Ruth Dalton v Southend University Hospital NHS Foundation Trust
Introduction
The claimant argued that there was a negligent delay in diagnosis of her breast cancer. Fortunately, by the time of the trial she was considered cured despite the delay in diagnosis. She had suffered physically and psychologically as a result of the delay in diagnosis although the details are not available given that there was an agreement on the value of the case should the claimant be successful. Quantum was agreed at £145,000.
Of interest in this case is the argument made by the defendants that having been reassured by the hospital, the claimant delayed in seeking a re-referral to hospital when the lump appeared to be getting bigger. They argued that she failed to take reasonable care for her own health and safety, and if successful her award should be reduced on the basis of her own contribution.
The Facts
In February 2011, the claimant noticed what she described as a small hard lump in her right breast. She promptly consulted her GP who noted a 2-3cm lump in the upper outer quadrant of her breast. She was referred to the breast clinic at Southend Hospital.
She attended on 08/03/2011 where she underwent assessment, including a clinical examination, ultrasound examination, and mammography but she did not undergo a biopsy of the lump.
Neither the claimant nor the surgeon who saw her had a clear recollection of the visit which is not surprising given that the visit occurred in 2011. The court relied heavily on what was written in the clinical notes and also on the “usual practice” of the surgeon. I have previously noted the weight UK courts appear to place on “usual practice” of doctors/nurses, and the argument made in the Australian courts that evidence of usual practice is not direct evidence of what occurred at a given time. It is merely evidence of what the doctor normally does.
On examination the surgeon had found a lump on the upper quadrant of the breast she marked as a cyst and a further area in the lower breast which she thought was an area of benign fibrocystic changes.
The claimant underwent mammography which did not identify any suspicious features, and ultrasound which was reported as benign. It is unclear from reading the decision whether it was possible to review the mammograms and ultrasound interpretations. It was accepted that in March 2011 she did have a small cancerous tumour in the upper quadrant of the right breast which was approximately 3cm. No discrete mass had been found on imagining to explain the lump that had been felt by the GP and also the surgeon. The surgeon conceded that she would have expected the ultrasound to show a fluid-filled cyst. The claimant was reassured that she had a cystic lump and was discharged.
The claimant felt that the lump had got bigger from 2012. She mentioned it to the practice nurse at her GP surgery in February 2013 but understood she should only return if she had new symptoms. In November 2013, the skin on the right side of her breast became puckered and indrawn and she attended her GP who referred her to hospital and the diagnosis of a large Grade II ductal cancer was made. The cancer diagnosed in 2013 was in the same part of the breast as the lump detected in 2011.
Guidance Considered
The relevant national guidelines “Best practice diagnostic guidelines for patients presenting with breast symptoms” were published in November 2010. The stated aim of the guidance was to raise the quality of the diagnostic process, and ensure consistency.
The guidelines were based around the “Multidisciplinary Triple Diagnostic Method” which provided for a three-stage review which included clinical assessment, imaging assessment and needle biopsy. The level of suspicion for malignancy on clinical and imaging assessment should be recorded on a scale of 1-5. The “P” score relates to physical examination. P1 is normal, P2 benign, P3 uncertain, P4 suspicious and P5 malignant. The claimant was given a P score of 2 although the consultant had not recorded that within the clinical notes.
The national guidelines required imaging for women presenting with a breast lump or lumpiness with a P2 score or above. The selection of which imaging was appropriate was dependent on the age of the woman. In this case, due to the policy of the hospital the claimant underwent mammography and ultrasound both of which were scored as normal. Because of local policy she underwent a mammogram as an extra form of imaging not mandated in the guidelines.
The guidance did provide if there was any doubt about the nature of the lesion or discrepancy between the clinical and imaging features, needle biopsy should be performed. Where a definitive diagnosis is not established, repeated clinical assessment and needle biopsy should be considered.
The Legal Argument
The argument on negligence focused on whether a core biopsy was indicated in this case when she had attended hospital in March 2011. The claimant’s expert Professor Fentiman stated that a biopsy should have been performed in March 2011, and had that been done the diagnosis would have been made.
The lump had not been detected on ultrasound which it was argued would have made biopsy difficult. Professor Fentiman was of the view that the palpable lump would have provided a reasonable target for the biopsy. The claimant also argued if the biopsy in March had not identified cancer then a repeat or excision biopsy should have been performed as the lump remained unexplained.
The defendants expert Professor Wishart was of the view that a biopsy was not required in March on the basis of the clinical examination and radiography findings. He advised the court that the claimant would not have undergone a biopsy in his unit and that was in accordance with national guidelines for patients referred to hospital breast units. Even if a biopsy had been performed, he was of the view that it is unlikely that any tumour would have been detected due to its small size.
Legal Principles
Applying the Bolam test in England and Wales a doctor is not negligent if he or she has acted in accordance with a practice accepted as proper by a responsible body of medical opinion [1]. The test is the standard of the ordinary skilled man exercising and professing to have that special skill.
The Scottish test is found in Hunter v Hanley [2]. Lord President Clyde said that in the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man is clearly not negligent merely because his conclusion differs from that of other professional men. The true test for establishing negligence in diagnosis and treatment on the part of a doctor is whether he has been proved guilty of such failure as no doctor acting with ordinary skill would be guilty of if acting with ordinary care. This statement of law has been approved by the House of Lords [3].
It is no longer the case that a defendant can be acquitted of negligence simply because he/she is able to lead expert witness evidence that the practice was one adopted by the profession. Expert witness opinion evidence on issues of negligence must be subject to analysis in terms of the “Bolitho” test [4]. Where it can be found that the expert evidence is not capable of withstanding logical analysis a judge is entitled to hold that the body of opinion is not reasonable or responsible and reject it [5]. To conclude that the claimant should have had a biopsy in March 2011 the court would require to reject the opinion of Professor Wishart as not capable of withstanding logical analysis.
