QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| Yvonne Lesforis
|- and -
for the Claimant
Mr Philip Havers QC (instructed by Hempsons Solicitors) for the Defendant
Hearing dates: 16, 17, 18, 19 and 23 April 2018,
Crown Copyright ©
Mr Justice Martin Spencer:
The treatment by Mr Tolias
"We reviewed together the MRI scan from April of last year which revealed an L3/4 grade 1 spondylolisthesis with narrowing of the lumbar canal and exit foraminal stenosis. I demonstrated this to Mrs Lesforis and explained that this is the cause of her symptoms but obviously clinically she is improving and therefore intervention at this point is not warranted. I suggested that she continues with her efforts to lose weight and to also take up some exercise like swimming, walking, cycling which will improve her overall fitness and that will help with her pain as well.
With regards to surgical intervention in the spine, there is a likelihood that it might be necessary in the future as osteoarthritis progresses, however at the moment as her clinical symptoms have almost disappeared there is no reason to intervene. I will review her routinely in six months time and we can make plans either for discharge or surgery at that point."
"It is almost six months since her last review. Unfortunately her symptoms continue to be present, in particular on the left side and it does not seem that she is improving significantly. I explained that I am happy to offer her a lumbar decompression and postero-lateral fusion of the level in order to improve her pain in the back as well as her leg pain. She still wants to think about it. I described the procedure to her including the risks, including risks of damage to the nerve, CSF leak, infection, haemorrhage, failure to improve, recurrence of problems. She will think about it and let me know. In the meantime I have requested a repeat MRI and CT scan of her lumbar spine and we will let you know of her progress."
The MRI, carried out on 8 October 2012, was reported as showing a seven millimetre anterior subluxation of the L3 vertebral body upon L4 causing moderate to severe canal stenosis and bi-lateral moderate foraminal stenosis with some impingement of the exiting nerve roots. These appearances were similar to those from April 2011.
"I described the procedure once more. I explained the risks including the risk of leg weakness, paralysis, loss of bowel and bladder control, persistent pain, haemorrhoids, infection, failure to improve DVT or numbness. In view however of the persistent problems the benefits outweigh the risks. Mrs Lesforis is keen to proceed, I gave her a booklet to read and she has signed the consent form."
The consent form, also dated 20 February 2013 and signed by Mrs Lesforis, contained the following:
"I have explained the serious or frequently occurring risks and risks of particular significance in the patient's circumstances. If patients make clear they have particular concerns about certain kinds of risk, discussion must include information about these risks, even if they are very rare and those discussions must be documented here. I have stated that any additional procedures at the time of operation will only be performed to protect the patient's life or future well-being.
Leg weakness/paralysis/loss of bowel/bladder/ CSF leak/persistent pain/haemorrhage/infection/failure to improve/DVT/numbness."
Thus, it seems clear that the Claimant was comprehensively warned of the risks of surgery which she was electing to undergo and Mrs Lesforis does not assert otherwise.
"Patient complained of not feeling her legs. There was minimal WB. Unable to wiggle toes once in bed.
Plan: discuss with Mr Tolias.
[Telephone conversation] with Mr Tolias, explained patient can't feel her legs, and was unable to wiggle toes in bed."
"Says that today she had difficulty walking
Can feel her legs well, ? less so on left; can feel catheter tug
o/e: normal sensation to soft touch L3 S1
No ankle movements, unable to wiggle toes
Hip flexion 3/5 B ext. 4/5
Knee flexion 3-4/5 B ext. 4/5."
Mr Al-Barazi noted that Mrs Lesforis was to have a CT scan of her lumbar sacral spine and that he would then discuss the case with Mr Tolias.
" an MRI scan was not possible at the Harley Street Clinic out of hours or on the weekends. No MRI trained radiographers were on call at HSC or at the nearby private hospital. If a clinical emergency necessitated an MRI scan then the patient would, most likely, have been transferred to an NHS emergency department. I do not know how long this would have taken but it might well have been several hours."
Mr Tolias also suggests in his witness statement that a CT scan was preferable to MRI, stating:
"The difficulty with MRI as an alternative modality in these circumstances is multi factorial. In the first place, post-operative MRI is not very good at showing acute blood and blood products. The interpretation is even more difficult when metalwork is present. The next problem was that we had put titanium in her spine and whilst this is not sensitive to a magnet, it does create signal change, an artefact which makes it harder to interpret an MRI. Above all, there was no problem with the imaging of the area of the spine about which we were concerned: the CT scan showed that there was no lesion in her lower spine the area distal to where we had operated and where her symptoms pointed to a problem. It was vanishingly unlikely that MRI would have provided more information about that area."
In my view, this passage smacks of retrospective justification for a failure which, in reality, Mr Tolias recognised, which is that, in 2013, any surgeon carrying out spinal surgery of this kind needs to have arrangements in place for emergency MRI scanning. It may be true that, in terms of visualising the metalwork, CT scan gives as good a view as MRI, but that is not true of visualisation of soft tissue and nerve roots. I shall return to this issue in paragraph 75 below.
