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OUTER HOUSE, COURT OF SESSION
[2007] CSOH 08
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OPINION OF LADY
CLARK OF CALTON
in the cause
MRS ENID SMITH (AP)
Pursuer;
against
LOTHIAN UNIVERSITY
HOSPITALS NHS TRUST
Defenders:
ญญญญญญญญญญญญญญญญญ________________
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Pursuer:
Stewart, QC, Charteris; HBM Sayers
Defenders: J. R. Campbell, QC, Stephenson; Scottish Health Service CLO
18 January 2007
Overview
[1] The
pursuer was born on 25 February
1931. From about 1991 she
had a history of back problems, pain and related surgical operations. On 6 February
1997 the pursuer was a patient in the Western
General Hospital, Edinburgh
and was the subject of an operation for the implantation of a trial electrode,
a dorsal cord stimulator to alleviate back pain. The implant was carried out under general
anaesthetic by Mr Bashir, a registrar with surgical experience employed by
the defenders. The operation was
supervised by Mr Steers, a consultant neurosurgeon also employed by the
defenders. After the operation the
pursuer had a paraplegic condition which is permanent. This was a result of the operation.
[2] In
this action the pursuer seeks damages for alleged medical negligence. There were three specific grounds of fault in
relation to the surgeons Mr Bashir and Mr Steers which are set out at
page 16 of the closed record.
Firstly, "it was their duty not to undertake placement by open procedure
under general anaesthetic. It was
standard practice to undertake trial of stimulation by percutaneous placement
under local anaesthetic." For
convenience I refer to this as the "percutaneous placement case". Secondly, "it was standard practice before
seeking consent for the procedure carried out, to warn of the risk of
paraplegia. No such warning was given to
the pursuer". For convenience I refer to
this as the "warning case". Thirdly, "it
was their duty not to cause trauma to the pursuer's spinal cord. No surgeon of ordinary competence using due
skill and care would have caused trauma to the pursuer's spinal cord". For convenience I refer to this as the
"trauma case".
[3] During
the second day of evidence (see page 253 of the notes) and confirmed in
submissions, senior counsel for the pursuer abandoned the first ground of
fault. The second and third grounds
require to be considered and determined by me. Although the defenders admit on record on the
balance of probabilities that the paraplegia was a consequence of said surgical
procedure, they aver that the precise cause thereof is unknown. They further aver "it is possible that the
dura was penetrated. Alternatively there
may have been compromise of the blood supply to the spinal cord".
[4] Most
of the pleadings relate to the first ground of fault, the "percutaneous
placement case". Considerable dispute
arose about the admissibility of evidence in relation to the "warning case". I deal with this in paragraphs 29-36. Most of the evidence, and the main medical disputes
about the evidence, relate to the "trauma case" insofar as developed in
evidence without objection on the basis of sparse and general averments. There was an objection which was maintained
to one aspect of this case and I deal with this in paragraphs 68-69. No issue about quantum arose because by
interlocutor dated 22 July 2004
proof was restricted.
[5] I
heard evidence in the action over seven days commencing 14 February 2006 but the case, including
submissions, was not concluded until 20 October
2006. The witnesses led for
the pursuer were Dr James Lawrence Jenkinson MB ChB, FRCA (Retired
Consultant Anaesthetist), Mr Donald McArthur BSC, MB ChB, DM, FRCS
Glasgow, FRCS Neuro. Surg. (Consultant Neurosurgeon, Queen's Medical Centre,
Nottingham), Mr James Steers MB BS, FRCS (Consultant Neurosurgeon, Western
General Hospital, Edinburgh), Carole Mackay (daughter of the pursuer),
Dr Robert Sellar MBBS, BSC, MRCP, FRCR, FRCP, FRCS (Consultant
Neuroradiologist, Western General Hospital, Edinburgh), Dr Leighton Walker
MA, MB ChB, MRCP, FRCR (Consultant Neuroradiologist, Southern General Hospital,
Glasgow), Mr Paul Eldridge BA, MA BChir, MA, FRCS, MChir (expert witness
for the pursuer), Brian Smith (son of the pursuer) and the pursuer. The witnesses led by senior counsel for the
defender were Mrs Eleanor Clausen (former clinical nurse practitioner at
the Western General Hospital),
Mr Saad Bashir MB ChB, FRCS Neurosurgery, FRCS Surgical Neurology
(Consultant Neurosurgeon, University Hospital,
Karachi, Pakistan)
and Professor John Miles MB, B Ch, FRCS (Retired Consultant Neurosurgeon
and expert witness for the defenders).
[6] The
case was not completed in the dates allocated.
I invited written submissions in addition to oral submissions. As no early date for submissions was allocated
and in view of a motion by the pursuer to recall Mr Eldridge for further
evidence, I ordered a transcript of the notes.
I granted the pursuer's motion to recall Mr Eldridge. I heard further evidence from Mr Eldridge
on 3 October 2006. I heard oral submissions on behalf of the
parties over four days commencing 10 October
2006. Submissions were
concluded on 20 October 2006. The written submissions on behalf of the
pursuer are 24 of process. The written
submissions on behalf of the defenders are 25 of process. These are the submissions which were
developed orally.
A Summary of the pursuer's history prior to the operation on 6th
February 1997
[7] The
pursuer stated her age as 74 and described herself as a retired nursing
sister. She had a history of working as
a nursing sister with geriatric patients and she had worked in school
nursing. She worked post-retirement for
Victim Support Scotland
which is an organisation supporting victims of crime. From 1991 the pursuer was troubled by a
growth of haemangiomas in her spine. Haemangioma
is a benign vascular growth. The growth occurred
from the vertebral bodies within the spinal canal and impinged on the spinal
cord and nerve routes at various levels within her spine. From about 1991 the pursuer had various and
varying problems of mobility.
