Mr Justice Supperstone :
Introduction
- Necrotising myositis is a rare condition with a high mortality rate which in July 2008 infected the upper right thigh of Mrs Karen Jones, the Claimant. It led to the progressive removal of all the muscles in her upper right thigh and the recommendation to amputate her right leg through the knee. The necrotising myositis was caused by Group A streptococcal bacteria, which probably started with a sore throat that the Claimant had had during the week leading up to her admission to Queen Alexandra Hospital in Portsmouth ("QAH").
- The Claimant arrived at QAH at about 1025hrs on Sunday 20 July 2008. She was taken to theatre at about 0300hrs on 21 July when Mr Richards operated on her. A second operation was performed by Surgeon CDR Hill at 2230hrs on 21 July. On 4 August the decision was taken to amputate; the amputation was carried out the following day.
- The Claimant's Particulars of Claim contain 18 allegations of negligence. Mr Michael Kent QC in his opening note on behalf of the Claimant helpfully suggests that they may be grouped under three broad heads: (1) negligent delay in getting the Claimant to theatre; (2) inadequate remedial surgery carried out at first and second operations; and (3) negligent advice as to available reconstructive options once necrotising myositis had been overcome, leading to an unnecessary through-knee amputation.
- At this stage the court is concerned with issues of breach of duty, causation and extent of injury.
The Legal Framework
- The test for the standard of care required of a doctor is that a doctor is not negligent if he acts in accordance with practice accepted as proper at the time by a responsible body of medical opinion skilled in the same area of medicine. In Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, McNair J stated, in so far as is material, as follows:
"The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.
I myself would prefer to put it this way, that he is not guilty of negligence if he has acted in accordance with the practice accepted as proper by a responsible body of medical men skilled in that particular art… Putting it the other way round, a man is not negligent if he was acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view."
- A doctor is not negligent if a responsible body of medical opinion would have done the same. Lord Scarman in Maynard v West Midlands Regional Health Authority [1984] 1 WLR 634 at 639 stated:
"A Judge's 'preference' for one body of distinguished opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions truthfully expressed, honestly held, were not preferred. Failure to exercise the ordinary skill of a doctor (in the appropriate speciality, if he be a specialist) is necessary."
- The test is to be applied prospectively, not retrospectively. In Maynard Lord Scarman said (at 638):
"It is not enough to show that subsequent events show that the operation need never have been performed, if at the time the decision to operate was taken it was reasonable in the sense that a reasonable body of medical opinion would have accepted it as proper."
The factual background
- In July 2008 the Claimant was a 40 year old woman with four children who was normally in good health. On 17 July 2008 she visited her GP as she had had a sore throat for about three days. On 19 July she felt a lot worse. It was painful to swallow and she was getting muscle pains, particularly in her right thigh. At 2032hrs she went to see Dr Hikmat at Gosport War Memorial Hospital. At around 0645hrs on Sunday 20 July she saw Dr Farmer at Drayton Road Surgery. She diagnosed a trapped nerve and gave her an injection of diclofenac. The pain by now was the most excruciating, she says, she had ever experienced. At 0930hrs on 20 July she went to Accident & Emergency at the Haslar Hospital. The doctor did not think it was a trapped nerve. She was referred for urgent medical attention to QAH where she arrived at around 1025hrs on Sunday 20 July.
The Evidence
Part 1: The Clinical Notes
- Shortly after her arrival at QAH on 20 July the Claimant was examined at 1130hrs by Dr AJP in Accident & Emergency Department ("A&E"). The clinical note (4/492) includes the following:
"Right thigh pain; no history of trauma; spontaneous pain; yesterday; gradually increasing; ??? in the thigh; no back pain; full weight bearing; full range of movement at hip and knee; seen by general practitioner, treated with diazepam; no history of deep venous thrombosis; pain not getting better; past medical history – nil.
On examination pain
Right thigh
Tense, swollen, anterior thigh only
No loss of sensation
No loss of pedal pulses
No obvious myositis
Full weight bearing
Full range of movement
? cause
? muscular spasm
??? compartment syndrome
Plan: orthopaedic review
Analgesia
Observations until reviewed."
- At about 1200hrs on the same day the Claimant was seen by an orthopaedic SHO (Dr V). The clinical entry is at 3/215. He was asked by A&E to review her. The presenting complaint was "pain in right thigh since ?? yesterday". The notes include:
"Sudden onset of pain right thigh yesterday.
No pain in back
No history of any injury or trauma
No fever or nausea
Able to weight bear
Past medical history: nothing of significance
On examination right leg sensation intact. Power normal. Hip movements – full range of movement
Knee – full range of movement. Not tender to palpation, no erythema
Discussed with [Mr Richards]
Does not need orthopaedic intervention."
- At 1520hrs a blood sample was taken from the Claimant and sent to the laboratory (3/216). The request (4/585C) requests assays of, inter alia, "creatinine kinase" and "CRP".
- At 1920hrs the Claimant was seen by SPR orthopaedic Mr Bolland. The clinical note is at 3/216-7. The record includes the following:
"Three day history of anterior thigh pain.
Sudden onset of thigh pain gradually increasing in intensity; spasmodic and colicky in nature.
No history of trauma. No systemic symptoms of infection.
Able to weight bear.
Pain now ??? along medial aspect to knee.
No history of back pain, pins and needles or numbness lower legs.
On examination: in obvious discomfort.
Temperature: apyrexial
Haemodynamically stable
Anterior thigh swollen. Hard but not tense.
No erythema. Very minimal increase in temperature.
Adductor compartment tender but soft.
Posterior compartment normal.
Knee – effusion ++. No erythema, very minimal increase in temperature.
No joint line tenderness. Range of movement 0-110, painful at extremes.
Well perfused lower limb. Compartment soft.
Pedal pulses present.
No femoral stretch.
Creatine kinase – 3030
X-ray normal.