As seen, the nerves, controlling different functions, exit the spinal column at different levels. Damage to the spinal cord will affect the nerves which remain in the cord at that level, but not those which have already exited at a higher level. Thus, clinically, the presentation of a patient may give the surgeon a strong clue as to the likely level of any lesion or problem affecting the spinal cord. In the course of the evidence, Mr Leach, the Claimant's neurosurgical expert, produced a document from the American Spinal Injury Association ("ASIA") showing International Standards for Neurological Classification of Spinal Cord Injury. In terms of motor function, the chart shows the following key muscles affected by the nerves exiting at the following levels:
|L5||Long toe extensors|
|S1||Ankle plantar flexors|
In terms of sensory function, the surface of the skin is divided into specific areas called dermatomes, a dermatome being an area of skin in which sensory nerves derive from a single spinal nerve root. Thus, a doctor can test for nerve root damage using a pin and testing for pin prick sensation. The key sensory points appear from the chart to be as follows:
|L1||The hip girdle and the groin/inguinal area|
|L2||Anterior aspect of each thigh|
|L3||Anterior aspect of each thigh; anterolateral thigh and continues down to the medial aspect of the knee and the medial aspect of the posterior lower leg|
|L4||Posterolateral thigh and the anterior tibial area|
|L5||Posterolateral thigh wrapping around to lateral aspect of the anterior lower leg and dorsum of the foot;|
|S1||Hips and groin|
|S2||Back of the thighs|
|S3||Medial buttock area|
"In conclusion, there are post-operative appearances as described following L3-4 laminectomy and pedicle screw and rod fixation. The intra-spinal ridges at site of surgery are markedly degraded by artefact from the pedicle screws. It is difficult to exclude some encroachment from dorsal epidural soft tissue swelling at the site of surgery. There is some equivocal intra-spinal soft tissue density extending superiorly within the upper lumbar canal. There is a locule of intrathecal air (? Related to intra-operative CSF leak) at L1 level. If further clarification of the imaging findings is required then MRI is suggested."
"I had excluded compression below the L4 level."
In relation to the area of the operative site he said that the impression on CT was of a slight bulge which is seen not infrequently in the post-operative situation but he accepted that a compressive haematoma could not be 100% excluded because of artefact at that level. However, he said that there was an incredibly low probability of compressive haematoma at the site of the laminectomy. Finally, Dr Connor said that there was an unusual finding at the L2 level which he could not explain but which appeared to be clinically irrelevant because, as stated, the origin of Mrs Lesforis' problems appeared to be much lower down at L5/S1.
"16.00 Tolias apparently patient very well until late last night
- felt some moderate back pain and paraesthesia down both legs
- now unable to move both feet (ankle/toes)
- able to lift both legs off bed bend hips and knees/extend both knees against gravity
- can feel catheter/wound ok
CT spine / d/w Steve Connor (consultant neuroradiologist) ? no obvious acute clot
- soft tissue posteriorly (explained by Tisseal/muscle plug)
- (L) upper screw slightly medial
- D/W Mr Malik
- We cannot explain the delayed sudden bilateral distal weakness
- Levels at a distance from operative site
- Agreed to start steroids and reassess situation
- Explained problem to Mrs Lesforis and her husband. Also explained our consensus opinion and plan"
"The clinical and radiological picture did not suggest an acute, clinically significant compressive haematoma, that neuropraxia was more likely and the best thing was to give steroids to reduce the potential oedema and to observe her closely, but to re-operate if she did not improve within a few hours."
"Mr Tolias came to review the result of the scan. Plan is for her to start on steroids ASAP and also to sit out. Continue on physio input and neuro obs. If pt not improved by Monday: then MRI scan. Dexamethasone 4 mg given."
It has to be said that the plan disclosed by the nursing notes does not appear to be consistent with the plan which Mr Tolias said was the actual plan, namely to re-operate if Mrs Lesforis did not improve within a few hours. Mr Aldous QC submits that the nursing note genuinely represents Mr Tolias' plan at that stage, and betrays his muddled and illogical thinking at that time. Mr Havers QC submits that, given the subsequent events, it appears that the nurse may have mis-understood what Mr Tolias was saying, or alternatively that Mr Tolias' plan was relayed to her through a second or third party and became garbled in the process.
"Mrs Lesforis was improving well following her procedure and was moved on to the ward after her stay in the Intensive Care Unit. However, unfortunately on the morning of 29 June, she quite suddenly noticed that she could not really move both her feet. She did not experience any significant pain or any other symptoms but she reported that some time during the night she felt something happening in her legs. When the physiotherapist tried to mobilise her on Saturday morning, it proved impossible. She was reviewed immediately by my colleague, Mr Barazi, who was in theatre at Harley Street, and he noticed that there was complete weakness of the plantar and dorsiflexion of both feet (0/5), 4/5 on knees and 4/5 on hips. There was some sensory hypoaesthesia in the S1 dermatome. Mrs Lesforis could feel her bladder catheter tug. There was anal wink and was, on inspection, ability to squeeze her anal sphincter. An emergency scan of the lumbar spine was organised which was reviewed by our neuroradiology colleague, Dr Steve Connor, and there was some retrodural collection which we expected in view of the patch that we created to protect her from the CSF leak. There was no real evidence of a large clot, both above and below the decompression area. The screws were in good positions. The left upper screw at L3 was slightly more medial but there was no other evidence of problem. We started Mrs Lesforis on a course of steroids but over the next few hours no specific improvement was noticed in her feet. She was still quite briskly lifting both her legs off the bed but was unable to move her feet. In view of that and due to lack of any improvement, we decided to proceed to exploration of the wound in order to at least exclude the possibility of a significant compression of the nerve rootlets and theca by any clot."
"After general anaesthetic she was given a further dose of antibiotics, positioned prone on a Montreal mattress, and the wound was re-opened. Copious amounts of Betadine saline were instilled. There were no clots in the superficial layers however just epidurally there was a clot of identified solidified [matter] and causing compression of the dura itself, which was removed with copious amounts of wash and pituitary rongeurs. It was found that the epidural veins, particularly in the anterior aspect of the laminectomy, were oozing continuously and it took considerable effort to stem the bleeding using Flowseal pressure and wash. Again the wound was washed with Betadine saline and closed in layers with staples to skin over Redivac drain and suction this time."