[8] On
21 October 1991 Mr Johnston, Consultant Neurosurgeon, Institute of
Neurological Sciences, Southern General Hospital, Glasgow performed a
laminectomy at T6 partially extending to T5 and T7 in the pursuer's spine to
decompress an haemangioma. Following the
operation the pursuer suffered from neurogenic pain at the lower thoracic level
T6 to T11. On 30 March 1994 Mr Johnston performed an
operation enlarging her laminectomy to carry out a dorsal root entry zone
(DREZ) lesion at T4, T5 and T6 segment on the left side in the pursuer's spine. This was an attempt to mitigate her
pain. It was recorded in the hospital
notes that there was a small risk of motor weakness left and sensory loss right
leg which she does understand (610-612).
The pursuer's pain became worse.
On 23 January 1996
Mr Johnston performed a laminectomy and decompression of haemangioma at
level T7 to T8 in the pursuer's spine.
It was recorded in the hospital notes that Mr Johnston stated "...
I've spoken to her several times about the small risks of the surgery causing
paralysis and she is fully aware of this ..."
In examination in chief the pursuer denied that entry was correct, then
said she did not remember any paraplegia (613).
She agreed in evidence in chief (608) that she was aware in general
terms, depending on the nature of the surgery that spinal surgery could involve
a risk of paraplegia. And in cross
examination she accepted she was aware in these circumstances of a risk, albeit
small, of paraplegia (614).
[9] The
pursuer continued to suffer from neurogenic intercostal pain though possibly of
lesser severity. There were no further
surgical options in Glasgow. They tried everything at the pain clinic but
that did not work (642). The pursuer did
obtain some relief from a transcutaneous electrical nerve stimulation (tens)
machine but her skin broke down and the treatment was discontinued. The pursuer's pain was assessed as being
secondary to haemangioma and previous surgery and as being genuine. In 1994 she purchased a powered wheelchair
which she used occasionally for long distances outside (641). She had a ground floor flat and help with
housework. She still ran victim support
and said she led a normal life (642). Post
1994, the pursuer had pain down the whole left hand side of her body, back and
front from shoulder to waist. It
affected her, spine to breastbone and also travelled around her left side (644). She had pain in her back and in the area of
her ribs. It was that pain that
eventually led her to seek a referral for the insertion of a dorsal column
stimulator because the pain was quite severe.
The pain was intractable and driving her to distraction (646 - 648). She was also experiencing a feeling of
numbness and loss of sensation in her left leg with poor walking by 1995. By May 1995 the pursuer was concerned
that she might become paraplegic, one way or the other, within the next five or
six months because of her medical problems. She was worried about this up until her
admission to hospital in February 1997 (651).
After the operation on 23
January 1996 the pain was still severe but better than it had been
before (656). No other pain relief
treatment was on offer and the pursuer was actively looking for help (657).
[10] The pursuer with the assistance of her son researched treatment
and asked for a referral in relation to a dorsal column stimulator
procedure. She was referred in 1997 and
was seen by Dr Jenkinson in the pain clinic in Edinburgh
on 14 November 1997. Even before the pursuer saw
Dr Jenkinson, she thought that the dorsal column stimulator would have to
be implanted into her spine slightly above T5-6 because that was where her
first tumour had been removed. The
pursuer had nursing expertise and took an active part in discussions about her
medical treatment. Dr Jenkinson
explained to the pursuer that because of complications arising from previous
surgery to her spine, he felt unable to offer percutaneous implantation of the
trial electrode by the normal procedure.
The normal procedure was by percutaneous placement to implant the trial
electrode under x-ray vision and local anaesthetic. Dr Jenkinson discussed the matter with Mr Steers
and a trial by open placement surgery under general anaesthetic was considered. This was an unusual procedure. Further investigations were carried out,
including an MRI scan. At about the end
of November 1996, Dr Jenkinson telephoned the pursuer to discuss the
proposed procedure. As a result of the
various discussions which the pursuer had with Dr Jenkinson, the pursuer
thought the operation was a much smaller operation than the drez lesion
operation. She said that Dr Jenkinson
had told her she would be perfectly fit to go on a holiday on 3 or
4 March (616-619). Matters were
complicated by the existence of a further haemangioma at level T5 and T8. Dr Jenkinson discussed this with the
neurosurgeon who reportedly expressed the view that there was no indication for
spinal surgery in relation to that as the spinal cord was not being
compressed.
[11] On Wednesday
5 February 1997, the pursuer was admitted to the Western
General Hospital
under the care of Mr Steers for implantation of the trial electrode and,
if the trial proved successful, for implantation of the permanent dorsal cord
stimulator seven days after the trial. It
was not until 2002 that the pursuer discovered that the operation was carried
out by Mr Bashir not Mr Steers (631).
[12] My understanding is that although the medical history of the
pursuer was complex, it was not in significant dispute. In his written submissions, senior counsel
for the pursuer summarised some of this history. I have drawn upon that in paragraphs 7 to 11
and supplemented that, where I considered it appropriate, to reflect the
evidence of the pursuer. I consider that
the pursuer assisted by contemporaneous medical records, did her best to
explain this history and I have no reason to consider that she was deliberately
exaggerating or under emphasising her problems and her reaction to them. But with such a history over a long period of
time, I consider that the contemporaneous notes insofar as reflected in that
history are more likely to be accurate than the pursuer's memory as to dates,
procedure and what was said.
The "warning case"
[13] As I understood the
submissions on behalf of the parties, there was no significant dispute about
the applicable law in this case.
[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.
