I intend to publish a series of posts on litigation arising out of delay in diagnosing cancer in the hope of highlighting at least some of the issues that arise in these difficult cases. In this first post I look at breach of duty.
At the risk of stating the obvious, clinical negligence claims for damages for delay in diagnosing cancer are brought by claimants who had cancer at the time of the alleged negligence and who now know that they have cancer (or have had cancer) due to a subsequent diagnosis. Some claims of course are brought by bereaved relatives. Let's call the time when the claimant ought to have been diagnosed as the "opportunity date" and the time when they were actually diagnosed as the "diagnosis date".
The first step is to establish whether and when the opportunity date(s) arose. Generally the closer the opportunity date to the diagnosis date, the easier it will be to prove negligence because the cancer will be closer to the size, grade and stage it was at the diagnosis date - if it was diagnosable at the diagnosis date then it ought to have been diagnosed at the opportunity date. However in such cases proving causation is difficult - if the cancer at the opportunity date has similar characteristics to those at the diagnosis date then how can you prove that the delay made a difference? Conversely, if the opportunity date is long before the diagnosis date then causation may more easily be established, but breach of duty may be more difficult to prove - the cancer may have been too small to detect, for example.
You have to know whether the claimant had cancer which was detectable at the opportunity date. Clearly you cannot bring a claim on the basis that the GP failed to refer for a breast lump which was in fact benign. This will involve obtaining expert evidence as to whether the cancer found at the diagnosis date was present and detectable at the opportunity date (more on that in a later post). So usually there will be a need two experts just to establish whether there has been a breach of duty - a GP expert and an oncologist or other expert to advise if the cancer was detectable at the opportunity date (District Judges doing costs budgeting please note!)
Rarely will the alleged breach of duty be that the healthcare professional failed to diagnose cancer at the opportunity date. Rather the allegation is usually that they failed to refer the claimant to someone who would have been able to make the diagnosis after further investigation. The majority of cases are brought against GPs for failing to refer patients with signs or symptoms which should have mandated referral. Occasionally a case may centre of a practice nurse who has failed to refer a patient to a GP who would or should then have referred on to a specialist. Of course there are other types of claim such as those against breast clinics for misinterpretation of mammography, or claims arising out of failures in the cervical screening programme. I will focus on claims against GPs because those claims are the most common. Indeed I understand that claims for failure to refer for suspected cancer are the most common clinical negligence claims brought against general practitioners. But GPs are not expected to make a diagnosis. What they are expected to do is to suspect cancer and to recognise when it is necessary to refer the patient to a specialist.
In 2000 the Department of Health published guidelines on referring cases of suspected cancer. In 2005 NICE published Guidelines. No claim against a GP should be brought without attention being paid to these Guidelines (whichever were applicable at the relevant time). They set out evidence based recommendations for immediate, urgent or non-urgent referral where there are grounds for suspecting the most common kinds of cancer. Immediate referrals should be sent to the specialist or hospital without any delay. Urgent referrals should be seen by a specialist within 2 weeks. If the allegation is a failure to make a non-urgent referral then you may need to obtain evidence as to how long a non-urgent referral to, say, the pigmented skin lesion clinic, should take.
There are specific guidelines for each cancer type. Some are quite mechanistic - take the "scoring" system for suspected malignant melanoma or the age-specific PSA levels beyond which referral should be considered for suspected prostate cancer. For others, the clinical skills and judgment of the GP will play a role. Is the breast lump palpable on examination and if so is it fixed and hard? Some depend on objective test results, others on the patient's report of symptoms or signs (such as blood in faeces, night sweats etc.)
The Guidelines do not have the force of law! They are recommendations only. However, in Adshead-v-Tottle (2007 unreported but on Lawtel) Mr Justice Gray found that it was negligent for a GP to have failed to refer a patient with a potentially life-threatening condition in circumstances where there was a clear recommendation to do so in the Guidelines. He said that the Guidelines were not prescriptive but that failure to follow them was at least prima facie evidence of negligence. That is an approach which most Courts would be expected to follow.
The following considerations should be borne in mind when using the Guidelines to determine whether or not there has been a breach of duty:
- The Bolam test applies just as much to breach of duty in these cases as in other clinical negligence cases, but the Guidelines help the court to discern what would be an acceptable standard of care.
- Failure to refer in circumstances where the Guidelines clearly recommend referral will be strong, prima facie evidence of negligence. A clear justification for not referring would be required. However in some cases there may be such a justification.
- There may be occasions where the GP will have been negligent even if he has not failed to follow the Guidelines - there may be specific reasons mandating referral even though the triggers for referral within the Guidelines were not present.
- The Guidelines are in part designed to prevent over-referral - see MOJ-v-Carter  EWCA Civ 694. So defendants may use the Guidelines to justify a decision not to refer.
The Guidelines cannot cover every conceivable situation - there is no substitute for expert evidence.
Next time ..... what happens after referral.