Rai v University Hospitals Coventry And Warwickshire NHS Trust

1. This is a clinical negligence claim arising as a consequence of a laparoscopic sleeve gastrectomy performed by employees of the Defendant on the Claimant on 16 February 2013. Quantum has been agreed, and therefore I am concerned with issues of liability only. It was alleged that as a result of the Defendant’s failure to diagnose and manage a post-operative staple line leak, the Claimant endured avoidable suffering until a diagnosis was made on 11 March 2013, by which time she was suffering from severe abdominal sepsis. Thereafter she suffered the avoidable effects of a persistent fistula and the complications of complex and lengthy treatment and is left with residual physical and psychological injury.

2. I heard evidence from the Claimant, her mother, the surgeons Mr Menon and Mr Fraser and the experts Mr Fiennes and Professor McMahon. In the interests of providing a briefer judgment I have placed the summary of the oral evidence in annexes. The Claimant

3. In her witness statement the Claimant referred to the weight problems that she had had and the suggestion made to her that it might be possible to have a laparoscopic sleeve gastrectomy. She attended the hospital on 16 February 2013 for surgery. She said that when she woke up after the operation she was in a lot of pain. She was given morphine for the pain and that allowed her to go to sleep until the 17th. She said that on the 17th she tried to have sips of water but felt really sick and would vomit it back up again and could not keep anything down and was also in a lot of pain. Apart from that she did not remember much about that day as she was in so much pain.

4. She said that on 18 February she was still being sick. She remembered seeing Dr Fraser, who had carried out the surgery and being told the operation was a success and she needed to try and eat something before she was able to go home. She remembered telling him that she did not feel well and was in pain. She was given a yoghurt to eat, the first thing she had eaten since the surgery and had one spoonful and immediately vomited it back up. She said that she was unable to drink anything because it hurt when she did so and her lips were extremely dry.

5. She was told she was being discharged home and her mother said she was shocked that they were talking about discharging her when she could not eat. She said she was told that she would feel much better once she was at home in her own environment. She did not remember being offered any more food, and certainly did not eat anything. She said she was sent home that afternoon despite being unable to eat or drink anything and remembered saying she was still not able to eat or drink and was told she would be fine once she was at home and eating again and if she did not feel any better she should speak to her GP.

6. She went to her parents’ house. She was concerned on the next day, the 19th, that she was not getting any better. Her mother brought her a yoghurt but she vomited it straight back. She said she had not eaten or drunk anything since the surgery and was in a lot of pain.

7. She went back to the hospital on 20 February. Staff tried to get her to eat but she could not and the nurse commented that her lips were very dry and she said it was because she had not drunk anything since the surgery. Her mother told the doctor she was really worried because she had not been eating or drinking and the doctor said she should have little bits at a time. She was given some liquid to drink which she was told was some sort of test and was kept in for two days and discharged home on 22 February.

8. She said she was still unable to eat or drink and was still in a lot of pain over the next few days. She saw her GP on 25 February and spoke to the GP again on 1 March. She went back to hospital on 3 March 2013 and was kept in until 5 March. There was talk of her having a CT scan but that did not happen.

9. She was admitted back to hospital on 10 March 2013 as she had been being sick all weekend. She was in hospital for several weeks and ultimately had further surgery on 31 March 2013. An oesophageal stent was inserted on 17 April. She was discharged on 29 April 2013, continued to suffer from pain and vomiting and subsequently it was learned on 13 May 2013 that she had a pulmonary embolism. She remained unwell and went back to hospital on 11 June 2013 and on the following day had a procedure to reposition the stent. She subsequently suffered from sepsis and she described the difficulties she experienced subsequently.

10. I do not set out the detail of those subsequent events since the claim is focused essentially on the events of mid-February 2013. Mrs Nirmla Kalair

11. The next witness was the Claimant’s mother Mrs Nirmla Kalair.

12. In her statement she said that she with other family members visited the Claimant after her surgery and they could tell how much pain she was in. They were told by the nurses this amount of pain was to be expected following the surgery.

13. She returned to the hospital the next day to see the Claimant, who was in constant pain. She was unable to eat or drink which was concerning and also vomited on a number of occasions. Over the course of the next couple of days the Claimant was only able to drink very small sips of water through a straw and was unable to eat anything and was in a lot of pain and looked very weak. There were several occasions when the Claimant was in hospital that she screamed with pain. The doctors kept saying that medically she was fine, which they could clearly see was not the case.

14. She was discharged on the 18th. She was very worried about the Claimant being discharged when she was still so poorly and she had told the doctors she was unable to eat and could hardly drink and they had said everything was normal and in time she would be able to eat. By the time of discharge she was much weaker than she had been immediately after her surgery as she had been unable to eat.

15. After discharge the Claimant remained in a lot of pain. She had initially been given intravenous painkillers while in hospital but was unable to take them when she went home. She had tried to feed her and if she ate at all it would be the tiniest amount of food and half of the time she was sick after eating even a little food. She was sent back to hospital following a visit to the GP, after a couple of days. She was again discharged after a couple of days and remained very unwell and eventually went back to hospital several weeks later and she was given a scan and they were told there was a leak. She then referred to subsequent treatment that the Claimant had. Mr Vinod Menon

16. Mr Vinod Menon then gave evidence. He is a Consultant General and Upper Gastrointestinal Surgeon employed by the Defendant. He has been a consultant since September 2002.

