Smith v Lothian University Hospitals NHS Trust [2007] ScotCS CSOH

[14 ] My attention was drawn by counsel to Sidaway v Board Governors of the Veteran Royal Hospital (1985) AC 871 and Chester v Afshar (205) 134 particularly Lord Hope of Craighead at paragraphs 86-87. In many cases the issue of a duty to warn of the risks of the procedure and the obtaining of informed consent can give rise to difficulties. The case of Chester does give particular emphasis to the patient's right to exercise informed judgement. In the present case, however, difficulties which arise are not in my opinion difficulties of law. I am of the opinion that the issue is whether the pursuer has proved on a balance of probability that contrary to her right in the circumstances of this case to be warned of the risk of paraplegia, she was not so warned. If she was not so warned, I did not understand it to be disputed that she did not give informed consent. The main issue in dispute in this chapter of the case requires a consideration of the particular facts of the case.

[15] It was a matter of concession in evidence by Mr Steers that the procedure carried a risk of paraplegia and that he had a duty to warn about it (227). In this case the experts, Mr Eldridge and Professor Myles, agreed that there was a duty to advise of the risk of paraplegia, albeit that was a very low risk of the surgery. There was no evidence that any particular formulation of words required to be used. It was not essential to use the word "paraplegia".

[16] The factual averments of the pursuer are:

"The procedure carried a risk of paraplegia. The pursuer was not warned before the operation of the risk of paraplegia. Had she been warned she would not have consented to the operation". (7A-B).

A specific call by the pursuer is made "the defenders are called on to state who purported to have consented the pursuer for the operation and what warnings were given". (7D-E). The defenders aver that on 5 February 1997:

"the pursuer was seen by Mr Steers, accompanied by nurse practitioner, Eleanor Clausen. The surgical procedure was discussed with the pursuer by Mr Steers. The risk of the procedure were explained to, and discussed with, the pursuer. The pursuer was told by Mr Steers that there was a risk that she would be left after surgery not able to use her legs, in a wheelchair, and without the use of her bladder. Later the same day the pursuer was seen by Mr Bashir who obtained the pursuer's formal consent to surgery".

In the productions there is lodged a consent form signed by the pursuer (7/1 of process, sheets 18-20) and signed by Mr Bashir. That form specifically states that the nature of the procedure has been explained to the patient but the form makes no reference to any explanation of risks. The form also makes reference to the right of the patient to refuse to participate in "training procedures".

[17 ] The clear and obvious reading of the record, in my opinion, is that the pursuer maintains that she was not warned of paraplegia by anyone and that in consequence no informed consent was given by her to the operation on 6 February 1997. In answer, the defenders maintain, against the background of a specific call, that Mr Steers warned of risk as specified by the defenders in the pleadings. In paragraphs 21-27, I deal with this part of the case.

[18 ] The evidence tendered by the defenders was not, however, limited to evidence to risks about which Mr Steers allegedly warned the pursuer. I turn in paragraphs 29-33 to deal with the evidence and the objection by senior counsel for the pursuer thereto, in relation to risks about which Mr Bashir allegedly warned the pursuer. This was evidence which senior counsel for the defenders wished to introduce.

[19 ] There was also further evidence which senior counsel for the pursuer wished to rely on, which was submitted to bear upon risk and consent and was described as a development of the pursuer's case. I deal with this in paragraph 34-36.

[20 ] In paragraph 28, I deal with the issue of whether the pursuer would have been likely to give her consent if the warning of paraplegia which ought to have been given, had been given. Plainly if the pursuer would have agreed to the operation even if she had been warned of the small risk of paraplegia, there would be no causal connection between any breach of duty in failure to warn and the outcome.

Risks explained to the pursuer by Mr Steers
[21 ] Direct evidence about what was said by Mr Steers to the pursuer prior to the operation on 5 February 1997 was given by the pursuer, Mr Steers and Mrs Clausen. In addition Mrs Mackay gave evidence as to what the pursuer said to her during a phone call on 5 February 1997, the night before the pursuer's operation. Mr Smith and Mrs Mackay also gave evidence about their recollection of what Mr Steers said at a meeting with them on 25 February 1997 to discuss what had occurred to the pursuer. Mr Steers also gave evidence about this. I have considered all the evidence about this and in the following paragraphs I give what I consider to be a fair summary of the main points of this evidence.

[22 ] The pursuer accepted that Eleanor Clausen was present during the time Mr Steers spoke to her. When asked about the risks which were explained to her by Mr Steers, the pursuer said:

"Mr Steers told me that my walking might not be just as good as it was, but I still would be perfectly able to walk.

Did he explain to you that there was a risk of paraplegia or paralysis?

Definitely not." (Page 64).

In cross-examination the pursuer rejected that there was any mention by Mr Steers of permanent weakness, that he mentioned a risk that she would end up dependant on a wheelchair and that he mentioned that there was a risk that she would have loss of sensation in her legs (page 674). She further described the meeting with Mr Steers as him coming to tell her he was doing the operation, that it was a minor operation and that she should have no problems apart from perhaps her legs not being quite as good as they were before the operation. As she thought that this was a minor operation, she did not expect there to be any risks. She thought only a major operation could cause paraplegia (675). Later in cross-examination the pursuer accepted that she did not remember all the details of what was said to her but she maintained that Mr Steers told her that she would still be able to walk but it might not be just as well (677). She conceded that the discussion was a long time ago and that her recollection might not be as good as others. She was very ill following the operation so of course a lot of it is blocked out. She maintained however that Mr Steers did not mention she would be in a wheelchair (page 678).

[23 ] Mr Steers disagreed with senior counsel for the pursuer when it was put to him that he did not disclose to the pursuer the risk of paraplegia. He said it was his recollection that he did:

"I would have told her that she could have lost the use of her legs. Did I use the word paraplegic? I'm prepared to say that I may not have used that word. But I would have told her that the movement of her legs could be at risk and she might not be able to use her legs" (page 223).

He accepted that he could not remember the exact words which he used and the exact level of detail which he gave. He said he was quite sure that the pursuer was warned that the function of her legs were at risk. Albeit very small but at risk (page 224). In cross-examination he repeated that he could not say specifically the words used as he could not recollect them. "I think I would have used paraplegia. I think I might well have used weakness of the legs, unable to use the legs and a need for a wheelchair." "And with that the sensory loss obviously that goes with that" (265).

[24 ] Eleanor Clausen described Mr Steers' usual practice of explaining risks in terms of a surgical supermarket analogy, also spoken to, by Mr Steers. She said Mr Steers also explained the actual risks of the procedure itself. When asked to recall the risks put to the pursuer by Mr Steers she said:

"It was a complicated situation because Mrs Smith had previous neurosurgery and had ... a weakness on admission. So it was described in terms of the potential for that to become much worse ... that she might not be able to walk independently that she might be dependent on a wheelchair" (page 717).

Then she was asked what the worse outcome that Mr Steers mentioned to Mrs Smith was. She said "The loss of power in her legs". She did not recall the word paraplegia being used but she understood the description as being paraplegia. She understood Mr Steers to be describing something in lay person terms (page 719). Mrs Clausen did not accept that Mr Steers told the pursuer that she would still be able to walk. She thought that would be a strange thing to say (page 727).

[25 ] Mrs Mackay spoke to the pursuer by telephone on the evening of 5 February 1997. She said that during that telephone conversation, the pursuer had said that Mr Steers had explained that her legs might not have quite the same amount of power (page 354). This witness and her brother, Brian Smith, also spoke about what occurred at the meeting with Mr Steers on 25 February 1997. Mrs Mackay claimed that Mr Steers said he had not discussed paraplegia with the pursuer because he did not consider that to be a risk of the operation (page 358). Mr Brian Smith went to the meeting of 25 February with a list of prepared questions (6/12 of process). He asked inter alia question 8 on the list about whether the risks were explained to the pursuer (page 543). He said that Mr Steers said that he had explained the risks verbally to the pursuer. He said "The risk was that she would end up with less mobility than she had prior to the operation, that is some loss of mobility to her legs" (page 543). At a later part of the conversation Mr Smith said that Mr Steers had said that before the operation he had not been aware of risks that the patient might end up being paralysed from the armpits down (page 546). This witness was unable to say whether Mr Steers had said at the meeting whether or not he had warned the pursuer of the outcome which had occurred (page 546).

[26 ] Plainly there is a difficulty with the evidence in that witnesses were being asked to recall what was said on a particular occasion some nine years after the event. The onus of proof is on the pursuer. I am unable to accept the pursuer's evidence that she was given no warning of a kind to inform her of the risk of paraplegia. I am satisfied that the pursuer now believes that she was not warned of the risk of paraplegia, but I am not satisfied that I can rely on her recollection about her meeting with Mr Steers on 5 February 1997. The pursuer was aware that all back surgery carries risks and depending on the circumstances, a risk of paraplegia (608,614) but the general anticipated outcome and hope for this surgery was positive. The pursuer's evidence about the risks of surgery about which she was informed do not reflect the actual risks of surgery. But they do reflect the general optimistic view expressed at the time from Mr Jenkinson and Mr Steer that the likely outcome of the surgery would be positive. I consider that the pursuer, for understandable reasons, focussed on that. I consider that the pursuer was optimistic, as she was entitled to be, about the likely outcome. That state of mind in my opinion was probably reflected in the conversation which she had with her daughter, Mrs Mackay on the evening before her surgery. At the meeting on 25 February there was discussion about many matters at a time when the family witnesses were emotional and anxious about the pursuer's condition. It is a matter of some significance that in evidence no one suggested that within the weeks after the operation, the pursuer's attitude or that of the family witnesses was challenging to Mr Steers alleging at that stage that he had never warned the pursuer of the risk of paraplegia. Question 8 prepared for the discussion by Mr Smith was a question as to whether the risks had been explained. It was not an assertion that the risk had not been explained. This apparently led to a general discussion about the risks. If the pursuer's position after the operation was that she had never been warned of the risk of paraplegia and was complaining about that, one might have expected the questions and discussion to proceed on a different basis. Other factors which make it difficult for me to accept the pursuer's evidence about this are the passage of time and the pursuer's acceptance that she did not recall all the details. In addition even where there was a recorded note in 1996 in relation to an earlier operation that she had been warned of paraplegia in respect of the earlier operation, the pursuer denied that, then said she did not remember (613).