Implication: concerned this lady has ischaemic muscle in anterior thigh.
?aetiology ?vasculitic ?inflammatory ?infective
Plan: needs to exclude space occupying lesions in anterior thigh. ?bleed
Ultrasound scan
Ideally MRI scan would be ???imaging
Discussed with [Mr Richards]. Suggests general surgical review for ??
Will review after ultrasound scan."
- The ultrasound scan was done. The clinical note included the following:
"Muscles of the medial and posterior compartment appear normal. Orthopaedic registrar informed. Appearance would suggest muscle oedema/inflammation.
Femoral vessels show normal"
- At 1950hrs Mr Bolland made a note of his conversation with the general surgical specialist registrar. The clinical note is at 3/217 and includes:
"Will kindly review and give opinion. Will also ? H/O to orthopaedic SpR tonight to review and liaise with general surgery SpR. Needs regular review re pain levels. Accident & Emergency happy to monitor in A&E until reviewed by general surgeons."
- At about 2000hrs the general surgical registrar saw the Claimant. His clinical note is at 3/218 and includes the following:
"Spontaneous painful swelling right thigh this morning.
No history of trauma
Recent urinary tract infection/laryngitis
Right thigh swollen and tender
Implication: right thigh developing compartment syndrome secondary to ?spontaneous rhabdomyolysis
Plan: Urgent review by orthopaedic surgeons
Discussion with orthopaedic registrar and Mr O'Leary, consultant surgeon agrees not general surgical. Orthopaedic registrar has kindly agreed to review."
- At 2100hrs the Claimant was seen by Mr Stenning, the orthopaedic special registrar who had replaced Mr Bolland. His clinical note is at 3/218 and includes the following:
"Patient's pain continues
Thigh tender but not tense to touch
No increased pain expressed on passive stretching of thigh
Clinically not acute compartment syndrome yet."
- At 2130hrs Mr Stenning made a request for blood assay.
- At 2245hrs Mr Bland, an A&E consultant, saw the Claimant. His clinical note is at 3/219. It refers to
"Frequent discussions with orthopaedics but no surgical management
Moved to resuscitation
Need senior orthopaedic review ??surgery
Clinically a compartment syndrome
Aim: urinary output 1000ml per hour
If myoglobin urea a high risk of acute tubular necrosis [illegible]
Bloods repeated by orthopaedic team"
- At 2250hrs there is a nursing note (4/500):
"Transferred back to major/room 1 due to deterioration awaiting orthopaedics."
- At 2300hrs there was an orthopaedic review by Mr Stenning. His clinical note is at 3/220.
"Patient's thigh deteriorating
Mottled areas over skin anterior and posterior
Pain continues
Discussed with [Mr Richards]
ITU opinion
Prepare for theatre tonight"
- Clinical notes record an update by Dr Bland at 0040hrs (3/220) and Mr Stenning seeing the Claimant at 0045hrs (3/221), recording:
"Area of discolouration increasing in size and number.
Discoloured skin insensitive.
Creatine Kinase 12000
[Mr Richards] called. Await ITU opinion before decision."
- At 0100hrs on 21 July the ITU specialist registrar saw the Claimant. The clinical note is at 3/222. It includes the following:
"Three days of laryngitis recently. Nil else
Presented yesterday during the day with right thigh pain with no obvious cause
Seen by orthopaedic surgeon – clinically not a compartment syndrome
Transferred to observation ward for further investigation.
Throughout the day increasing pain and swelling and now skin discolouration – much worse on lateral aspect of thigh
The worst pain has been over the last 3 hours
Right thigh tense
Implication: compartment syndrome in thigh ?causing acute renal failure
Needs urgent fasciotomy"
- Mr Stenning made a note at 0110hrs (3/221).
"ITU have reviewed. No point in resuscitating prior to surgery.
2 theatres currently running (appendicitis and bleeding AAA)
Our case for theatre as soon as one of these is finished."
- At 2000hrs Mr Richards reviewed the claimant. The note is at 3/224.
"Very tense thigh
Very difficult to feel pedal pulses, but has normal sensation in foot
Has very high creatinine kinase causing incipient renal failure
There appears to be a compartment syndrome, worse over last four hours with signs of rhabdomyolysis
There is no history of orthopaedic injury or problem but nonetheless she needs an urgent fasciotomy. The vascular surgeons earlier were not keen to operate, but since then has deteriorated."
- At 0305hrs there is an ITU note (4/864) which ends:
"Implication: ?compartment syndrome ?necrotising fasciitis
Plan: resuscitation is continued… Patient is to go urgently to theatre for fasciotomies"
- At 0306hrs ITU note:
"Leg impressively bruised antero-medial and antero-lateral thigh plus areas over knee and lower thigh
Cause unclear, quite probably sepsis ?strep
Blood cultures taken here."
- Mr Richards performed a fasciotomy at about 0320hrs on 21 July, decompressing the anterior thigh. The operation note is at 3/225. Mr Richards explored the tissues, but he did not carry out any debridement (removal of dead, damaged or infected tissue) at that stage. The note includes the following:
"Lateral incision whole length of thigh. Deep fascia opened.
Dead-looking oedematous muscle.
??fluid slightly cloudy sent for culture and sensitivity
Muscle biopsy sent for culture and sensitivity
Muscle biopsy sent for histology
Muscle bulged out decompressing anterior compartment where most pressure was. Left open.
Post operatively to ITU. I will review later today."
- The Claimant was returned from theatre at 0432hrs. At 0507hrs the fluid results were received. The note reads:
"Fluid from leg taken in theatre… numerous gram positive cocci"
Mr Richards was informed of this at about the time of his ward round at 0800hrs on 21 July. He noted (3/230)
"There is probably an infective cause for her rhabdomyolysis. Hopefully with appropriate medical management now, antibiotics and fluid support, she will recover. She may well require a further look at her thigh to see whether there is any necrotic muscle that needs to be excised but I suggest that this does not need doing until at least Wednesday. This can be then managed clinically. Hopefully as it was decompressed within six hours the degree of muscle necrosis should be minimised."
