Introduction
This is a clinical negligence action brought by Ms Pepper for damages against the Royal Free London NHS Foundation Trust. She alleged that Professor Malago, who is a Professor of Hepato-Pancreatic-Biliary Surgery was negligent and the focus in the case was on a pancreaticoduodenectomy (Whipple’s procedure) [1] undertaken on 17/11/2014. The hearing before the court was limited to the issue of liability.
The Facts
In March 2014 the claimant began to suffer from episodic right upper abdominal pain which increased in intensity. She had been seen by her GP and then attended the A & E Department at Whittington Hospital on 12/06/2014. An ultrasound and CT were performed. An ill-defined area of low attenuation [2] was seen in the pancreatic head [3]. A multi-disciplinary team (MDT) recommended a MRI scan of the liver and magnetic resonance cholangiopancreatography (MRCP). The MDT then considered that malignancy needed to be excluded and a endoscopic ultrasound (EUS) [4] was required. The claimant was transferred to the Defendant’s hospital for specialist investigation.
Following transfer a EUS was performed. This demonstrated at 1.5cm irregular diffuse lesion. Biopsy material from the lesion demonstrated normal tissue and bloods were normal. A further EUS and fine needle aspiration (FNA) [5] were recommended.
A further EUS was performed on 17/10/2014 and this was reported as showing a 1.3 cm hypoechoic lesion [6] and the report stated that this was probably a malignant tumour in the pancreas. A core biopsy and a FNA were also performed and the core biopsy demonstrated no malignant cells. The cytology report of the FNA stated that the appearances were suspicious of malignancy but that an inflammatory lesion could not be excluded.
The claimant first saw Professor Malago on 12/09/2014. Prior to surgery the claimant had undertaken research on the internet and she was aware that there were different procedures available if she had pancreatic cancer. She also accepted that she realised that her condition was potentially very serious. She subsequently received documentation with information for patients having pancreatic surgery which included information on the most common procedures for pancreatic cancer and the risks and benefits of those procedures.
On 31/10/2014 Professor Malago reviewed the claimant and recommended surgery. The claimant stated that he said he was still very suspicious that she had cancer and that she could wait for 3 months but that patients had died as a result of waiting. With surgery she would have a chance of life. She suggested that he explained this in an overdramatic way.
Her position was that she consented to surgery on the basis that if the biopsy was positive Professor Malago would perform a Whipple’s procedure but if it was negative he would leave the pancreas untouched. She said that he did not say that the biopsy was notoriously unreliable nor did he discuss the consequences for her if she lost part of her pancreas.
Professor Malago’s position was that he did offer the claimant the option to wait or proceed with surgery. He said he did advise the claimant of the risks of surgery and indicated that he may still perform surgery if the biopsy was negative. He was supported in this by evidence from a nurse who was present at the meeting and documentation.
Surgery was performed on 17/11/2014. During the course of the surgery a biopsy was performed and reported as negative for tumour. Professor Malago was of the view that the head of the pancreas felt hard on examination and he proceeded to undertake a Whipple’s procedure. Histopathology results from tissue removed during surgery demonstrated no malignancy but acute pancreatitis [7] and cholecystitis [8]. The claimant did not have pancreatic cancer.
Argument for the claimant
On the question of Bolam [9] negligence it was argued that Professor Malago:
Failed to take account of the extensive investigations including radiological findings that were more suggestive of benign disease
Failed to proceed to a further period of observation and further imaging which would have avoided surgery
Failed to take account of the fact that the two biopsies and blood tests which were all negative
Proceeded to resect the pancreas when he should not have done so and when he should have appreciated that the appearances were consistent with a resolving inflammatory process
It was alleged that there were failures in the disclosure of information to the claimant in relation to the full clinical picture and the consequences of losing part of her pancreas. The claimant argued that she only consented to the performance of a Whipple’s procedure if there was evidence of malignancy when the intra-operative biopsy was reviewed. It was also argued that following the biopsy he should have closed and allowed the claimant to make a decision about surgery.
Addressing the question of causation the claimant said that had the appropriate information been disclosed she would not have undergone the Whipple’s procedure on 17/11/2014 and she would have elected to have a further period of observation during which the abnormality would have resolved and she would not have required surgery.
The claimant gave evidence that when she was consented on the day of the procedure she had amended the consent form to say specifically that she only consented to surgery on the basis that malignancy was confirmed but this amended consent form was not produced with the records.
Argument for the defendant
The defendants denied any failures in care. It was argued that the claimant had consented to the surgery and to a biopsy. She agreed that if the biopsy was reported as malignant, or if Professor Malago believed that the appearance of the pancreas was very suspicious he would perform a Whipple’s procedure. Professor Malago denied that a positive pre-operative biopsy was a pre-condition to him carrying out the Whipple’s procedure because he knew that such biopsies were notoriously unreliable.
His position was that the claimant had been made aware of the poor prognosis of pancreatic cancer and she was aware of the option of waiting to see whether a confirmed diagnosis could have been made or undergoing surgery and she had opted for surgery. Although the intra-operative biopsy was negative, the mass at the head of the pancreas felt suspicious, hard and typical for carcinoma. It appeared worse than on radiography and there was no classic sign of pancreatitis.