[27 ] On this issue, I prefer the evidence of Mr Steers and Eleanor Clausen. Mr Steers, did not consider the risk of paraplegia as likely. It was a very low risk but one of great magnitude. There was no dispute in this case that surgical intervention involving laminectomy at thoracic level carried risk to the cord. Risk to the cord included the risk of paraplegia. Although the placement of a trial electrode at thoracic level during an operation of this type was extremely rare and this was the first such placement at the Western General Hospital (771-779), the risks were no less than other operations involving laminectomy. The risk with a laminectomy, even without the insertion of the electrode is the risk of affecting the spinal cord and therefore the feeling and function of the nervous system below the level of operation (247). I consider that it is inconceivable that a neurosurgeon of the expertise and experience of Mr Steers could have said to Mr Smith or anyone else that he did not discuss the risk of paraplegia with the pursuer because he did not consider it to be a risk. I draw the same conclusion about the risk factors. The risk factor was not a mere weakness to the legs and I consider it is inconceivable that Mr Steers could have thought or said that bearing in mind his expert knowledge. I was impressed by the evidence of Mr Steers who appeared to be a careful, caring surgeon who had developed a way of explaining the general risks of surgery to patients as well as dealing with the particular risks of specific procedures. This is not a case in which it is disputed that it is the type of risk which should be warned about. Mr Steers accepted that is so. That is in accord with the rest of the evidence from the medical and nursing witnesses who spoke about this. The magnitude of the risk, albeit of low probability, is not in dispute. It is not disputed by the pursuer and is in accord with the contemporary hospital note, that there was a meeting during which inter alia Mr Steer explained about risk factors. I accept that Mr Steers was aware of the risk of paralysis and that his intention and attempt at risk explanation was to explain that risk to the pursuer. I consider Mr Steers to be an experienced and sympathetic doctor used to dealing with lay patients in such situations. I accept he explained the risks of paraplegia to the pursuer and Nurse Clausen concluded from what he said to the pursuer that he had done so. I do not find it surprising that after all this time neither Mr Steers nor Miss Clausen can recollect the exact words used. Nor do I consider it helpful to pick over details of their testimony, for example, where reference is made to "weakness in the legs", (Mr Steers at page 266). Their evidence must be taken in context and considered as a whole.

[28 ] Even if I am wrong in my interpretation of the evidence and conclusion, I am not satisfied on the balance of probability, that the pursuer would have refused the operation if she had been warned of the low risk of paraplegia. This was an elective procedure. There is evidence, which I accept, that the pursuer was finding the pain very difficult, despite painkillers, and that this was her last option (83-90). She displayed a robust attitude to surgery prior to 1997 and even after 1997 when she opted for surgery, which was said to be life threatening but more likely than lesser procedures to alleviate her symptoms. I consider that the pursuer was well able to make an assessment of risk and benefit. She impressed me as a courageous lady of spirit and determination. She was well aware that all surgery under general anaesthetic in relation to her back carried some risk. I am of the opinion that if informed of the low risk of paraplegia, she would have concluded that the risk was unlikely and the benefit to be gained by surgery was likely so she would have consented to the surgery. That in my opinion is the most likely outcome if the pursuer had been informed of the risk of paraplegia prior to the operation in February 1997.

The risks explained by Mr Bashir
[29 ] Mr Bashir was called by counsel for the defenders to give evidence on day 5. Prior to that, in cross-examination on day 4, it was put to the pursuer by counsel for the defenders that Mr Bashir explained the risks of the procedure to the pursuer (679). Objection was taken by senior counsel for the pursuer. This objection was renewed when senior counsel for the defenders attempted to lead direct evidence about this from Mr Bashir (657-72). I allowed the evidence under reservation but now require to deal with the objection, as senior counsel for the pursuer maintained his objection in relation to this.

[30 ] Senior counsel for the pursuer submitted that the line of evidence is not within the scope of the record et separatim fair notice is not given. In my opinion the two issues overlap. Taking into account the specific call by the pursuer, I am satisfied that the record does not give notice that the defenders contend that anyone, apart from Mr Steers, warned the pursuer about risks of the operation. The call on behalf of the pursuer asks not only who purported to consent the pursuer but also for specification of the risks. The averments of the defenders do not give any indication that Mr Bashir warned about risks or about what risks. I am unable to read the record as intimating anything other than that Mr Steers warned of the risks.

[31 ] There is also evidence that the first time Mr Bashir heard from the defenders about the case was October 2005. The amended closed record is dated July 2004. As of that date, the defenders were not in a position to advance a specific defence in relation to a warning about risks by Mr Bashir. The defenders did not seek to amend prior to or during the proof. The issue of warning about the risk of paraplegia is plainly a critical issue and that is highlighted in the pleadings by a specific call.

[32 ] I have carefully considered the submissions on behalf of the defenders but I am not persuaded by them. In essence, it was submitted that the matter should be properly understood by analysing the pleadings of the pursuer. According to senior counsel for the defenders, the pursuer makes a case of fault directed against "the surgeons" which includes Mr Bashir alleging they were negligent because they failed to advise the pursuer of the risk of paraplegia. Senior counsel for the defenders submitted that it would be a bizarre position if Mr Bashir could not be asked about this allegation and whether or not he advised the pursuer of the risks. I accept that the general duties were so expressed but there was no attempt on behalf of the pursuer to develop any case in relation to a failure to warn by Mr Bashir during the consenting process. The case which was explored and developed on behalf of the pursuer was in line with the defenders' position on record that Mr Steer advised about risks. Senior counsel for the defenders submitted that proper investigations on behalf of the pursuer should have been carried out by obtaining further information about the consent process which is referred to on record. He said such investigations would have revealed to the pursuer's representatives that Mr Bashir warned about the risks. I consider that the defenders are not well placed to criticise the pursuer's preparation in relation to this matter. It is the defenders who wished to lead and rely on this evidence which they apparently did not receive until shortly before the proof and about which they have given no notice on record despite a specific call. I consider that they have not given fair notice. Even if they realised very late in proceedings that they wished to rely on this evidence, they ought in my opinion to have sought an amendment of the record. I also conclude that there is prejudice to the pursuer. The pursuer is aged 75 years. She is paraplegic and has suffered a great deal. This action has been outstanding for a very long time. The first intimation of this line of defence was given on day 4 during cross-examination of the pursuer. After all the years when this case was meant to be investigated on behalf of the defenders as well as the pursuer, it is unacceptable that the pursuer may be taken by surprise at a time when her agents are no longer entitled to discuss and investigate the matter with her. I consider it is also unacceptable that the issue was never raised on behalf of the defenders in cross-examination of earlier witnesses, particularly Mr Steers. Mr Bashir gave his evidence about warning the pursuer about the risks in the context of the general practice which operated in the Western General Hospital and at a time when he was responsible to Mr Steers. Plainly issues may arise where a consultant in charge has himself warned the patient of risks and, in his absence, a junior doctor independently warns of risks which may be the same or different in the context of the formal consent process. By the time this issue was raised on behalf of the defenders, Mr Steers had completed his evidence. During his evidence the defenders did not ask him anything about the practice in his department in relation to consent forms or whether it was within his knowledge that Mr Bashir allegedly advised the pursuer about the risk of paraplegia in the formal consent process or whether that was likely, standing any general practice in the department.

[33 ] In all the circumstances I consider that the objection on behalf of the pursuer is well founded and I sustain that objection. As the matter was not fully explored, I express no views about the evidence of Mr Bashir in relation to this matter.

Training opportunity and consent
[34 ] Senior counsel for the pursuer asked Mr Steers whether he had told the pursuer that a registrar on a training placement would be carrying out the operation (227-228). Objection was taken on behalf of the defenders on the basis that there was no record that the chosen operator was insufficiently trained or was at the wrong level or anything of that nature. That was accepted by senior counsel for the pursuer who explained that he was not making a case to that effect. He said it was of relevance to consenting. I allowed the question under reservation. Mr Steers accepted and answered the question, "not to my recollection". The cross-examination then continued in relation to different matters. Mr Steers also conceded that it was a training operation for Mr Bashir and agreed that it was in a sense a teaching session for Mr Bashir albeit at an advanced level (201). Later on day 4, there was a short passage of evidence when the consent form (7/1 of process) was put to the pursuer. The pursuer was asked whether she was given the opportunity to refuse to participate in the teaching opportunity for Mr Bashir. She answered in the negative. She was then asked to confirm that paragraph 2.3 of the consent form stated:

"Training health professionals is essential ... The treatment may provide an important opportunity for teaching students or one or more members of staff under the supervision of a more senior member of staff. You may refuse to participate in such teaching sessions without this adversely affecting your care and treatment."

