Ovarian Cancer Claims: Establishing Breach of Duty and Causation

Ovarian cancer is the most common cause of death from gynaecological cancer in the UK. The UK is low down the league table of survival from this disease. The National Ovarian Cancer Audit has shown that around 40% of cases are diagnosed following an emergency admission, often at advanced states, and in many cases, symptoms are ignored until they became severe.

Litigation for ovarian cancer occurs following delayed diagnosis. This may be when appropriate blood tests and scans are not performed, or when common symptoms are misattributed to other conditions, with warning signs mislabelled as irritable bowel syndrome, perimenopause or even endometriosis. Surgical errors including inadequate surgery or damage to surrounding organs make up a number of litigation cases. Finally concerns over the use of talc on surgical gloves being associated with ovarian cancer has led to class actions against several manufacturers.

Delayed Diagnosis: Establishing Breach of Duty and Causation

Delayed diagnosis allows the cancer to spread, requiring more invasive treatments with lower success rates. At stage 1, around 90% of women will survive for 5 years from diagnosis. At stage 4 the survival rate is closer to 30%. Late diagnosis is most common - 70-80% of cases present at stage 3 or 4. Late diagnosis leads to poorer outcomes.

One problem for solicitors investigating delayed diagnosis claims, is to show that a missed opportunity to investigate, leading to an earlier diagnosis, would have changed the woman’s treatment or outcome. Establishing breach of duty will require expert examination of consultations, symptoms, examination findings and referral decisions. In many cases the cancer will already have been advanced at initial presentation with a poor potential outcome irrespective of the delay; hence proving Causation will depend on whether earlier investigation would have resulted in an earlier diagnosis, different or less invasive treatment options, or a better prognosis.

Ovarian Cancer Screening and the Challenges of Early Detection

Screening improves the early diagnosis of other female cancers; for example, regular cervical smears and mammograms detect cancer or precancer before symptoms occur and provide early diagnosis with improved outcomes. Sadly, studies of ovarian cancer screening show that even with annual testing advanced cancer will develop in the interval between checks. Annual Ultrasound scanning increases the detection of benign ovarian cysts and may result in unnecessary surgical procedures to remove them. Effective screening is therefore a challenge.

The tell-tale symptoms of ovarian cancer are persistent abdominal distention or bloating, feeling full, loss of appetite, pelvic or abdominal pain and increased urinary urgency or frequency. These are extremely common symptoms in Primary Care a GP will see a woman with similar symptoms several times a week but will encounter a new case of ovarian cancer less than once every 5 years. The NICE guidance for ovarian cancer advises primary care clinicians to make an urgent referral to a gynaecological cancer service if a physical examination identifies ascites and/or a pelvic or abdominal mass, which is not obviously fibroids. This requires a GP to undertake a physical examination. However, by the time ascites or a detectable pelvic mass has developed, the cancer will often have progressed to stage 3 or 4.

Investigating Potential Failures in Primary Care

In Primary Care, clinicians are advised to check the tumour marker CA125 if the abdominal symptoms are ‘persistent or frequent’. An elevated CA125 should lead to an ultrasound examination. A lower cut off level for CA125 is now advised for older women; the traditional upper value of 35iU/mL still applies to women under 50 but lower values apply to women between 60 and 79, with the cutoff now 24iU/mL. Any ultrasound evidence of ovarian cancer requires an urgent Gynaecological referral through the ‘2 week’ pathway. If the scan is normal, other causes for the symptoms should be investigated.

The problem in primary care is the vague definition of ‘persistence’. Given the risks of delayed and missed diagnosis, and the potential litigation relating to delay and poorer outcomes, persistence which is measured in months is too long for a woman to experience symptoms without being tested. CA125 levels at diagnosis are often so high that many women would have had elevated levels several months before presentation.

In claims involving Primary Care, the date of commencement of symptoms, repeated presentations for the same concerns, whether appropriate tests were performed, and any, changes in symptoms or abnormal findings should be considered. GP consultation records, CA125 results and Ultrasound reports should be reviewed to establish whether the available information should have prompted further investigation or referral. This must be interpreted against applicable clinical guidance. The reasonableness of referral decisions must be assessed in the context of the woman’s presentation at the time, rather than with hindsight.

Referral Pathways and Specialist Investigations

The acute oncology service (AOS) is often the first port of call for women presenting as an emergency. Every hospital with an emergency department must have an AOS and clinicians handling emergency attendances must involve that service if they suspect that they are dealing with a woman with cancer.

Planned referral will usually be to a local gynaecological cancer unit at a general hospital. Further investigations may include CT scanning and tissue biopsies to obtain histological material for a diagnosis and, if present, samples of ascitic fluid for cytological examination.

The most common cancers are serous adenocarcinomas; however, testing will also detect fewer common types. The CA125 value may not be raised in younger women, who may have ovarian germ cell tumours. For this reason, NICE recommends ultrasound as the first investigation for younger women rather than awaiting a raised CA125. Germ cell tumours are rare, but specialised treatment has a very high cure rate.