17. In his statement he said he was one of the Claimant’s treating surgeons. He had assisted Mr Fraser in the surgery and was involved in the Claimant’s care before and after the surgery.

18. He said the surgery was performed by him and by Mr Fraser with him assisting and it was a little awkward because of the Claimant’s size but this was not unusual with bariatric patients and the surgery was completed with no particular difficulty.

19. The Claimant was monitored closely and observations were taken at regular intervals that night and over the next two days until her discharge. There was nothing particularly unusual in her post-operative progress that would have given him or any of the other doctors reason to be worried or suspect a potential leak. She had full blood tests every day and the results were all completely normal. Whilst it was true that she had some nausea and some difficulty in keeping fluids down that was not unusual after this type of surgery. The surgery significantly reduces the size of the stomach and added to that there would be swelling from the trauma of the surgery itself, so it was not surprising that some patients had difficulty initially. She also reported some pain but nothing beyond the range that would be expected after this surgery.

20. At 8.30 on 17 February the nurses recorded that the Claimant had a settled night and was having occasional sips of water and there were no new concerns. He had reviewed her on the afternoon of 17 February and gave instructions for a trial without catheter and that she could have free fluids and start a liquid diet from the following morning.

21. She was reviewed by Dr El-Sayed and Dr Oldroyd [his name is misspelt in the witness statement but was corrected at the hearing]. They reviewed the Claimant at 10.30 on 18 February. She was complaining of pain but had only paracetamol and was still having difficulty in keeping down fluids, but she was sitting out of bed and her abdomen was soft and non-tender on examination and they felt she was well.

22. Mr McCullough had seen her at 12 o’ clock and he noted she was stable with good urine output but still having difficulty tolerating water.

23. Mr Fraser had seen her during his ward round on the afternoon of the 18th. She had complained of being unable to keep down water so he told the nurses to give her yoghurt or soup. Her observations and blood test results were all within expected limits so the plan was for her to go home that afternoon. It was noted at 2 o’clock that pain relief had been given with good effect and that she had eaten some lunch without vomiting. She was discharged later that day with a supply of medication to be followed up in Mr Menon’s outpatient clinic.

24. The Claimant returned to hospital on 20 February. She was no longer vomiting but was complaining of pain on swallowing which made her apprehensive about drinking and she seemed to be mildly dehydrated.

25. She was reviewed at 2000 hours. She was swallowing liquids but complaining of epigastric pain after swallowing. This was not getting any worse but it was not going away and she did not have any other symptoms.

26. She was reviewed on the morning of the 21st. The Specialist General Surgery Registrar, Mr Ang, had the impression she was well but a water soluble contrast swallow investigation was arranged to rule out any leaks. That was carried out at 11.59 on 21 February, and it was reported that contrast was observed to pass without impediment from the oesophagus into the gastric sleeve and no leak was seen. She was reviewed after that procedure and reviewed again the following morning and was discharged later on, on 22 February. He considered the decision to discharge was reasonable on both the 18 and 22 February. Mr Ian Fraser

27. The next witness was Mr Ian Fraser, now retired, but at the time of the claim a Consultant General Surgeon employed by the Defendant, having been employed as a Consultant since 1986. He was the operating surgeon in this case, assisted by Mr Menon. He was also involved in the Claimant’s follow-up care until her discharge from hospital on 18 February 2013 and again during her admission between 20 and 22 February.

28. In his statement he said that he did not remember any particular difficulty with the operation. The Claimant was subsequently monitored closely and observations taken at intervals throughout the evening after the surgery and night and over the course of the next two days. There were no particularly unusual features in her post-operative course that would cause him any concern. She had some nausea and difficulty tolerating fluids but that was common after this type of surgery. Likewise the pain she experienced was not unusual; different patients’ experience of discomfort and immobility could vary after surgery and there was nothing in her presentation that was out of the ordinary or that would cause concern.

29. He noted that she was reviewed by Mr Menon on 17 February and by Dr ElSayed and Dr Oldroyd on the 18th. He noted that she was complaining of pain but was observed to be only on paracetamol. She said she was having difficulty in keeping down fluids. She was prescribed Diclofenac per rectum for her pain. He noted that she was seen by Mr McCullough on his ward round at noon and was noted to be stable with good urine output but was having difficulty tolerating oral fluids.

30. He saw her during his rounds sometime before 2 o’clock on 18 February. She complained of being unable to keep down water. He instructed the nurses that she could have yoghurt or soup. He did not have any concerns about her progress: her observations and blood test results were all within expected limits. If there had been anything out of the ordinary in her presentation or test results he would not have recommended her discharge. As it was he was entirely satisfied with her progress and said she could be discharged home later that day so long as she felt well enough. He noted that the nurses at 2 o’clock on 18 February noted that pain relief had been given with good effect and she had eaten some lunch without vomiting. She was discharged later that day with a supply of medication but was readmitted on the 20th complaining of pain on swallowing which made her apprehensive about drinking and she appeared to be mildly dehydrated. She was seen by the General Surgery Specialist Registrar at 2000 hours on the 20th and it was noted that she was swallowing liquids but complaining of epigastric pain after swallowing which was not worsening but was persistent. A water soluble contrast swallow investigation was carried out at 11.59 on 21 February and the contrast was observed to pass without impediment from the oesophagus into the gastric sleeve and no leak was seen. He agreed with the Consultant Surgeon’s plan to discharge her home, on 22nd February, and she was discharged later that afternoon. As regards the readmission between 20 and 22 February he remained satisfied that there was nothing in her presentation then, her blood tests and observations that might have caused him to question the findings of the radiologist or to suspect a leak. There was no reason to find the report of the contrast swallow was anything but reassuring and it would not have been reasonable to request a CT scan, exposing her to radiation, unless there was good reason to do so such as evidence of deterioration in her condition or sepsis. Her symptoms were within the range of post-operative symptoms experienced by some patients after a sleeve gastrectomy as the result of functional adjustment of the gastrointestinal tract and the surgery itself. Sister Deborah Ursell

