This case took place in England and refers to a local rule on cancer referral waiting times. However, we have decided to include this case because it carries valuable learning on the importance of being aware of local policies and processes
Mr L, a 62-year-old retired accountant, presented to his GP surgery with a lump over his sternum, which had been present for approximately four weeks. Dr C considered the lump to be a small lipoma measuring 1cm x 1.5cm and advised Mr L to monitor it and to return if it changed.
After six weeks, Mr L returned to see Dr C, stating that the lump had increased in size and had been uncomfortable for the past day or two during heavy exercise. Dr C noted that the lump was now approximately 2cm x 2cm in size, but still clinically considered it to be a lipoma. Dr C advised Mr L to try a topical analgesic to relieve the discomfort and emphasised he should return for consideration of referral for excision if the discomfort did not settle or the lump altered further in any way.
Mr L returned to the practice five months later, reporting that over the preceding seven or eight weeks the lump had increased in size and “felt different”. On examining the lump, Dr C found it to have significantly increased in size to approximately 8cm x 5cm and to have changed in nature, now feeling more cystic on palpation. Dr C referred Mr L for an urgent general surgical opinion but did not utilise the two-week wait process.[i] This was because the local hospitals at the time were struggling with the volume of two-week wait referrals and Dr C’s experience was that patients were being seen quicker if he wrote directly to the relevant department.
Mr L was reviewed by a general surgeon three weeks later and underwent a series of further reviews and investigations, ultimately resulting in a diagnosis of chondrosarcoma. Despite extensive surgical resection, disease free margins were not obtained and Mr L suffered recurrence of the tumour and sadly died.
Mr L’s partner subsequently brought a claim for clinical negligence against Dr C, alleging that at the second and third consultations, Mr L should have been urgently referred using the two-week wait process and that the NICE guideline that was in use at the time, CG27: Referral guidelines for suspected cancer, should have been followed, specifically the section on soft tissue sarcomas that states:
1.13.7 In patients presenting with a palpable lump, an urgent referral for suspicion of soft tissue sarcoma should be made if the lump is:
• greater than about 5cm in diameter
• deep to fascia, deep or immobile
• increasing in size
• a recurrence after previous excision.
If there is any doubt about the need for referral, discussion with a local specialist should be undertaken.[ii]
It was alleged that had a two-week wait referral taken place at the time of either the second or third consultation, the required surgery would have been less extensive; the tumour would have been excised with wide tumour free margins; and Mr L would not have died.
The case was reviewed by the legal team at Medical Protection, and Dr C was considered to have acted reasonably under the circumstances. It was also unclear whether the outcome for Mr L would have been any different with earlier referral as his tumour was demonstrated to be particularly aggressive with a very poor prognosis.
A number of experts were instructed, including a GP and cardiothoracic surgeon.
With respect to breach of duty, the GP expert considered that it was reasonable to consider the lump to be a lipoma at the time of the first presentation and to advise Mr L to return. The expert deemed that Dr C was an experienced GP and would have been able to clinically diagnose a lipoma, based on his familiarity with the appearance and feel of such masses.
It was also acceptable to continue a “watch and wait” approach at the time of the second consultation and reiterate to Mr L that he should return should the lump change in any way. It was noted that Mr L attributed the discomfort from the mass as relating to his new exercise regime and that it was not uncomfortable at rest. The expert therefore considered that the guidelines for referral in relation to a suspected soft tissue sarcoma were not met.
At the third consultation regarding the lump, following the significant change in size and nature, the expert considered that urgent referral was warranted. The expert further considered that Dr C’s approach in referring urgently to the general surgical department rather than via the two-week wait process was reasonable, given the hospitals in the local area at the time were struggling to process two-week wait referrals and many were being delayed or rejected.
The cardiothoracic expert considered that, with a two-week wait referral at the third consultation (rather than the urgent referral made to the general surgeons), the nature, extent, and outcome of surgery would not have been different, and Mr L would still have died when he did. Had a two-week wait referral taken place at the time of the second consultation, when the mass was significantly smaller, then the extent of surgery is likely to have been less but, given the aggressiveness of the tumour, it may well have been the case that the resected margins would not have been free of disease. However, there would have been a greater likelihood of obtaining tumour free margins (and therefore increasing the chance of survival) had surgery taken place at this time.
A letter of response was sent to the solicitors acting on behalf of Mr L’s partner denying breach of duty and causation. The solicitors subsequently indicated they intended to continue pursuing the claim and therefore a trial date was set.
Medical Protection met with the experts and Dr C in conference and concluded that the claim remained defensible, and the next step would be to prepare for trial.
At trial, the judge considered that the second consultation conducted by Dr C was in accordance with a responsible body of GPs and there was no breach of duty.
However, the judge found there to be a breach of duty with respect to the third consultation and the decision to make the referral to general surgery urgently by letter rather than under the two-week wait process, despite the issues described by Dr C with respect to two-week wait referrals at the relevant time. The judge, after hearing the evidence presented by the GP expert acting for Mr L’s partner, considered that additional steps, such as a phone call, could have been taken to ensure the referral was not rejected or delayed.
Conversely, the judge, after hearing evidence from the two cardiothoracic surgeons instructed in the case, preferred the view of the expert instructed by Medical Protection and determined that even had referral under the two-week process been made at the time of the third consultation, the nature of the surgery undertaken and the outcome for Mr L would still have been the same.
The judge concluded there was no causation in relation to the breach of duty and that no damages were awardable to Mr L’s partner.
- Give clear advice to patients about when to return if symptoms worsen or do not settle, and ensure this advice is documented. In this case, Dr C clearly documented the advice provided and Medical Protection was able to use the records to demonstrate that Mr L had been advised to return if there were any changes to the lump.
- Be cautious if choosing not to follow standard procedures, such as electing to refer urgently to a specific department or team rather than utilising the two-week wait process, and be prepared to justify your chosen approach.
[i] The two-week wait is an NHS England rule that the maximum waiting time for suspected cancer should be two weeks from the day an appointment is booked through the NHS e-Referral Service, or when the hospital or service receives the referral letter.
[ii] Since this case occurred, the NICE guideline CG27 has changed to NG12