggested a 6 x 5 mm complex cyst in the left breast. A six-month follow-up mammogram was recommended by the radiologist.

The patient continued to see the internal medicine physician for her routine thyroid care and management of her osteoarthritis. In February 2009, the patient complained of a knot in her right breast that had developed over the last three weeks. The nurse practitioner performed a breast exam and detected a 7- to 8- mm tender mass in the right breast. The patient was sent for a mammogram and ultrasound, which were interpreted as showing a speculated mass in the retro-areolar region of the left breast measuring 1.5 cm.

The patient was referred to a surgeon for a biopsy in March 2009. The biopsy suggested the patient had an invasive ductal carcinoma, grade III. The surgeon discussed the various treatment options with the patient and she decided to undergo bilateral partial mastectomies. Axillary lymph node dissection revealed that four of seven nodes were positive for metastatic carcinoma. A subsequent CT showed six tiny lung nodules all measuring less than 1 cm in size.

The patient was started on a course of radiation and chemotherapy. Her prognosis was poor, as the cancer had spread to her brain.


Allegations
A lawsuit was filed against the internal medicine physician. The allegations included:

  • failure to follow well-established guidelines for managing patients with an increased risk of developing breast cancer;
  • failure to recognize that the patient’s age, race, family history, and obesity contributed to an increased risk of developing breast cancer; and
  • failure to have policies and procedures in place to ensure follow-up imaging studies were completed.

The plaintiffs also claimed that the patient’s cancer would have been diagnosed at a much earlier stage — which would have increased her chances for survival — if the internist had procedures in place to ensure timely follow up of imaging studies.


Legal implications
Physicians who reviewed this case for the defense were unable to support the care provided. While the reviewers believed the patient had a responsibility to ask about follow-up mammograms, the physician should have had a system in place to document whether recommended studies had been completed or refused by the patient.

The reviewers were also critical of the quality of the documentation in this patient’s chart. The handwritten notes were disorganized and illegible and showed no appreciation for the prevention of breast cancer in a patient with increased risk factors. There was no evidence that routine breast exams were performed.


Disposition
In light of the challenges in finding expert support for the care of this patient, this case was settled on behalf of the internal medicine physician.


Risk management considerations
According to a data sharing report issued by the Physician Insurers Association of America, breast cancer is listed as number two of the top five most expensive conditions that account for more than 13% of total indemnity for all paid claims. In this report, the specialty of internal medicine reported the highest number of closed claims, compared with other specialty groups. The most prevalent and expensive misadventure noted in claims against internal medicine physicians is errors in diagnosis. (1)

In this claim, experts were critical that breast exams were not performed at regular intervals. Every medical practice should implement a tracking system to review test results and set patient reminders. A delay in follow up can lead to serious consequences. Having this type of system in place may help identify lost test results, delays in getting results, or non-compliance of patients.

Regarding the documentation issue, organized, legible medical records that identify and address a patient’s risk factors can enhance patient care and help in the defense of a claim.


Source 
1. PIAA. Data sharing project: semiannual report 2012 edition. Rockville, MD.


These closed claim studies are based on an actual malpractice claims from TMLT. These cases illustrates how action or inaction on the part of physicians led to allegations of professional liability, and how risk management techniques may have either prevented the outcome or increased the physician’s defensibility. These studies have been modified to protect the privacy of the physicians and patients.

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