31. The next witness was Sister Deborah Ursell (formerly Moore).

32. There was legal argument at the start of the hearing about whether I should permit the Defendant to rely upon her witness statement and to allow her to give oral evidence.

33. In his skeleton argument Mr Coughlan accepted that the trial was not imperilled by this application no matter how it was determined, but it was not agreed that she should be allowed to give evidence given the late stage at which her witness statement was produced, contrary to the timetable set out on 19 February 2018, and the fact that the note was not accepted from the outset of these proceedings. Mr Coughlan sought to rely on what had been said in Wisniewski v CentralManchester Health Authority [1998] PIQR P324, where an adverse inference was drawn from the Defendant declining to call a witness to add necessary weight to a critical record. It was argued also that further witness evidence with regard to the presence of vomit on the bedsheets might have been sought. It was contended that if the statement was admitted, leeway in examination-inchief would be sought for the evidence of the Claimant and her mother but there was a potential injustice in any event.

34. I ruled that the statement could be allowed in and that Sister Ursell could be permitted to give oral evidence. I did not see that the matter fell within what was said in Wisniewski where it was said that either B, the midwife had negligently failed to inform the doctor, R, of a quick foetal heart beat (tachycardia),or R had negligently failed to attend the mother of the Plaintiff who suffered from athetoid cerebral palsy from birth. R was in Australia and declined to return from there. The statement made no reference to what he might have done if he had been summoned by B. The judge placed considerable weight on his non-attendance, addressing himself to what R would have done if summoned and to what a hypothetical competent doctor would have done in his place.

35. In contrast in this case I accept what is said on behalf of the Defendant that it was only thought necessary to call Sister Ursell after a letter of 9 May 2019 from the Claimant’s solicitor put the Defendant on notice that they intended to invite the court to draw an adverse inference from the failure to call Sister Ursell. There was already in the bundle a note of what she had observed on 18 February and it was a question of it not having been thought necessary to get a witness statement from her and to have her give oral evidence in light of what was already provided as part of the evidence from her in the bundle.

36. It seemed to me upon consideration that the overriding objective was best served in this case by admitting the statement and allowing oral evidence from Sister Ursell. The question of what the Claimant ate or drank if anything on 18 February was a key piece of evidence with regard to breach of duty, and it is not as if there was evidence that took the Claimant by surprise. In fact that note was not accepted in the Particulars of Claim and it did not entail that a witness statement would be provided by Sister Ursell and oral evidence sought. Accordingly, I admitted it into evidence.

37. In her witness statement Sister Ursell (previously Sister Moore) said that at the time of the incident she was a Band 6 Clinical Sister working on the surgical ward. She had reviewed the records and could see from her handwriting that she had completed the daily care plan for the Claimant on the 18th, noting her heart rate, temperature, blood pressure, respiration, oxygen saturation and MEWS at 10 o’clock and 1400. She could see from the observation chart for 18 February that at 0139 no nausea or vomiting was recorded, at 6.19 there was nausea but no vomiting, at 10.25 there was no nausea or vomiting and at 1415 there was nausea but no vomiting. She said that normally the healthcare assistants completed the observation charts and she would not have recorded the observations at 01.39 or 06.19. She could not say for certain whether or not it was she who recorded the observations at 10.25 or 1415.

38. With regard to the entry at 1400 hours on 18 February and in particular the part reading “has had some lunch and not vomited”, she confirmed that this was her writing and her signature and that she had made the entry in the records. She had no specific independent recollection of making the entry but could say that she would not have written that the Claimant had had some lunch and not vomited if she was not satisfied that it was correct and that she would not have been discharged if there was any concern that she was not happy to go home or that she was still vomiting. Her invariable practice would be to ask the patient if she had managed to eat any lunch and how much she had managed. They did not expect patients to be able to eat a great deal after bariatric surgery. They were only allowed small amounts and would only usually be able to manage a small amount of yoghurt or ice-cream. What she had written down could only be because that was what the Claimant had told her when she asked her. If she had said she had only had one spoonful and then vomited she would certainly have recorded that in the records and the Claimant would not have been allowed to go home. She was fairly certain that if the Claimant had been sick she would have known about it. She remembered that she had been very reluctant to get out of bed so if she had vomited the nurses would have known about it because they would have had to clean it up, remove the bowl or change the bed covers. It was very doubtful that she could have vomited without them knowing about it and if she had then they would have made a note about it. Lunch was usually served around 12 to 12.30. There would be absolutely no reason for her to write that she had not vomited unless she was satisfied that it was correct.

