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You are here: BAILII >> Databases >> England and Wales High Court (King's Bench Division) Decisions >> MJF v University Hospitals Birmingham NHS Foundation Trust [2024] EWHC 3156 (KB) (12 December 2024) URL: http://www.bailii.org/ew/cases/EWHC/KB/2024/3156.html Cite as: [2024] EWHC 3156 (KB) |
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KING'S BENCH DIVISION
BIRMINGHAM DISTRICT REGISTRY
The Priory Courts 33 Bull Street Birmingham B4 6DS |
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B e f o r e :
(Sitting as a Judge of the High Court)
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MJF (A Protected Party proceeding by her mother and litigation friend, ITZ) |
Claimant |
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- and - |
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University Hospitals Birmingham NHS Foundation Trust |
Defendant |
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Hearing dates: 16th, 17th, 18th, 19th, 20th, 23rd September 2024
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Crown Copyright ©
Her Honour Judge Emma Kelly:
Background
"Four quadrant peritonitis with feed solution within the abdominal cavity (no faeces). Necrosis around gastrostomy site due to position of PEG being too high (positioned almost to fundus) resulting in tension at the gastrostomy site.…"
Summary of the claimant's case
i) Insertion of the PEG with too much tension between the internal bumper (inside the stomach) and the external bumper (on the surface of the skin);
ii) Failure to insert the PEG so that the external bumper had a centimetre or two of play between its position on the line and the surface of the skin;
iii) Failure to detect that the PEG was under too much tension and correct the same before concluding the operation.
Summary of the defendant's case
i) Reasonable care was taken to site the PEG in an appropriate position in the body of the stomach;
ii) Reasonable care was taken to place the external bumper at 2.5 cm from the internal bumper, with approximately 1.5 cm excess over the 1 cm between the surface of the abdomen and the stomach;
iii) After the external bumper was placed, the PEG was manipulated to ensure that the distance between the bumpers was not too tight and there was no tension on the PEG.
Issues
Issue 1: Whether the PEG was placed with too much tension between the internal and external bumpers in breach of the duty of care owed by the defendant.
Causation
Issue 2: If so, whether the tension prevented the supply of blood to the stomach wall causing the tissue to die resulting in peritonitis and sepsis.
Acceleration
Issue 3: If so, whether the admitted deterioration in the claimant's condition is wholly caused by the negligence or whether it accelerated an inevitable deterioration in the claimant's condition by a period of six years.
i) Whether the skin to gastric lumen distance on 22 March 2016 was 2.5 cm, as contended for by the claimant, or 1 cm, as contended by the defendant.
ii) Whether the claimant's level of functioning was already deteriorating in the period before 22 March 2016, and in particular, in respect of her mobility, continence, and swallow function.
The lay witness evidence
The claimant's lay evidence
i) The claimant's father.
ii) The claimant's mother.
iii) Molly Evans, a carer who worked with the claimant for approximately four years between 2012 and 2016.
iv) Lois Evans, a carer who worked with the claimant from approximately 2011 to 2020.
v) Tracy Sheasby, a carer who has worked with the claimant for nearly 26 years and continues to do so.
The claimant's father
The claimant's mother
Ms Molly Evans
Ms Lois Evans
Mrs Tracy Sheasby
The Defendant's lay evidence
i) Dr Mark Andrew, the consultant gastroenterologist performing the PEG procedure.
ii) Sinead McCann, the nurse endoscopist assisting in the PEG procedure. Dr Mark Andrew
Nurse McCann
The expert evidence
i) General surgery: Mr Abeezar Sarela for the claimant (report dated January 2024) and Mr Andrew Wyman for the defendant (report dated February 2024).
ii) Gastroenterology: Professor Ian Gilmore for the claimant (report dated January 2024) and Dr George Bird for the defendant (report dated February 2024).
iii) Neurology/Neurorehabilitation: Dr Ganesh Bavikatte, Consultant in Neuro-Rehabilitation Medicine, for the claimant (report dated January 2024) and Dr John Bowler, Consultant Neurologist, for the defendant (report dated February 2024).
The general surgeon experts
i) The insertion of a PEG would inevitably place some tension on the stomach wall. However, in most cases, this tension is clinically insignificant.
ii) Excessive tension between the internal and external bumpers is a possible cause of necrosis at the PEG entry site.
iii) Leakage of gastric contents from the PEG entry site was a complication that was inherent to a PEG insertion procedure, despite the exercise of due care and skill. Necrosis of the stomach wall around the PEG site is one possible cause of such leakage.
iv) If the court finds that the skin-to-gastric lumen distance was 1 cm, then the necrosis of the claimant's stomach wall around the PEG site was the manifestation of a 'recognised' risk.
v) On 24 March 2016 the claimant had necrosis of the stomach wall at the entry site of the PEG tube.
