Misdiagnosis or Delayed Diagnosis of Breast Cancer
Breast cancer is the most common female cancer in the United States, the second most common cause of cancer death in women (after lung cancer), and the main cause of death of women between the ages of 45 and 55. Every year, approximately 205,000 American women are diagnosed with breast cancer and more than 40,000 die from this disease.
Because of the prevalence of breast cancer, it is not surprising that the most common medical legal claim against physicians, as reported by the Physician Insurer’s Association of America, arises from a delay in the diagnosis of this cancer. According to various studies cited in the Archives of Internal Medicine, 6% to 16% of women with breast cancer experienced physician caused delay in diagnosis. This suggests that at least 10,000 of the approximately 180,000 women diagnosed as having breast cancer each year experience delay of treatment because of misinterpretation or misapplication of tests by their physicians.1
Despite improvements in screening for and treatment of breast cancer, many women suffer needless injuries and death due to errors in diagnosis and treatment. Examples of the type of negligence occurring in this area include:
- Failing to properly interpret a mammogram (x-ray of the breast);
- Disregarding a persistent and palpable breast lump or other abnormal changes in the breast which may include dimpling of the skin, a change in the size or shape of one breast, inversion (inward turning) of the nipple when it previously tuned outward, or a discoloration of the skin of the breast;
- Overreliance on a normal mammogram in a patient with a persistent and palpable breast lump;
- Failing to order additional, indicated imaging or other tests including diagnostic mammogram, ultrasound, fine needle aspiration, or biopsy;
- Failing to refer a patient with abnormal physical findings of the breast to a specialist such as a breast surgeon;
- Misinterpretation by the pathologist of breast cytology (cells) or tissue specimens following needle or surgical biopsy;
- Inadequate or inaccurate sampling of breast cytology or tissue by the physician performing the needle or surgical biopsy resulting in the cancer being missed;
- Mismatch of pathology specimens (i.e. the pathology department mixes up and mislabels the specimens of two different patients, so that one patient is mistakenly thought to have cancer and undergoes unnecessary and disfiguring surgery, while the other patient is mistakenly thought to be cancer free);
- Absent or poor communication between practitioners or with patients
Evaluating Breast Cancer Cases
If you or a loved one suspects that a diagnosis of breast cancer was missed or delayed, contact our office. A thorough initial interview will be conducted by an attorney or nursing staff. If indicated, pertinent medical records, imaging studies and pathology slides will be gathered to obtain more detailed information regarding your claim. Our office has ready access to and experience in consulting with actively practicing, board-certified specialists in radiology, gynecology, clinical and gynecologic oncology, and pathology. We also have an extensive medical library regularly updated with standard texts in various fields of medicine which have a bearing on the diagnosis and treatment of breast cancer. Only cases which have merit as verified by qualified experts will be pursued. You will not be charged any attorney’s fees or costs unless a monetary recovery is made on your behalf.
For example, if you have been diagnosed with advanced breast cancer after having previously undergone periodic mammograms which until recently were reported as benign, or if your gynecologist or primary care doctor disregarded a persistent breast lump, which resulted in delay in diagnosis and treatment, you may have a claim which deserves investigation. The length of delay which meets the threshold for bringing a valid case will vary with the “grade” of the cancer. Some breast cancers are fast growing and virulent, so that a shorter period of delay will likely have a greater adverse effect on outcome relative to other less virulent cancers. The characteristics which determine whether a breast cancer is high or low grade can be seen under the microscope by a competent pathologist.
There are various other clinical situations involving a delay in diagnosis or wrong diagnosis not outlined above which may warrant further inquiry.
If you have questions or doubts about the medical explanations you have been given by your physician, we would like to speak with you about your concerns.