39. Sister Ursell adopted her statement as her examination-in-chief. Expert Evidence Mr Alberic Fiennes

40. The next witness was Mr Alberic Fiennes who is an experienced Consultant Surgeon with long experience of and expertise in general, upper digestive and bariatric surgery.

41. In his written evidence Mr Fiennes stated that as the Claimant did not improve on the first post-operative day she would on the balance of probabilities not have been considered fit for discharge on the second day. Appropriate investigation and clinical re-examination would have raised the possibility of early staple-line failure or of a self-contained leak at that stage. Without this failure on the balance of probabilities the intractable fistula would not have developed and the ensuing peritonitis, sepsis and nutritional depletion would not have occurred. There was a failure in the standard of care in not registering that the Claimant had not made proper progress in her recovery, still needed strong analgesia, had an unexplained drop in Sa02 (it had been 100% on admission), there was no clear explanation for her fluid intolerance: localised oedema of the staple line, portending failure, should have been on the list of possible explanations.

42. Had she been kept in, the fluid intolerance would have persisted and on the balance of probabilities she would not have improved spontaneously. Imaging investigations would have been undertaken, which might or might not have indicated cause for concern along the upper gastric staple line, but given the recognised significant limits to the sensitivity and specificity of both contrast swallow and CT scan, no responsible bariatric surgeon would have been reassured by negative findings in the face of clinical evidence to the contrary. In a situation where any doubt persisted that imaging accurately reflected the clinically evident or suspected actual process, any responsible bariatric surgeon would reasonably have recognised early laparoscopy with or without methylene blue dye testing as the most accurate reliable investigation. In this case, he considered, such doubt would indeed on the strongest balance of probabilities have applied, leading to early laparoscopy. Early (3-4 days post-operative) repair in the course of that laparoscopy stood a better than even chance of success. Professor Michael McMahon

43. The next witness was Professor Michael McMahon who is an Emeritus Professor of Surgery at the University of Leeds and a Consultant Surgeon at the Nuffield Health Leeds Hospital having been a Professor of Surgery at the University of Leeds between 1996 and 2007. His was the first surgical team to perform a sleeve gastrectomy as a stand-alone bariatric procedure.

44. In his written evidence Professor McMahon considered that on the first postoperative day observations were within expected limits and in particular there was no tachycardia. It was unusual that 10 mg of morphine was required at 02.30 and 13.00 but the reason for and nature of pain and discomfort were not recorded. He considered that the actions taken on 17 February were reasonable and appropriate. On the second post-operative day the Claimant’s observations were within the expected range. The oxygen saturation of 94 or 95% on air was reasonable in the circumstances. He observed the nursing note at 2.00 p.m. of Sister Moore, and considered that it appeared that the Claimant’s ability to take fluids orally may have improved as the day went on and she may have found it easier to take things such as yoghurt even though she had difficulty with water. He noted that for the blood tests on 18 February the white blood count was normal and C-reactive protein was reassuringly low. It was unusual that 10 mg of morphine was administered on 10.40; the reason was unclear. He considered that from the standpoint of medical review, nursing review, observations and blood results, the Claimant appeared to be making satisfactory progress and was able to be discharged. The small element of concern, her ability to take oral fluids, appeared to have improved. There was no indication to carry out an investigation for a leak prior to discharge. If a leak test had been carried out at the time of surgery on either a contrast swallow or a CT scan performed prior to discharge, no leak would have been revealed. The contrast swallow carried out subsequently on 21 February showed no leak, and he agreed with the radiologist, Dr Tolan, that it would have been routine surgical practice, as well as radiological practice, to accept the findings of the swallow and not proceed to CT scan. Conclusions on the EvidenceThe Claimant Professor Michael McMahon

45. Rightly it was not suggested that the Claimant had been dishonest in any respect. At the highest it was put by Ms Mishcon that she was confused as a consequence partly of the pain and other problems she experienced after surgery and also the fact that on several occasions subsequently she returned to the hospital having been sick at home.

46. The Claimant found herself having to contend that the nursing records were wrong in not recording vomiting when she said she had vomited. She also had to contend with the contrast between the pain levels recorded and her evidence that she screamed with pain at times. It is also relevant to note that she did not go to solicitors until some two-and-three-quarter years after the index event. Both she and her mother said they told the nursing staff of her pain and the fact that she was vomiting everything she drank on 17 and 18 February, but the nursing notes do not corroborate this. The nursing records of 17 February record nausea on one occasion but do not tick vomiting, and again nausea is ticked on two occasions on the 18th but vomiting is not recorded. The pain scores for 17 February are 0, 2, 1, 1, 1 and

1. The Claimant did not accept that she had had lunch and not vomited, as contended by Sister Ursell in her note on the day.

47. It is also relevant to note that the evidence is that all the medication given to the Claimant on 18 February was oral medication other than a suppository on one occasion. She said in oral evidence that she vomited instantaneously when she attempted to swallow water.