- A clinical note at 1805hrs records:
"Group A streptococcus on venous blood cultures. … Condition worsening… Wound examined with Mark Pemberton… Wound probed and non-viable muscle seen. Mark is seeking a second opinion from Graham Hill."
- At 2016hrs there is a note by Dr Blakely, an ITU consultant, recording events since 5pm which includes the following:
"Review of right thigh with Mr Pemberton – necrotic muscle seen in fasciotomy scar but worrying dusky mottled skin over medial aspect and over lower leg. Altered sensation over most of right leg now. Pulses hard to feel. The surgery that is needed is likely to be extensive with the possibility of needing to progress to an amputation. He will speak to Mr Hills (orthopaedics) to gain a second opinion.
Subsequent review with Mr Hills – agreed extensive necrosis, will need laying open of medial compartment and lower leg compartments ?need to open other compartments to see if further pockets of infection/necrosis. May well lead to amputation but this will be the first option.
CT shows extensive necrosis with some tracking of oedema fluid up right psoas muscle to retro-peritoneal space (explained right-sided abdo pain). …
After discussion with all surgical parties with her and her family Karen will go to theatre tonight for opening up of the muscle compartments and excision of necrotic muscle but what exactly will be done will be guided by the findings at the time. Karen and her family are aware of that including the possibility of amputation at some stage."
- There is a further note by Dr Blakely at 2025hrs:
"Karen and her family have been spoken to by myself, Mr Hill and Dr Turner (Anaesthetics). They are aware that she will need fairly drastic surgery and that an amputation may be a possibility at some stage. Both her and Paul agree that it is better to lose limb than life."
- The second operation on the Claimant was performed by surgeon CDR Hill at 2230hrs on 21 July. This was the first time debridement of dead tissue was performed. The note made by Mr Hill is at 3/227 and includes the following:
"The findings are of necrotic tensor fascialata, vastus lateralis, vastus medialis and vastus inter medialis with a great deal of oedema and necrotic fat.
Most of anterior compartment is removed because necrotic. The knee is found to be full of pus, which is drained and lavaged.
The postero-medial compartments contain viable muscle.
The gluteal muscles appear viable.
Extensive lavage is carried out.
It is not clear whether the fat and skin needs to be removed."
- Following the second operation the Claimant returned to theatre on a number of occasions for further debridement. Between around 28 July and 4 August when she gave her consent to amputation there were discussions involving the Claimant, her husband and family with consultants and doctors about the options, including amputation. This evidence as to these discussions is in dispute and I shall consider it further below. On 5 August the amputation was performed.
Part II: Witnesses of Fact
- Mrs Jones gave evidence of her medical condition and communication with doctors prior to her arrival at QAH on Sunday 20 July (see para 8 above). She said that when she went to see Dr Farmer her husband had virtually to carry her into the surgery as she could not bear weight through her right leg and he half-carried her back to the van to return home. She was unable to travel in the van seat and had to kneel, wedging her right leg between the seat and the door. Later when they went to QAH, her husband helped her into the hospital. She said in her witness statement dated 13 November 2012 that she and her husband "made sure that every Doctor we spoke to was aware that I had been suffering from a sore throat before I developed sudden and very severe leg pain with no history of trauma, and yet none of them made the link until after I had had the first surgery" (para 57). However in cross-examination the Claimant said that she does not now remember going into A&E at QAH. She cannot now recall anything between the time when she arrived at A&E and waking up about two months' later when she realised that her leg had been amputated through the knee.
- The Claimant accepted that she signed the consent form for the amputation of her leg (3/356). She said that the signature was not her normal one. She does not remember anything about it or discussing options with anyone. Personally she would rather have kept her leg. Her foot was working as a foot. If she had been told that an option (other than amputation) might not have worked, she would have tried it first and seen whether it did work. She assumes that the discussion of the options was with her husband. She appreciates from the medical records that she has now seen that the option of amputation was discussed with her at the time, but she comments that she really did not know what was going on then and perhaps they could have waited until she was more lucid to discuss it with her.
- Mr Paul Jones, the Claimant's husband, said that he told the doctor who examined his wife in A&E at 1130hrs on 20 July that his wife had had a sore throat for about a week. He said that he constantly mentioned the sore throat to the doctors without exception. Their daughter had had meningitis three month's earlier so he knew the implications of a sore throat. He said that the doctor was wrong in noting that his wife was full weight bearing.
- Mr Jones said that on 31 July 2008 his wife was quite confused. He said in his witness statement (at para 39):
"We were spoken to by the consultant in rehabilitation who talked about the pros and cons of either amputation, or complete fusion of the leg. Karen was still quite paranoid about everything and I was worried that she might refuse the amputation although this seemed to be the best option. I remembered Karen saying at the beginning that her life was more important than the leg."
- Mr Jones said that there were a number of meetings during the days leading up to the amputation. However he only had one meeting with the plastic surgeon, Mr Demetrius Evriviades, about the pros and cons of amputation and that was late at night. He said he was told that keeping the leg was not a viable option. It would be a hindrance. The advice that was given led him to believe that amputation of the leg was the best option for his wife. Complete fusion of the leg, he was told, was not a viable option. He said that he did ask about saving Karen's leg and was told by the plastic surgeon that he would be overruled. They said that Karen had given her permission when she first went to ICU. He said what Karen actually said was "take my leg if it means saving my life". However at the time the leg was amputated he did not think that her life was at risk.
- Mr Bolland, who was then employed as a Specialist Registrar Trauma and Orthopaedics at QAH, saw the Claimant at 1920hrs on 20 July to carry out a full review. Referring to his note at 3/216, he said that the Claimant did not mention any history of trauma and there were no "systematic symptoms of infection". He would not have written that if she had said that she had had a severe sore throat. If she had told him she had had a sore throat and had had it for a number of days he would have noted that. He noted that she was able to bear weight. That meant that she was able to stand up on her legs.