Surgical Management: Assessing Standards of Care

Definitive management is usually undertaken following review by a multidisciplinary team in a gynaecological cancer centre and discussion with the woman. In the last 10-20 years the national pathway has been for surgery to be carried out by a gynaecological oncologist in a cancer centre. In fact, this means that many women with pelvic masses who are not eventually found to have cancer are unnecessarily managed in cancer centres, whilst some women with cancers present as an emergency to cancer units and undergo surgery there.

It is important that women with ovarian a cancer are treated by surgeons with the relevant expertise. None of the complex diagnostic indices developed give an absolutely clear-cut discrimination between benign and malignant masses prior to surgery. After almost 20 years of centralising surgery in cancer centres, the European Society of Gynaecological Oncology has recently accepted that the gynaecologist leading the local team at the cancer unit should be able to perform surgery. The clinician leading the cancer unit team needs the relevant expertise to undertake a complete diagnostic operation when probable cancer is found, with optimal tumour excision, biopsies etc.

Where a claim concerns surgical management, solicitors may need to establish whether the operating clinician had the appropriate expertise. Where the woman presents through the cancer referral pathway, pre-operative imaging and multidisciplinary team records can be central to that assessment as the MDT will usually delegate surgery to an individual or team. Where presentation is as an acute emergency, operative notes, histopathology reports, and the relevant expertise of the operating surgeon will be relevant. In both cases it is necessary to establish that the proposed procedure was reasonable and that the extent of surgery met the expected standard of care. Expert evidence may also be required to distinguish recognised surgical complications from avoidable injury or inadequate tumour removal.

Chemotherapy, Maintenance Therapy and Ongoing Treatment

Surgery may be deferred allowing treatment to reduce the extent of the cancer – this is known as neoadjuvant therapy and usually involves chemotherapy. At the other end of the spectrum, women with very early cancers (stage Ia or stage Ib) will have disease that is so limited that there is no risk of residual cancer at the end of the surgical procedure. They will not usually undergo further treatment. However, all women with stage 1c disease or greater will require chemotherapy or other systemic anti-cancer therapy (SACT).

If a woman requires SACT this will be undertaken by Medical Oncologists or sometimes Clinical Oncologists. Treatment is often undertaken in a cancer centre, though some cancer units have the expertise to deliver SACT.

Where possible women should be entered into clinical trials to increase that understanding of the disease and its treatment. Entering a woman into a trial requires careful assessment of the woman including their general fitness and ensuring that their continuing needs throughout treatment are met. They will require access to an acute oncology service (AOS) to manage complications. They will need to give informed Montgomery Compliant consent after detailed discussions.

Once the initial treatment with chemotherapy is completed, maintenance therapy inevitably follows. Maintenance therapy has developed over the last decade to include continuous treatment either by injections of monoclonal antibodies such as bevacizumab, which control the development of blood vessels in residual tumour deposits or PARP inhibitors, which affect the ability of tumour cells to repair the damage to DNA. Treatment requires continuity of care over an extended period.

Follow-Up Failures and Communication in Ovarian Cancer Claims

After treatment has finished, there is a period of follow up. A very high number of tumours will recur, usually within the first two to three years or even earlier. It is not clear whether regular attendances at clinics for assessment lead to earlier detection of recurrence. It may be preferable for the woman to report her symptoms when they occur rather than to attend clinics repeatedly when asymptomatic. Whatever follow-up strategy is preferred, the woman should always have a clear route back to specialist review for her cancer and also be aware of the important symptoms that she should report.

One of the weaknesses of the UK’s systems in ovarian cancer management is the lack of clear pathways for women to receive help and reassurance. Often this help is provided by access to a Clinical Nurse Specialist or MacMillan Nurse. Cancer services must be easily accessible. Litigation may arise when care is shared between cancer centres and cancer its units due to breakdowns in communication, or due to delays or inability to access treatment when symptoms return.

For solicitors examining alleged communication failures, it is important to establish the appropriate clinical team with responsibility for monitoring and communicating results and care plans. This is especially relevant where care is undertaken in different clinical settings. Where care is shared for example between a cancer unit and a cancer centre, the examination of correspondence and clinical / MDT records between the two organisations may demonstrate unnecessary delays in acting on test results or MDT discussions.

Establishing that follow-up was inadequate may be an element of a claim. It is however important to consider whether the arrangements made with the woman for follow up, especially at the end of planned treatment, were appropriate, and to establish whether she was informed of the indications to seek review if she experienced symptoms that might suggest a recurrence of the cancer. Expert evidence must then consider whether an earlier return to follow up would probably have altered the woman’s treatment or outcome.

The management of ovarian cancer is gradually improving but late diagnosis remains the main challenge. Centralisation of surgery for late stage cancer has not significantly improved survival for most women, but managing ovarian cancer as a chronic disease, with maintenance therapy, is more promising.