- Post op wound exploration
No significant change
Still 0/5 at the ankles, 3/5 knee extension/4/5
Able to lift leg off the bed
Can feel catheter/anal tone present unable to squeeze
100 ml in drain
Will need intense physio and rehabilitation."
This note is supplemented by the final part of Mr Tolias' dictated medical report of 1 July 2013 where he states:
"Post-operatively Mrs Lesforis recovered well from the procedure. She noticed some subjective improvement, in particular in the sensation in her legs but the next morning she could still lift her legs off the bed but could not move her feet still. On examination she could feel the catheter and there was anal tone but she could not squeeze on the finger. We agreed that she will try to mobilise. I explained the seriousness of the situation and I also contacted her husband about it. We agreed with the physiotherapist that we will continue to mobilise as able, remove the drain at 24 hours and assess neurological improvement. Following this, I contacted Mrs Lesforis' GP, Dr O'Leary in order to try to arrange some neuro rehabilitation support for her as it is obvious that she will require more long term support until she is stabilised or further improves."
"DW [discussed with] Mr Tolias, happy for patient to be mobilised gently this morning. Patient went to theatre last night, due to blood clot." (emphasis added)
The rest of the physiotherapist's note is not relevant for present purposes.
"Op note findings noted
Patient feels 'Better in myself'
Hip + knee movements 4-5/5 (bi-lat)
No ankle movements; no toe movements
Feels catheter tug
Normal sensation to soft touch
Feet warm and well perfused"
The plan was for her to continue with physiotherapy.
The allegations against the Defendant
a) Whether it was negligent to administer Clexane (that is, chemo-prophylaxis in the form of LMWH) within six hours of the operation;
b) [Diagram or picture not reproduced in HTML version - see original .rtf file to view diagram or picture]Whether it was negligent to delay intervention after 14.30 until surgery at midnight;
c) Whether the early administration of Clexane and/or the delay in intervention were causative of the permanent nerve damage that reduced the Claimant's mobility and left her using a wheelchair.
I agree that these are the principal issues for determination in this case, although I also need to say something about the pleaded allegations of negligence in relation to the failure to carry out MRI scanning. I shall deal with causation in conjunction with the allegations of breach of duty rather than as a separate third issue.
Issue 1: Was it negligent for the Defendant to arrange for the administration of chemo-prophylaxis within six hours of the operation?
"13. At the end of the operation I prescribed subcutaneous Clexane for her once daily. I see that that prescription is criticised and I can only say that it is my invariable routine to give patients anti-coagulation after this sort of operation. An overweight patient such as Mrs Lesforis, particularly one who is going to remain flat for 48 hours after the operation because of the durotomy, is at increased risk of venous thromboembolic events and therefore Clexane is indicated, along with intermittent calf compresses which were also prescribed (in accordance with NICE guidelines). However, it is my normal practice to give anti-DVT chemo-prophylaxis (Clexane) very early post-operatively to all my cranial or spinal patients and I am surprised to see it is criticised in the Letter of Claim."
Of course, the giving of chemo-prophylaxis is not criticised as such, rather it is the timing which is criticised. From Mr Tolias' statement, it seems clear that, in relation to the timing, he did not discriminate between his patients in this regard: thus, he did not say that he prescribed Clexane that early post-operatively for Mrs Lesforis because of any particular individual circumstances pertaining to her particular case. Rather, he said that this is the timing for all his cranial and spinal patients.
"3.3 as a Posterior Lumbar Inter-body Fusion can be associated with a post-operative haematoma compressing the thecal sac and this can cause cauda equina syndrome, chemo-prophylaxis against venous thromboembolism is not given in the very early post-operative period. Mechanical prophylaxis in the form of graduated compression stockings and Flowtron boots are used in the first 1224 hours post-operatively. Chemo-prophylaxis against venous thromboembolism is usually commenced on the first post-operative day. The commencement of chemo-prophylaxis against venous thromboembolism within six hours of surgery increases the risk of post-operative haematoma formation."
Although Mr Leach acknowledges that the surgeon must exercise judgment when deciding on appropriate timing of chemo-prophylaxis he states that to prescribe it within six hours of a Posterior Lumbar Inter-body Fusion represents a breach of duty. He states:
"3.12 a reasonable spinal surgeon would exercise caution with the use of post-operative chemo-prophylaxis against venous thromboembolism. This is because chemo-prophylaxis against venous thromboembolism increases the risk of a post-operative haematoma. That risk of haematoma formation decreases with time, such that use of chemo-prophylaxis 12-24 hours post-operatively has a much lower risk of association with post-operative haematoma than administration of the same drug within six hours of surgery.
Although the NICE guidelines are silent on the issue of timing of chemo-prophylaxis following major spinal surgery, my clinical experience informs me that it would be normal to commence chemo-prophylaxis the day after surgery, such as a Posterior Lumbar Inter-body Fusion and you use mechanical prophylaxis in the form of graduated compression stockings and compressive Flowtron boots in the first 24 hours. In my opinion, it represents a breach of duty to prescribe a medication associated with increased risk of post-operative haematoma formation within six hours of the completion of a Posterior Lumbar Inter-body Fusion."