- She told him of a three-day history of anterior thigh pain and how intense the pain was. He examined her. Her thigh was swollen, "hard but not tense". That did not imply to him a compartment syndrome. Further, he said, it is very rare to have compartment syndrome without trauma.
- Mr Bolland said that he did not know what was going on in the thigh, and that is why he thought there was need for further investigation. He had blood results, available to him, which showed a high creatinine kinase level at 3,030 which made him concerned that the Claimant may have some ischaemia in the muscle in her anterior thigh which was of unknown cause. He said it did not all add up. She had no temperature and no inflammation of the muscle. He wanted to discuss the matter with Mr Richards, his superior, the orthopaedic consultant on duty.
- At 1950hrs, at Mr Richards' suggestion, he discussed the Claimant's case with a General Surgical Registrar and asked him to review it and give an opinion.
- Mr Bolland said that if he had been told about the Claimant's sore throat that would not have changed his management of the case at the time.
- Mr Bolland said that he requested an ultrasound test to be done.
- At 2000hrs he went off duty and Mr Stenning took over from him.
- Mr Richards, consultant orthopaedic surgeon, said that he was on duty at QAH on Sunday 20 July 2008. He said that he was contacted at about noon by the orthopaedic SHO (whose name is not known). He referred to the SHO's note which is at 3/215. He said that there was no evidence of trauma to explain the pain in the Claimant's upper thigh. His view was that this was a matter for the A&E team to deal with and perhaps refer to either the vascular surgery or general surgery team in case there may be evidence of DVT or vascular compromise. He thinks he would have been told that the pain started at 1600hrs on the previous day; so it was a sudden onset. There was no relevant past history. What was reported to him indicated that it was not compartment syndrome.
- Later that day Mr Bolland contacted him after his examination of the Claimant at 1920hrs. Mr Bolland discussed with him his findings and concerns. Mr Richards indicated that given there was no orthopaedic trauma on which to place any potential orthopaedic diagnosis this was really a matter for a general surgical registrar given there was a differential diagnosis of ischaemic muscle in the thigh. Mr Richards advised Mr Bolland to refer Mrs Jones's case to the general surgical team for a full review.
- Mr Richards said his overall impression after the case was presented to him by Mr Bolland was that it did not sound as if she had established compartment syndrome. He was concerned as to the cause of her symptoms. That is why he suggested general surgery be asked to review the case.
- Mr Stenning, the orthopaedic registrar who saw the Claimant at 2100hrs recorded that this was not yet a compartment syndrome. He said he agreed with the diagnosis at that time. Her symptoms were not indicative of compartment syndrome. Mr Stenning noted that there was no increasing pain "on passive stretching of thigh" (3/219). One would normally expect pain if there was compartment syndrome. Therefore he formed the view that clinically there was no acute compartment syndrome yet.
- However by 2245hrs it was apparent that her symptoms were getting worse. A note made by Dr Bland, an A&E consultant, suggested that by this stage she had compartment syndrome. Mr Richards did not agree. He was contacted again at 2300hrs by Mr Stenning. He instructed the orthopaedic registrar to ensure that Mrs Jones was prepared for surgery (3/220). He considered that in order to obtain a proper diagnosis it would be necessary to look into the thigh to see what was happening in the muscle and to take biopsy samples for microbiology. He thought there was a risk that the Claimant was going into some form of septic shock and she needed to be resuscitated before she was suitable for surgery. He was concerned to improve her general condition before surgery.
- Mr Stenning contacted Mr Richards at 0045hrs on 21 July. Again he advised that it was necessary for the Claimant to be resuscitated before she went to theatre.
- By 0110hrs on 21 July there was a concern she had gone into kidney failure, her CK level had increased to 12,000 which indicated further muscle breakdown. It was at a very, very high level, but it still was not known what caused it. However a theatre was not available. There were only two operating theatres that night and there were two major surgical interventions going on at the time. No other cases were waiting. The intention was to prepare the patient and get her in next (3/221).
- Mr Richards examined Mrs Jones at 0200hrs (3/224). She had very tense thigh. This appeared to be a compartment syndrome, but not yet a well defined compartment syndrome as she still had feeling in her foot. She was approaching renal failure. Plainly she was very unwell. She had deteriorated from 2300hrs on 20 July. Mr Richards could not understand what reason she had developed a compartment syndrome, but whatever the cause, she was very unwell and needed release from the tension. Her condition was deteriorating and the thigh was showing signs of deterioration.
- Mr Richards proceeded to an operation which commenced at about 0320hrs and performed a fasciotomy of the right thigh. When the fascia was opened, she was noted to have swollen muscle and free fluid in the thigh area. There was evidence of some muscle having reduced vascularisation. Mr Richards said that in his view it was inappropriate at that stage to debride any of the muscle until such time as there was a clear diagnosis and they knew exactly what the source of the pain was. This was a very major surgical procedure. There was need to balance the benefits and risks before proceeding. Earlier when she had developing compartment syndrome it would be unlikely that much dead muscle would be seen, and therefore at that time the risks outweighed the benefits. The operating note is at 3/225. The operation started at 0320hrs on 21 July. There was very high pressure in the compartment. He saw "dead-looking swollen muscle". He decided not to remove the muscle for two reasons. First, it was not clear why the thigh swelling had developed; and second, in the case of compartment syndrome there can be some recovery if an operation is done within six hours of it having started. She was very ill and he was concerned about doing further surgery. He considered that the safest thing was to have her resuscitated. He considered the muscle might recover considering it had got worse over the last four hours, but within the six hour window.
