Joseph Grillo, M.D.
Globally, breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death in women. In the United States, breast cancer is the most commonly diagnosed cancer and the second most common cause of cancer death in women. In addition, breast cancer is the leading cause of death in women ages 40 to 49 years.
Failure to diagnose breast cancer is the second most common medicolegal allegation filed against physicians and has been reported to account for the greatest liability costs in medical malpractice cases.
Kern, K.A. Causes of Breast Cancer Malpractice Litigation: A Twenty Year Civil Court review, ARCH. SURG. Vol. 127, May 1992, pp. 542–547.
Medical Aspects in the Diagnosis and Treatment of Breast Cancer
Analyzing a breast cancer case is complex. The attorney will need to identify the various potential levels of failure in order to develop an approach to litigation. He should, therefore, have a fundamental knowledge of the medical processes involved in the evaluation and treatment of breast cancer.
The tools used for breast cancer treatment include surgery, radiation, chemotherapy, and new methods such as hormonal therapy, and biologic response modifiers including immunotherapy.
Most often, a combination of therapies is needed to adequately address all components of the malignancy. This necessitates selecting and sequencing therapies according to the particular needs and responses of each patient.
Kesson EM, Allardice GM, George WD, et al. Effects of multidisciplinary team working on breast cancer survival: retrospective, comparative, interventional cohort study of 13 722 women. BMJ 2012; 344:e2718.
The attorney should be certain that the process of staging, and all that it entails was proper and accurate. The treatment approach depends entirely on the stage at presentation. Breast cancer is first characterized using the Tumor, Node, Metastasis system (TNM). Once the TNM status is determined, the patient’s cancer is stratified into a stage. This anatomic staging system was designed and set forth by the American Joint Committee on Cancer (AJCC). This staging system represents the standard.
TNM (tumor, lymph nodes, metastasis)
The T (size) category describes the original (primary) tumor:
- TX means the tumor can’t be assessed.
- T0 means there isn’t any evidence of the primary tumor.
- Tis means the cancer is “in situ” (the tumor has not started growing into healthy breast tissue).
- T1, T2, T3, T4: These numbers are based on the size of the tumor and the extent to which it has grown into neighboring breast tissue. The higher the T number, the larger the tumor and/or the more it may have grown into the breast tissue.
The N (lymph node involvement) category describes whether or not the cancer has reached nearby or distant lymph nodes:
- NX means the nearby lymph nodes can’t be assessed, for example, if they were previously removed.
- N0 means nearby lymph nodes do not contain cancer.
- N1, N2, N3: These numbers are based on the number of lymph nodes involved and how much cancer is found in them. The higher the N number, the greater the extent of the lymph node involvement.
The M (metastasis) category tells whether or not there is evidence that the cancer has traveled to other parts of the body:
- MX means metastasis can’t be assessed.
- M0 means there is no distant metastasis.
- M1 means that distant metastasis is present
For example, a T1 tumor refers to a size of 0 to 2 cm. N refers to the number of lymph nodes involved, and M refers to the presence or absence of distant metastasis. Thus, the TNM score is then used to determine the stage – which ranges from IA, IB, IIA, IIB, IIIA, IIIB, IIIC, and stage IV.
Over 95% of breast cancers are non-metastatic at the time of diagnosis. Non-metastatic breast cancer is broadly considered in two categories:
- Early stage – This includes patients with stage I, IIA, or a subset of stage IIB disease (T2N1).
- Locally advanced – This includes a subset of patients with stage IIB disease (T3N0) and patients with stage IIIA to IIIC disease.
- Approximately 5 percent of patients will have simultaneous metastatic disease identified at the initial presentation (de novo stage IV breast cancer).
Staging is important for a number of reasons:
- Survival data exists for each stage, hence a patient’s chance of survival can be accurately predicted.
- The stage will determine the various treatment regimens – which include pre and post-chemotherapy, radiation therapy and surgical options (lumpectomy or mastectomy).