She confirmed the wording. She was then asked whether if she had been informed of a risk of paraplegia and that the procedure was to be performed not by Mr Steers but by a registrar in training, what would she have said. She replied "Again I would have said no" (628-629). The questions then turned to another matter. The matter was also raised briefly with Mr Bashir. There was no objection taken to specific questions. On the basis of that evidence and the lack of objection, senior counsel for the pursuer developed a case. The choice of the word "developed" is his. The submission he made was that that on the basis of the evidence which was not challenged, there was plainly a lack of consent. The pursuer had not consented to an operation by a trainee under supervision. The pursuer, as was plain from the consent form, was entitled to refuse consent but she had not been provided with the essential information that the operation was a training opportunity for Mr Bashir. Senior counsel for the pursuer submitted that this case was a development of the existing case on record. Mr Bashir accepted that whether the consultant or the registrar was performing the operation might have a bearing on the patient's perception of risk (105-109). The development in the case arises out of the consent form founded on by the defenders. Senior counsel for the pursuer made his submission under reference to McGlone v British Railways Board 1966 SC (HL) 1.

[35 ] In fairness to the defenders, the evidence relied on by senior counsel for the pursuer is of such short compass that I do not think senior counsel for the defenders could be reasonably criticised for not making the imaginative leap to this "development" in the case. Plainly senior counsel for the defenders, when he objected to the question put to Mr Steers, had in mind more obvious cases and he made reference to that in his objection. There was no clear sustained line in the evidence developed on behalf of the pursuer which might have reasonably caused concern to the defenders' counsel that the pursuer was attempting to develop the case in a new way or indeed to found a new case. In this complex case it was not always clear where evidence might be leading. There was certainly no detailed exploration of issues leading to the submission on this point in the case. Indeed senior counsel for the pursuer never even put to Mr Steers that what he described as a "training opportunity" was the type of situation envisaged in the consent form. It was never suggested to Mr Steer that he in some way had neglected to advise the pursuer that this was or might become a training opportunity for Mr Bashir and that this altered the risk factor and therefore should have been explained to the pursuer.

[36 ] There are simple factual averments on behalf of the pursuer to found her case to the effect that she was not warned before the operation of the risk of paraplegia (7A-B). The simple duty which is averred is that "it was their duty to warn the pursuer of the risk of paraplegia" (16B-C). In my opinion in order to found upon a lack of consent because of failure to advise that this was a training opportunity, the pursuer requires some basis on record. I do not regard it as a development of the pursuer's existing case. In my opinion it is a new case which is not pled and no fair notice has been given. Even if I am wrong about that and properly analysed, it can be regarded as a development of the case, I am not prepared to uphold the submission by senior counsel for the pursuer. I consider that I have inadequate evidence which is not appropriately focussed in the circumstances of this case to persuade me on the balance of probabilities that his submission is well founded.

"The trauma case"

[37] The pleadings about "the trauma case" are sparse. No expert report was lodged by either party. This led to some difficulties. For example, some matters which became important were not put to relevant witnesses and there were problems about the proper scope of the evidence because of the sparse pleadings. These problems were exacerbated by the failure of senior counsel for the pursuer to lead Mr Bashir early in the proof when establishing the factual framework. I accept there were some practical difficulties in relation to legal aid with a foreign based witness. Nevertheless, there are good reasons for encouraging a practice in which evidence is led from essential factual witnesses before expert evidence is led.

[38 ] In essence the pursuer's case on record and developed in evidence was that the pursuer's paraplegia was caused by trauma to the cord by Dr Bashir during the surgical procedure of positioning the trial electrode and that no surgeon of ordinary competence using due skill and care would have caused trauma to the pursuer's spinal cord. The position of the defenders on record was "while on the balance of probabilities the said loss of sensation was a consequence of said surgical procedure, the precise cause thereof is unknown. It is possible that the dura was penetrated. Alternatively there may have been compromise of the blood supply to the spinal cord. Each is a recognised complication of said procedure".

Evidence about the operation on 6 February 1997
[39 ] There was direct evidence about the operation from Mr Steers led on behalf of the pursuer and from Mr Bashir led on behalf of the defenders.

Mr Steers

[40 ] Mr Steers has held the post of consultant neurosurgeon in the Department of Clinical Neurosciences, Western General Hospital, Edinburgh since 1987 and has been a consultant equivalent since January 1979. His CV is set out in 7/4 of process. Mr Steers considered that the procedure was within the capability of Mr Bashir, who was in 1997, a fourth year plus neurosurgical trainee. He thought Mr Bashir would have done numerous laminectomy operations but he had not previously put a wire in as was intended in this operation.

[41 ] Mr Steers was not "scrubbed" and was present as an observer supervising Mr Bashir under direct supervision. Mr Steers marked out the incision for Mr Bashir which is an important step. He was present for the part of the operation which he regarded as critical which was after the bone removal was completed. That would include the incision of the ligamentum flavum which exposed the epidural fat and dura. Mr Steers was standing at the patient's head. He accepted that in observing surgery "... you can't obviously tell what somebody is feeling and you can't tell how hard someone is actually pushing. But you can see what somebody is doing. And from the position in which I was, I think I could see the majority of the surgical process" ... "not absolutely everything, to be fair" (196-197). He said he could see the point at which the needle (a reference to the electrode) was being placed in the epidural space which is the space underneath the ligament and outside the dura where there is usually a layer of fat of variable thickness. Thereafter the procedure was blind because the electrode was pushed under the lamina (206-7). Having placed the tip of the electrode in the space it is advanced, using feel to know whether or not it is meeting with significant obstruction (211). He thought it was pushed 1.5cm blind but accepted that it might have been as much as 3cm (213). After the CSF leak was detected, Mr Steers said that he had to accept that the dura had a breach in it. He could not remember if Mr Bashir had specifically accepted that but he would hope that he did (219-220).

[42 ] In cross-examination Mr Steers said that risk to the cord arises sometimes for unexplained reasons. A technically totally correct operation can be completed and there would still be a neurological consequence. Of course misused surgical instruments could equally produce the same result (248). He accepted that a CSF leak is usually very obvious and recognisable (257). He confirmed that the operation was a level above the previous operation which had been carried out between T4 and T6. They left a level and went one above which would make it T2 (285). They were not directly entangled in the previous surgery. He confirmed that the dura was identified during the operation (291). He was comfortable with Mr Bashir's technique at removing part of the lamina (299). When asked in cross-examination about the actual insertion of the electrode under the lamina he replied "... I recall that it was only placed on one occasion, it wasn't taken out and put in, tried again in different directions ... as far as I can see, and I accept, you know, that I couldn't see absolutely everything - that it was an uncomplicated placement. This is what you would expect." (300). In his view there was a single insertion of the electrode, that so far as he could see seemed to go in without difficulty. He saw no CSF leak. He was quite certain that Mr Bashir did not see such a leak because he would have drawn it to Mr Steers' attention. He accepted that one would not always see a CSF leak, if the hole in the dura was small to start with and if the CSF was not under great pressure. He thought however that was probably unlikely. Nevertheless, he accepted that just because a CSF leak was not seen does not mean that it was not started at that point (301-303). After the surgery and after he saw the x-ray, he thought the electrode shown in the x-ray was parallel to the dura and that it did not stick into the spinal cord itself. That made it more difficult for him to understand how the electrode might have caused the damage (310-311). In what he saw of Mr Bashir's operation it did not suggest to him that any mistake was made at the time (314). He confirmed that when the dura was exposed, the epidural fat was not significantly compromised. He saw normal epidural fat. And that is the reason they were able to proceed with confidence (318-319). It should be noted that it was never put to Mr Steers on behalf of the defenders that if there had been a penetration of the dura by the electrode during the operation, he would have seen a sudden forward movement of the type later described by Mr Bashir and Professor Miles. Mr Steers said that one of the things that would perhaps be more difficult to judge is how much the electrode was being pushed in (321). His best estimate was 11/2 cm. He thought that the physical area of the dura that was exposed was about the area of his little fingernail (333). No estimate of that size was ascertained for the notes. He explained that dura means tough, durable and hard, but in fact not all dura is like that and it does have "thin, thin bits". Sometimes you can look at dura and you can see the spinal cord and the nerves (340).

[43 ] In re-examination Mr Steers accepted that in this case two possible explanations had been given and if one is eliminated, at the very least on the balance of probabilities, the other is the explanation. Mr Steers explained that he had difficulty with the hypothesis that there was a penetration of the dura by the electrode bearing in mind that the dura can vary in thickness and that the report of the MRI scan was not compatible as it referred to an area of high signal from C7 to T8. He agreed that if the proper interpretation of the MRI report was an area of high signal from C7 only to T3, that would be consistent with the penetration by the electrode causing trauma to the spinal cord and therefore paraplegia (342-343).