The leading cause of physician delay in diagnosing breast cancer continues to be inappropriate reassurance that a mass is benign without biopsy. As concluded in the previously cited breast cancer study published in the Archives of Internal Medicine, reducing delay in diagnosis will require less willingness (by the primary care physician or gynecologist) to rely upon clinical examination to decide that a mass is benign, less reliance on benign mammography reports to decide not to biopsy a mass, and a requirement that fine needle aspiration biopsy be done by persons with demonstrated competence in that procedure.
The American College of Obstetricians and Gynecologists published guidelines in April of 2003 pertaining to the clinical evaluation of palpable breast masses. According to these guidelines, women with a palpable mass should initially be evaluated with diagnostic mammography or ultrasound breast imaging. However, even if the mammogram or ultrasound is reported as benign, the standard of care requires that the physician further investigate a solid, persistent, and dominant mass by fine needle or tissue biopsy.
Relying on a negative mammogram to rule out cancer in a woman with a clinically suspicious breast mass is unacceptable. False negative results from mammography in women with palpable breast masses have been reported to be as high as twenty-two percent (22%).2
A physician conducting a breast examination may also mistakenly conclude without adequate testing that a palpable breast lump represents benign fibrocystic disease. Some of the features which raise the index of suspicion for breast cancer include a mass which has a hard or gritty texture, is fixed or immobile, has irregular borders, and does not vary in size during the menstrual cycle. In clinically evaluating the patient, the examining physician should also consider whether the patient has any risk factors for breast cancer including age (over 40), onset of menstruation before age 12, menopause after 55, a family history of breast cancer among first-degree relatives, or a history of hormone replacement therapy.
Breast Cancer & Mammography
Advances in screening mammography have led to earlier detection of breast cancer and improved chances of survival among women diagnosed. Results of an analysis of breast cancer screening trials found a 26% reduction in breast cancer mortality over 7-9 years among women screened at ages 50-74 years old.3 The American Cancer Society recommends that women who are 40 or older undergo yearly screening mammograms.
Screening mammography offers the advantage of identifying malignant masses before they become clinically detectable. This highlights the difference between screening and diagnostic mammograms. Screening mammography is an x-ray of the breast performed at regular intervals on women who have no signs or symptoms of cancer for the purpose of promoting early discovery of this disease. Diagnostic mammography is an x-ray of the breast performed on women who have a lump or other symptoms suspicious for breast cancer, or who have a possible abnormality detected on screening mammography. Other mammography techniques such as magnification views or breast compression studies offer the physician more detailed radiographic information as to areas of the breast which have been identified as needing further investigation.
Certain mammographic features such as clustered microcalcifications, increasing density or a new mass (not seen on prior mammograms), a mass with irregular or spiculated (spiked) borders, or certain asymmetries between the right and left breast are suggestive of malignancy, and require further imaging or biopsy. Comparison with earlier mammograms is essential to a thorough evaluation and assessment by the radiologist. This is why, whenever possible, a woman undergoing periodic screening mammography should return to the same imaging center every year, or at least bring her previous mammogram films with her if she is undergoing imaging at a new facility for the first time. Digitalized mammography is now available at some centers with computer assisted detection software. This software is designed to assist the radiologist in detecting worrisome areas.
In conjunction with other organizations, the American College of Radiologists has developed a uniform system for classifying and reporting the level of suspicion for breast cancer on mammography or ultrasound, and what action, if any, should be taken in follow-up. This system is known as the Breast Imaging Reporting and Data System (BIRADS). Under BIRADS, a score should be given indicating the radiologist’s opinion on the absence or likelihood of breast cancer. The BIRADS scores range from 0 to 6 and are classified as set forth below:
Despite advances in imaging technology and development of reporting standards, delays still occur as a result of failing to report or underreporting worrisome findings, failing to recognize important changes by comparison with prior mammograms, failing to recommend or carry out additional needed imaging or biopsy, and communications break downs resulting in patients not being informed of abnormal results.