"The use of Low Molecular Weight Heparin (LMWH) (subcutaneous slow release or IV) has been variably introduced across the UK. Some neurosurgical and spinal units give a LMWH type medication, (anti-coagulant) routinely 12-24 hours after spinal surgery unless the operating surgeon specifically states otherwise. my own practice in this situation is to prescribe LMWH at 24 hours after this type of surgery usually an hour or so after the wound drain has been removed."
This was hardly a ringing endorsement of Mr Tolias' routine practice to give very early chemo-prophylaxis: indeed, Mr Cadoux-Hudson did not suggest that there was a reasonable body of spinal surgeons in the UK in 2013 who would give chemo-prophylaxis at such an early stage as opposed to 12-24 hours after spinal surgery.
"Was it appropriate to prescribe chemo-prophylaxis against venous thromboembolism within six hours of surgery?"
The experts provided the following answer:
"The experts agree that there is paucity of good quality clinical evidence on the subject of timing of chemo-prophylaxis against VTE following spinal surgery. The NICE guidelines are acknowledged.
Mr Cadoux-Hudson notes that there are a number of different practices within surgery and particularly within neurosurgery. Whilst NICE guidelines exist for other surgical disciplines such as orthopaedics where venous thromboembolic prophylaxis is given before hip and knee surgery, neurosurgery units in 2012 had a range of times for extra dural spinal surgery ranging from before and after surgery.
Mr Leach holds the view there is not a reasonable body of spinal surgeons that administers chemo-prophylaxis against VTE within six hours of surgery.
NICE guidelines indicate a requirement to exercise a balanced judgment between risks of bleeding and risks of VTE. For procedures where post-operative bleeding can have devastating consequences, such as spinal surgery, mechanical prophylaxis is used in the peri-operative and early post-operative period and chemo-prophylaxis, if indicated, is delayed until the next day. Mr Leach notes that in neurosurgery there is some evidence of a bleeding rate of 2%."
"2 The Timing of chemoprophylaxis on 27th June 2013
2.1 Do you agree that there is a wide range of opinions about the optimal time to start chemoprophylaxis for Venous Thrombo Embolus (VTE)?
The Experts agree as this will depend on patient risk factors and type of surgery performed.
2.2 Do you agree that some surgeons start chemoprophylaxis for VTE:
a. before surgery?
b. some shortly after ?
c. some after 12 hours?
d. some after 24 hours?
e. some not at all?
The Experts agree. The timing of prophylaxis will depend on patient risk factors for VTE and bleeding risk of surgery.
2.3 Do you agree that there is little high level (Level One or Two) evidence covering chemoprophylaxis in patients undergoing cranial surgery and less in spinal surgery that supports any of these positions?
The experts agree.
2.4 Do you agree that the risks of fatal VTE are much greater than the risk of paralysis due to epidural haematoma as a result of chemoprophylaxis?
The experts partially agree.
The experts agree that the risk of fatal pulmonary embolism after extra-dural spinal surgery is rare, as low as 1:2000 whilst the rate of deep venous thrombosis as detected by ultra-sound is between 2-9%.
The experts also agree that the rate of epidural haematoma is also low (0.2-0.4%).
Mr Cadoux-Hudson states that the rate of epidural haematoma is not increased if early (before 24hrs) LMWT heparin is given (see Gerlach et al 2003).
Mr Leach states that the rate of paralysis due to epidural haematoma as a result of chemoprophylaxis is not known and that the NICE guidelines on VTE prophylaxis recognise this.
The NICE guidelines list lumbar puncture within the next 12 hours as a bleeding risk to be considered when deciding on the use of chemoprophylaxis against VTE. In this context, Mr Leach states that a Posterior Lumbar Interbody Fusion certainly represent a bleeding risk. The NICE guidelines state: "In spinal surgery the catastrophic long term neurological consequences of extradural bleeding need to be balanced against the risk to life of VTE disease."
Mr Cadoux-Hudson notes that lumbar puncture is an intra-dural procedure exposing intra-dural arteries and venous to direct trauma of the lumbar puncture needle, out of sight of the person performing the procedure and is not a reasonable analogy, for operative or post-operative Lumbar surgery.
2.5 Do you agree that Mrs Lesforis was at increased risk of VTE because:
2.5.1 She was slightly overweight:
The experts agree.
2.5.2 She was expected to be nursed flat for an extended period as a result of having sustained an intraoperative durotomy?
The experts agree.
2.6 Do you agree that there are some spinal surgeons who would have prescribed chemoprophylaxis against venous thromboembolism within 6 hours of surgery?
The experts disagree.
Mr Cadoux-Hudson, as pointed out above, is of the view that chemoprophylaxis is theoretically more effective the closer to the surgery event (best results have been demonstrated if given before surgery). The precise timing is at the surgeon's discretion, weighting the risks and benefits to the patient.
Mr Leach believes that there is not a reasonable body of spinal surgeons that would commence chemoprophylaxis against VTE within 6 hours of major spinal surgery.
2.7 Do you think that it can be said that their opinion does not stand up to analysis because there is sufficient evidence to show that it is dangerous?
The experts partially agree.
Mr Cadoux-Hudson sites Gerlach et al where LMWT heparin was given at 08.00hrs in the morning after surgery (within 24hrs) in over 1,299 patients undergoing lumbar surgery and no increase in the epidural haematoma rate or timing, with the largest group (5 of 13) developing the haematoma on the day of surgery (before LMWT heparin was given.
Mr Leach states that in the Gerlach study "early" is defined as prophylaxis commencing at 8am the day after surgery. None of the patients in this study had chemoprophylaxis commencing within 6 hours of surgery.
2.8 If so, can you identify the evidence?
Both experts agree that the evidence is limited.