- Mr Richards took muscle specimens from the Claimant which included fluid which was sent to microbiology for urgent investigation. He also took a muscle biopsy which was sent to histology. He was suspicious that there was infection and that was why he sent the specimens for urgent investigation. The result showing gram positive cocci was phoned through at 0505hrs on 21 July. That told him that the cause of the swollen thigh was infection, but he did not know what infection. It was not until about 0830hrs that morning that he was informed that the organism was a group A streptococcus. He was unaware at the time of doing the operation that it was that organism or that it caused such widespread damage. He said that if he had known that it was that organism and the extent of the damage it did then they would have taken more of the muscle out during the first operation, whether it was dead or not.
- Some 4-5 hours after surgery Mr Richards reviewed Mrs Jones who was on the intensive care unit. He discussed her case with his colleague, Mr Pemberton, a vascular surgeon, who agreed to take over her care. A streptococcal infection was not primarily an orthopaedic issue. Mr Pemberton then enlisted the assistance of Commander Hill, an orthopaedic colleague of Mr Richards, who performed a major debridement which involved removing a good deal of necrotic tissue, including most of the anterior compartment. He also removed the quariceps muscle, and drained the knee joint which was filled with pus.
- Mr Richards said that the Claimant's condition was extremely rare and not often seen amongst practising orthopaedic surgeons. Compartment syndrome in the thigh is very rare; if there is no trauma, it is even rarer. He began as an orthopaedic consultant in 1993. He had never come across a case of necrotising myositis before. He said that the purpose of the first procedure was to obtain a biopsy for the microbiologist to identify the precise nature of the potential infection so that they could investigate the correct treatment. All of her initial symptoms and right up until the point when he was performing the biopsy, there was no indication that she was suffering from necrotising myositis. As there was no clear diagnosis, in his judgment at that time there was no need to immediately debride until such time as the cause of the poor perfusion was diagnosed and until it was clear that irreversible ischaemia of the muscle had occurred; that would not be appropriate where there was still an opportunity for the muscle to revascularise. Mr Richards did not accept the opinion of the plastic surgeons expressed in their joint statement (2/494) that compartment syndrome had developed by 1520hrs on 20 July. She had a painful swollen thigh which is one feature of the syndrome, but none of the other features were present. Mr Richards put the time of her deterioration as starting at 2300hrs on 20 July (3/220).
- Mr Hand has been a consultant orthopaedic surgeon since 2003. He said he had never come across a case of necrotic myositis before, but it has twice since. He described himself as a limb salvage surgeon who is in the business of saving limbs.
- He said he discussed the options with Mrs Jones and her family. He understands that Mrs Jones alleges that she was not given sufficient information regarding the condition of her leg in order to give an informed consent with regard to the amputation; and that she also suggested that her lower leg was still viable and she should have been given additional time to consider the amputation. He said that he discussed the options with Mrs Jones and her family.
- Mr Hand said that the prospect of her having a normal knee was non-existent. Further, the area between the top of the kneecap up to the hip joint muscle was missing. It would be a massive undertaking to get muscle tissue from another area of the body. Mr Evriviades suggested taking major muscle from the shoulder. Mr Hand differed from Mr Evriviades on soft tissue reconstruction. He said that the fused option would involve repeated operations, whereas amputation would involve one operation for a very sick lady. With modern prosthetics she could be more mobile after an amputation. He was asked for his preferred option and he said amputation and fillet of the leg.
- Mr Hand said that the normal practice is for two surgeons from different departments to take a decision as to whether to amputate or not. He considered the operation to be urgent. There was a difficult balance here; the Claimant had been knocking on death's door on a few occasions; they had to improve her metabolically but they also had to get on top of the infection.
- Mr Hand accepted that his witness statement was not clear as to when he had his meetings with Mrs Jones and the family. He said he did not take notes of meetings; they were normally taken by more junior doctors.
- Mr Hand said that there was always more than one option in this case, as he told the family. Mrs Jones was included in discussions as much as possible, but she displayed paranoia and short-term memory problems.
- Mr Hand was asked about clinical notes that suggested that by 31 July a decision had been taken to amputate (4/797-800). He said that a date for surgery had been planned for the following Tuesday, but it was still open as to what surgery would take place. His state of mind, as he thought it was the best solution, was that it was likely to be an amputation.
- Mr Hand said that he was one of the doctors who was present at the meeting at 0821hrs on 4 August. The clinical note (4/823) states:
"Evaluation: DRS has spoken with Karen and her husband and she has seen the pictures of her [leg]. Karen has spoken with the physio about prosthetic limbs and the consequences of above and below knee amputation. Karen is naturally angry with her situation but appears to be starting the process involved in resolving her altered body image."
- Mr Hand said that he saw Mrs Jones again later that day at 1631hrs. He had a meeting with her that lasted half an hour or more. He said that amputation had to be a mutually agreed procedure. He filled in the consent form beforehand (3/356). He took it to Mrs Jones and went though it with her. Recorded on the form is the proposed procedure, the intended benefits and serious or frequently occurring risks. He said he explained why it was the best thing to do. He was satisfied Mrs Jones understood and chose the option of amputation. There is a clinical note (4/827) which records as follows:
"Situation discussed with family, option of amputation v/s limb salvage discussed. Family and patient agree with preferred option of through-knee amputation.
All aware that unlikely to go without any complication at all.
Patient consented, complications explained."
- Mr Evriviades is a consultant plastic and reconstructive surgeon. He became involved in the Claimant's treatment on or around 24 July 2008.
- He described Mrs Jones's condition after further debridement procedures had taken place on 25, 27 and 29 July. He said that by that stage she had lost all the skin, tissues and muscles of the right thigh although her right calf remained viable. The only remaining part of the upper anterior thigh was the bone and main arteries. She had lost the knee extensor and therefore was in a position where she would have been unable to use the knee of the right leg.
- He met with Mrs Jones's husband and her family and discussed the condition of her leg with regards to reconstruction. He explained that from a plastic surgery perspective reconstruction in order to save the leg would be very difficult. The only way of retaining the leg would be to remove skin and muscles from her shoulder and upper back and graft these onto the upper thigh. She would require a fusion of the knee joint which would leave her unable to bend her knee.