Mr Bashir

[44 ] Mr Bashir gained medical qualifications MBChB at the University of Karachi in Pakistan and graduated in 1982. He commenced his surgical training as a first year SHO in the UK and held various posts until he completed his fellowship in general surgery. Thereafter, he did six months of specialist training in Lodgemore Hospital which is a large centre for spinal cord injuries in the north of England. He started specialist training in neurosurgery in early 1991 at the Royal London Hospital as a registrar. He transferred to a similar post in Aberdeen and worked there from 1991-96 at which point he moved to the Western General as a specialist registrar in neurosurgery. He was appointed a consultant at Ninewells Hospital, Dundee in 1999. He had carried out 444 operations in which he had exposed the dura before he joined the Western General and additional operations at the Western General prior to the operation on Mrs Smith. He had carried out 5 replacements of dorsal column stimulators in the Royal London Hospital with permanent electrodes. He accepted that the procedure in relation to the pursuer was unusual as it was a placement of a temporary electrode. There was no discussion about his personal experience of operating in the thoracic spine in contrast to the lumbar spine where the anatomy differed and the risks were less serious.

[45 ] Under reference to the operation note (7/1 of process) and medical illustration (7/3 of process, page 38), Mr Bashir explained that he made the midline incision superior, or just above where the previous wound scar existed, along the line drawn by Mr Steers. He removed the spinous process and part of the laminae and then a number of millimetres of bone extending slightly for a few millimetres from each side of the midline in order to expose part of the ligamentum flavum in order to expose the dura mater which is the membrane covering the spinal cord. This was done by making an incision, or separating the partial existing gap that usually exists between the two halves of the ligamentum flavum in the midline. This is done in midline because the spinal cord lies a greater distance away from the ligamentum flavum in the midline in order to minimise inadvertent injury to the spinal cord. This enables access to the epidural space. Then he would have teased apart any fatty deposits to see the surface of the dura. His practice was if he encountered something unusual, he would mention it in the operation note as something out of the ordinary. There is no mention in the operation note of any unusual amount of fat or anything out of the ordinary with the dura. This procedure gave him a "window in the epidural space". He confirmed that he was able to see the dura. The intention is to slide the electrode along the surface of the dura upwards between the dura and the fat itself. He said what he would have done is hold the electrode about 1 cm behind its tip with bayonet-shaped forceps in the gap in the ligamentum flavum so that it was lying parallel to the spinal cord. He would then edge it under the edge of the lamina which had been removed (899-930). "Once it's there, slide it up piece ... I mean millimetre by millimetre so that there is no resistance. So I can feel any resistance, that is if there is any ... because if there is any resistance felt then one would have to stop" (932). He explained that the aim was to achieve the passage of the electrode parallel to the dura because, for example, if it went perpendicular to the dura, there was a risk that the dura might be penetrated or if not penetrated would be indented enough to impinge on the spinal cord. That potentially could cause injury to the spinal cord. He accepted that compression of the cord was a danger. Correctly done there is no effective pressure on the cord (934-5). The fat does not tightly fill the epidural space. He accepted that, if resistance is felt, the electrode is not going smoothly so obviously it has actually been against some tissue. It would be unwise to keep pushing in the same direction (937-9). He stated that he encountered no resistance. "None, none whatsoever" (939). His recollection was that there was one insertion approximately at the level of the second thoracic vertebrae, T2. Thereafter he moved the electrode 2 or 3 cm (940). He did not see any CSF (941). If he had, he would have stopped the procedure. He did not think that a pinhole type of perforation was possible because that would be too small for the electrode to go through. He accepted that bleeding was possible and this is dampened by putting pieces of tissue or cloth so that it does not enter the operating field (943). In this procedure he was not aware of any bleeding coming from within the epidural space. At the end of the procedure he secured the electrode in place with a suture around the electrode itself through adjacent tissue. That procedure did not present any particular difficulties. The time from the first incision to the last suture was 30-40 minutes (950). He estimated the size of the window created as about 1 cm squared approximately (952). He did not consider that he needed a bigger window. As the primary aim is to protect the spinal cord at all costs, if he thought that he required to remove extra bone and more of the ligamentum flavum, he would have done that (956). His recollection is that Mr Steers was present from almost the beginning as he exposed the spine until he started to close the wound. Up to that point he had no suspicion that the dura had been damaged. If he had he would have carried out further investigations.

[46 ] Dealing with matters after the surgery, Mr Bashir said, having examined the pursuer his first thought was the electrode that he had placed in the pursuer had actually gone into the spinal cord or damaged the spinal cord in some way. The purpose of the x-ray was to check the position of the electrode (974-975). When he wrote "query perforated dura" on the x-ray request sheet, he said that the one thing that would immediately come to mind, regardless of everything else, is that the object actually caused damage to the spinal cord. And the only way it could do that would be to go through the dura and the other membrane surrounding the spinal cord and damage it. That is something one would like to exclude (981). He confirmed that up to the time of completion of the operation he had no suspicion that the dura had been damaged (982). When he viewed the x-ray, he took the view that the dura had not been perforated (996). He accepted that the x-ray was not definitive of the position (997). A few days later in accordance with normal rotation, Mr Bashir moved to work with Professor Whittal albeit he still dealt with the pursuer when he was on emergency duty (998).

[47 ] In cross-examination, Mr Bashir said that he could not accept that his surgery had caused injury to the spinal cord and he considered there was an alternative explanation (1006). He left the NHS in 1999 to work in Pakistan. At that time he was unaware that this was potentially a litigious case and had given no report to the NHS Trust or to the Central Legal Office (1015). He remained throughout on the general medical register (1016). His first contact by the Central Legal Office was in 2005 (1019). His first consultation with the defenders' representatives was on 20 February 2006 but there had been correspondence before that with both parties' representatives (1021). When dealing with the surgery, Mr Bashir accepted that the open procedure which he did was offered for the purpose of avoiding a specific risk of trauma to the spinal cord from a trial electrode (1064). He did not accept that an inference could be drawn that if the risk which the choice of procedure was intended to avoid arises, that the procedure has been undertaken without due skill and care. He explained that he did not think it was the surgery which caused the problems because there are other causes (1071-1072). He explained that even if he accepted that there was penetration of the dura, he still did not think that is evidence of lack of skill or care in the procedure (1073). He accepted that the dura was not penetrated while the dura was under direct vision (1074). He thought it very unlikely that a blunt object could penetrate the dura without the operator being aware of it. He said the operator can feel a distinct pop when the dura is punctured deliberately (1075-1076). He appeared to accept that the dura might have been punctured but not at the time of surgery (1077). He drew comfort from the position of the electrode in the x-ray which shows the electrode lying well away from the spinal cord (1091-3). Mr Bashir said that he did not puncture or penetrate the dura with the electrode during the operation (1093). Even if he had penetrated the dura, he did not consider that consistent with a lack of due care and skill. If there is a regular pattern then he accepted that a person is not properly trained and does not have the requisite skills (1094). He raised the possibility that if there was penetration during the operation, it might have been during the time when he was removing the bone to expose the dura (1096). He accepted that if the dura had been penetrated, albeit from a blind spot, that is something he must have known about or at least expected at the time (1098). He accepted he must have known about it or at least expected it at the time and that is why he filled in the x-ray request as he did (1098-1099). He accepted that if the dura had been punctured and consequently presumably the spinal cord traumatised, during his operative procedure, he would have felt that happening (1102). In relation to the MRI scan he had for long considered that this demonstrated a systemic insult to the spinal cord. He noted that there was a mistake in the MRI report when he first saw the MRI scan a few days before he gave evidence (1106). Nevertheless he maintained that the lesion shown from C7 to T3 is consistent with systemic insult (1108-1112). He accepted that would depend on the anaesthetic and neuroradiological evidence (1113). Mr Bashir accepted that he was doing the procedure slowly and he ought to have been aware of any resistance but he was not (1115). He did not accept that he punctured the dura and caused trauma during the unseen placement. The only other explanation apart from systemic insult which he could offer was that during the opening of the bone, a hole might have been made in the dura and the arachnoid membrane (1115-1116). He accepted that such an explanation would not explain the absence of CSF nor explain the trauma to the spinal cord (1118). In re-examination Mr Bashir said that he took particular procedures to eliminate or reduce risk as much as possible and that even in the best of procedures one can still penetrate the dura but that does not imply incompetence or lack of care (1121).

The MRI scan on 9 February 1998
[48 ] Mr McArthur played some part in the post operative care of the pursuer checking her neurological condition and noting on 9 February 1997 that the pursuer had been leaking CSF implying the electrode had punctured the dura. Mr Steers gave him the instruction about removing the electrode and he arranged an MRI scan. He explained that, generally speaking, it would be considered dangerous to do an MRI scan with a metal object next to his spine. He refused to be drawn into speculation about what might have happened at the operation. In cross-examination, he accepted that the nurses may have told him that there had been a leakage of watery fluid for some hours before. The fact that the CSF had been leaking alongside the wound implied that at some stage there had been penetration of the dura. Putting that together with the neurological deterioration following surgery implied that there may have been some damage to the cord.

[49 ] Dr Sellar explained that he did the original report about the MRI scan of the pursuer which was done on 9 February 1997 (6/15/8 of process). That report has his manuscript correction which did not find its way into the file of the pursuer's case records (7/1/70 of process). He confirmed that the proper interpretation of the MRI scan was the presence of high signal extending from C7 down to T3. He said it was quite defuse and that quite a long segment of chord was involved consistent with a lesion C7 to T3. This evidence was not cross-examined.