48. I see force in the point made by Ms Mishcon that it would be extremely surprising if none of the nurses who gave her her medication would have noticed her vomiting it up again. There is of course an absence of any record of vomiting in the notes. It is also relevant to note the reference in the nursing notes on 18 February to “oral analgesic given with effect”. It is further relevant to note that the urea, electrolytes and creatinine levels were normal on 18 February and that is an indication again of adequate hydration. I consider that the Claimant’s evidence has to be seen in the context of the suffering she undoubtedly experienced, then and thereafter, as well as the elapsing of time between the events in question and the time when she provided her written statement and gave her oral evidence. It is also relevant to note the reference in her witness statement to her vomiting straight back up a yoghurt which her mother gave her at home on 19 February. It is entirely possible that this event has been confused with what she says happened on the 18th. In terms of how she gave her evidence, she was clear as to what she thought she recalled and did not accept that her memory was at fault. The Claimant’s Mother Mrs Kalair

49. Mrs Kalair referred to the Claimant vomiting on a number of occasions on the 17th and being unable to eat or drink, only to have very small sips of water through a straw over the next couple of days. On several occasions she screamed with pain. She said she told the doctors that the Claimant was unable to eat and could hardly drink and that after she had taken her home half the time she was sick after eating even a little food.

50. Again her evidence was provided some years after the events in question and there is again, as Ms Mishcon argued, the possibility of confusion bearing in mind that the Claimant was in and out of hospital on a number of occasions over several months. As Mr Coughlan pointed out, the fact that she did not claim to remember the yoghurt vomit incident is a positive in the sense that she is not inventing evidence, though I see it as no more than a neutral factor rather than being an indicator of reliability. Again her evidence about vomiting and levels of pain has to be seen in the context of the evidence recorded by the hospital staff. Again there is no question of dishonesty in her case but it is contended that her memory is fallible and possibly that there was an element of exaggeration with regard to the screaming with pain. Mr Menon

51. As was suggested by Mr Coughlan, Mr Menon is not a central witness. It is relevant however to note that he said that if he had been told on 17 February when he saw the Claimant that she was not able to tolerate water without vomiting he would not have ordered her to progress on to free fluids that evening and a liquid diet the following morning. His evidence was perfectly straightforward, and he accepted that there were flaws in the procedures, such as the absence of clinical notes for the 17th. Mr Fraser

52. Mr Fraser agreed that there needed to be a good trend of good observations prior to discharge and that if there were a new complaint of nausea and vomiting this was not consistent with being “well”. He accepted that “something had to change” in order for the Claimant to be allowed home and this his definition of “wellness” included non-dependency on opiate analgesia and tolerating adequate fluids and semi-solids sufficient to maintain physiology. He was content to delegate the decision on discharging the Claimant to the nurses who were very experienced, particularly on the ECU. Sister Ursell

53. Like the other witnesses there is no question as to the honesty of Sister Ursell. She is clearly an experienced nurse who gave her evidence to the best of her recollection. She noted that she did not recall seeing the Claimant vomit and there was no documented evidence that she had vomited. If she had not deemed her well she would not have discharged her. She did not remember the Claimant being taken to the car in a wheelchair but that was not unusual. She accepted that she could not say for sure that she had observed the Claimant eat lunch and not vomit and that the information might have come to her from a healthcare assistant. Mr Fiennes

54. Mr Fiennes is clearly a very experienced expert, and his report was carefully constructed and clearly set out. He accepted that he had made a mistake as to whether it was 6.00 a.m. or 6.00 p.m. on the 17th that nausea/vomiting was first recorded, and that there might be a mistake in his chart, but otherwise his evidence demonstrated clear expertise and knowledge. Professor McMahon

55. Professor McMahon was subjected to detailed criticism by Mr Coughlan. To a certain extent I consider that criticism is merited. His report was not structured in the way in which it would have been ideal, for example setting out all the evidence that he had received, and in particular his omission to refer to the witness statements was surprising. Like Mr Fiennes there was an element in his report of taking the line of the party he was instructed by, and they are both liable to some minor criticism in that regard. There are elements of the medical evidence that were not referred to by Professor McMahon, and that must be a matter of note as well.

56. However he is clearly a very experienced expert with a longstanding interest and expertise in this particular type of surgery. The deficiencies in his report do not, in my view, go to the heart of it. In endeavouring to present an objective picture, he erred in that he failed to take into account and therefore balance into what he had to say about the subjective evidence particularly that of the Claimant and her mother, which was a mistake, and also in failing to take into account and point out the deficiencies in elements of the medical evidence. As a consequence he fell short in fulfilling his duties to the court. As I say, I do not consider the deficiencies in his evidence go to the heart of that evidence though I take them into account in the evaluation of what he had to say in going on, as I do now do, to consider first the issue of breach of duty and second the issue of causation. Discussion

57. The Claimant’s pleaded case on breach of duty is that the respondent failed to heed or adequately act upon the Claimant’s persistently high analgesic requirement, dropping oxygen saturation levels, de novo nausea and inability to tolerate food and drink which taken together amounted to a failure to progress as one would have expected following the procedure. It was also claimed to be negligent in that the Defendant failed to investigate for leak prior to discharge and discharged the Claimant rather than keeping her in for further monitoring and investigation. As was suggested in Mr Coughlan’s skeleton argument, the case essentially resolves on the court’s assessment of whether the Claimant was “well” at the point of the decision to discharge.