Likely skin-to-gastric lumen distance on 22 March 2016
i) He asserted (at para. 5.19 - 5.25 of his report) that the average skin-to- gastric lumen distance, based on data from different studies, was 2.6 cm (using data from a study by Chaves et al.) or 3.5 cm (using data from a study by Kim et al.). When calculating the average distances, he added to the data from the Kim and Chaves studies to data as to the mean thickness of the gastric wall of the distal body. He took this latter measurement from a study by Abu Ghanem et al., which found the mean thickness of the gastric wall was 2.2 mm. Mr Sarela concluded that a skin-to-gastric lumen distance of 1 cm was a possibility, but represented a point towards the extreme low end of the spectrum. He did not believe the claimant's then body mass index of around 20 placed her at the extreme end of leanness such that a distance of 1 cm was likely.
ii) He further opined (at para. 5.26 – 5.28 of his report) that the position of the claimant's current PEG supports the proposition that the skin-to- gastric lumen distance on 22 March 2016 would have been 2.5 cm. The claimant's present feeding tube is set at 2.7 cm. He acknowledged the present feeding tube is not located at the same site as the original PEG but concluded that the different location was only likely to account for a few millimetres of change. Any scarring at the PEG site was very unlikely to increase the distance by more than a few millimetres.
i) He noted that the range of abdominal measurements in the Chaves study was +/- 1.7 cm such that extrapolating the data to conclude that 2.5 cm is the more likely measurement is unreliable, particularly given that the claimant was at the lower end of the BMI spectrum. He also pointed to another study showing that the average abdominal wall thickness in non- obese individuals was only 1.7 cm.
ii) He did not consider that the current skin-to-gastric lumen distance was a reliable indicator of the distance in March 2016: the PEG is in a different part of the stomach and correspondingly a different part of the abdominal wall; the claimant has gained between 7–10 kg of weight since 2016 and will thus have more subcutaneous fat; and longer-term PEG cannulation leads to a buildup of scar tissue, tissue oedema and granulation tissue, all of which can lead to a gradual thickening of the abdominal wall.
Cause of the necrosis
The gastroenterologist experts
i) The standard of reasonable care requires a PEG to be fitted without any tension between the internal and external bumpers and with a centimetre or so of 'play' between the two.
ii) If the skin-to-gastric lumen distance was found to be 2.5 cm, then the outer bumper would have been right up against the skin surface.
iii) If the skin to gastric lumen distance is found to be 1 cm, and the outer bumper was at 2.5 cm, then there would have been a reasonable amount of 'play'.
iv) Any tension between the internal and external pump should be identified and corrected.
v) If the court accepts the account given in Dr Andrew's witness statement, the procedure was performed to an acceptable standard save for the inaccuracy in documenting the measurements. Creating a record of a skin-to-gastric lumen distance that is incorrect by a factor of 2.5 does fall below a standard of reasonable care but, if the court accepted the evidence of Dr Andrew on the actual distance between the buffers, the error would not have resulted in any harm.
vi) It is not standard practice to note in a patient's medical records the measurement at which the outer bumper is placed, the skin-gastric lumen distance, or the margin of 'play'. There is no standard way in which a report should be written or what measurements should be included in it. Endoscopy reporting computer software differs between hospitals and some versions will require a measurement to be documented whilst others will not. Whether a measurement is recorded or not is at the discretion of the endoscopist.
vii) Failing to note a skin-to-gastric lumen distance in a patient's records does not fall below the standard of reasonable care.
Likely skin-to-gastric lumen distance and the standard of care
2.5 cm, such positioning would not necessarily indicate substandard practice given the range of opinion as to how much 'play' is recommended.
Cause of necrosis
The neuro-rehabilitation/neurology experts
i) The claimant had congenital cerebral palsy, epilepsy, autism, and learning difficulties, which preceded the placement of the PEG in 2016.
ii) As a result of the episode following the PEG insertion:
i) The claimant sustained peritonitis and sepsis.
ii) There was an episode of hypoxia, which resulted in brain damage.
iii) There was a worsening of the claimant's neurological condition.
iv) There was a significant increase in the claimant's physical, cognitive, and psychosocial restrictions.
v) There was a significant change in the claimant's functionality and consequent dependence and needs.
iii) The claimant's life expectancy after the PEG procedure is 47.19 years.
Life expectancy
The applicable law
The standard of care
"…The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill or an ordinary competent man exercising that particular art
…
… [A doctor] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in this particular art … Putting it the other way around, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that would take a contrary view."
"… in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning the defendant's conduct, the defendant can properly be held liable for negligence … In my judgment that is because, in some cases, it cannot be demonstrated to the judge's satisfaction that the body of opinion relied upon is reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular, where there are questions of assessment of the relative risks and benefits of adopting a particular medical practice, a reasonable view necessarily presupposes that the relative risks and benefits have been weighed by the experts in forming their opinions. But if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible."
