Wednesday, 3 April 2019

Missed Diagnosis of Cancer

Claims for delay in diagnosing cancer are difficult to litigate. The goal-posts tend to move as time passes. It is difficult to prove what would have been present at an earlier time than actual diagnosis, and what the prognosis would have been after earlier diagnosis and treatment.

Yip J has given judgment in a delay in diagnosing cancer case which has reminded me of a recent trial of mine (March 2019) which has not been reported. Both involved a failure to diagnose breast cancer after referral by a GP to a breast clinic. In each case the NICE guidelines for triple assessment (clinical examination, radiography and, if indicated, biopsy) were followed and the patient was reassured and discharged with no follow up. In each case, it was contended, the cancer was present at the time and grew undetected before actual diagnosis. In each case, fortunately, the cancer was treatable and the claims were for the avoidable injury caused by more extensive or invasive treatment, and the financial consequences of that. 

In Dalton v Southend University Hospitals NHS Foundation Trust [2019] EWHC 832 (QB) C was diagnosed with grade II ductal carcinoma in right breast in November 2013. She had been referred to D's breast clinic in March 2011 by her GP who had found a lump 2-3cm in same breast. At the breast clinic, NICE guidelines had been followed. Clinical examination had revealed a discrete lump believed to be a cyst. Mammography was normal. Ultrasound was classed as U2 ("benign") and reported as showing benign fibrocystic change. Prof. Fentiman, the expert witness for C said this was probably a 3mm core of cancer surrounded by compressed tissue. There was discordance between clinical examination and US scan because the scan did not explain the finding of a suspected and palpable cyst. There ought to have been a biopsy. Prof Wishart for D said that the lump palpated was unlikely to have been the cancer later diagnosed and that and in any event NICE Guidelines were followed and no biopsy had been required because the findings had been of benign changes. It had been appropriate to have given reassurance. 

Triple assessment misses 0.2% of cancers. Any biopsy in Mrs Dalton's case in 2011 would have been blind - radiology showed nothing to biopsy. Yip J preferred the evidence of Prof Wishart and considered that Prof Fentiman had perhaps used retrospect to come to his view about the likely presence of cancer and surrounding compressed tissue in 2011. Professor Wishart had dismissed that suggestion as being one with which he was unfamiliar from his training and clinical experience and knowledge. The judge found that there had been no breach of duty and that in any event causation would have been very difficult to establish. 

The judge roundly rejected a (tentative) submission of contributory negligence for C not returning to a doctor once the lump increased in size - see para [33] for future cases.

In the case that I conducted at trial in March 2019 damages had been agreed subject to liability, as in Dalton. Clinical findings had included a unilateral inverted nipple of recent onset, and tethering around the areolar (again unilateral). Mammography and ultrasound imaging had shown no benign or malignant features at all. Therefore there was, C argued, a discordance. There being nothing to biopsy, an MRI should have been arranged. The expert evidence was that the clinical findings were "red flags" which could have been due to malignancy. The Defendant relied on the fact that the NICE guidelines (which post-dated the clinic attendance but which represented standard practice at the relevant time) did not cover the use of MRI in such circumstances, but we contended that the fact that guidelines did not cover the use of MRI did not mean that clinical judgment had to be suspended. In the circumstances there were unexplained clinical signs that could be due to cancer and they needed investigation. Biopsy was not possible and so MRI was mandated. The Judge agreed and judgment was entered for the Claimant for the agreed damages.

It can be seen that there are significant differences between the two cases, even though they share many similar features.

Guidelines are not to be treated as though they were legal statutes. Litigators can fall into the trap of over-reliance on guidelines and over-interpretation. Nevertheless they are highly relevant to the assessment of the standard of care. 

The 0.2% of cancers missed at triple assessment (if that is a reliable figure) will include some that are missed due to negligence, non-negligent error and which were not detectable even with the greatest care having been taken.

Yip J roundly rejected a tentative submission (but one pleaded) that Mrs Dalton had been contributorily negligent by failing, as advised, to return to seek medical advice if the cyst grew or became painful. The Judge said at [31] to [33]:

[31] "I find unhesitatingly that Mrs Dalton did not display "unreasonable care for her own health and welfare". I find, without any doubt, that she is an entirely sensible woman who consulted her GP promptly when she first found the small lump. She then continued to check her breasts and appropriately raised her concerns about what she should look out for with her practice nurse. She returned to her GP promptly when it became apparent that there was cause for concern. Mrs Dalton bears no responsibility whatsoever for any delay in diagnosis.

[32] "Although it was alleged that she had been advised to return if the cyst enlarged, it was notable that when Miss Gray gave evidence, she said more than once that she would advise a patient to come back if they noticed anything "new or different". I consider that this fits with what Mrs Dalton understood and what she in fact did.

[33] "I consider that the circumstances in which a finding of contributory negligence can properly be made in a clinical negligence claim will be rare. Certainly, they do not arise here. I imagine that the allegation was a difficult one for Mrs Dalton to read (particularly at a time when the prognosis was less optimistic than it is now). I am not entirely sure that there was a sufficient evidential basis for it to be made. However, I commend Mr Kennedy for not persisting with it and make it clear that I find Mrs Dalton blameless."

See my previous blog post or a different approach to contributory negligence in a suicide case.