58. Mr Fiennes considered that purporting that the Claimant was “well” as noted by the junior doctors, was hard to reconcile with their remark about intolerance of oral fluids and vomiting. He noted Mr McCullough’s concern to reorder a reestablishment of intravenous fluids and Mr Fraser’s note that the Claimant was intolerant of oral intake. He did not consider it was reasonable to describe the situation as one warranting “no concerns”. He considered it was slightly inconsistent to be satisfied with the Claimant’s progress yet to sanction discharge “so long as she felt well enough”. He also criticised Mr Fraser for not operationalising how to determine “well”. There was no clear action or decision making plan for the junior doctors or the nurses. He also, Mr Fiennes thought, appeared to ignore the Claimant’s requirement for 15 mg of morphine at 10 o’clock a.m. that day which was documented in the records available to him at the time. He considered that the Claimant was sent home without proper focus on her persistent intolerance of oral fluids, her persistent analgesic needs and her drop in SaO2. Mr Fraser had not ensured that the conditionality of discharge was understood and he considered the Claimant was sent home through a careless and haphazard lack of process.

59. In his report Professor McMahon considered that the Claimant appeared to be making satisfactory progress on the 18th and was able to be discharged. He considered that the only small element of concern related to her ability to take oral fluids, but by the time of her discharge this appeared to have improved. He made the point that it was important to appreciate the post-operative progress after sleeve gastrectomy is quite variable. In his opinion the results of the blood investigations were very reassuring and suggested that no complication had developed by the time the Claimant was discharged from hospital on the 18th. In his opinion there was no indication to carry out an investigation for a leak prior to discharge from hospital on 18 February. Not only were the Claimant’s observations within the expected post-operative range, but there was no suggestion on the blood tests of a leak . In particular a level of C-reactive protein of 11 mg/L on the second post-operative day strongly suggested that no leakage was present. He considered that there was no reason to keep the Claimant in hospital after 18 February and if she had been kept in hospital for further monitoring and investigation it was probable that she would have been discharged within the next day or two.

60. The picture on 18 February therefore was, looking first at the doctors’ notes, at 10.30 a.m. Dr El-Sayed and Dr Oldroyd, two very junior doctors, saw the Claimant. They reviewed the operation note and noted that she was experiencing pain and was only on paracetamol. They noted that she was unable to drink fluids without vomiting. Urine was passed easily and the bowels were not yet open. On examination she had very mild wound pain and on inspection was well.

61. When the more senior Mr McCullough saw her at around noon he noted that her urine output was good but she was not tolerating oral fluids (water). He described her as being stable. He wanted IVI to be re-established and care to be continued.

62. The Claimant was next seen by Mr Fraser. It appears to have been quite soon after Mr McCullough, and indeed the time listed is prior to Mr McCullough seeing the Claimant but it is I think sufficiently clear from the order in which the notes are set out on the form that he must have seen her after Mr McCullough did. He noted that she was unable to keep water down without vomiting. His plan was for her to go home today if well. He appears not to have thought it necessary for IVI to be re-established.

63. The Claimant’s evidence was that she was continuously vomiting and at times crying out with pain and that was essentially the evidence of her mother also.

64. We do not have the fluid balance charts which is unfortunate. We do however have the planned nursing care notes. Sister Ursell (at the time Sister Moore) saw the Claimant at 1400 hours. She noted that the Claimant had been seen by Mr Fraser and was for discharge home that day. Volterol had been given with good effect for pain relief. She could have yoghurt and soup and her clips were for removal ten days after the operation, at the practice nurses. Sister Ursell noted that the Claimant had had some lunch and had not vomited and analgesia had been given with effect. She was aiming to go home and they were awaiting TTOs.

65. As I have noted above, in her witness statement and oral evidence Sister Ursell said that she would not have recorded that the Claimant had had some lunch and not vomited if she was not satisfied that it was correct, and she would not have been discharged if there was any concern that she was not happy to go home or that she was still vomiting. Her invariable practice would be to ask the patient if she had managed to eat any lunch and how much they had managed. As she had written in the records that the Claimant had managed to have some lunch and not vomited then that could only be because that was what she told her when she asked her, otherwise she would not have written it down. She accepted that this information might have been given to her by an orderly, but said that if the Claimant had said that she had only had one spoonful and then vomited she would certainly have recorded that in the records and she would not have been allowed to go home. She was fairly certain that if the Claimant had been sick she would have known about it. There would be absolutely no reason for her to write that she had not vomited unless she was satisfied that it was correct.

66. In the observation chart for 18 February nausea is recorded at 6.19 a.m., though not at 10.25, but recorded at 1415. Vomiting was not recorded in respect of any of those three observation times.

67. The Claimant’s clinical observations were all within the accepted normal range on 18 February as were the laboratory values for a patient on the second day after sleeve gastrectomy. It was unusual but not unheard of for someone in her position to require as she did opiate analgesia on the second post-operative day. The experts agreed that her recovery on that day lay within the expected range with the exception of analgesic requirements and the ability to take fluid orally. They agreed that if she was able to tolerate adequate oral intake it was satisfactory to allow her to go home. They also agreed that if she had some lunch and did not vomit it would be consistent with the description “well”. It was reasonable to discharge her as long as there was adequate oral intake.

68. I was impressed by Sister Ursell’s evidence. She is clearly an experienced nurse and I find entirely credible her statement that she would not have allowed the Claimant to go home if she had vomited, she would not have written that the Claimant had had some lunch and vomited if she was not satisfied that that was correct. Whether she obtained this information from her own observation or from an orderly seems to me to be essentially by the way. Either way she was satisfied that what she wrote in the notes was the true situation.