Assessing witness reliability
"22. …the best approach for a judge to adopt in the trial of a commercial case is, in my view, to place little if any reliance at all on witnesses' recollections of what was said in meetings and conversations, and to base factual findings on inferences drawn from the documentary evidence and known or probable facts."
"In my opinion this approach applies equally to all fact-finding exercises, especially where the facts in issue are in the distant past. This approach does not dilute the importance that the law places on cross- examination as a vital component of due process, but it does place it in its correct context."
Contemporaneous medical records
"…it is too obvious to need stating that simply because a document is apparently contemporary does not absolve the court of deciding whether it is a reliable record and what weight can be given to it. Some documents are by their nature likely to be reliable, and medical records ordinarily fall into that category..."
"…As a contemporaneous record that Dr Johnson was duty bound to make, that record is obviously worthy of careful consideration. However, that record must be judged alongside the other evidence in the action. The circumstances in which it was created do not of themselves prevent it being established by other evidence that that record is in fact inaccurate."
"Clinical records are made pursuant to a clear professional duty, serious failure in which could put at risk a practitioner's registration. Moreover, they are not compiled simply as a historical record, they fulfill an essential and ongoing purpose in informing the care and treatment of a patient. Contemporaneous records are for these reasons alone inherently likely to be accurate."
Causation
"…subject to the exception in Fairchild's case, a claimant will only succeed if, on balance of probability the negligence is the cause of the injury. If there is a possibility, but not a probability, that the negligence caused the injury, the claimant will recover nothing in respect of the breach of duty…"
"Where there are competing alternative, rather than cumulative potential causes of a disease or injury, such as in Hotson v East Berkshire Area Health Authority [1987] AC 750, I can see no reason in principle why epidemiological evidence should not be used to show that one of the causes was more than twice as likely as all the others put together to have caused disease or injury."
"It is not an uncommon feature of litigation that several possible causes are suggested for the mishap which the court is investigating. If the court is able, for good reason, to dismiss causes A, B and C, it may be able to reach the conclusion that D was the effective cause. But the mere elimination of A, B and C is not of itself sufficient. The court must also stand back and, looking at all the evidence, consider whether on the balance of probabilities D is proved to be the cause."
"The fact that the defendant had not proffered any plausible explanation for the claimant's injury consistent with the exercise of due care did not convert the case into one of res ipsa loquitur. Nor did it reverse the burden of proof. Nevertheless this was a material factor, which the judge was entitled to take into account."
Findings of Fact
The claimant's skin to gastric lumen distance on 22 March 2016
i) Dr Andrew's evidence was that the reporting software preset the skin- to-gastric lumen distance to 4 cm so the operator writing the report had to change the distance. If so, it does not make sense why Dr Andrew changed the 4 cm to 2.5 cm if he thought the correct measurement was 1 cm. He made a conscious decision to change the figure from the default 4 cm so his approach is not explicable by him simply ignoring the question. It is however consistent with his belief at the time that the correct figure was 2.5 cm. His explanation that he changed it to 2.5 cm because that was the distance at which he set the flange is illogical as he knew the software descriptor was not of the flange to gastric lumen distance.
ii) Dr Andrew admitted his clinical record was not accurate. A failure to make an accurate clinical record is a breach of the General Medical Council's Good Medical Practice publication. Dr Andrew explained that there was a free text box under the heading 'Aftercare and Treatment'. If he thought at the time his clinical record was inaccurate, he could have used the free text box to clarify the position as to the inaccurate recording of the skin-to-gastric lumen distance. The fact that he thought it appropriate to leave a clinical record in an inaccurate state is a cause for concern.
iii) There were times during cross-examination when Dr Andrew did not directly answer a question asked of him. When asked whether he accepted that his clinical record was inaccurate on its face, the question had to be asked three times before a clear answer was given.
iv) At other times, parts of his evidence were internally inconsistent. At one point in cross-examination, Dr Andrew suggested that he would not have known that the reporting software would record the skin-to-gastric lumen distance as 2.5 cm until the report had been printed, by which time the computer system was locked such that he could not go back and edit the record. That was at odds with earlier evidence he gave to the effect that he could use the free text box as a workaround to correct the error.
v) Dr Andrew's first witness statement asserted that, after the procedure, he had spoken to the claimant's father and offered an overnight stay as a precaution but the father was very keen to take the claimant home. In cross-examination he was taken to the medical notes which recorded "Dr Andrew reviewed patient. It is alright to go home when ready." Dr Andrew accepted that there was no record in the notes as to an overnight stay being offered or to the claimant's father wanting to take her home. He told the court he had a clear recollection of speaking about an overnight stay but conceded that perhaps he had those discussions directly with the hospital staff only. The fallibility of accurate memory so many years after the event is demonstrated by this exchange.