It was argued that it was in the claimant’s “best interests” to operate to avoid the possibility of aggressive cancer with a poor prognosis. It was also argued that it was common (between 5-11% of cases) for a Whipple’s procedure to be performed for presumed cancer only for it to be found to be benign and that this did not constitute a breach of duty.
The expert evidence
The claimant led expert evidence from Professor Colin Johnston, Consultant Surgeon and the defendant led expert evidence from Professor Steve White, Consultant Surgeon who supported the decision to perform a Whipple’s procedure. It was common ground between the experts that pancreatic cancer is a devastating disease which can be aggressive and has a poor prognosis. Professor White was of the view that early diagnosis was essential and that a patient presenting as here with right upper quadrant pain and a mass in the pancreas should be regarded as having pancreatic cancer until proven otherwise. The court preferred the evidence of Professor White.
Both parties had expert radiological evidence but this did not appear to be take matters any further in terms of the dispute between the parties.
The Law
On the issue of consent the claimant relied upon the decision of the Supreme Court in Montgomery v Lanarkshire Health Board [10] and the subsequent decision of Duce v Worcestershire Acute Hospitals NHS Trust [11]. On the question of causation the claimant relied upon a passage from Lord Hope in Chester v Afshar [12] where Lord Hope discussed modification of the normal approach to causation in consent cases [13].
The defendants relied upon a number of authorities [14] on the question of the weight to be given to verbal evidence unsupported by contemporaneous documentation where there is a conflict of evidence.
The Decision
The court concluded that Professor Malago explained to the claimant that even if the biopsy was reported as negative, it could not be assumed that the claimant did not have pancreatic cancer and that even with a negative finding on biopsy he reserved the right to perform a Whipple’s procedure if there was a suspicious appearance.
Comment on the Decision
This is a case that was ultimately decided on the facts. The defendant’s case was supported by contemporaneous documents in the form of clinic letters and the signed consent form. The claimant’s case was founded on her evidence at times supported by her partner, but not by contemporaneous documents. The defendants referred to a number of cases reinforcing the importance of contemporaneous records.
The claimant also failed on causation. The claimant had said in evidence that she would not have undergone surgery if there was a 10% risk of cancer. However, the court found as a fact that the risk of benign disease was no greater than 50% and probably significantly less. The claimant had not been directed to this risk and the court then required to assess what she would have done if faced with a risk of malignancy of 50% or greater and concluded that she would have accepted surgery. It is vital when asking a claimant to provide a view on causation that the correct factual hypothesis is put to them.
The defendants submitted that it was in the claimant’s “best interests” to operate to avoid the possibility of aggressive cancer with a poor prognosis and appeared to be using this argument to trump the right of a patient to make their own healthcare decisions. It is interesting to see a “best interests” argument being made on behalf of a doctor in 2020 in the case of a patient with capacity particularly against the backdrop of the recognition of a patient’s right to choose by the Supreme Court in Montgomery and against the the facts of this case.
[1] The Whipple’s procedure is an operation. It is one of the most common types of surgery for pancreatic cancer. It is usually used for tumours in the head or neck of the pancreas that haven’t spread beyond the pancreas. The surgeon will remove the head of the pancreas. They may also remove the lower end of the stomach, the duodenum, the gall bladder, part of the bile duct and the surrounding lymph nodes. As part of the pancreas is removed during a Whipple’s operation, digestion will be affected and the patient will need pancreatic enzyme supplements to help digest food. There is also a chance that the patient might get diabetes.
[2] This is a feature of a scan and on a CT scan it means that one particular area is less intense than the surroundings
[3] The pancreatic head is one of the three parts of the organ. The wider end is the head and the middle section the body and the narrow end the tail.
[4] This is a procedure that allows a doctor to obtain information and images of the digestive tract
[5] FNA is where a needle is inserted into a lump or mass to collect a sample of cells which are then looked at under a microscope to determine if there is malignancy
[6] A hypoechoic mass is tissue in the body that is more dense or solid than usual
[7] This is a condition when the pancreas becomes inflamed.
[8] This is inflammation of the gallbladder
[9] Bolam v Friern Hospital Management Committee, [1957] 1 W.L.R. 582
[10] [2015] UKSC 11
[11] [2018] EWCA Civ 1307
[12] [2004] UKHL 41
[13] Paras 86-87
[14] Regina (Bancoult) v Secretary of State for Foreign and Commonwealth Affairs (No 3) [2018] 1 WLR; Armagas Ltd v Mundogas SA (The Ocean Frost) [1985] 1 Lloyds Rep 1; Gestmin SGPS SA v Credit Suisse (UK) Ltd [2013] EWHC 3560 (Comm); Smith v Barking, Havering and Brentwood Health Authority [1994] 5 Med LR 285; Duchess of Argyll v Beuselinck [1972] 2 Lloyd’s Law Reports 172
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