69. I consider that, unsurprisingly, the Claimant and her mother may not have had had clear memories of what happened at what time given the number of occasions upon which she vomited and experienced pain and the number of different times on which she had to return to hospital. I intend no criticism of either of them in this regard, but I consider the evidence that the Claimant could not eat lunch without vomiting, which is an essential part of their evidence, is not borne out, in light of the evidence in particular of Sister Ursell.

70. The picture was clearly a developing one. The Claimant in the morning of the 18th was unable to drink fluids without vomiting as noted by both Dr El-Sayed and Dr Oldroyd and Mr McMahon and indeed by Mr Fraser also. The pain levels were raised, as can be seen by the recordings on the 18th of 0 at 1.39 a.m., 2 at 6.19, 2 at 10.25 down to 1 at 1415. The analgesic requirement was raised, and though unusual that was not such in my view and on the evidence as a whole as to give rise to any significant concern.

71. In the words of Dr Fraser “something had to change”. That something was the assessment made by Sister Ursell at 2 o’clock in the afternoon. The Claimant was recorded as having had some lunch and not having vomited and also had oral analgesia with effect. That combination is such in my view as to amount to wellness as subsequently defined by Mr Fraser. It essentially equates to being in a condition where the person is able to go home and cope, and it was in my view perfectly appropriate to decide that discharge could go ahead at that time given that evidence at the time when that decision was made. It was clearly open to the nursing staff to whom the final decision of discharge had been delegated to conclude in light of this evidence that the Claimant had reached a stage of recovery where she could safely be sent home.

72. As a consequence I find no breach of duty in this case. Causation

73. The pleaded case on causation is that had the Claimant been kept in hospital her fluid intolerance and other symptoms were likely to have persisted or worsened. Imaging of the upper gastric staple line would have been performed on postoperative day two or three. It was accepted in the Particulars of Claim that on the balance of probabilities such imaging would not have revealed signs of emerging staple line leak; however, regardless of the findings of such imaging, it is argued, the Claimant’s clinical picture warranted continued admission and further investigation of the staple line. It is said that early laparoscopy (postoperative days three or four) with or without methylene blue dye testing would have been undertaken and early over-sewing repair along with drainage (postoperative days three or four) would have successfully prevented the full failure of the staple line. It is claimed that the Claimant would have avoided the injuries she suffered.

74. In the joint medical report it was agreed that the majority of leaks are detected several days after the operation, agreeing with the figures quoted in the Kim paper. It was agreed that there are both localised and generalised clinical features of staple line failure. The localised features include epigastric pain and pain on swallowing, difficulty with swallowing and vomiting. Generalised features that may occur somewhat later include pyrexia, tachycardia, tachypnoea, low oxygen saturation and low urine output. It was agreed that there were no features of overt staple line leak on 18 February and that her presentation on that day was not such that laparoscopic or open exploration was indicated. Mr Fiennes was of the opinion that it would have been reasonable not to re-explore on the 19th as long as alternative close monitoring modalities were in place. Professor McMahon considered that the Claimant’s condition on the 19th would not have indicated the need for re-exploration.

75. It was agreed between the experts that there is significant variability in the recovery process amongst different patients. If the Claimant was substantially unable to take adequate amounts of food and drink on the second post-operative day and still had high analgesic requirements, her presentation would have been at or close to the limit of the range expected for a normal recovery.

76. It was agreed that the staple line failure was a progressive process that in all probability had begun to develop by 20 February as evidenced by the relatively modest rise in C-reactive protein. It was agreed that on the basis of the clinical history and the level of C-reactive protein on 3 March it was probable that the frank leak developed on 1 March.

77. In light of the report of the radiology expert Dr Tolan, who concluded that a CT scan performed on the 18th or 19th was likely to have shown a small area of fluid in the area around the operation, which would have been judged to be within normal limits for the patient’s post-operative status, Mr Fiennes considered that he would have been relatively reassured by negative findings in the context of the patient’s overall clinical condition. Professor McMahon considered that he would have been reassured by negative findings given the known clinical condition of the Claimant on 18 and 20 March. It was agreed that if the result of imaging had not provided reassurance, further monitoring and investigation would have been carried out in a manner set out by Kim in the research paper, to which I refer in more detail below. Mr Fiennes was of the opinion that intervention on the 19th offered a reasonable prospect of preventing full staple line failure. Professor McMahon considered it improbable that failure of the staple line would have been prevented by intervention on 19 or 20 February. It was agreed that even if primary repair of the staple line was unsuccessful it was probable that the Claimant would have had a far shorter stay in hospital and that, while a fistula might have developed, it would have been “controlled”. It was difficult to know whether or not a stent or stents would have been avoided. It was probable that the pulmonary embolism would have been avoided.

78. The paper by Kim et al is a position statement of the American Society for Metabolic and Bariatric Surgery (ASMBS) on the prevention, detection and treatment of gastrointestinal leak after gastric bypass and sleeve gastrectomy, including the roles of imaging, surgical exploration and non-operative management.