[50 ] Dr Walker was not involved in the care of the pursuer. He is a consultant diagnostic radiologist at the Southern General Hospital, Glasgow. He confirmed that on the MRI scan there is an area of high signal from C7 to T3 and an area of CSF fluid, extra dural, consistent with the dural sheath having been penetrated at some stage (395). He confirmed that a preoperative scan of the pursuer from 14 November 1996 showed no high signal within the cord at the mid to lower thoracic level adjacent to the cord. He estimated by reference to 6/19 of process that the electrode device had been passed under the vertebral lamina in the region of about 4 cm (408-409). Taking into account the degree of magnification he thought a minimum distance was probably 3 cm (410). In the very short cross examination an attempt to suggest that there was high signal at T3 to T5 was rejected (412-414).

Expert Evidence

Mr Eldridge

[51 ] Mr Eldridge, aged 49 and a consultant neurosurgeon since 1993, explained his qualifications and CV (421-429). His current post is at the Walton Centre for Neurology in Liverpool. His understanding was that the cordous electrode would have the physical ability to penetrate the dura but he did nor have personal experience of the use of that electrode (435-436). In his expert role, he addressed the questions of causation and quality of care in relation to the pursuer's paraplegia. In relation to the quality of care he applied the standard of care applicable as at February 1997. He was aware that factual issues are to be determined on the balance of probabilities. He considered that the level of skill, was the skill to be expected of a consultant neurosurgeon (441).

[52 ] He agreed with Mr Steer that if a situation arises where the operator cannot be confident that he can pass the electrode safely without risk to the cord, he should take one of the options referred to by Mr Steer (444). On the balance of probabilities, he considered it is unlikely that there would be no resistance to feel. Feeling is important and he accepted that there would be a stage in which the careful operator, one exercising due skill, would recognise that there was resistance and in that event, look into one of the two options about better vision or abandoning the procedure (445-447). His likely explanation of the damage is perforation of the dura by the electrode with the electrode subsequently injuring the cord. Puncturing the dura would not be of consequence as it would not necessarily come into contact with the cord (449). But he was of the opinion that the x-ray note indicated that Mr Bashir had a belief that he had or might have perforated the dura during the operation (451). On the issue of whether the dura was penetrated by the electrode, he considered that it was physically so capable. Subsequent injury to the cord, coincidence of timing and onset of the injury, a coincidence in that the final neurological levels are consistent with the level of the operation site and no plausible competing explanation are factors which he considered pointed to the fact that the dura was penetrated by the electrode (453-455). During his preproof assessment of the case, Mr Eldridge noticed inconsistency in the MRI scan and report and asked the pursuer's solicitors to follow it up (456). His view was formed independently of Dr Sellar but was in agreement with Dr Sellar's opinion as corrected by him in his manuscript note. Mr Eldridge said his opinion about the distance of blind passage is subject to some caution because of the magnification effect. He considered that the electrode passed blind a distance of 3-4cms. An operation window of approximately 1 centimetre square was he considered overly small. The smaller the aperture the steeper the approach (462). He thought the angle would almost force the operator to be heading in the direction of the spinal cord. On the balance of probabilities in his opinion the dura was penetrated by the electrode (463). Mechanical trauma to the spinal cord in this case could not have been caused by a surgeon of ordinary competence professing the skill to do the procedure if he was exercising reasonable skill and care (470).

[53 ] In cross examination, Mr Eldridge explained that he had trained partly with Professor Miles who had a substantial role in developing the techniques of the procedure used in this case. Referring to his view that on the balance of probabilities the operator would feel resistance, he conceded that this means that statistically it is more likely than not that the operator would feel the resistance. That implied a degree of cases where the operator would not feel resistance (485). In his opinion the dura can be very very thin, very rarely. In the pursuer's case everything appeared absolutely normal and it would be very unlikely that the dura would become so different away from the area of inspection or indeed at any other part through the spinal cord (485-486). He did not think the pursuer's dura was sufficiently thin that the operator would not receive a resistance. When it was put to him that he was not able to exclude the possibility that Mr Bashir did not meet resistance which would put him on notice of a problem, he said

"Yes I can only repeat my views that that is unlikely in this instance. And part of your due care and attention is that you pass the wire in a manner that is such that you are sensitive to resistance.... because clearly if you use over much force then you will not feel resistance because you will not be able to... and that would clearly be an absence of due care and attention if you were to use a force that didn't allow you the possibility." (489)

His position is that leaving theoretical possibilities aside, because of the otherwise normal appearance of the dura in the pursuer's case it is unlikely that the operator did not encounter any resistance (491).

[54 ] Mr Eldridge pointed out that Mr Steer's evidence flagged up the fact that he was not in a position to feel the passage of the electrode and that Mr Steer's view was obscured by the instruments. He accepted that Mr Steer was not of the view that the aperture was too small but in his view Mr Steers should have been concerned about the angle of approach. In Mr Eldridge's opinion, the operator can undertake a procedure that carries a higher risk than it should do and the operator may get away with it. But, the operator is exposing the patient to a greater risk than should he. Mr Eldridge was of the opinion that the technique did not allow entry at an appropriately shallow angle because of the size of the aperture (505). If an electrode was inserted at an appropriate angle and an appropriate method of force applied with no resistance, he considered that it would be highly unlikely that the injury could have occurred in those circumstances (508).

[55 ] On recall, Mr Eldridge was asked about the hypothesis of the electrode sliding subdurally between the dura and the arachnoid. (All references are to the Notes of Evidence of 3 October 2006). He considered this would be incredibly unlikely because the arachnoid membrane is so flimsy (14). He agreed the electrode necessarily penetrated the dura, on the balance of probabilities, in the sense of "transgressed the dura" (15). He agreed with the hypothesis that the electrode entered the spinal cord which he considered to be consistent with the observed injury, both clinically and on the MRI scan (15). He also agreed that there could be contact with the spinal cord by the electrode without penetration and in that event it is more likely the electrode would come back up near the dura (16). Referring to the post-operative lateral x-ray (6/12 of process) dated 6 February 1997, he agreed with the hypothesis that the final resting position of the electrode is consistent with the electrode having passed ventrally towards the cord and then bending and travelling dorsally towards the roof of the canal so that the tip eventually ends in a position not in contact with the cord (19-20). Ventrally means down, dorsally means up. His interpretation of the MRI evidence is that the cord shows injury over a distance of 2 to 3cms and the damage to the cord plus the secondary effects is consistent with the electrode having passed over that sort of distance within the dura in contact with the cord (23). He considered that the MRI scan dated 9 February (frame 12 part of 6/12 of process) and the photographic copy supports his interpretation (25-26). He accepted the hypothesis that the likeliest place where penetration of the dura occurred would be just beyond the aperture for insertion. The MRI scan shows trauma to the cord consistent with the electrode having entered the dura at an angle and contacted the cord just beyond the aperture for insertion. That opinion is based on the correspondence between the site of entry and the location of the MRI changes and the correspondence between where the operator tells us that he inserted the electrode and the MRI changes representing trauma of the cord. The outline hypothesis put at page 1194 involved the electrode going down towards the cord and entering the cord. The more likely hypothesis is that the electrode went down towards the cord and traumatised the cord over the length of the cord. He said that it is perhaps a fine distinction between touching the cord and actually penetrating it. The surface of the cord has a membrane called the pia mater and if that was severely bruised, the severe bruising might be considered effectively a penetration as opposed to a complete transfixion. That might be described as "grazing the surface of the cord" and traumatising it over a distance and then on this hypothesis deflecting dorsally away from the cord. If the electrode had gone within the substance of the spinal cord one could describe it as a physical penetration rather than a severe contusion, but in practice the effects would not be different. His conclusion was that taking account of where the electrode ended up it is more likely to be a grazing/contusion type injury (27-31). He considered that such an angle of approach would be hazardous (32). He considered that the relatively steep angle of approach was confirmed because of the coincidence of the physical location of the point of entry and the point of damage (33-34). The damage is more or less underneath the point of entry. (34). This suggested a relatively steep angle of approach.

[56 ] Mr Eldridge's position is reflected in these passages of evidence

"Have you consistently held to a theory as to how this patient's cord came to be damaged? My view which I believe to be consistent, is that it's consistent with trauma by the electrode to the spinal cord. ... Is the skill and care used in the operation ... what you would expect of a neurosurgeon of ordinary competency professing the skill to place this electrode? I believe that is not the case; in other words, it was not an adequate standard, ... Would you say that no competent neurosurgeon would have done what you understand to have been done in this case? Yes." (53-54).

In cross examination he conceded that experts might differ about the standard of care In re-examination he said, in the absence of any explanation of how the damage occurred consistent with due skill and care, he did not accept that opinions could responsibly differ (56-57).

Professor Miles

[57 ] Professor Miles first became interested in chronic pain in the early 1970s and implanted the first dorsal column simulator in Britain in about January 1973, having studied the treatment in the United States. His CV is 7/5 of process. He has placed a trial electrode by open surgery about five to ten times (1170). Normally it is done by percutaneous insertion. He ceased practising in 1999 and agreed that magnetic resonance imaging has advanced since then.

[58 ] Professor Miles stated he did not have a confident explanation for the pursuer's condition (1175). He accepted she suffered "damage, injury or whatever" to the spinal cord during the operative procedure (1175). X-rays would be undertaken after the problem to reassure the surgeon that the wire was not in an outrageous position. The surgeon was rightly reassured by the x-ray (1176 and 1177).

He described the procedures in this way:-

"... When you are introducing the electrode you can feel the passage ... and if you were to do any damage to the dura or even the spinal cord ... you would feel an increased resistance. And if it was a matter of the dura being transgressed then there would be this jerk, definitely. And I've done that. I've seen that. I know that can occur. ... sudden giving way so that the quite mild pressure that you are applying to the electrode is unnecessary and you feel you've gone through a membrane of some kind".