The onus was also upon the claimant to establish causation. To succeed the claimant would require to establish on balance of probabilities had a biopsy been performed this would have led to a diagnosis of cancer, and that there would have been a difference in outcome.
Decision of the court
The claimant could only succeed if the court was persuaded that no ordinarily competent breast surgeon acting with ordinary skill and care would have failed to perform a core biopsy with this presentation. The court was not able to reject the evidence of the defendant’s expert as illogical in terms of Bolitho and the claimant failed to establish that the omission to perform a biopsy was in the circumstances of this case negligent.
Even if the claimant had established negligence to be successful, she also required to succeed on causation. She required to prove on “balance of probabilities” that had there been earlier investigation by core biopsy the diagnosis would have been made, treatment would have commenced and the outcome would have been different.
On the issue of causation, the court found that it was possible that the lump detected in 2011 was cancer, but it could also have been nearby. Even if the lump was cancer, it was possible but not “probable” that a core biopsy would have diagnosed the cancer.
Since the lump was not visible on ultrasound scan the biopsy would require to be performed free hand and may not have sampled the cancer. The claimant therefore would have failed to establish that a diagnosis would have been made had the core biopsy been performed.
On the issue of whether there should have been a repeat biopsy the court applied Bolitho principles to this question and found if the biopsy had been negative, there would have been no need for a repeat biopsy.
Contributory negligence
The defendants in this case argued that the claimant had a duty to take reasonable care for her own safety. She had a duty to re-refer herself to the breast clinic and in failing to do so she was contributory negligent. It was said the claimant “displayed unreasonable care for her own health and welfare. It is just and reasonable that she should be considered contributorily negligent and partially responsible for the consequences of the delay.” [6]
In this case the claimant’s position was that she had been investigated and reassured. She understood that she should only return if she had new symptoms. She had felt that the lump had got bigger and when the skin became puckered and indrawn she immediately attended her GP and was referred to hospital and the diagnosis was made. In evidence the surgeon appeared to support the claimant’s recollection that she would normally advise patients to return if they noticed anything new of different.
The defendants did not press this argument in court but the court gave consideration to the issue and said that the claimant bore no responsibility for any delay in diagnosis. The court recognised that this allegation must have been a difficult one for the claimant to read particularly at a time when the prognosis was less optimistic than it was by the time of the court hearing. It was said that the circumstances in which a finding of contributory negligence can properly be made in a clinical negligence action will be rare.
Comment
Courts are frequently asked to consider national or college guidance when assessing the actions of clinicians. It is arguable that there is no legal requirement to follow “guidance” however failure to follow guidance issued by a reputable national body, a college or the GMC without sufficient reason must place a clinician in a vulnerable position should an action proceed to court unless there is justification for that course of action. Equally a clinician who does follow guidance will be afforded some protection as occurred in this case.
Guidance can be useful in providing a yardstick to test what is expected from the ordinarily competent doctor. It could also be said that it provides a more useful tool for assessment of a clinician’s actions than the now outdated professional practice test found in Bolam and Hunter v Hanley even with Bolitho’s gloss. It can also be argued applying Bolitho principles that national or other guidance may be relevant when using Bolitho to assess the logic of the practice.
Where a doctor has acted in accordance with professional guidance relevant to the time period in question it could be extremely difficult (as in this case) to suggest that their actions are negligent. However, the claimants team did attempt to argue that there were reasons why the guidance did not apply and this should always be considered.
It is highly unusual to see a plea of contributory negligence in a clinical negligence case, and there have been few successful cases although it is recognised in law that the plea can be taken. The effect of the plea if successfully argued is to reduce the damages awarded to the claimant. The reduction would be to the extent that the court thinks is just and equitable having regard to the claimant’s share in responsibility for the damage.
Where patients ignore medical advice by discharging themselves from hospital against that advice or by not attending medical appointments this could be a situation where there may be contributory negligence. In Pidgeon v Doncaster Health Authority [7] a claimant was held to be two thirds contributory negligent in failing to have further smear tests done despite persistent reminders. In the Australian case of Young v Central Australian Aboriginal Congress Inc [8] a patient who died as a result of coronary thrombosis was found to be contributory negligent because he failed to attend appointments and failed to follow up on tests or advise staff of previous concerns about his health.
In this case the claimant had properly raised her concerns about the lump and had been reassured following investigation. She proceeded on the basis she should not return unless there was a change in her circumstances. It is difficult to see on what basis she failed in her duty of reasonable care and the argument was properly not insisted upon.
[1] Bolam v Friern Management Committee [1957 1WLR 582.
[2] 1955 S.C. 200
[3] Maynard v West Midlands Regional Health Authority [1984] 1 W.L.R 634 at 638; Sidaway v Bethlem Royal Hospital Governors [1985] A.C. 871 at 897
[4] Bolitho v City and Hackney Health Authority [1998] A.C. 232
[5] See R. Mulheron, Trumping Bolam: a critical analysis of Bolitho’s gloss (2010) 69 C.L.J. 609
[6] Para 30
[7] [2002] Lloyd’s rep. Med. 130
[8] [2008] NTSC 47
Core biopsy? Usually undertaken by a radiologist rather than a surgeon? Pedantic but mostly true?
Thankyou for Sharing this case report and also the explanations. Though I am as far away from a breast surgeon ( being and Orthopod fixing broken bones and dealing with soft tissue injuries) but it is good to keep my Medicolegal CPD intact with such detailed explanations especially the advantages of having college / national guidelines and following them in our day to day clinical practice. Well written and thanks once again.