i) Dr Andrew accepted that he had been interviewed for an internal investigation in 2016 leading to a report, dated 30 June 2016, by Consultant Surgeon Martin Richardson. That report makes no mention of either the endoscopy report being inaccurate as regards the skin-to- gastric lumen distance or that the inflated distance was only 1 cm.
ii) The claimant's solicitor sent a letter of claim to the Defendant on 5 July 2018. The defendant responded by letter dated 9 May 2019. The response did not assert that the skin-to-gastric lumen distance was recorded incorrectly in the endoscopy report, that the correct distance was 1 cm, or that around 1.5 cm of play had been left in the tube. The first time the defendant asserted that the skin-to-gastric lumen distance was only 1 cm, and thus there was around 1.5 cm of play, was in the Defence, dated 27 April 2023. It is highly surprising that it took the defendant so many years to proffer this factual case.
i) The Chaves paper involved a small study of 60 patients, of whom just 10 were in each of the underweight and normal weight categories. Prof Gilmore and Mr Sarela agreed when cross-examined that the data in the paper was consistent with 1 in 10 patients in the claimant's weight category having an abdominal thickness of 1 cm. The other 9 in 10 patients had a greater abdominal thickness. The paper indicates that the mean abdominal thickness of a patient with a BMI of 20 (as the claimant had) was in the region of 2 cm. To the abdominal depth, one must add the gastric wall thickness of approximately 1.3 mm (accepted under cross-examination by Prof Gilmore and Mr Sarela.) A skin-to-gastric lumen distance as low as 1.13cm would thus fall at the lowest end for patients of the claimant's weight category whereas the mean distance would be around 2.13 mm. The latter is self-evidently far closer to the
2.5 cm contended for by the claimant, and indeed Dr Andrews, once the stomach is no longer inflated.
ii) The Kim paper has limitations as it does not consider the abdominal muscle thickness at the same position as the claimant's PEG nor does it consider the subcutaneous fat thickness at anything other than the umbilicus level. However, standing back and looking at the data in the paper as a whole, it demonstrates that a skin-to-gastric lumen distance of as low as 1 cm would represent a patient at the very lowest end of the spectrum.
The claimant's level of functioning in the period prior to 22 March 2016
- Able to walk around the home with assistance only (but not requiring aids).
- Ability to transfer with 1-2 people. The other answer options on the form were 'independent' and 'hoist'.
- Using a wheelchair every day both indoors and outdoors. The form does not make it clear whether 'indoor' use means only the home or other indoor environments such as a café.
- Time sitting in a wheelchair: 2-8 hours.
i) 28 October 2014: GP entry noting "seen with mother and carer. Concerned re weight loss – 1 stone in 10/12, pale, hair thinning, sleeping
+++, not able to walk as far, falling, incontinent of faeces incontinence of urine, not appear to be in pain, less sociable than used to be, will eat if given food but does try to avoid meals, constipated – long standing problem."
ii) 4 November 2014: GP's referral letter to Adult Rehabilitation Team: "…Of late she has started falling often and is unable to walk as far as she used to. She is incontinent of faeces and urine and I am arranging some investigations for her recent weight loss."
iii) 4 December 2014: GP entry noting: Problem swallowing, for some time, does eventually get food down, has soft diet, not opening mouth as wide as used to, food visible in mouth, still losing weight…"
iv) 14 December 2014: GP's referral letter to Queen's Hospital, Burton upon Trent: "…she has had problems with swallowing for quite some time and she struggle to get food down. She has a soft diet, but food is sometimes visible in her mouth for quite a long time. They feel she is not able to open her mouth as wide as she used to. She has been loosing [sic] weight over the last few months and has lost about a stone in weight over the last 10 months."
v) 5 January 2015: Consultant ENT Surgeon's letter to GP: "has a long standing history of swallowing difficulties but apparently this has become more noticeable in the last year. She appears to hold her food in the mouth and seems reluctant to swallow. There are no actual choking episodes. She appears to manage liquids satisfactorily. There has been some observed weight loss of approximately 1 stone in the past year. I note she has quite severe cerebral palsy with learning difficulties and epilepsy. According to her carer, there has been decline in several functions over the past year or two. She was previously able to walk but can now only transfer from her wheelchair…"
vi) 28 January 2015: GP entry noting: "chat with mother, worried, as started passing urine +++, mum thinks is not a urine infection as urine clear, flooding out of pad in the morning, which is out of keeping for her, sweating +++…Dementia screening declined not appropriate – patient not able to communicate, has severe learning difficulty."
