After confirming a breast cancer diagnosis, doctors face more major challenges: It’s an emotionally stressful situation, and patients need to be treated with sensitivity while being fully informed of what’s to come. As a team, doctors must develop a treatment plan according to medical guidelines. Any mistakes in the diagnosis and treatment of breast cancer can have grave medical – and legal – consequences.
What is breast cancer?
Breast cancer (mammary carcinoma) refers to malignant tumors in the breast. Its most common form is ductal breast carcinoma, which originates in milk duct cells, followed by lobular, which stems from glandular lobes. Breast cancer encompasses a considerable variety of mixed and specialized forms of carcinomas. The earliest form is ductal carcinoma in situ (DCIS); here, the natural tissue boundaries remain untouched, although the cells already have malignant properties.
How is a breast cancer diagnosis made?
Diagnostic procedures and methods
These days, there is a vast arsenal of diagnostic options to ensure early breast cancer detection, which can clear up exact symptoms or suspicious findings. The main methods are:
- Palpation: Examining the breast and armpits with the fingers and inspecting the skin and nipples. This is a basic exam that gives an initial indication of whether there are any benign or malignant changes.
- Mammogram: The main exam for early breast cancer detection and which can confirm suspicion of breast cancer. The international BIRADS (Breast Imaging Reporting and Data System) scale categorizes findings into levels I – VI. This indicates the likelihood that a change is malignant, providing recommendations for further action.
- Sonogram: Ultrasound exams can’t replace mammograms, but still offer useful basic diagnostics in cases of dense breast tissue, in young women, or as a further step in confirming findings.
- Magnetic resonance imaging (MRI) or nuclear magnetic resonance (NMR): If the findings from the mammogram and/or ultrasound are still unclear, then additional MRI scans using a contrast agent can be carried out.
- Biopsy: Once level IV of the BIRADS scale is breached, a tissue sample should be taken to clarify and confirm the diagnosis. Generally, it’s enough to carry out a minimally invasive procedure, such as a punch or vacuum biopsy. A histological examination is the only reliable diagnosis of breast cancer. It’s also vital to determine the biochemical and molecular tumor characteristics to find the right treatment plan.
After a breast cancer diagnosis: Determining the tumor stage
Once a histology has confirmed the breast cancer diagnosis, and the tumor has been localized in the body, the next step is to determine the tumor stage. The international TNM system helps outline three central tumor characteristics:
- T is the size and spread of the primary tumor. The scale goes from T1 to T4. Non-invasive pre-forms, such as DCIS, are classified as “tis” (tumor in situ).
- N is the involvement of lymph nodes (nodi). The scale ranges from N0 (no lymph node involvement) to N3.
- M stands for the absence (M0) or presence (M1) of distant metastases.
Additional notes such as c (clinical) or p (pathological) denote the tumor classification method.
How is breast cancer treated?
After a confirmed breast cancer diagnosis, the treatment plan depends on several factors: these include the tumor type, stage and characteristics, as well as the age, general health and personal wishes of the patient. An interdisciplinary approach has been proven to be the best way to optimize treatment, involving the teamwork of different experts on a “tumor board”.
Essentially, breast cancer treatment is based on these main methods:
- These days, operations can usually remove a tumor while sparing the breast. However, in certain cases, breast removal (mastectomy) is unavoidable
- Radiotherapy is a common adjuvant treatment after operations to prevent cancer recurrence. For palliative care or bone metastases, radiotherapy inhibits tumor growth and alleviates symptoms
- Chemotherapy is an effective adjuvant or neo-adjuvant treatment, depending on the cancer type. Adjuvant means that chemotherapy is given after surgery to prevent recurrence. In contrast, neo-adjuvant therapy aims to shrink the tumor before the operation so that the operation can be performed more gently and with a greater chance of success.
- Hormone therapy is an adjuvant treatment for hormone-sensitive tumors
- Immunotherapy is an adjuvant or neo-adjuvant treatment for specific (non-hormone sensitive) cancer types
What mistakes must be avoided when diagnosing breast cancer?
Medical errors during breast cancer diagnosis can have serious consequences – and not just in medical terms. If patients are harmed due to any errors in the diagnosis or treatment stages, there can be legal consequences.
Radiologists are at particularly risk here: a retrospective study in the US has shown that medical malpractice lawsuits for breast cancer are most frequently filed against radiologists (43%), followed by surgeons (27%) and gynecologists (26%).
The following errors can occur during breast cancer diagnosis and treatment:
Insufficient patient comprehension
Patients have the right to receive comprehensive information on all aspects of their diagnosis, prognosis and treatment. Before each treatment step – and especially before invasive procedures – doctors must fully explain the chances of success, as well as possible risks or side effects, in ways that the patient can understand. The patient should also be given treatment alternatives. Ultimately, the patient must be supported to make an informed decision.
All this information must be passed on verbally, with written documents only given as a supplement. In addition, the discussion must take place in good time before the planned treatment, so the patient has enough time to consider their options.
There are only two exceptions for when this explanation is unnecessary:
- If there is a medical emergency and treatment can’t be postponed. However, a doctor must offer a full explanation as soon as possible after the intervention
- If the patient expressly states that they don’t want to receive any information. To avoid later problems, this decision must be made in writing
Medical malpractice
If the given treatment does not comply with current medical standards, this may constitute malpractice. The term doesn’t only refer to treatment, but also to the diagnostic process.