79. A key passage in this paper, which is in effect a summary of current published peer reviewed scientific evidence and expert evidence, is to be found at page 743 (bundle page 202) of the paper. I think it may be helpful to quote the entire paragraph in question:- “Tachycardia, fever and abdominal pain (often radiating to the left shoulder or scapula region) are the most common, but not exclusive, signs of a GI (gastrointestinal) leak after SG (sleeve gastrectomy). In general, laboratory examinations are rarely contributory. In patients with clinical signs or symptoms of a suspected leak after SG, UGI contrast studies have a low sensitivity (0% to 25%), though higher specificity (90% to 95%)). Because of its higher sensitivity, most studies recommend obtaining a CT with oral and IV contrasts as the method of choice for diagnosis of a leak in patients who show signs and symptoms suggestive of a leak but remain clinically stable. Inclusion of the chest may help rule out other causes of tachycardia such as pneumonia, pulmonary embolism or pleural effusion. CT results are also influenced by patient factors, the experience of the radiologist, the size of the leak and the contrast material used; however, high sensitivity (83% to 93%) and specificity (75% to 100%) are reported in most series. As with GI leak after GB (gastric bypass) laparoscopic or open re-exploration is also an appropriate diagnostic option, regardless of the feasibility of obtaining a post-operative imaging test, when a GI leak is suspected. Re-exploration is characterised by a higher sensitivity, specificity and accuracy than any other post-operative test to assess for leak and should be considered to be the definitive assessment for the possibility of leak when the patient is clinically unstable, or in the scenario wherein alternate diagnoses are being excluded and/or clinical suspicion remains.”

80. As noted above, the contrast swallow carried out on 21 February showed no leak, and there is of course the evidence referred to above of Dr Tolan that a scan on the 18th or 19th would not have identified a problem.

81. The experts differ as to the degree of reassurance they would have taken from this. Mr Fiennes would have been relatively reassured and Professor McMahon would have been reassured. I should say that there is no suggestion that the contrast swallow carried out on the 18th or imaging on the 18th would have revealed any different picture from that actually shown by the contrast swallow on the 21st, bearing in mind also Dr Tolan’s evidence about what a scan would have revealed on the 18th or 19th.

82. I think it is right to suggest as Ms Mishcon did, that there is something of a change in Mr Fiennes’ evidence from what he said in answer to question 13a in the joint statement as to his relative reassurance by negative findings of imaging on the 18th or 19th and what he said in oral evidence that the investigations carried out on the 19th would probably have shown a rise in CRP to between 11 (as recorded on the 18 February) and 52 (as recorded on 20 February) which would have led to a CT scan being carried out on the 19th and if the Claimant’s condition did not improve it would have been reasonable to undertake a laparoscopy on the evening of 19 February.

83. His evidence contrasted with that of Professor McMahon who was adamant that that would not have been a prudent course of action because it would have been important to wait and see how the picture developed. He pointed to the risks to the patient attaching to surgical intervention, although Mr Fiennes made the point that if there were risks of the kind of deterioration that in fact occurred to the Claimant then that type of response was necessary.

84. The position is then that on the 18th if either contrast swallow or imaging had been carried out they would have revealed nothing that would have given rise to concern. I bear in mind the other points of potential concern referred to by Mr Fiennes, in particular the rising of the CRP.

85. My reading of what is said in the Kim report is that as was said in the first part of the paragraph quoted above, most studies (and this includes the Burgos study referred to in evidence) recommend obtaining a CT with oral and IV contrasts as the method of choice for diagnosis of a leak in patients who show signs and symptoms suggestive of a leak but remain clinically stable. It was I think agreed by the experts that the Claimant was clinically stable. It is of course true as the paper goes on to say that laparoscopic or open re-exploration is also an appropriate diagnostic option and that it should be considered to be the definitive assessment for the possibility of leak where the patient is clinically unstable or in the scenario where alternative diagnoses have been excluded and/or clinical suspicion remains.

86. My reading of this is that contrast swallow and/or CT scan on the 18th would normally have been regarded as being sufficient bearing in mind that the Claimant was not clinically unstable even if clinical suspicion remained. I do not read the paper as mandating laparoscopic or open re-exploration in a case where there is clinical suspicion but rather that it is stating that such intervention is the definitive assessment for the possibility of leak. That has I think to be read subject to what was said earlier in the paragraph about the approach recommended in most studies of a CT with oral and IV contrast in the case of a patient who as in this case was clinically stable.

87. I think Mr Coughlan is right to argue that on this point it is not a question of the Bolam test of whether there is a class of practitioners who might reasonably recommend either alternative, since we are concerned at this stage with causation rather than breach of duty. Rather I have to make a choice as between the approaches put forward by Professor McMahon and Mr Fiennes. In light of the evidence as a whole which I have set out above, and bearing in mind the criticisms that were made of Professor McMahon’s report by Mr Coughlan, I consider that Professor McMahon’s approach is the one to be preferred. There were not such signs in existence on the 18th as to give rise to the kind of concerns which would have justified the surgery which would have been Mr Fiennes’ preferred option by the evening of the 19th. It is the case that the changes in the Claimant’s laboratory results between 18 and 20 February involved only a relatively modest rise in the CRP and everything else, in particular the WBC, urea and electrolytes and creatinine levels remained well within the normal range. I consider the approach of Professor McMahon of a suspicion of a leak keeping the Claimant in hospital in order to monitor her progress but not rushing to carry out over-sewing repair without more is the better view in this case. I bear in mind also Mr Fiennes’ evidence that the intervention on 19 February offered a reasonable prospect for preventing full line staple failure was that this was 50% likely to succeed and hence not meeting the balance of probabilities test.

88. I conclude that on causation as also on breach of duty this claim must fail.

89. As a consequence of my findings on breach of duty, the claim fails, but, even if I were wrong in that regard, it fails because of a lack of causation.