vii) 28 April 2015: Nursing Care plan: "[the claimant] does not communicate verbally but can use some signs to indicate her needs in context to her environment and with others who know her well…continence is an issue and finding the right products to help her manage her continence…[the claimant] is unable to communicate the needs of what she wants to do…
viii) 18 November 2015: Videofluoroscopy report: "…[The claimant] has been coughing, retching and vomiting all diet and fluids. A PEG has been discussed but currently eats pre-mashed diet and naturally thickened fluids. [The claimant]is reported to be on PPI once a day for reflux. There are ongoing reports of reflux symptoms i.e. small amounts of stomach contents have been seen on her pillow at night…evidence of oropharyngeal dysphagia characterised by oral stage difficulties; reduced oral control; reduced chew and manipulation of bolus. Her pharyngeal stage was largely intact although normal consistencies of diet and fluids were not assessed due to baseline recommendations…on today's assessment there were no signs of aspiration or significant residue that would explain [the claimant's]symptoms. Her symptoms suggest she may have hypersensitivity in her pharynx and larynx, possibility due to laryngopharyngeal reflux…"
ix) 8 December 2015: GP entry noting: "has recently had videofluoroscopy, advised ENT referral, being sick after some meals every few days."
x) 11 December 2015: GP's referral letter to Queen's Hospital: "has recently been struggling to eat orally, often coughing, retching and vomiting after all diet and fluids. She currently eats a pre-mashed diet with syrup thickened fluids and is treated for reflux with a PPI."
xi) 20 January 2016: Enteral Feeding Dietitian's letter to GP: "in view of her increasing difficulties to meet her dietary and fluid requirements, mum would like to be referred to a gastroenterologist for consideration of placement of a PEG…I am aware of her recent videofluoroscopy results which suggest her swallow is essentially normal but suggested ENT review is required due to her reflux…"
xii) 2 February 2016: Consultant ENT Surgeon's letter to GP: "no specific ENT treatment required. However, may benefit from PEG if this relieves her difficulty eating and maintains fluid intake…"
xiii) 4 February 2016: GP entry noting: "…having problems eating, looking towards peg feeds, being sick while eating, medication all coming up…"
xiv) 8 February 2016: GP's urgent gastroenterology referral letter to Good Hope Hospital: "there have been concerns over the past few weeks about her increasing difficulties with swallowing…she has recently started to have difficulty tolerating her medication…"
xv) 18 February 2016: Nutrition nurse's letter to claimant copied to GP: "…you attended clinic today in your wheelchair, accompanied by your Mom, Dad and your Carer, you remained quite sleepy throughout the discussion. Your parents and carer report that your food tolerance varies from day to day, sometimes tolerating multiple spoons but other times becoming quite fatigued, particularly with fluids which can be difficult to take enough of. We also discussed that you suffer vomiting after eating food but again there appears to be no particular pattern for this and it can vary…"
xvi) 22 March 2016: PEG Procedure admission form. Notes that the patient has had recent seizures, can transfer, needs assistance but not a hoist or pat slide.
xvii) 24 March 2016: Critical care admission notes: "…Normally bedbound…"
i) The claimant was incapable of walking around her ground-floor cottage independently. She could, however, mobilise short distances in the cottage, such as from a sofa to a chair, or from her bed or chair to the toilet, but required a carer to stand next to her, provide encouragement and hold her hand. (Molly Evans accepted the need for assistance when cross-examined and Lois Evans accepted this was routinely the case.) Transfers required assistance from a carer by way of a helping hand and encouragement. The claimant could not be described as 'bedbound'.
ii) The wheelchair was usually kept in the carer's car and the claimant could walk from the cottage to the car on 'good days' with encouragement and hand-holding. However, her deterioration was such that on 'bad days' it is probable that the claimant needed to be transferred to the car by wheelchair.
iii) A wheelchair was required for trips outside the home.
iv) The claimant's ability to swallow both liquids and solids had deteriorated. Contrary to the evidence of some of the claimant's witnesses, the concerns on this topic were not limited to primarily fluid intake but extended to concerns about her ability to eat food. The days of eating jacket potatoes and sandwiches had long since passed. The claimant was struggling to maintain her weight notwithstanding her diet of mashed foods and thickened fluids. Keeping medication down was also a concern. The very fact that a decision had been made to move to PEG tube feeding, supports the deterioration in this regard. The expectation was that the PEG would be used, initially at least, to supplement oral fluid and food intake.
v) The claimant was largely incontinent of urine and faeces. The carers had moved to a rectal irrigation system in around 2013. Urinary continence had deteriorated although the claimant retained some daytime control with accidents from time to time.
vi) The claimant's communication was limited to a small range of Makaton signs but that did enable her to communicate very basic needs.