A Dutch retrospective study analyzed reasons for late diagnosis within breast cancer screening. The most common cause at a technical level was incorrect BIRADS classifications based on mammograms.
Errors can occur along the entire chain, from early detection to diagnosis and treatment. Possible treatment errors within early detection and diagnostics include:
- Not recommending breast cancer screening to eligible women
- Not recording a family history of breast cancer and associated tumors as part of early detection
- Not offering risk counseling to women with known risk factors (e.g., family history of breast cancer)
- No further investigation of symptoms in very young, old, pregnant or lactating patients
- Deciding against diagnostic clarification in cases of suspicious symptoms (e.g., swollen lymph nodes, retracted nipples, changes in the skin or the shape and size of a breast)
- No further diagnostics used despite abnormal palpation findings coupled with an unremarkable mammogram
- No further diagnostics despite an abnormal mammogram but unremarkable palpation and/or ultrasound findings
- Technical errors during the mammogram
- No further diagnostics (ultrasound or MRI) despite difficult to interpret mammograms, due to issues such as dense breast tissue
- Incorrect biopsy sampling
- Incorrect diagnosis of the biopsy tissue sample
Case studies of significant treatment errors
Significant treatment errors can also have legal consequences:
In Hamm, central Germany, for example, a Higher Regional Court ruled in favor of a patient who sued her gynecologist, demanding compensation for pain and suffering caused by a diagnostic error. The gynecologist had ordered a mammogram after a suspicious palpation finding, but the result was unclear. She did not advise the patient to have an additional punch biopsy, and the court declared this a treatment error. (OLG Hamm, judgment from October 12, 2018, Case file: 26 U 172/17)
In a similar case in Hamm, Germany, the attending gynecologist found a suspicious lump in the right breast and armpit during a palpation. He then performed an ultrasound and decided that the lump was a harmless cyst. He did not advise the patient to have a mammogram and biopsy. However, the patient later died of breast carcinoma. The Higher Regional Court ruled that the lack of further diagnostics constituted a gross treatment error. (Judgment from November 28, 2001 – 3 U 59/01)
In Pennsylvania, a young breast cancer patient was awarded $19.16 million in compensation after a delayed breast cancer diagnosis. The 22-year-old saw her gynecologist and nurse practitioner multiple times to check on a suspicious lump in her breast. The nurse believed the lump was harmless and did not arrange an ultrasound. After 9 months, the young woman was diagnosed with breast cancer, which by then had metastasized to three lymph nodes.
Treatment errors can also occur during follow-up exams. In Maryland, a breast cancer patient was recently awarded $2.4 million for such a medical error. Due to triple-negative breast cancer, the patient underwent a mastectomy. A follow-up mammogram was performed one week later, but the radiologist failed to see that the tumor and biopsy marker had not been properly removed. It wasn’t until 9 months later that the remaining tumor was detected via ultrasound. The patient had to undergo a further mastectomy and radiotherapy.
Advising against conventional medical treatment after a breast cancer diagnosis
Of course, it’s not just the breast cancer diagnosis, but also the treatment that must always conform to rigorous medical standards.
In a landmark case in Germany, the district court in the city of Kiel awarded a patient’s family 40,000 euros in compensation for pain and suffering caused by the death of the patient. The responsible doctor had expressly advised the patient against conventional medical treatment, instead opting for alternative medicine, such as Schuessler salts, volcanic mud and alkaline foot baths. According to the court, the patient would have survived if she had received evidence-based medical treatment. (Judgment of March 29, 2019 – 8 O 190 / 16)
From a legal standpoint, advising against conventional medical treatment is a willful violation of a doctor’s obligation to provide comprehensive medical information, and is a grave treatment error. The doctor should have urgently advised the patient – even against her wishes – to take evidence-based treatment and, if necessary, advise that the “alternative medicine” should only be a supplement. Patients capable of making medical decisions have the right to refuse a medically necessary treatment. However, doctors must still provide detailed information on the consequences of doing so and have the patient’s decision to deny treatment recorded in writing.
Inadequate documentation
Administrative errors, such as inadequate documentation, can also lead to breast cancer misdiagnosis. If patients suffer harm as a result, there may be legal consequences.
In a case in New York State, a plaintiff was awarded a settlement of US$ 2.3 million after her radiologist diagnosed her breast cancer a year late. The 50-year-old plaintiff had a mammogram as part of her breast cancer screening in 2010; the radiologist deemed it normal. In the next year’s mammogram, the radiologist found a suspicious lump. He also noticed a transcription error had been made in the previous year’s mammogram: the abnormality was already present in 2010. Although he had dictated this, it did not appear in the findings. As a result, the stage IIB cancer was only diagnosed a year later. A timely diagnosis could have prevented the subsequent bilateral mastectomy.
After a breast cancer diagnosis: Observing current guidelines and patient rights
Doctors have a particular duty of care when diagnosing breast cancer. To protect themselves from claims for damages or other legal consequences, they should ensure that diagnostics and treatment are carried out in accordance with current guidelines, as set out by professional bodies such as ESMO (European Society for Medical Oncology) or NCCN (National Comprehensive Cancer Network).