At this point Professor Miles moved his hand forward in a sudden movement. "If you created the hole ....the surgeon would feel it. Mr Steers would see it" (1178-1179). The first aspect which puzzled him was that no resistance was seen or felt.

[59 ] The second aspect which confused Professor Miles is that no CSF was observed during the operation (1179-1180). He considered that if there was a breach at the initiation of the procedure, CSF would have been immediately seen (1181). One explanation is that there was a deficiency in the dura at some point. He explained that is unusual but he had seen it, but only in abnormal dura (1185) and not just once. If there was such a thin dura as to be actually deficient, then there might not be any sensation of resistance that the dura normally gives if you are pressing against it with an electrode... but if the arachnoid had not been ruptured and the electrode slid in between the arachnoid and the dura, which he described as a really long shot, then you might not get CSF coming out. He said there was also a possibility of a hole created by the bone forceps "but these are long shots" (1180-1182). He accepted he was making hypothetical suggestions (1186). He confirmed that he had no supporting evidence for something wrong with the dura. That is just a postulate (1191). He considered there is more of a risk of the dura being abnormal near the site of the operation site but going one level above should not be a problem. If there was a problem, Mr Bashir should have seen that in the opening that he made as he should have seen the dura stuck by adhesions at that lamina. If the dura that was visible did not appear to be affected by adhesions, that does not totally exclude adhesions at a higher point but it is very reassuring (1192-1193). Adhesions following surgery are worse closer to the former incision and much less elsewhere.

[60 ] He did not think it possible to go any further in determining the cause of the pursuer's ongoing problems. He could not find any logical explanation. He could postulate unlikely things that might have allowed it to happen. "Those are extremely uncertain - that is extremely uncertain logic, I think. It doesn't allow me to suggest that I would use that as the explanation" (1194).

[61 ] He accepted that it is possible to delay a leak of CSF. It is very common to put in a blood absorbing sponge around the site of the operation and that sponge might allow for a barrier to the flow of CSF and delay it for some time. "...so it is not a big deal to have a delay of three days" (1197).

[62 ] When asked whether breach of the dura and damage to the spinal cord is compatible with a properly carried out operation he replied

"...it is such a bad thing to happen...mistake, error, accident ...it is such a thing that is not sought, is not what the procedure is about and is very much the opposite of that. It is what the procedure is attempting to protect against. That is within in my opinion those risks that occur when that operation is undertaken ....". He illustrated that with the first case that he saw where the surgeon did damage with his instrument (1189-1190). He had no cause for concern about the way in which the pursuer's surgery was carried out.

[63 ] In cross examination he accepted that it is not a routine part of training to pass anything into the extradural space in the thoracic region. That is a specialist skill. Procedures in the lumbar spine are not analogous. The best place to master the techniques involving passing devices into the epidural space is at the lumbar spine where potential adverse outcomes are unlikely to be so catastrophic (1214). He did not support a wide removal of the ligamentum flavum because that would merely allow the electrode to move (1239). He accepted the electrode was passed under T2 and T1. He did not accept the word "blind". He preferred the word "unseen" (1247). He emphasised the importance of feel.

"... If it tends to go up to the side you can feel it bending. And if it goes to the other side you can feel it bending. If it seems to run without obstruction and you get the feeling that it's straight, you assume its straight. You do not know". (1254).

[64 ] He accepted that the first time he mentioned the theory about the electrode travelling between the dura and the arachnoid in the subdural space was while giving evidence (1266). He accepted that the defence to the action based on some kind of ischemic event was a distinct possibility because of the report but "... since that has been corrected, which is only corrected since I have been here in Edinburgh, in the court, I have dismissed that because I think there isn't evidence for that". So "... having been here I'm sure you would expect me to think very carefully about what has gone on, in light of not knowing what is the cause, what has happened. Therefore I have, and I've suggested this as a very unlikely situation. It depends on so many uncertainties. But I can't think of any other way of doing it". (1269). When asked whether the puncture of the dura and damage to the spinal cord occurred during the operation has not been proved scientifically. He responded "Yes if there had been a surgical puncture of the dura at the point where the introduction is occurring, I am amazed that CSF was not seen. And the other factors of sensation, movement not recognised by two surgical observers" (1270-1271). Exploring his hypothesis that it is possible the tip of the electrode got into the layer between the dura and the arachnoid and travelled for a distance within that layer he commented "It's so hypothetical it would be wrong to imply credibility to suggest the possibility". Not credible but interesting to explore as a theoretical possibility (1278). Leaving aside scientific certainty, he does not appear to accept at this point in his evidence even on a balance of probabilities that the cord was injured by the electrode, as he could not explain how these things come together in the context of the information that he had heard and seen. "Therefore I don't know how it occurred and I am still struggling" (1279-1280). He accepted that he had not had the advantage of hearing the radiological evidence.

[65 ] In dealing with causation, he was asked:- "If we are talking about trauma to the cord between the window for insertion and the point where the electrode ended up, can I suggest that on a balance of probability the cause of that trauma was the electrode? I think we have to accept that on a balance of probabilities" (1280). Professor Miles accepted that the event occurred unequivocally during the operation and there is unequivocal damage to the cord, but he maintained that he could not fit the final piece together and say that happened. He appeared to accept that the spinal cord was traumatised by the electrode over a distance of 3cms (1282). When asked if contact with the spinal cord is another opportunity to feel resistance, he replied "I would have thought it was. I have never done it". ... One would expect to have some sensation of resistance at that stage I suppose (1285). But when faced up with the conclusion "But if we have an operator who does not sense the trauma to the cord, we postulate that that is the same operator who does not sense the trauma passing through the dura. Is that right? No, I don't know what sensation you get by passing it into the cord. I know what it is, what sensation you get if you pass it through the dura" (1291). He accepted that he has expressed the view that he arrived at certain conclusions by giving credit to the operator's account (1292). Having explored his theory, it is put to him that the likeliest thing that happened is that the penetration took place not far, superiorly to the aperture where he was passing it. He accepted that but said it would be hard to believe that CSF did not appear. He accepted that if the spinal cord is injured over a distance of more than a centimetre, perhaps 2 or 3cms plus secondary effects, that would be consistent with the electrode passing over that sort of distance within the dura (1297). He is unable to explain why CSF was not registered at the time of the operation. He thought there were various possibilities including the effect of the sponges (1298-1299).

[66 ] He stated that there would be dramatic resistance particularly with a blunt nosed electrode. In his surgical procedures he used his fingers and not instruments because the fingers are more sensitive. When using forceps, the sensation is lessened. It was put to him that within the normal range the operator who professed the skill to pass the electrode safely should be capable of feeling a resistance which signals the risk of penetration of the dura. He said "You would expect him to feel that resistance" (1307). He concluded the likeliest time for penetration was possibly at the point of insertion where the angle would have been obtained (1309). His view about the standard of care is underpinned by his belief that the two observers did not see the features associated with penetrating the dura and the CSF not leaking immediately (1311).

[67 ] In re-examination he accepted having regard to the actual CSF leak and the findings of the radiologist, that at some stage the electrode on a balance of probabilities penetrated the dura (1321).

Objection to evidence

[68 ] Before I deal with the chapter of evidence relating to the surgery, I require to rule on another objection. This relates to a line of evidence which was led under reservation to the effect that there was, or was possibly a defect in the dura. I accept the submission by senior counsel for the pursuer that there is nothing in the record which gives notice of this line expressly or by implication. It is contended on behalf of the defenders that no such notice requires to be given as this was part of the exploration of the facts and circumstances of the operation. Senior counsel for the defenders submitted that the parties had explored the issues without constraint or notice, for example, he said there was no notice in the record that the pursuer was making complaint about the size of the aperture and angle of approach. That is correct but no objection was taken on behalf of the defenders to that evidence and the evidence is before me. On behalf of the pursuer there is an objection to evidence which I require to deal with. If parties choose to embark upon a proof on a Record which has very sparse averments, questions of fair notice and the scope of the Record may cause considerable difficulties. I consider the matter to be finely balanced. I am satisfied that the defenders attempted to introduce a new line of defence to the alleged negligence. It is a matter of some importance and I consider that the pursuer was entitled to notice to consider, investigate and if so advised lead evidence about this. The thrust of the evidence of Mr Bashir and Mr Steers was that the dura looked normal and there was no suggestion by them that they had any reason to fear that the dura was abnormal. If they had such a concern, new issues of negligence might arise. There is, in my opinion, prejudice as the pursuer was not able to prepare in advance for such a case both in relation to factual and expert evidence which might be led and in relation to possible alternative grounds of fault. In all the circumstances, I consider that the objection should be sustained and the evidence disallowed.

[69 ] If the evidence about a defective dura was to be considered as evidence in this case, I certainly would not have been persuaded to conclude that, on a balance of probability, it was likely that the pursuer's dura was defective or abnormal in the area in which the surgical procedure was carried out. The person who was best placed to give evidence about the dura of the pursuer in the area of the operation site was Mr Bashir. He saw it. This issue of a possible defective dura was never raised by him as an explanation. There was no evidence that this was considered, even as a possibility, when the surgery was discussed in the weeks after the operation. Both Mr Steers and Mr Bashir considered the dura seen by them to be normal. There was no evidence that a defective dura was for some reason likely in the pursuer's case. Indeed, the evidence of Professor Miles was to the effect that by working above the level of previous operation sites and the fact that no abnormality of the dura was noted when it was inspected at operation, would give the operator confidence about the position. Mr Eldridge was of the opinion that it was unlikely that the dura was anything other than normal and unlikely that the operator did not encounter any resistance (See para.53).