Mr Cadoux-Hudson is of the view that the hypothesis was reasonably tested in the Gerlach et al paper and that some of the patients would have had LMWT heparin with hours of their operation.
Mr Leach states that the evidence does not support safe use of chemoprophylaxis within 6 hours of surgery and an element of judgement must be exercised as recognised in the NICE guidelines. Mr Leach does not believe that there is a reasonable body of spinal surgeons that commence chemoprophylaxis against VTE within 6 hours of major spinal surgery."
"Our study provides an up to date evaluation of the literature from across the world of the general estimate of the risks and benefits of using chemo-prophylaxis in patients undergoing cranial or spinal procedures. We found, based on moderate to good quality of evidence trials, that chemo-prophylaxis is beneficial in preventing VTE while resulting in no statistically significant increase in bleeding complications (both minor and major).
Based on the moderate to good quality of evidence, chemo-prophylaxis is beneficial in preventing VTEs in patients undergoing management of cranial or spinal pathology, with no significant increase of either major or minor bleeding complications. The adverse impact of VTE in untreated patients appears to outweigh that of haemorrhage in patients receiving chemo-prophylaxis. Further research is needed to determine whether this conclusion holds true for the more specific sub-populations, and for the optimal timing for initiation of chemo-prophylaxis."
Based on this passage, Mr Havers suggested to Mr Leach that the giving of chemo-prophylaxis does not give rise to any statistically increased risk of bleeding complications. Mr Leach disagreed with that proposition. He pointed out that the Khan paper, being a meta-analysis, provides no new research evidence that is not already in the literature and furthermore the study refers to the use of chemo-prophylaxis in a general neurosurgical population, but the authors were cautious not to apply their findings to particular patients such as those undergoing spinal surgery or Posterior Lumbar Inter-body Fusion. Mr Leach said that, looking at the detail of the Khan review, the only papers which looked at studies involving spinal patients which were reviewed were those by Gruber and Hamidi. He said that the conclusion drawn by the authors of the Khan paper were not borne out by the evidence from the papers which are pertinent to the present case.
"1.5.22 If using LMWH for people undergoing elective surgery, start giving it 24 - 48 hours post-operatively according to clinical judgement, taking into account patient characteristics and surgical procedure. Continue for 30 days or until the person is mobile or discharged, whichever is sooner.
1.5.23 If needed start LMWH earlier than 24 hours after the operation for people undergoing elective spinal surgery. Base the decision on multi-disciplinary or senior opinion, or a locally agreed protocol."
Mr Leach said that these guidelines very carefully reflect the evidence available at the time they were drawn up and NICE had come up with a conclusion that, if indicated, LMWH should be given at 24 - 48 hours post-surgery. He said:
"They are a long, long way from suggesting that chemo-prophylaxis is safe and it doesn't matter when you give it."
Although these NICE guidelines were not published at the time of the surgery to Mrs Lesforis, they do, to a certain extent, provide an answer to the suggestion that, as at December 2017 (the date of the publication of the Khan paper), the conclusion of those authors reflected the medical literature at that time.
"I had to look at the guidelines as they were at the time and look at the evidence and come up with an answer for the court about whether there was a reasonable body of surgeons in the UK spinal surgeons who gave early, less than six hours chemo-prophylaxis. It is a treatment that has a potential to cause significant harm, so there would need to be evidence of safety to do it. And on that basis my view is that there is not a reasonable body of surgeons who give chemo-prophylaxis very early after spinal surgery within six hours, because of the risk of haemorrhage. I'm not aware of a reasonable body of surgeons in the UK who give it pre-operatively and if I'm presented with evidence, for example that there is a protocol at King's College Hospital that all surgeons give it early or I'm presented with evidence that there is a body of surgeons that gives it early, within six hours, then I will accept that is reasonable. But where there is a lack of good clinical evidence and where there are just guidelines I do have to fall back and rely upon experience, having worked in many centres in the UK. I also noted Mr Cadoux-Hudson's statement that he also gives it in a delayed fashion, and I have not been presented within this process of any protocol or suggestion that there is a group of surgeons in the UK that give it within six hours. I will be prepared to alter that opinion if I was presented with evidence to the contrary."
i) The quality of the evidence is weak in that paper;
ii) The study did not compare giving chemo-prophylaxis early to giving it later;
iii) The study had 13 instances of haemorrhage which was treated immediately;
iv) 38% of the haemorrhages presented on day 2 or 3;
v) The implication from the paper is that none of the patients had prophylaxis within six hours.
"Unless the surgeon states otherwise. So we are back to this issue of protocol versus senior surgeon decision."
Mr Aldous interpreted this answer as meaning that the only case of which Mr Cadoux-Hudson would be aware of a reasonable body of practitioners administering LMWH within, say, three hours of surgery is if the surgeon specifically states that such early chemo-prophylaxis is necessary in the particular case. He then said:
"Well, my opinion is based on the evidence here that there is no strong guiding evidence either way. It is difficult for me to argue on a Bolam basis that this was below Bolam standards is what I think I'm trying to drive at. There is enough variation here to account for that, there is no specific data to say that three hours has a significantly higher risk than any other period."
"In 2013, with a patient who was overweight and who it was intended would spend the next 48 hours lying flat, would giving chemo-prophylaxis three hours post-surgery have fallen within the variation of practice in the UK which you referred to earlier in your evidence?"