Another critical factor in determining treatment is the presence of certain “receptors” located on the surface of the tumor. These include estrogen, progesterone and human epidermal growth factor 2 (HER2) receptors. Receptor status drives the choice of chemotherapeutic agents.
Worth keeping in mind is that breast cancer treatment also involves post-treatment surveillance. Also, this discussion is limited to invasive breast cancer. There are other types (for example, ductal carcinoma in situ) which is beyond the scope an introductory discussion.
There are many potential levels of failure that can occur as a function of treatment progression.
The process begins with surveillance or screening. Surveillance or screening for cancer involves the use imaging tests (x-ray, ultrasound and MRI) to try to catch cancer in its early stages, when it is most treatable. Surveillance doesn’t prevent cancer. However, early detection improves a person’s chance of surviving their cancer. There are guidelines that all women are recommended to follow. The standard of care is that women should all be screened based on these published guidelines. A failure at this level may constitute a breach in duty if the physician fails to direct a patient towards preventative screening.
When breast cancer is suspected
Self-examination, clinical examination by the physician and mammography are the tools used in screening. For those not at an increased risk, mammography is endorsed beginning at age 50.
At times, suspicion comes about when the patient complains of symptoms to her primary care or GYN physician. Suspicion may also occur when the physician finds an abnormality in an otherwise asymptomatic patient on physical exam. A breach in duty may occur if the physician fails to properly investigate such findings.
Once suspected, the diagnosis requires first imaging and then tissue sampling if imaging is positive. Imaging will provide the size and location of the mass. Once a positive imaging test occurs, a tissue sample is always required for absolute diagnosis, staging, and stratification. This involves an invasive procedure, attaining an adequate sample, sampling of appropriate lymph nodes and providing a properly preserved sample to a pathologist. The pathologist will need to properly process the sample, analyze and provide a reading. Hence, there are a number of people involved in making an accurate diagnosis. There are a number of details that the attorney should be aware of. Most important include determination of the presence of previously mentioned receptors. Also, once a diagnosis is made, the patient should undergo genetic testing to determine genetic mutations such as BRACA1 and BRACA2. If present, a double mastectomy will likely be recommended and increased surveillance of other cancers is indicated. Keep in mind that if a breast-conserving strategy is pursued, it always involves concomitant radiation therapy (RT). Failure at any level may indicate a breach.
Making a tissue diagnosis involves the surgeon, radiologist and pathologist – any of which can thwart the process by error.
Once properly diagnoses and stratified, the next step is treatment. Here the steps include:
Surgery – where the treatment team and patient must determine what type of surgery and reconstructive strategy to pursue. This also entails the sampling of lymph nodes.
Chemotherapy – the details of what agent(s) (conventional chemotherapy, targeted therapies and endocrine therapies) to use and when to initiate treatment must be determined. These decisions are driven by standards of care. There is some flexibility in choice, but they must conform to acceptable practice.
Role of RT — Postmastectomy RT is indicated for patients at high risk for local recurrence, such as those with cancer involving the deep margins and pathologically involved axillary lymph nodes. If the likelihood of postmastectomy RT is high preoperatively, this may affect the choice of mastectomy type, the choice of the reconstructive approach, and optimal timing of the breast reconstruction (immediate versus delayed).
Note that coordination of care is required in order to achieve the best outcome. Therefore, a breach may occur when a patient advocate is not involved in case management. Bear in mind that treatment is always driven by tumor characteristics, patient status, and patient preferences.
Evaluation of the axillary nodes — The risk for metastases to the axillary nodes is related to tumor size and location, histologic grade, and the presence of lymphatic invasion within the primary tumor. The evaluation of the regional nodes depends on whether axillary involvement is suspected prior to surgery. This step in the process is critical as it drives treatment. Error at this level can have significant consequences.
For patients presenting with enlarged axillary lymph nodes, a preoperative work-up including ultrasound plus fine needle aspiration (FNA) or core biopsy is required to determine the best surgical approach.