The standard of care and breach of duty
i) It is highly unlikely sufficient play could have been left if the skin-to- gastric lumen distance was 2.5 cm and the outer flange was also set at
2.5 cm.
ii) Even if Dr Andrew had been attempting to adopt the method of allowing only a few millimetres of play, such an account is undermined by Dr Andrew's own evidence that he left 1 – 1.5 cm of play.
iii) Dr Andrews is an inherently unreliable witness in other respects (such as the timings of the procedure and the endoscopy photographs, his suggestion that the claimant's father wanted an early discharge, the 7- year time lapse before a positive case was averred and his admission that his clinical record was inaccurate) such that his evidence on leaving sufficient play should not be accepted.
i) Insofar as the claimant seeks to rely on the injury to prove a breach, such an argument should be rejected as there are several potential causes of the injury, which may occur despite the exercise of reasonable care and skill. [I did not interpret the claimant's submissions as seeking to advance this argument and, in any event, agree that the mere existence of the injury is not an appropriate matter to take into account when determining any breach of duty in this case.]
ii) Neither the skin-to-gastric lumen nor bumper-to-gastric lumen distance is precise, such that it cannot determine whether there was insufficient play.
iii) Dr Andrew's evidence that he checked the bumper for play and confirmed it was without tension should be accepted.
iv) Dr Andrew's evidence as to the check he undertook was not challenged and the challenge that he 'left very little play in the tube' is consistent with the required standard of care.
v) It is implausible that someone with Dr Andrew's considerable experience would have abandoned his usual approach of fitting the bumper allowing for play by reference to feel and by checking the appearance and manipulating the PEG tube in the operation room and procedure room.
Causation
The parties' cases on causation
i) The original Defence, dated 23 March 2023, denied that the tissue breakdown was caused by tension between the bumpers and averred a positive case to the effect that it was likely that the tissue breakdown was instead caused or contributed to by one or more of (1) manipulation of the PEG by the claimant when awake, (2) pressure placed on the PEG by the claimant when awake or asleep and (3) poor wound healing arising from the claimant's condition, nutritional status and use of naproxen.
ii) Mr Wyman, the defendant's general surgeon, prepared his expert report in February 2024. He concluded that the cause of the necrosis was uncertain but identified four possible contributing factors as being (1) poor wounding healing as a result of the claimant's nutritional condition, (2) use of non-steroidal medication delaying wound healing, (3) pressure placed on the PEG when the claimant was asleep, (4) impaired gastric perfusion if the stomach was distended by enteral feed or the weight of a feed pulled the stomach down on the internal bumper. Mr Wyman's factors (1) – (3) had been pleaded in the Defence but (4) had not.
iii) The general surgeon experts prepared their joint statement in May 2024. They agreed that excessive tension was a possible cause of necrosis although disagreed as to the likelihood of that occurring if the court found the skin-to-gastric lumen distance to be 2.5 cm. Mr Wyman's position on possible alternative causes shifted and both experts agreed that manipulation of the PEG, pressure placed on the PEG and poor wound healing (i.e. the three positive factors pleaded in the Defence) were unlikely to have caused the necrosis.
iv) By Amended Defence, dated 6 September 2024 and thus 10 days before trial, the defendant amended its statement of case to remove reference to the three alternative positive causes identified in the original Defence. Instead, the defendant pleaded simply that the breakdown of tissue and so leak of stomach contents into the abdomen "occurred despite the exercise of reasonable care and skill". It was pleaded that a breakdown of tissue and leak of stomach contents was a rare but recognised complication of the insertion of the PEG that may occur with appropriate care and "it is likely that is what occurred in the claimant's case."
v) In closing submissions, the defendant submitted that the claimant could not establish causation on the basis that there were other possible causes of the necrosis including infection; gastric content coming into contact with the PEG wound; tension caused by the PEG tube being larger than the hole made by the trocar; or tension caused by feed being retained in the stomach causing the stomach to pull against the internal bumper (together 'the Alternative Theses'). The defendant's written closing submissions provided a detailed analysis of the oral evidence given by the general surgeons and the gastroenterologist experts insofar as such evidence touched on the Alternative Theses.
i) The experts were deprived of the opportunity to discuss the Alternative Theses at the joint statement stage.
ii) Mr Wyman gave evidence and advanced the theories after the claimant's expert, Mr Sarela, had already given his evidence.
iii) The claimant has been deprived of the opportunity to investigate and explore the merits of the Alternative Theses through further investigations, such as literature review.