To which Mr Cadoux-Hudson answered:
"Yes it would. Yes. "
He also agreed with the proposition that if a surgeon took the view that a patient who is overweight and would be lying flat for the next 48 hours should have chemo-prophylaxis three hours following surgery that would be a reasonable view for the surgeon to take. In answer to a question from the court, Mr Cadoux-Hudson said that there were surgeons in 2013 who had a system of giving LMWH on the evening of their surgery even if the surgery ended in the afternoon.
i) In 2013 there was no consensus among spinal surgeons as to when chemo-prophylaxis should be given in terms of timing post-operatively but there was a disparate range of practice;
ii) Mr Cadoux-Hudson said that he was aware of surgeons who have given chemo-prophylaxis within six hours;
iii) The NICE guidelines current at the time of this operation were silent as to the timing of chemo-prophylaxis;
iv) The Claimant had specific risk factors for VTE;
v) Mr Cadoux-Hudson stated that to give chemo-prophylaxis to such a patient three hours following spinal surgery in the UK in 2013 would have fallen within the variation of practice to which he referred;
vi) Mr Cadoux-Hudson said that if a surgeon had taken the view that it was appropriate to give chemo-prophylaxis three hours following spinal surgery then that would have been a reasonable view for the surgeon to take given the variation in practice;
vii) It was Mr Cadoux-Hudson's view that it is reasonable to give it within six hours;
viii) There is no evidence in the medical literature that giving chemo-prophylaxis within six hours increases the risk of post-operative haemorrhage.
"We are dealing with a situation here where a senior neurosurgeon, an experienced neurosurgeon, has taken into account the risk factors before him at the end of the operation with another neurosurgeon who is operating with him, Mr Malik, and a consultant anaesthetist, and typically in my experience these discussions are things that you start discussing during the procedure, and I suspect it would have happened during the procedure because one of the decisions that was made was made on the basis of the incidental durotomy. So a fairly significant amount of thinking has gone on, if that is the right way of putting it, to consider the use of Low Molecular Weight Heparinoids."
In response to this Mr Aldous QC suggested that Mr Cadoux-Hudson was assuming such a discussion took place because it should have, to which Mr Cadoux-Hudson responded:
"Because it can do. In the guidelines it is about senior surgeons making that decision."
Mr Aldous QC was critical of Mr Cadoux-Hudson because he was speculating about a matter which was not in fact reflected in the evidence of either Mr Tolias or Mr Malik.
"Had [Mr Tolias] carried out a proper risk assessment then he has not said what conclusion he would have come to. On the evidence it is likely that he would or should have come to a similar conclusion to that of the only two witnesses to have addressed the issue, the experts, who would have waited. Thus the bleeding and its consequences would have been avoided."
"I am not saying that there weren't any surgeons around the world who had studied pre-operative chemoprophylaxis. I had to look at the guidelines as they were at the time and look at the evidence and come up with an answer for the court about whether there was a reasonable body of surgeons in the UK spinal surgeons who gave early, less than 6 hours chemoprophylaxis. It is a treatment that has a potential to cause significant harm, so there would need to be evidence of safety to do it. And on that basis my view is there is not a reasonable body of surgeons that give chemoprophylaxis very early after spinal surgery, within 6 hours, because of the risk of haemorrhage."
"Was it appropriate to prescribe chemo-prophylaxis against venous thromboembolism within six hours of surgery?"
Mr Cadoux-Hudson responded:
"Mr Cadoux-Hudson notes that there are a number of different practices within surgery and particularly within neurosurgery. Whilst NICE guidelines for other surgical disciplines such as orthopaedics where venous thromboembolic prophylaxis is given before hip and knee surgery, neurosurgery units in 2012 had a range of times for extradural spinal surgery ranging from before and after surgery."
It seems to me that if Mr Cadoux-Hudson was aware of other neurosurgical units who routinely administered LMWH within six hours of spinal surgery, this was the moment when he could and should have said so. Had he done so, I am sure that Mr Leach would have conceded the point. However, he did not and it seems to me likely that this is because he was not so aware. Question 2.6 of the Defendant's agenda asks the question:
"Do you agree that there are some spinal surgeons who would have prescribed chemoprophylaxis against venous thromboembolism within six hours of surgery?"
To this Mr Cadoux-Hudson responded:
"Mr Cadoux-Hudson, as pointed out above, is of the view that chemo-prophylaxis is theoretically more effective the closer to the surgery event (best results have been demonstrated if given before surgery). The precise timing is at the surgeon's discretion, weighting the risks and benefits to the patient."
It seems to me this is not an answer to the question and Mr Cadoux-Hudson's failure to answer the question directly is surprising.
"It represents a breach of duty to prescribe chemo-prophylaxis against venous thromboembolism within six hours of a Posterior Lumbar Inter-body Fusion".
Dealing with the arguments raised by Mr Havers QC:
i) Although I accept that there was quite a disparate range of practise across the UK in relation to the timing of the giving of chemo-prophylaxis after spinal surgery, in my judgment this range will have been within the period 24 hours to 48 hours post-surgery or perhaps 12 hours to 48 hours post-surgery but not within six hours of surgery. Thus, whilst I accept that there was no consensus amongst spinal surgeons in the UK in 2013 as to when chemo-prophylaxis should be given in terms of timing post-operatively, I do not accept that there was no such consensus as to when chemo-prophylaxis should not be given. I accept Mr Leach's evidence that no reasonable body of spinal surgeons in 2013 would have given chemo-prophylaxis routinely within six hours of spinal surgery in 2013. To give such early chemo-prophylaxis required specific justification in the specific circumstances of the case having weighed the risks and benefits of so doing.
ii) Although Mr Cadoux-Hudson stated that he was aware of surgeons who gave chemo-prophylaxis within six hours, I do not accept that evidence: had he been so aware, I consider he would have said so much earlier than re-examination, probably in his report and certainly in the course of his discussion at the JEM with Mr Leach.