Adjuvant therapy — is treatment provided in addition to the primary therapy (i.e. surgery) This usually refers to using endocrine therapy, chemotherapy, and/or biologic therapy.
Tumor characteristics predict which patients are likely to benefit from specific types of therapy. For example, hormone receptor-positive patients benefit from the use of endocrine therapy.
The use of postoperative (adjuvant) systemic therapy is guided by the patient’s clinical status and tumor characteristics. Most patients with locally advanced breast cancer should receive neoadjuvant systemic therapy. The goal of treatment is to induce a tumor response before surgery and enable breast conservation.
Surgical approach after neoadjuvant treatment — All patients should undergo surgery following neoadjuvant systemic therapy, even if they have a complete clinical and/or radiological response. In addition, patients who experience progression while on neoadjuvant systemic therapy should be advised to proceed with surgery, rather than switching the chemotherapy regimen.
Fertility preservation — Clinicians are required to discuss with patients the risk of infertility and possible interventions to preserve fertility prior to initiating potentially gonadotoxic therapy. This discussion should occur soon after diagnosis, since some interventions to preserve fertility take time and could delay the start of treatment. This is consistent with guidance from the American Society of Clinical Oncology
Older women — For some patients with estrogen receptor (ER)-positive breast cancer, in whom surgery is not an option or life expectancy is limited, primary hormonal treatment with either tamoxifen or an aromatase inhibitor without surgery or radiation therapy (RT) can be used
Post Treatment Surveillance
Cancer survivors who have completed treatment for breast cancer should advised by their physicians to undergo regular follow-up. Annual mammography should also be performed in patients who underwent breast-conserving therapy (BCT).
Legal Aspects of Breast Cancer Malpractice
Massachusetts Breast Cancer Malpractice Cases
Renzi v. Paredes, 452 Mass. 38 (2008);
Joudrey v. Nashoba Community Hosp., Inc., 32 Mass. App. Ct. 974 (1992);
Cusher v. Turner, 22 Mass. App. Ct. 491 (1986);
Santos v. U.S., 603 F. Supp. 417 (D. Mass. 1985);
Glicklich v. Spievack, 16 Mass. App. Ct. 488 (1983)
In a medical malpractice action based on a misdiagnosis of or failure to diagnose cancer, the plaintiff must prove that the defendant departed from the required standard of care in examining and diagnosing the patient. It is not sufficient to prove merely that the diagnosis was incorrect.
The plaintiff must establish that the diagnostic methods and procedures that led to the incorrect diagnosis fell short of acceptable medical practice. Departure from the required standard of care may be established by using the above discussion as a guide. As mentioned, there may be evidence of inadequate examination, omission of or delay in diagnostic tests and procedures, misinterpretation of results of diagnostic tests, failure to refer the patient to an appropriate specialist or facility, case management and clerical errors, or failure to disclose information to the patient. All procedures require the attainment of proper informed consent, including a discussion on the risks involved.
Bear in mind that for each step in the process, there are multiple areas where failure may occur. For example, with each type of radiological study, there can be a failure to order, failure to interpret, failure to report and failure to inform the paitent. Nested within each is a failure at the clerical level.
Selected representative breaches and cases follows.
Inadequate physical examination of the patient.
See Verdicchio v. Ricca, 843 A.2d 1042 (2004) (failure to physically examine patient’s leg);
Glidewell v. S.C. Management, Inc., 923 S.W.2d 940 (Mo. Ct. App. S.D. 1996) (physician failed to conduct proper and thorough rectal examination);
In breast cancer cases, the plaintiff may be able to show inadequacy of an examination with evidence that the defendant failed to find a lump or mass complained of by the patient. Renzi v. Paredes, 452 Mass. 38 (2008)
The plaintiff may be able to establish negligence with evidence that the defendant was inattentive to the patient’s complaint, and did not attempt to resolve it. In Renzi at 42, the patient complained of a lump in her breast, and her doctor noted a clinical history of increase in breast tissue, but the radiologist performed a routine screening mammogram rather than a focused diagnostic mammogram, which delayed the diagnosis of her breast cancer by more than a year, resulting in her death.