"This is not therefore a case, as sometimes happens, where one or other of the parties seeks to run a different case at trial from that pleaded. That itself is unsatisfactory and can cause difficulties, as has been said recently by this Court more than once: see UK Learning Academy Ltd v Secretary of State for Education [2020] EWCA Civ 370 at [47] per David Richards LJ where he said that statements of case play a critical role in civil litigation which should not be diminished, and Dhillon v Barclays Bank plc [2020] EWCA Civ 619 at [19] per Coulson LJ where he said that it was too often the case that the pleadings become forgotten as time goes on and the trial becomes something of a free-for-all. As both judges say, the reason why it is important for a party who wants to run a particular case to plead it is so that the parties can know the issues which need to be addressed in evidence and submissions, and the Court can know what issues it is being asked to decide. That is not to encourage the taking of purely technical pleading points, and a trial judge can always permit a departure from a pleaded case where it is just to do so (although even in such a case it is good practice for the pleading to be amended); in practice the other party often, sensibly, does not take the point, but in any case where such a departure might cause prejudice he is entitled to insist on a formal application to amend being made: Loveridge v Healey [2004] EWCA Civ 173 at [23] per Lord Phillips MR."
"In my view the judge was not entitled to find for the claimant on the basis of the third man theory. It is fundamental to our adversarial system of justice that the parties should clearly identify the issues that arise in the litigation, so that each has the opportunity of responding to the points made by the other. The function of the judge is to adjudicate on those issues alone…"
"To these statements of principle I wish only to add the following. These problems are all concerned with the interests of justice and, in particular, with circumstances which cause prejudice to the losing party. The common sort of prejudice which is to be avoided is that a new point has arisen in such a way that the losing party was not given a proper chance to call evidence or ask questions which could have addressed it. That is why the function performed by pleadings, lists of issues and so on, which is to give notice of and define the issues, is an important one; but is also why a judge can always permit a departure from a formally defined case where it is just to do so. It is also why the judge's function is to try the issues the parties have raised before them, rather than to reach a conclusion on the basis of a theory which never formed part of either party's case. By placing the emphasis on prejudice, the point I am making is that the modern approach to the definition of the issues requires judges to adopt a pragmatic approach in line with the overriding objective and not seek to be governed by unnecessary formality, provided always that it is just not to do so."
i) The general surgeon and gastroenterology experts did not have the opportunity to reflect on and discuss the Alternative Theses at the joint statement stage. The process of preparing a joint statement, away from the pressure of the witness box, is an important part of the evidential process. Following discussions with an expert colleague, experts may and often do change their views or narrow issues. Indeed, that happened in this case when Mr Wyman abandoned the theses taken from his original report and pleaded in the Defence. Had the defendant made a timely application to further amend its statement of case to advance the Alternative Theses, a further joint statement would likely have been obtained to address the same. The defendant's approach has deprived the claimant of the opportunity for Mr Sarela to discuss the theses with Mr Wyman at a joint meeting. If that had occurred, it may once again have resulted in Mr Wyman changing his opinion following discussion and considered reflection.
ii) The Alternative Theses first started to be ventilated in the cross- examination of Mr Sarela on day 3 of the trial. Mr Wyman had touched on the notion of impaired gastric tissue perfusion if the stomach was distended in the briefest of terms in his original report but the theory was not advanced in the Defence and the experts were not asked to consider it in the agenda set for the joint meeting. Mr Wyman did not raise any of the other Alternative Theses in his written report. (The defendant's gastroenterologist, Dr Bird, did not raise any of the Alternative Theses in his report.) Mr Sarela, although providing an impressive and considered analysis of the questions, was undoubtedly at a disadvantage when cross-examined about these matters. He had no time for considered reflection or further investigation of any relevant literature. Prof Gilmore found himself in a similar position.
iii) Mr Wyman gave his oral evidence after Mr Sarela's evidence had concluded. This only exacerbated the claimant's disadvantage as the claimant's counsel was not hitherto aware from the written expert reports that Mr Wyman was postulating new theses.
iv) The claimant's legal representatives were deprived of the ability more generally to investigate and explore the merits of the Alternative Theses as part of their trial preparation.
Proof of causation (without the Alternative Theses)
i) Mr Sarela and Mr Wyman agreed in their joint statement that excessive tension between the bumpers was a possible source of necrosis. A possibility rather than probability will not, of course, suffice.
ii) Mr Sarela told the court in re-examination that he "cannot conceive another cause for necrosis other than excessive tension."
iii) Mr Wyman accepted in cross-examination that, if the court were to accept there was excessive tension, the likely cause of the necrosis was excessive tension "but you have to think about where the tension might be coming from…" and he postulated other causes of tension which form the discounted Alternative Theses.
iv) Prof Gilmore was asked in cross-examination whether he was prepared to comment on causation or wished to defer to the surgeons. He indicated he was able to comment and stated "he could conceive of no other credible mechanism" other than tension being caused by the bumpers being too close together.
v) Dr Bird accepted that if the court found there was undue tension, such would be "the leading cause" of the necrosis.
i) The audio on the video states: "Tighten the tube until a slight resistance is felt without exerting excessive pull. Special care should be taken to avoid necrosis."
ii) The instruction booklet has the following wording in bold type: "Important!