Submissions by counsel

[70 ] Senior counsel for the pursuer submitted that there was negligence on the part of Mr Bashir. He submitted that the evidence demonstrated, on a balance of probabilities, that the pursuer's injury was attributable to trauma to the pursuer's spinal cord, caused by the passage of the temporary electrode into the dura by Mr Bashir thus traumatising the spinal cord. He relied on the absence of any other explanation supported in the evidence. He pointed out that even Professor Miles said his various hypothesis were untenable. He emphasised the unanimous evidence given by all the relevant witnesses. They spoke to the need for care and sensitivity when moving the electrode bearing in mind the risk factors which were undisputed. He submitted that the evidence of Mr Bashir that he felt no resistance is not conclusive or persuasive that he was proceeding with appropriate care in all the circumstances. In essence his submission was to the effect that whatever the exact mechanism or angle of penetration, the skilled and careful operator ought to have felt resistance and desisted. No explanation has been offered which could explain penetration as being consistent with reasonable care if, as is the case, penetration is proved to have happened. I was invited to accept the evidence of Mr Eldridge in preference to Professor Miles insofar as there was a conflict in relation to the standard of care, particularly, as it was submitted, Professor Miles gave the impression of some partisanship.

[71 ] Senior counsel for the defenders was critical of the pursuer's failure to lead Mr Bashir and emphasised that there were serious difficulties for the pursuer in that the hypothesis which underpins Mr Eldridge's evidence that the aperture was too small and the angle too great was never put to Mr Bashir. He submitted Mr Bashir was not cross examined on this basis and gave unchallenged evidence that he placed the electrode parallel to the dura. He submitted that the size of the aperture and angle were problematic in that Mr Eldridge had given evidence on the basis of an aperture of 1/2cm x 1/2cm. Mr Bashir's unchallenged evidence was that the size was 1cm x 1cm. Properly analysed, the criticisms of Mr Eldridge are that Mr Bashir was on the wrong trajectory. Senior counsel submitted that the criticisms made of Mr Bashir about his x-ray request were ill founded and could not be interpreted as some "hideous doubt" which occurred to Mr Bashir in the course of the operation. He was critical also of Mr Eldridge's approach which appeared to conclude that if damage was done, that must have been in a situation where there was resistance. Senior counsel submitted that was not always the case and even Mr Eldridge appeared to accept that resistance was not always present.

[72 ] I was invited by senior counsel for the defenders to accept the evidence of Mr Bashir and Mr Steers that the procedure proceeded without any obvious problem and that there was no resistance. If there was no resistance and no CFS leak observed, there was nothing to put the operator on guard. I was invited to conclude that Mr Bashir had taken care to ensure insertion in an appropriate plane, broadly parallel to the dura, and that this was a case in which there was no resistance to feel. He prayed-in-aid the evidence given by Mr Steers who noticed nothing untoward during the operation or about the technique. I was invited to bear in mind Mr Bashir's previous experience and that he was aware of the resistance issues. Senior counsel submitted that it was never put to Mr Bashir that there would also be resistance if he penetrated or grazed the cord. The evidence about the steep angle of approach was also not raised. It was not contended that Mr Steers or Mr Bashir should have seen CSF. These were all critical matters which should have been put in cross-examination. Indeed the pursuer's first case appeared to be a parallel insertion "then a nosedive" in order to explain the fact that no CSF was seen. The steep angle theory which was later developed was not put to Mr Bashir or to Professor Miles. Indeed it was the contrary parallel theory which was put to Professor Miles (1292-1295). Under reference to McKenzie v McKenzie 1943 S.C.108, Keenan v Scottish Wholesale Co-op 1914 S.C.959 and Walker & Walker on Evidence, it was submitted that in some circumstances the failure to cross examine on a material matter may cause fatal damage to a case. It was submitted that in a case of medical negligence a failure to put to the doctor under attack, the crucial factors underpinning the pursuer's case, means that the court is not entitled to draw the necessary inference from the expert evidence. In any event, senior counsel submitted that in this case there is no factual evidence to found operator error.

[73 ] I was also addressed by senior counsel for the defenders on the proper approach when there are two bodies of expert evidence in relation to operative technique. He submitted that if Mr Steers and Mr Bashir's evidence was accepted about what happened at the operation, the Court is faced with two competing bodies of opinion. Essentially Mr Eldridge said an operator cannot do that damage, if exercising due care and skill. In contrast Professor Miles said that having heard both surgeons he considered the operative technique entirely appropriate and no cause for concern. This submission was made under reference to Maynard v West Midlands AHA 1985 1 All.E.R.635 and Bolitho (Deceased) v City of Hackney HA [1998].A.C.232. Senior counsel for the defenders submitted that the Court cannot prefer one expert to the other unless there is a proper logical basis to enable one to be dismissed. That would be a rare event, not appropriate in this case. Professor Miles applied logic and commonsense and was basically of the view that this is simply one of the risks that one informs patients about. Professor Miles had the advantage of seeing and hearing Mr Bashir's evidence and Mr Bashir himself was well aware of the risks. The proper conclusion is that this was an example of the risk occurring without negligence.

[74 ] In response, senior counsel for the pursuer accepted that the angle point was not put to Mr Bashir. He explained that it was only when the defenders' expert accepted the pursuer's theory of causation that the angle point and trajectory were explored in more detail. He did not accept that resistance to the cord had not been put. He referred to the evidence at page 1102. On the proper approach to expert evidence he prayed-in-aid Gordon v Wilson 1992 S.LT.849.

Discussion

Comments on the expert witnesses.

[75 ] Professor Miles has been retired from practice since 1999 and fairly conceded that there have been advances in MRI technology since his time in practice. I accept he had taken a lead in the development of dorsal column stimulator operative technique in the UK and had many years of practical experience which included the use of an electrode of the type used in the pursuer's operation. While I am confident he had the necessary and appropriate expertise in relation to the surgical procedure which is the subject of dispute, I am less confident about his understanding and appreciation of the role of an expert witness in the present proceedings. Senior counsel for the defenders did not explore this with him in any detail although Professor Miles appeared to be familiar with giving evidence in Court. As he described it "I'm retired from clinical neurosurgery. I am still being dragged back to court for various medical or legal reasons" (1147).

[76 ] Professor Miles volunteered views about credibility and appeared to proceed on the basis that what was said by Mr Bashir and Mr Steers was true. He volunteered such views even in a context, such as the consenting process, where he had not even heard all the relevant factual evidence. He said "I have heard evidence from the two surgeons involved which I consider to be adequate and appropriate" (1211). I was surprised and concerned about this as I did not consider this part of the role of an expert. In my opinion this influenced his approach to the case as he appeared to rule out of his thought processes, the consideration that even if Mr Bashir felt no resistance that did not necessarily and inevitably mean that there was no resistance to be felt. Instead Professor Miles appeared to search about towards the end of evidence for hypotheses which even he said were untenable and incredible. I am of the opinion that the reason he did this was because, in the course of evidence, it became clear that the explanation which had been relied upon by the defenders since 1977, and supported by him, was ill-founded because the defenders had failed to properly check their own records. For an expert witness to start speculating about new theories in his own evidence without even communicating these theories to counsel, is unusual and not helpful. It demonstrates in my opinion a failure to fully understand his own role as an expert. In addition, when Professor Miles made comments about the circumstances in which negligence might occur, he appeared to be influenced by the number of times damage was caused rather than the issue of care and skill in a particular case. I was also concerned by a passage in his evidence which I interpret as indicating a partisan rather than independent attitude. I refer in particular to his evidence summarised in paragraph 65 where he appears to accept that contact with the spinal cord is another opportunity to feel resistance. But when faced with the implication of that answer he appears to alter his position. I was left with serious reservations about his evidence.

[77 ] In contrast, I was very impressed by Mr Eldridge who seemed to have a clear understanding of his independent expert role in the context of this case. I was also impressed by the thoroughness of his preparation and by the fact that he had used his expertise to alert the pursuer's solicitors that there was a potential error in the report about the MRI scan. He impressed me as a witness who had made careful analysis of the case and was doing his best to assist the Court with complex medical issues in a fair and balanced way.

Comments on the evidence of Mr Steers and Mr Bashir

[78 ] Mr Steers impressed me as a competent and caring doctor and I accept his evidence as credible and reliable in relation to the events which he witnessed. I cannot however draw the comfort, which the defenders insisted should be drawn, from the fact that the surgery appeared to proceed uneventfully and without problem. It was plain from all the medical witnesses who spoke to the surgical procedure that critical matters in relation to the surgery were the sensitivity with which the procedure was carried out to the feel of the structures and resistance and the requirement to carry out the procedure with such sensitivity to note and respond to resistance. I accept Mr Eldridge's opinion that it is important that the movement of pushing is not so strong or hard to overcome that resistance without the knowledge of the operator. It was plain from Mr Steers' evidence that in relation to this, he was not in a position to assist the Court because he could not tell what the operator was feeling and he could not tell how hard the operator was pushing (196-197). As it was never explored with Mr Steers, whether or not there would have been any observable movement, in his view, if the dura was punctured, I am not prepared to draw the inference that there was no resistance encountered. Indeed the weight of the evidence, in my opinion, is that it is likely the dura was normal and therefore there was resistance which ought to have been felt. I refer to the discussion in paragraph 69.