Breast Cancer Causation
In determining whether a breast cancer misdiagnosis case has merit, investigation is required into both standard of care and causation issues. Pennsylvania has adopted the increased risk of harm approach to causation, meaning that a physician may be held accountable if his or her negligence increased the risk of harm to his or her patient. Stated otherwise, if there had been any significant possibility of avoiding injury, and the physician destroyed that possibility through his or her negligence, then the physician is liable to his or her patient.4
Although learning that you have breast cancer can be devastating, the good news is that in many instances, breast cancer is curable, particularly if it is caught in its early stages before it spreads to distant parts of the body. Women are living longer with breast cancer than ever before, and at this time, more than 2 million women are survivors.
Clinical studies have proven that early detection and treatment improves survival. Prompt diagnosis and treatment of breast cancer may also avoid the necessity of extensive breast surgery or the toxic effects of chemotherapy in certain eligible patients.
Women who have been diagnosed with breast cancer undergo testing to determine the stage and other characteristics of their disease. This testing includes examination of surgically removed breast tissue under the microscope, blood tests, and imaging. From these tests, the clinical oncologist can obtain the following information which is useful in determining the patient’s prognosis and treatment options:
- The size of the tumor
- Its location
- Whether the abnormal cells are “in situ” or confined to the ducts which carry breast milk or to the milk producing glands of the breast, or invasive
- Tumor grade (i.e. aggressive or fast growing versus slow growing)
- Whether the tumor extends to the chest wall muscle or skin
- The absence or presence of certain proteins expressed within the tumor including hormone receptors or HER2
- Whether the cancer has spread to lymph nodes under the arm or near the breast bone and the number of nodes involved
- The absence or presence of cancer in distant parts of the body, including the lungs, brain, or bone
A staging system is a uniform or standardized method to summarize information about how far the cancer has spread. The most frequently used system to classify the stages of breast cancer is the TNM system published by the American Joint Committee on Cancer.
The initials T, N, and M are abbreviations which represent the following:
- T stands for tumor
- N stands for lymph nodes
- M is for metastasis (spread to distant organ)
Additional numbers or letters appear after T, N, and M, and give more detail regarding the extent of the cancer including the size of the tumor and the number of lymph nodes involved. The stages of cancer range from 0 (noninvasive carcinoma or carcinoma in situ) to stage IV (metastatic cancer).
Five (5) year survival statistics are available by stage. The five (5) year survival rate refers to the percentage of patients who live at least five (5) years after having been diagnosed with cancer. The data base for these statistics is derived from the National Cancer Institute & Surveillance, Epidemiology and End Results (SEER) study based upon women who were diagnosed with breast cancer between 1988 and 2001. Although these statistics are among the most current numbers available, advances in treating certain types of breast cancer since then may mean that the survival rates for certain classes of patients may be higher. While survival statistics are a useful guide, other factors affecting one’s prognosis may also come into play such as age and general health. If you have been diagnosed with breast cancer, and have read about survival rates, you should ask your oncologist how these statistics apply to you before drawing any conclusions.
The advantages of early diagnosis and treatment are apparent when one compares the relative five (5) year survival rates for women with breast cancer at various stages as described below:
|Stage||5-year Relative Survival Rate|
Despite scientific evidence proving the beneficial effects of prompt diagnosis and treatment on prognosis, many defendants in breast cancer misdiagnosis cases, particularly when the breach in the standard of care is clear, assert that the delay in question did not harm the plaintiff. The “tumor doubling” defense is one such tactic used in an attempt to avoid responsibility. A critical analysis examining this defense and exploring its fallacies is set forth under the heading ” Understanding the Tumor Doubling Defense.” The same principles refuting this defense apply to breast, cervical, and other cancer misdiagnosis cases.
1 Archives of Internal Medicine, Vol. 162, p. 1343 (June 24, 2004).
2 Ediken S., Mammography and Palpable Cancer of the Breast. Cancer 1988 Jan. 15; 61(2) 263-265.
3 Efficacy of screening mammography. A meta-analysis. JAMA 273: 1995; 149-154.
4 See Pennsylvania Suggested Jury Instruction 11.02.