Sarah Pepper v Royal Free London NHS Foundation Trust
| Jurisdiction | England & Wales |
| Judge | Hugh Mercer,Geoffrey Tattersall |
| Judgment Date | 25 February 2020 |
| Neutral Citation | [2020] EWHC 310 (QB) |
| Docket Number | Case No: QB-2017-003013 |
| Court | Queen's Bench Division |
| Date | 25 February 2020 |
[2020] EWHC 310 (QB)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
CLINICAL NEGLIGENCE
Royal Courts of Justice
Strand, London, WC2A 2LL
Geoffrey Tattersall QC
(sitting as a Deputy Judge of the High Court)
Case No: QB-2017-003013
Helen Mulholland (instructed by Messrs Bolt Burdon Kemp) for the Claimant
Andrew Bershadski (instructed by Bevan Brittan LLP) for the Defendant
Hearing dates: 18–21 and 25 November 2019
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Hugh Mercer QC
Geoffrey Tattersall QC:
Introduction
In these proceedings Ms Sarah Elizabeth Pepper [‘the Claimant’] brings a claim for damages against the Royal Free London NHS Foundation Trust [‘the Defendant’]. She alleges negligence on the part of the Defendant's employees or agents, and in particular Professor Massimo Malagò, a Professor in Hepato-Pancreatic-Biliary [‘HPB’] and Liver Transplant surgery, in respect of his treatment of the Claimant from about September 2014 which resulted in her undergoing a pancreaticoduodenectomy [‘a Whipple's procedure’] undertaken by him on 17 November 2014. Such a procedure involves removal of the head of the pancreas, part of the small intestine, the gallbladder and part of the bile duct and is performed to remove cancerous tumours off the head of the pancreas, sometimes known as a pancreatic resection.
Such surgery was undertaken because Professor Malagò believed that the Claimant was suffering from pancreatic cancer. In fact, tests after such surgery confirmed the absence of malignancy but disclosed that she had acute pancreatitis and cholecystitis.
It is contended by the Claimant, who was then aged 56 years and in full-time employment, that by reason of Professor Malagò's negligence she underwent an unnecessary laparotomy and Whipple's procedure. She is now aged 61 years and suffers from the effects of pancreatic resection in that she now suffers significant maldigestion and a pancreatic exocrine deficiency and has to take pancreatic enzyme supplements permanently, suffers from digestive malabsorption, has lost weight, has significant disturbance to her bowel function, has a 25–40% lifetime risk of developing diabetes and is currently only able to work part-time.
However, I am not concerned with the consequences of such surgery because the hearing before me was limited to the issue of liability. The question which I have to decide, put shortly, is whether the Claimant should have been advised by Professor Malagò to undergo such surgery at all and, in particular, whether she had given her consent for such surgery.
At the hearing before me Ms Helen Mulholland represented the Claimant and Mr Andrew Bershadski represented the Defendant.
At the hearing I heard factual evidence from the Claimant, her wife Eva Lewin [‘Ms Lewin’], Professor Malagò and Gemma Keating [‘Ms Keating’], an HPB clinical nurse specialist who worked alongside Professor Malagò.
I also heard expert evidence from Professor Colin Johnson [for the Claimant] and Professor Steve White [for the Defendant], both consultant general surgeons specialising in this field, albeit that Professor Johnson had retired from clinical practice in August 2014.
Although I did not hear oral evidence from either Professor Derrick Martin [for the Claimant] or Dr Stuart Roberts [for the Defendant], both consultant radiologists, the parties agreed that, since there was much agreement between such experts, I should have regard to their evidence without either of them being called to give evidence or be cross examined.
The structure of this judgment is as follows. Firstly, I will give a brief overview of the Claimant's case and summarise the pleaded cases of the parties. Secondly, I will review the relevant authorities relied on by the parties. Thirdly, I will review the evidence in detail and will set out my findings of fact on the basis of such evidence. Fourthly, I will review the expert evidence and express my conclusions as to such expert evidence. Finally, I will determine the merits of the Claimant's case.
A brief overview of the case
Given the complexity of this case it is helpful at the outset of this judgment to set out a brief summary of events.