- He said that he explained to Mrs Jones that the risk of the procedure was that the graft would not take well and therefore would fail. In any event she would be left with a significantly weakened shoulder or shoulders which meant that if she needed to use crutches or a wheelchair she could have great difficulty as her upper limb mobility and strength could be limited.
- He said he explained to Mrs Jones the other option which was a through-knee amputation. He would use the muscle, tissue and skin from the right calf and foot area and reconstruct this onto the upper thigh. She would be left with a stump for which she could then obtain an appropriate prosthesis. He said that he advised her that by grafting the skin in this way it had greater prospects of succeeding than the graft from the shoulder. Further he explained to Mrs Jones that she would be able to have a prosthetic limb with a hinged joint at the knee. This was likely to give her greater mobility than having a stiff leg with fused knee joint. Further it would also preserve her upper limb shoulder strength should she require crutches or a wheelchair in the future.
- He said he advised Mrs Jones that on balance a through-knee amputation was the best option for her. It was her decision but there was a limited amount of time for her to make the decision as the arteries in the upper thigh were exposed and therefore at considerable risk of further infection which could produce a catastrophic bleed.
- He said he had discussions with Mr Hand about the options. He described this as a very difficult, unique and challenging problem. Ultimately a consensus was reached. There were two options technically feasible, but they felt only one advisable. Reconstruction was technically feasible. The real problem was the weakness it produces in the shoulders and the consequences for Mrs Jones using crutches.
- He said he saw the family and the Claimant on two occasions. The first he believed was on 27 July. He had an extensive conversation with Mr Jones and an adult female member of her family. There was a long discussion about limb salvage versus amputation. He saw Mrs Jones at her bedside but he said she was not able to take anything in.
- The second consultation he had, he said, was when Mr Hand was present on 4 August. It is the one he refers to at paragraph 8 of his witness statement. What they covered could not have taken less than half an hour. This discussion was not when the consent form was signed. He thought it must have been the one at 0821hrs on 4 August. However a clinical note (4/823 made at 1251hrs on 4 August) suggests that he was at the Haslar Hospital on that day. Mr Evriviades was nevertheless sure that this conversation with Mr Hand and Mrs Jones was relatively soon before the operation. He did though accept that one would expect to see his name in the notes if he had attended a meeting.
- Paragraph 8 of his witness statement conflates, he said, two meetings. The first three lines relate to a meeting he had with Mrs Jones' husband and her family. The remainder of paragraph 8 refers to a meeting that he said took place with Mr Hand and Mrs Jones on 4 August (as do paras 9, 11 and 12). At that meeting he recalled her saying she could still wiggle her toes.
Part III: Expert Evidence
(A) Emergency Medicine
- Mr Cottingham, for the Claimant, and Mr Heyworth, for the Defendant, gave evidence on the standard of care provided when the Claimant attended the A&E Department at QAH on 20 July 2008. Mr Cottingham's report dated 30 April 2013 is at 2/154. Mr Heyworth's report dated January 2013 is at 2/179. Their Joint Medical Report dated 4 October 2013 is at 2/191.
- Mr Cottingham and Mr Heyworth agree in the Joint Medical Report the following:
i) Assuming that the record of his note and examination findings is true, Dr Jones-Pahdi's (AJP's) management at 1100hrs on 20 July and his decision to refer the Claimant to the orthopaedic team was "reasonable" (answers 6, 19, 46 and 55).
ii) A reasonable examination was undertaken by Dr AJP (answer 42).
iii) It was not mandatory to order blood tests, but better practice (answer 9).
iv) It was not mandatory to prescribe antibiotics (answers 13, 14 and 53).
v) It was not mandatory to seek the opinion of a microbiologist (answer 16).
vi) If the doctor (AJP) was informed of the Claimant's sore throat, that should have been recorded (answer 33).
- On 8 October 2013 Mr Cottingham wrote a letter to the Claimant's solicitors (2/199). He said that letter was written in response to an e-mail from the Claimant's solicitors in which they set out "perceived discrepancies" between his original report and the joint medical report. In the e-mail of 11 September 2013 the Claimant's solicitors refer to the damage done to the Claimant's case by his concessionary joint statement. At the outset of his letter of 8 October Mr Cottingham wrote:
"I refer to some perceived discrepancies between my original Report and the joint experts' Report. I found the interaction with the opposing Expert quite a difficult one. I gained the impression that he had been asked to deal with only one aspect of the case; the speed with which Dr AJP referred the patient. This was of course reasonable, but I could not adequately discuss other aspects of the case."
Mr Cottingham then draws attention to certain specific matters in relation to the documentation of the Claimant's history, blood tests and nursing care where he expresses views different from those in the joint report. He concludes the letter as follows:
"I felt that many of the defence questions were specifically designed to place me in a position where my views could be painted as expecting unattainably high performance from AJP, and I tried not to fall into traps of hypothetical practice that would have taken place had the initial actions been acceptable. As the defence Expert was unwilling to discuss other matters that I do feel were relevant and important, I felt that the joint Report only partially addresses the issues."
- The Defendant's agenda for the meeting of the A&E experts expressly states:
"If the agenda does not raise questions which you consider relevant please add in any additional questions and your opinions upon them… It is important that any reservations, qualifications, however minor, should be included, so that the text fairly reflects your views. If you disagree with the wording of a question please feel free to amend it."
- Mr Cottingham in his evidence accepted that the overriding condition of compartment syndrome is that it is connected with trauma; one would normally expect to see a temperature with an infection. The Claimant did not have a temperature; she had normal blood pressure; she did not have much in the way of haemodynamic response to infection (2/176 at para 115 of his report). Mr Heyworth said that the features of the Claimant's presentation would not have put her in a group of persons requiring urgent attention. There was a need to take time to consider her very unusual case. He commented that none of the GPs who had seen the Claimant had thought that her sore throat required treatment with antibiotics. This suggested that the sore throat represented inflammation rather than infection.