The tube should remain under moderate tension for 24 hours to promote good adaptation of the stomach wall to the abdominal wall. After that, the tube should be loosened. For further securing, leave 5-10mm additional space. Do not pull the tube too hard on the outside, otherwise pressure necrosis can occur."
Proof of causation (taking into account the Alternative Theses)
i) Mr Sarla viewed references in academic literature to periostomal leakage as referring to a minor complication whereby there was leakage onto the outside skin rather than within the abdominal cavity.
ii) He acknowledged there was a risk of infection at any point along the track but whether it resulted in the death of tissue would depend on the nature of the infection.
iii) He acknowledged that feed or stomach contents could leak from the stomach into the abdomen. He did not accept that would cause necrosis and death of tissue because it would be necrosis that caused leakage not the other way round. He could not postulate a mechanism whereby necrosis would happen.
iv) He acknowledged that there could be limited tissue trauma by pulling the PEG tube through the smaller hole made by the trocar but could not postulate a mechanism whereby that caused necrosis.
i) He postulated that tension could come from other causes such as:
i) Feed distending the stomach and putting tension on the internal flange on the gastric wall.
ii) The radial, outward, tension from the tube itself as it passes through the stomach wall.
ii) He also postulated that there may have been leakage of feed or gastric content around the side of the tube as it exited the stomach which caused necrosis of the stomach.
i) Mr Wyman dealt with causation in express terms in his first report. Whilst postulating other theories since abandoned, he did not refer to radial tension from the tube or leakage around the side of the tube. That these were mentioned by him for the first time in the witness box, when he had months to contemplate the position, undermines the cogency of that evidence to a very significant extent. He did make brief reference in his report to the possible consequences of a distended stomach putting pressure on the internal bumper. It is however telling that the defendant did not consider it an important enough issue to include in the Defence. Mr Wyman himself did not consider it of sufficient importance to warrant mention in the joint statement when he discussed the case with Mr Sarela.
ii) Mr Wyman's suggestions that the necrosis could have been caused by tension arising from a distended stomach or radial tension from the tube itself are not reported in the academic literature put before the court.
iii) His theory that there may have been leakage around the side of the tube was undermined by the defendant's gastroenterologist, Dr Bird, who initially told the court that leaking was associated with there being too much PEG tube rather than there being too little. Later in cross- examination, Dr Bird agreed with the proposition that, if there was hardly any excessive tube, the possibility of leakage was close to fanciful. In re-examination, he changed his mind and stated there was a risk of leakage however the tube was set. Dr Bird's change of evidence of itself undermined his credibility on this issue. Furthermore, the explanation he gave as to how such leakage occurred pointed to it being a risk associated with excessive tubing rather than too tight a fitting. He attributed leakage to the gastric wall not being 'sandwiched' to the abdominal wall. That would be consistent with there being an excess of PEG tube, as slack could mean that the abdominal wall and gastric wall were not pulled together. However, if there was excessive tension between the bumpers, as here, the structures would have been 'sandwiched' together. In short, Dr Bird's initial reaction that that the risk leakage without excessive tubing is fanciful is far more credible.
Acceleration
Mr Bradley: "Going back to our case, it is entirely feasible that an adult in their mid-20s who, in broad terms on the evidence that the court heard from the claimant's side, was ambulant indoors, perhaps with a bit of assistance either for reassurance or otherwise, holding a hand walking around the home, who was able to walk to the carer's car, but that who was wheelchair dependant over longer distance, would retain that sort of mobility to their mid to late 50s but would require hoisting by aged 60. That is Dr Bavikatte's view as to likely progression in those circumstances?"
Dr Bowler: "Yes, on those facts that would be approximately my interpretation as well."
Mr Bradley: "That is the pattern you would often see in a cerebral palsy patient with that sort of input."
Dr Bowler: "It is."
Dr Bowler: "…I would have to advise the court that estimating something like this is necessarily very approximately [sic] with very wide margins of error and in estimating those, I have taken an initial interpretation on the most clearly defined, which, if I remember my report correctly, was on mobility – and then in interpretation of the other matters, I have asked myself: is there any reason to suppose that advancement would be any different, and if they fall broadly within the same wide parameters, I have taken the view that they would approximately be the same."
i) A loss of mobility in circumstances where the claimant's mobility would otherwise have continued to deteriorate but she would have maintained some indoor ambulation with assistance to her mid to late 50s but have required hoisting by the age of 60.
ii) An acceleration of the claimant's progression to complete incontinence (from an already low starting point) by 6 years.
iii) An acceleration to complete feeding by PEG (from a position of a PEG already being required for some feeding) by 6 years.
iv) The need for a tracheostomy.
Conclusion