iii) It is true that the guidelines current in 2013 said nothing about the timing of giving of chemo-prophylaxis after spinal surgery. The 2018 guidelines do and suggest that, for routine chemo-prophylaxis, the appropriate time period is 24 48 hours after surgery (which accords with the practise of both Mr Leach and Mr Cadoux-Hudson). These guidelines are likely to reflect the practise that was common in the UK in the year or so before their publication, that is in 2016/2017. In my judgment, it is extremely unlikely that practise in the UK in 2013 was significantly different. If anything, the movement after 2013 was towards giving chemo-prophylaxis to more patients and sooner, that is a liberalisation of practise in the UK, and for these reasons the 2018 NICE guidelines are of some help.
iv) I accept that there were three risks factors for VTE in the Claimant's specific case, namely that she was overweight, she was expected to be immobile for 48 hours post-operatively and that her anaesthetic and surgery time had exceeded 90 minutes. However, these were reasons for giving the Claimant post-operative chemo-prophylaxis against VTE: they do not speak to the timing of the prophylaxis.
v) In so far as Mr Cadoux-Hudson stated that, in his view, the giving of chemo-prophylaxis to a patient such as the Claimant within three hours would have fallen within the variation in practise to which he referred and would have been reasonable, I do not accept that evidence but I prefer the evidence of Mr Leach in that regard.
"The complexity in this case one of many - is that the symptoms developed on the Saturday, the 29th, by which time she had received two doses. So now the issue is how much of the first dose would still be active in the early hours of the Saturday? And the evidence is that when Clexane is given, it reaches its peak effect in the blood stream four hours after you give it and then it has a half-life of around four hours, so every four hours that follows the concentration and its effect fall. It is removed by the kidneys. So therefore the activity of Clexane by 8 o'clock from the first dose the following day would be negligible or very small, hence the need to give another dose. And so therefore, had she not received the dose on the evening of the operation, but had merely received her dose on the Friday, 24 hours after the surgery, she was still at risk of a haematoma the following morning."
In answer to a question from the court "Are you assuming the haematoma occurred at about the same time as the symptoms?" Mr Cadoux-Hudson replied:
"I'm assuming that it may have preceded by a few hours but that sort of period of time. These haematomas are often complex and they may have a number of components to them, but I think the answer to the symptoms gives us some idea as to the temporal relationship to the clot forming."
"But for the breach of duty in prescribing and administering Enoxaparin chemo-prophylaxis against venous thromboembolism within a few hours of a Posterior Lumbar Inter-body Fusion, Mrs Lesforis would, in all probability, have avoided the complication of post-operative epidural lumbar haematoma and would not have suffered a neurological deficit as a result of the surgery."
"Do you consider the Enoxaparin to have caused, or materially contributed to, the development of the [haematoma], on the balance of probabilities?"
To this they responded:
"Mr Cadoux-Hudson recognises that LMWT Heparin such as Enoxaparin is an anti-coagulant and therefore theoretically can alter systemic blood clotting. However, a large study (more than 1,000 lumbar spine operations, LMWT Heparin given within 24 hours) failed to demonstrate an increased risk of epidural haematoma, with more than a third of epidural haematomas occurring before the Heparin was given to the patient. This observation suggests that Enoxaparin at the dose given would not have altered the systemic blood clotting capacity to alter wound haematoma formation.
Mr Leach is of the opinion that LMWT Heparin, such as Enoxaparin, should not be given within six hours of major spinal surgery due to the risks of bleeding that could cause a catastrophic neurological outcome."
"As they state, this is a retrospective series with no case control, so the level of evidence is weak. They were not comparing early use of Heparin against later use; they are just describing having a retrospective case series. They did have 13 instances of post-operative epidural haematoma in this series, 13 patients. They treated all of them immediately immediate treatment and with immediate treatment, 60% of the patients experienced a full neurological recovery. They also comment that 38% of the haematomas presented at day 2 and 3. So although they commonly present straight away, 38% present late. So there are a number of different conclusions from the paper. The headline one, I would say, is that this is weak evidence that use of chemo-prophylaxis at between 12 24 hours in this series didn't show a higher rate of epidural haematoma than other reported case studies. That is how I would conclude an assessment of this paper."
Mr Havers QC asked Mr Leach whether there is any evidence in the medical literature to say that giving chemo-prophylaxis before 24 hours increases the risk of post-operative haemorrhage. Excluding the Gruber paper where the Heparin was given pre-operatively, Mr Leach confirmed that there was not, because it had not been well studied:
"A: It has not been well studied, giving chemo-prophylaxis within six hours. Within six hours has not been studied.
Q: So the answer to my question is that there is no evidence in the medical literature that giving chemical prophylaxis within six hours of spinal injury increases the risk of post-operative haemorrhage?
A: I agree. And the experts have agreed there is a paucity of literature to answer that question."
"So my view is that the very early administration of anti-coagulant likely induced more wound bleeding than if it had not been given, therefore the production of a bigger wound haematoma than would otherwise have been the case.
Mr Tolias found an organised clot. So a haematoma is generally an organised clot. It is fairly solid and can exert mass effect. Not necessarily liquid active bleeding. So my view is a clot formed in the early post-operative period and must have been clinically silent, and then continued to ooze or grow or it is not entirely clear why some haematomas present in a delayed fashion, but presumably some more mass effect, might have discussed potential other mechanisms, but then presented in a delayed fashion at approximately 40 hours."