- As for "full weight bearing" ("FWB") Mr Heyworth said that different clinicians ask the question in different ways and so the question is rather meaningless; in any event it is for each doctor and specialist to test for themselves. He said that if AJP had noted what the out of hours GPs had noted about weight bearing that would have made no difference to his management of the Claimant.
- Mr Heyworth said that when Mrs Jones was reviewed by the Emergency Department Consultant at 2245hrs, in his opinion the consultant acted correctly in recognising the seriousness of her condition at this stage and arranging immediate transfer from the Observation Ward to the Resuscitation Room (2/188).
(B) Orthopaedic Management
- Mr Baird, for the Claimant, and Professor Atkins, for the Defendant, gave evidence. Mr Baird's report dated 22 April 2013 is at 2/202. Professor Atkins' report dated 12 January 2013 is at 2/277. Their joint medical report is at 2/332.
- In their joint medical report Mr Baird and Professor Atkins agreed as follows:
i) In relation to the first orthopaedic review by Senior House Officer (SHO) at 1200hrs on 20 July
a) assuming the orthopaedic note (2/334) to be accurate the orthopaedic management at this time was reasonable (answer 1), and that the SHO had discharged his duty of care by seeking the advice of his consultant, Mr Richards (answer 3.3c at 2/348);
b) it was not mandatory to do blood tests immediately (answer 2), nor was it mandatory to start broad spectrum antibiotics (answer 3);
c) it was not mandatory to seek the opinion of a microbiologist (answer 5);
d) since the contemporaneous literature does not list a sore throat as an association of necrotising myositis and since in any event it was far beyond the clinical competence of a Senior House Officer to make a primary diagnosis of necrotising myositis since it is such a rare condition, a history of a sore throat would have made no difference to the situation (answer 7).
ii) In relation to the second orthopaedic review by Mr Bolland at 1920hrs on 20 July
They agreed:
a) assuming the contents of the note and the recorded outcome of Mr Bolland's examination were true and appropriately reported to Mr Richards it was reasonable and appropriate for Mr Richards to seek a general surgical opinion to exclude a vascular cause for the problem (answer 9);
b) it was reasonable and appropriate for Mr Bolland to order an ultrasound scan (answer 10);
c) the timescale over which this occurred was appropriate (answer 4.2 at 2/349);
d) broad spectrum antibiotics were not indicated at this point (answer 12);
e) it was not necessary to seek the opinion of a plastic surgeon or a microbiologist (answers 13 and 14).
iii) In relation to the third orthopaedic review by Dr Stenning at 2100hrs on 20 July
They agreed:
a) that assuming the orthopaedic note (2/340) to be accurate in their opinion he acted appropriately at this time (answer 15);
b) at 2100hrs a reasonable body of orthopaedic surgeons would have opted to continue conservative treatment. They were agreed that
"simple clinical examination does not exclude a compartment syndrome, however a thigh compartment syndrome in the absence of trauma is an extremely rare phenomenon and it was reasonable and appropriate for the attending clinicians to have a high barrier to surgery in a case such as this, since at best a compartmental decompression of the thigh would be a cosmetically disfiguring operation and at worst an unnecessary compartmental decompression may lead to significant morbidity or even death." (Answer 6.1 at 2/350);
c) it was not mandatory or appropriate to start broad spectrum antibiotics at this point (answer 16);
d) it was neither mandatory nor appropriate to seek the opinion of a plastic surgeon or a microbiologist (answers 17 and 18).
iv) In relation to the fourth orthopaedic management at 2300hrs by Mr Richards
a) They agreed that assuming the orthopaedic note to be accurate the orthopaedic management recommendation made by Mr Richards to seek an ITU opinion and prepare for theatre was appropriate (answers 19 and 20);
b) it was not mandatory to start broad spectrum antibiotics (answer 20);
c) there was no indication at this point to seek microbiological advice or to involve a plastic surgeon (2/351-2).
v) The experts were agreed in relation to the first operation by Mr Richards that
a) measurement of the compartmental pressures, decompression of the compartments and taking samples for culture and sensitivity was appropriate management (answer 23);
b) if there was obvious dead muscle, this should have been debrided at this primary procedure. If the clinician judged the muscle to be dubious, that it would be reasonable to retain it, since when decompressing a compartment syndrome, apparently dubious muscle may recover (2/343);
c) an anterior compartment excision was not indicated at this point (2/353). In any event had there been a complete clearance of the muscles of the anterior thigh at this first operation, it would not have altered the ultimate reconstructive options available (answer 26);
d) it was neither mandatory nor appropriate to seek the opinion of a plastic surgeon (answer 24).
vi) In relation to the second operation by Commander Hill on 21 July
The experts agree
a) that this surgery was undertaken to debride dead tissue. The exact amount of tissue to be removed was a matter of fine clinical judgment. So far as they could judge the clinicians had reasonably judged the amount of tissue to excise (answer 27);
b) it was not mandatory to seek the opinion of a plastic surgeon (answer 28);
c) removal of the fat and skin overlying the anterior thigh muscles would have made no difference to the ultimate functional outcome (answer 30).
- Professor Atkins said in cross examination that the decision to stabilise the Claimant on ITU between the first and second operations was reasonable and that the timescale between the two operations was reasonable. He said that he had been in this position and that you stabilise the patient on ITU "assemble your forces and then do the best [debridement] operation you can". He said it would have been "quite wrong" to take her back to theatre for another operation before she was stable as it might have killed her.