[79 ] Mr Bashir impressed me as a caring doctor who has plainly achieved eminence in his profession. I consider that he was doing his best to assist the Court in relation to factual events at surgery which occurred many years before. I consider however that his evidence must be understood against a background that essentially he did not accept that he penetrated the dura and caused trauma to the spinal cord when passing the electrode. It is plain from his evidence which I summarised in paragraph 45 that he fully accepts the risks, the need to proceed cautiously to be aware of any resistance and to stop if any resistance is felt. I accept that his description of the operative technique was as reliable as he could give and that he had no recollection of any CSF leak or any resistance during the operation. Although I accept that at the time of the operation, he saw or felt nothing to alert him to a problem, I think it is not without significance that immediately there appeared to be a problem, he was far less sanguine. In paragraph 46, I refer to passages of evidence where he accepted that his immediate thought post-surgery was that he had perforated the dura during the surgery. My interpretation of the evidence is that Mr Bashir during the surgery thought and hoped that the surgical procedure had proceeded without problem, but this was a new procedure for him. It appears his immediate reassessment of the situation post-surgery, when problems had arisen, left him with doubt about his earlier interpretation. That is the inference I draw from this evidence. As it happened his concern and interpretation were well justified, albeit there was confusion about the interpretation and diagnosis at the time, partly because of the error in the MRI report. I do not consider that his attempts to provide other explanations some years later are well founded and they are not supported in the evidence.

Causation
[80 ] It became clear during the proof that if the evidence was such to enable a decision to be reached on the balance of probability about how the pursuer's paraplegia was caused, this might assist in coming to a view about the standard of care exercised by Dr Bashir. I propose therefore to deal with this aspect of the case before I deal with the issue of negligence.

[81 ] Shortly after the operation, problems about the pursuer's condition were noted. Mr Bashir examined the pursuer and ordered an x-ray writing on the form "query, perforated dura". The x-ray was interpreted by both Mr Bashir and Mr Steers as giving some comfort about the position of the electrode as they took the view that it was in a satisfactory position relative to the spinal cord. The x-ray did not give the same detailed information as an MRI scan and such a scan could not be done while the electrode was in position. Thereafter the pursuer's condition did not improve and it was not disputed that the pursuer has high thoracic paraplegia. This history was not in dispute.

[82 ] I heard evidence from Dr Sellar which I accept as I explain in paragraph 49. I also accept the evidence of Dr Walker. There was no contrary evidence led from a consultant diagnostic radiologist. Dr Walker's evidence was not cross-examined to any significant effect. I summarise that evidence in paragraph 50.

[83 ] Mr Eldridge independently reached the same conclusion as Dr Sellar and Dr Walker. Professor Miles with some hesitation appeared to agree.

[84 ] Mr Steers fairly accepted that his opinion was influenced by the uncorrected report of the MRI scan. He explained that he had difficulty with the hypothesis that there was a penetration of the dura bearing in mind that the dura can vary in thickness and that the report of the MRI scan was not compatible as it refers to an area of high signal from C7 to T8. He agreed that if the proper interpretation was an area of high signal from C7 only to T3, that would be consistent with the penetration by the electrode causing trauma to the spinal cord (342-346). Mr Bashir was the only witness who did not appear to accept that the proper interpretation of the MRI scan pointed to the pursuer's paraplegia being caused by trauma to the cord by the electrode during the surgical procedure. I consider that Mr Bashir drew false comfort from the x-ray and the typed MRI report. I did not accept his interpretation of the MRI scan because the overwhelming weight of evidence was that the pursuer's paraplegia was caused by trauma to the cord by the electrode during the surgical procedure. This conclusion is not dependent on any further evidence but it may be helpful to record that I also accept Mr Eldridge's opinion, for the reasons he gives, which I narrate in paragraph 55 that the most likely injury was a "grazing injury" to the cord over a length of approximately 3cms. That distance was supported also by Dr Walker and to a limited extent by Professor Miles.

[85 ] My conclusion from the evidence which I accept is that the mistake in the MRI typed report deflected attention from the fact that trauma by the electrode to the cord had been caused during the surgical procedure. The absence of any observation of a CSF leak during the operation also deflected attention from what I consider to be the probable cause of the damage. I accept that the failure to observe CSF was unusual, if there was a puncture in the dura. But in my opinion the evidence is to the effect that it is likely that the dura was punctured by the electrode during the operation for the reasons I set out above. I am certainly not persuaded in the circumstances of this case that the absence of an observed CSF leak at time of the operation means that the dura was not punctured during the operative procedure by the electrode. There is no dispute that there was a CSF leak identified some three days later. The only probable explanation for this in my opinion is that it occurred during the operative procedure. There is no other explanation supported in the evidence. The mistake in the MRI report and the unusual feature that a CSF leak was not observed may explain the failure to resolve matters in 1997. Thereafter Mr Bashir eventually left the hospital without the matter being further resolved. In retrospect with the assistance of the correct MRI report and the benefit of expert evidence, I think the issue of causation is now clearly resolved.

Negligence

[86 ] If one considers that, contrary to the defenders' position, the cause of the pursuer's paraplegia is not unclear or some form of medical mystery, but that causation is established at least on a balance of probability, it is in my opinion much easier to come to an opinion about the issue of negligence in this case. Although there was some difference of professional view about the size of the aperture and angle, I consider that these matters are not critical to the determination of the case. As I understand Mr Eldridge's evidence, the size of the aperture is to some extent a matter of intra-operative decision making. He appeared to accept that a skilled surgeon would be entitled to operate with a smaller aperture, than Mr Eldridge considered appropriate, albeit it was his opinion that this would make the operation more difficult. Essentially however there was no dispute about the proper approach to such a surgical procedure. I am also satisfied that the main elements about this proper approach were put to the relevant witnesses. There was no dispute that it was within intra-operative judgement to carry out the technique with forceps or fingers. Albeit there may be some differences in operative technique, essentially all the relevant witnesses agreed that the operator required to use care and skill to achieve the passage of the electrode blind or unseen under the lamina on a parallel approach to the dura using feel for the structures and recognising and responding to resistance. It was agreed that if resistance was felt the operator should stop. Mr Bashir also accepted that was the aim and technique of the operation (see paragraph 45). There was no dispute about the obvious dangers and that the aim of the procedure was to avoid compression or injury to the spinal cord by a parallel approach responding to any resistance by stopping. There was no dispute that the procedure involved in this case was highly skilled requiring the skill of consultant neurosurgeon because of the obvious dangers involved. The level of care and skill was all about the ability to judge the force required consistent with feeling resistance to any structures. There was no dispute that with normal dura one would expect to feel resistance. I accept Mr Bashir's evidence that he did not feel resistance.

[87 ] I do not consider that on the issues which I consider important to the present case that there are two different bodies of medical testimony which are in opposition. I consider that this is a case in which both Mr Eldridge and Professor Miles agree about the risks to be avoided, i.e. damage to the cord, agree that the electrode must be manoeuvred by feel with sufficient sensitivity to respond to resistance and stop if resistance is felt. Mr Bashir and Mr Steers also agree about this. The issue which I consider important and which separates the experts is whether it is likely that in the pursuer's case there was resistance to be felt bearing in mind that the operator said that he did not feel any. In my opinion Professor Miles had a closed mind about this and that is why he apparently sought out various theories, which I reject. Even Professor Miles did not appear to be persuaded. I am satisfied, as I have explained, that there was resistance to be felt but Mr Bashir did not recognise and respond to that resistance by stopping. I am satisfied that Mr Bashir, even if he placed the electrode parallel to the dura, did not push it parallel to the dura. Instead he punctured the dura and traumatised the cord. I am satisfied that on this one occasion when he was still in training and carrying out a novel and unusual procedure, Mr Bashir failed to exercise the ordinary skill of a consultant neurosurgeon acting with ordinary care because such a doctor should have detected and responded to resistance and stopped the procedure without penetrating the dura and traumatising the cord over 3cms. Professor Miles' evidence, was given on the basis that there was no resistance to be felt. I do not accept his theoretical reasoning about that. The evidence of Professor Miles is also strongly influenced by a theory of a defective dura and that evidence I have found to be inadmissible. I accept the evidence of Mr Eldridge to the effect that Mr Bashir in the circumstances of this case failed to exercise the requisite degree of care and skill.

[88 ] It was not contended that the failure to observe CSF was itself negligent. Although there was considerable evidence in this chapter of the case about the absence of any observation of CSF, I consider that feature is mainly relevant in relation to the difficulties of forming a view about causation.

[89 ] In these circumstances, I sustain the first plea-in-law for the pursuer and repel the first, third and fourth pleas-in-law for the defenders. I was not addressed on plea‑in-law 2 which relates to damages. The issue of damages remains outstanding and I have not for these reasons dealt with pleas-in-law relating to damages.

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	Scottish Court of Session Decisions
You are here: BAILII >> Databases >> Scottish Court of Session Decisions >> Smith v Lothian University Hospitals NHS Trust [2007] ScotCS CSOH_08 (18 January 2007) URL: http://www.bailii.org/scot/cases/ScotCS/2007/CSOH_08.html Cite as: [2007] ScotCS CSOH_8, [2007] ScotCS CSOH_08, [2007] CSOH 08

Scottish Court of Session Decisions