Thus it seems to me to be likely that the giving of chemo-prophylaxis within about three hours of surgery caused or at least materially contributed towards the formation of the haematoma at L2 4. But for the giving of the chemo-prophylaxis at the time that it was given, I find either there would have been no haematoma or, probably more likely, the haematoma would have been significantly smaller and would not have impinged on the dura compressing it, as Mr Tolias found when he re-operated on 29 June 2013.
"Q: Of course it is reasonable to consider all sorts of options before surgery. But here, despite those unusual features, it is agreed between you and Mr Leach that the most likely cause was the compressive haematoma?
A: I think in our joint statement we do discuss this and I think we came to the view that Mr Leach felt that it was a majority haematoma with some inflammation and I felt that it was haematoma with a significant component of inflammation."
Thus, Mr Cadoux-Hudson conceded that the haematoma which formed has caused or made a material contribution towards Mrs Lesforis' neurological deficit, albeit in conjunction with inflammation.
Issue 2: was it negligent to delay intervention after 14.30 until surgery at midnight?
i) The timing: it was unusual for such a response to occur some 40 hours after the operation;
ii) The absence of severe pain which was very unusual;
iii) The form of presentation being wrong for a haematoma: thus, if it were a new bleed, it would be expected to be a progressive lesion and the loss of two motor nerves in isolation would not be expected without further loss of motor, sensory and autonomic nerves;
iv) The deficit appeared to be at the wrong level for a haematoma: the haematoma visible on CT scan was at L1/2 and the implicated level, L5/S1, was clear of compression.
In the circumstances, Mr Tolias took a considered and reasoned decision not to re-operate immediately, but to give steroids and see whether treatment for inflammation alleviated the situation and gave Mrs Lesforis some recovery. However, once it became clear, at about 10pm, that the steroids were not having the desired or any effect and that Mrs Lesforis' condition was essentially unchanged, he then re-operated.
70. On behalf of the Defendant, Mr Havers QC submits that, in the above circumstances, this was a consultant surgeon who was doing his very best for his patient in the circumstances. These were the considered decisions and actions of a very experienced and expert consultant, not merely the actions/decisions of a junior doctor. In so far as this is a case which concerns a consultant's clinical judgement and decision making, that deserves great respect. He reminded the court of what was said in Maynard v West Midlands Regional Health Authority  1 WLR 634 at page 638 E:
"A case which is based on an allegation that a fully considered decision of two consultants in the field of their special skill was negligent clearly presents certain difficulties of proof. It is not enough to show that there is a body of competent professional opinion which considers that there was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. It is enough to show that subsequent events show that the operation need never have been performed, if at the time the decision to operate was taken it was reasonable in the sense that a responsible body of medical opinion would have accepted it as proper. I do not think the words of Lord President Clyde in Hunter v Hanley  SLT 213, 217 can be bettered:
"In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care "
I would only add that a doctor who professes to exercise a special skill must exercise the ordinary skill of his speciality."
Mr Havers QC submits that this is precisely the situation here: not only was Mr Tolias exercising his skill and judgment as a neurosurgeon but he was also enjoying the support of his colleagues and he now enjoys the support of Mr Cadoux-Hudson. Thus, he submits that there is a responsible body of medical opinion which did support Mr Tolias' decision-making at the time and continues to support it at trial.
"Although the great majority of stones do pass without surgical intervention, what happened in this case must have been a foreseeable risk. In my judgment the patient should have been referred to the Middlesex Unit as planned. The problem did not resolve itself as hoped by the end of the week of 23rd January. It appeared to do so as a result of the shortening of the Yate's drain but this assumed that the stone had passed through the system when in fact it had not In short the surgical team took an avoidable risk. It was bad luck that the retained stone did not pass, as it was expected to do, and as the sensation of the bile leak through the drain seemed to indicate that it had. The patient should have been sent for the proposed ERCP at latest during the week beginning 31st January despite the modest risk involved in the accompanying removal of the stone endoscopically (or even by further laparotomy)."
In the Court of Appeal, Beldam LJ commented on the above passages as follows:
"In these two passages the Learned Judge appears to hold that the deceased should have been referred to the Middlesex Unit even though the problem appeared to have resolved itself because in the event it was shown that the stone had not in fact passed through the duodenum. But the question for the Learned Judge was not whether the risk could have been avoided if the deceased had been sent for ERCP, but whether Mr Wellwood and Mr Bursle in deciding not to send the deceased for ERCP when the fistula appeared to have closed displayed such lack of clinical judgement that no surgeon exercising proper care and skill could have reached the same decision."
Having considered the evidence, Beldam LJ went on to say:
"In my view, therefore, the question whether Mr Wellwood and Mr Bursle were at fault in failing to refer the deceased for ERCP, although the condition appeared to have settled, could not be determined by finding that the stone had not passed and that therefore they had made an assumption which was wrong. The question was whether, on the evidence, it was reasonable for them to take the view that the condition had settled, and whether it was in accordance with a practise accepted as proper by a responsible body of medical opinion not to refer the deceased for ERCP at that stage and in those circumstances. In this case the allegations of fault with which the Learned Judge had to deal called into question the fully considered decision of two surgeons in a specialist field of surgery in which they were skilled and experienced. Their decision was endorsed as being in accordance with a practise accepted as proper within the profession by an eminent surgeon practising in the same field. There was evidence that the specialist unit which would have conducted the ERCP examination also considered the decision a proper one. The fact that two other distinguished surgeons were critical of the decision, or that the decision ultimately turned out to be mistaken, does not prove that Mr Wellwood and Mr Bursle fell short of the standard of care to be expected of competent surgeons."