In Gravitt v. Ward, 258 Va. 330 (1999) the physician failed to respond to patient’s complaint of lump in breast and was held liable.
In Beckcom v. U.S., 584 F. Supp. 1471 (N.D. N.Y. 1984) – the physician, held liable, told patient it was “ridiculous” for her to come in for examination so frequently, and recommended psychiatric counseling.
Physicians can be held liable for not properly working up a breast mass.
For example, in Bolles v. Vernon, 1998 WL 1292428 (Mass. Super. Ct. 1998), the court ruled that the physician deviated from the standard of care – he did not perform a work-up once he discovered a lump in the patient’s breast, and again when she returned for examination on two additional occasions.
In Ramos v. Corlette, 56 Mass. App. Ct. 1111 (2002) (unpublished), the court held that the gynecologist breached the standard of care by failing to follow up once notified that no mammogram was given at the hospital, despite a referral for the patient’s mammography.
Failure of the radiologist to correctly interpret – the mammogram or other imaging is another source for a missed diagnosis. There are no cases reported in Massachusetts.
In Skewes v. Ocean Radiology Associates, 2011 WL 7715895 (Conn. Super. Ct. 2011) (unreported opinion), the plaintiff failed to adhere to the standard of care, namely, properly reading a mammogram so as to facilitate earlier diagnosis. In short, the mass was present but the radiologist failed to make the diagnosis on mammography.
Breach may occur when there is a failure to interpret a biopsy correctly.
In Sacco v. Roupenian, 409 Mass. 25 (1990), a patient brought a medical malpractice suit against a surgeon for negligently failing to diagnose the patient’s breast cancer at the time of her biopsy.
Medication errors in chemotherapy
Medication errors inherently have high potential to cause harm.
Schwappach, et al., Medication Errors in Chemotherapy, Incidence, Types and Involvement of Patients in Prevention, 19 European J. of Cancer Care 285, 285–287 (2010) (abstract), available at http://www.ncbi.nlm.nih.gov/pubmed/19708929
The drugs used in chemotherapy are very potent. These drugs are chosen precisely for their ability to kill certain types of human cells – some are more specific than others, meaning they can indiscriminately kill cells. Hence, chemotherapy damages normal cells as well as tumor cells. In general, the older agents are more toxic than the newer. Targeted and hormonal therapies are much less toxic than the others.
Central Line Placement
In order to administer the chemotherapeutic agent, proper vascular access is required. Most often, this is in the form of a “porta-cath.” This requires an expert to insert the device – usually a surgeon or interventional radiologist. The patient should understand that this is a minor surgical procedure and there are complications. In addition, delay in placement can cause undue delay in treatment.
Extravasation – or the unintentional leaking of the drug, which is given intravenously, and it is instead introduced accidentally into surrounding tissue. The drug “strays” into the surrounding tissue. This can result in skin sloughing, surrounding tissue damage, and significant morbidity. The nurses’ role in safe and effective practice of chemotherapy administration is paramount.
- Infection is always a danger for breast cancer patients receiving chemotherapy.
- Patient death from chemotherapy is not common, however, it can happen.
Failure to provide chemotherapy
In Wroy v. North Miami Medical Center, Ltd., 937 So. 2d 1116 (Fla. 3d DCA 2006), a physician was held liable for misdiagnosing the patient’s type of breast cancer, claiming that she actually had a more aggressive cancer that required chemotherapy, which was not performed.
Covered here represent a small sampling of potential areas of liability that can occur at any point and at any of the multitude of levels of treatment. The patient or survivors are the best source of information when seeking to uncover liability for a specific case. These cases are quite complex from the attorney’s viewpoint and require a baseline knowledge of breast cancer treatment and the application of this knowledge in performing a detailed case analysis.