The Claimant attended the emergency department at Whittington Hospital on 12 June 2014 with right upper abdominal pain. An ultrasound was performed and computed tomography [‘CT’] were performed on 13 June 2014 which showed an ill-defined area of low attenuation in the pancreatic head. A discussion at a multi-disciplinary team [‘MDT’] meeting on 20 June 2014 recommended a magnetic resonance imaging [‘MRI’] scan of the liver and magnetic resonance cholangiopancreatography [‘MRCP’]. These scans were performed on 22 July 2014 and the recommendation was a discussion at a specialist hospital MDT as underlying cancer [‘malignancy’] needed exclusion with endoscopic ultrasound [‘EUS’]. The Claimant's care was thus transferred to the Defendant's hospital.
The specialist hepatobiliary MDT considered the Claimant's case on 2 September 2014 and concluded that there should be an EUS of the pancreas. An EUS performed on 30 September 2014 showed a 1.5cm irregular diffuse lesion. Biopsy material taken from the lesion showed normal tissue and the bloods taken were normal. A further CT scan and repeat EUS with fine needle aspiration [‘FNA’] were recommended.
The second EUS was performed on 17 October 2014 which reported a 1.3cm hypoechoic [i.e. more dense or solid than normal] lesion. The headline diagnosis of the report stated ‘Pancreas, Probably malignant tumour’ and a core biopsy and FNA biopsy were also taken at this EUS.
The core biopsy report dated 21 October 2014 reported that ‘no malignant cells are present’.
The cytology report dated 4 November 2014 noted that there were ‘crowded clusters of atypical glandular cells’ and that the ‘appearances are suspicious of malignancy but an inflammatory lesion cannot be excluded’.
On 31 October 2014 Professor Malagò saw the Claimant for the third time and recommended surgery which the Claimant underwent on 17 November 2014.
During such surgery an intra-operative ‘frozen section’ biopsy [referred to hereafter as an ‘intra-operative biopsy’] was negative for tumour but Professor Malagò adjudged 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 showed no malignancy but acute pancreatitis and cholecystitis.
Although the Claimant consented to surgery there is a factual dispute, which I will discuss below, as to the nature of such consent. Professor Malagò alleges that the Claimant consented to such surgery, during which there would be an intra-operative biopsy which would be reported on immediately, on the basis that in the event of a positive [i.e. malignant] biopsy or if Professor Malagò believed that the appearance of the pancreas was very suspicious, he would carry out a Whipple's procedure. By contrast, the Claimant alleges that her consent was given on the basis that Professor Malagò would only undertake a Whipple's procedure if there was evidence of malignancy from the intra-operative biopsy.
I should record at the outset that it is common ground that pancreatic cancer is a devastating disease which can be very aggressive, that it has a poor prognosis and that to undertake a period of observation of one to two months, rather than undertaking a resection, can potentially mean that ultimately surgery is undertaken too late to save the patient's life. So it was that the following general opinions were expressed by the parties' surgical experts.
Professor Johnson opined that the management of a lesion in the pancreas which is suspicious for malignancy but for which the radiological appearances are not diagnostic, is difficult and that until the advent of EUS it was accepted that 5–10% of pancreatic resections would turn out to have a non-malignant pathology although with the advent of EUS his experience was that the risk of a non-malignant pathology had fallen. In cross-examination he expressed the matter somewhat bluntly: the diagnosis of pancreatic cancer was a death sentence and the timing of treatment determined the duration of a patient's survival.
Professor White opined that pancreatic cancer is a devastating disease which spreads rapidly and has a poor prognosis with a 5-year survival of 5% even after surgery. It is important to diagnose it early and remove the cancer as soon as possible and the consequences of getting the diagnosis wrong is usually catastrophic. He believed that any patient presenting with symptoms such as abdominal pain, here right upper quadrant pain, and a mass in the pancreas should be regarded as having a pancreatic cancer until proven otherwise.
The Claimant's pleaded case
I turn to consider the Claimant's pleaded case.
The Particulars of Claim fully set out the facts relied upon and the pleaded allegations of breach of duty therein may conveniently be summarised in that Professor Malagò:
(1) failed to heed the fact that the extensive investigations which the Claimant had undergone made it more likely that she was suffering from a benign disease;
(2) failed to heed the radiological findings which because of the lack of a progression, possible regression, lack of change of size and lack of pancreatic and bile duct reduction were strongly suggestive of a benign disease;
(3) failed to proceed to a period of observation and further imaging when such would have avoided surgery;
(4) failed to heed that the two biopsies taken at EUS and...
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