- In relation to the recommendation for a through-knee amputation the experts agreed that
"it was not mandatory to advise the Claimant to retain her leg. The duty of the attending clinicians was to attempt to weigh up the various options which were available to Mrs Jones and to attempt to advise her as to what the best reconstruction was. [Mr Baird] believes that the choice of a through-knee amputation was favoured as it provided readily available muscle and skin to reconstruct the large soft tissue defect of the knee although it meant removing a sensate and useful foot. [Mr Baird] believes that if there were other plastic surgical options which would have been likely to successfully reconstruct the thigh then knee arthrodesis and a useful foot would have given her reasonable function and avoid amputation.
The experts were agreed that, so far as they could judge the clinicians had exercised this clinical skill appropriately and it was not mandatory to advise the Claimant to retain her leg." (Answer 31).
- They agree that the Claimant "represented a unique situation" (answer 31); the attending clinicians had come to an appropriate decision concerning the best reconstructive option for Mrs Jones, taking into account the clear urgency of reconstruction in view of the exposed femoral vessel and bone (answer 13.1); and through-knee amputation with modern prosthetic reconstruction was an appropriate procedure (answer 32).
- In answer to the question as to whether it was reasonable to carry out the amputation at this particular point in time or whether it was mandatory to delay it,
"The experts noted that at the time of the amputation the clinicians were concerned that desiccation of the femur and exposure of the femoral neurovascular bundle were occurring. These issues made surgery urgent and therefore it was not mandatory to delay surgery, nor was it clinically desirable to do so." (Answer 33).
They agree that it would have been possible to retain the leg, but it would have been fused at the knee, the residual limb would have a stiff knee and be somewhat short (answer 34).
- On 20 October 2013 Mr Baird wrote a letter to the Claimant's solicitors following, he said, a suggestion by them that there should be a review of the joint report and his earlier report with Counsel. He states at the start of the letter that notwithstanding the contents of the joint report he does not resile from the views he expressed in his own report on Breach and Causation. Then in the body of the letter he expresses a change of view on the answers to various questions given in the joint report. The explanation he gives in the letter for his change of view on certain matters is as follows:
"In relation to the Defendant's questions, I felt that the repeated use of the phrase 'mandatory in the Bolam sense' was pejorative and restricted my ability to express my opinion as to what a reasonably competent orthopaedic surgeon should have done. In addition the clinical picture outlined in some of the questions belied what I believe to have been the reality at that time which makes it appear that I support the view that the orthopaedic surgeons did not miss anything or act in a substandard way. This is not the view expressed in my own report."
In cross-examination he said that he did not know why he did not include his views in the joint report if they were truly his opinion. He said that before being approached by the Claimant's solicitors and counsel he did not think he had made inappropriate concessions in the joint report. He accepted that if he had thought that his ability to express his opinion was restricted during the course of the joint discussions he should have said so at the time. He accepted that what he said in his letter about the significance of a sore throat, the surgical management of the procedure and clearance of the muscles of the anterior thigh at the first operation represented a change of view to what he agreed in the joint report in Answers 7, 23 and 26 respectively.
- Mr Baird accepts, following discussion with Professor Atkins, that the decision to amputate through the knee was a reasonable decision. Accordingly the Claimant no longer pursues an allegation in that regard.
- The plastic surgeons in their joint report (2/494) agreed that the Claimant developed compartment syndrome that could/should have been diagnosed on the basis of the clinical signs and the elevated creatinine kinase at 1520hrs on 20 July. Professor Atkins said they were all wrong about this. Compartment syndrome cannot be diagnosed on the basis of elevated creatinine kinase.
- The microbiologists in their joint report stated that they would have performed emergency surgical debridement on "suspicion" of Group A streptococcus (2/404). Professor Atkins said he parted company with the microbiologists on this. He said it was important to do debridement in a timely fashion. The critical issue at the first operation was to save the patient's life. In his opinion the decision of Mr Richards not to debride was a reasonable one.
- As for the references in the notes to full weight bearing, Professor Atkins said that for any doctor to reach a decision on that they would have had to have asked a series of questions: can you stand? Can you walk? Is it painful? In his opinion if the Claimant had had a weight bearing problem and that had been known, he did not think that that would have accelerated her diagnosis.
(C) Plastic Surgery Management
- Mr Stone gave evidence for the Claimant and Mr Parkhouse for the Defendant. Mr Stone's report on condition and prognosis dated 7 October 2011 is at 2/406 and his report on breach of duty and causation dated 8 May 2013 is at 2/431. In addition Mr Stone wrote a letter dated 23 October 2013 to the Claimant's solicitors on the issue of blood tests and causation. Mr Parkhouse's report dated 22 January 2013 is at 2/478. the plastic surgeons' joint report, following a telephone meeting on 22 July 2013, is dated 26 September 2013 (2/493).
- The first page of the joint experts' report records the following (2/493):
"The Experts agree that there was multi-disciplinary input into the Claimant's care from doctors in emergency medicine, orthopaedic surgery and general surgery. There was no plastic surgery involvement until 22 July 2008, by which time the diagnosis had been made and the initial debridement had been performed.
The Experts agree that we have been tasked to comment upon aspects of the Claimant's management by specialities other than our own, with the benefit of hindsight."
- In answer to the question "Had [the Claimant] gone to theatre six hours earlier (around 2100hrs on 20.07.2008) and radical surgery been undertaken what would have been the result?", the experts agree that it is likely on balance that some anterior compartment muscle would have been preserved, but it is not possible to know how much (2/494). Mr Parkhouse said when he came to give evidence that from what he has learned listening to the evidence, in particular from Mr Evriviades, of damage to certain parts of the Claimant's leg, which was more than he appreciated, he is not sure about this. In his opinion it might not have made any significant difference to the amount of muscle eventually debrided if the Claimant had gone to theatre six hours earlier. He could not say that there would have been no amputation.
- In answer to the question "Were there features of a compartment syndrome?", the experts agreed that the Claimant had developed a compartment syndrome that could/should have been diagnosed on the basis of the clinical signs and the elevated creatinine kinase at 1520hrs on 20 July (2/494).
- The experts agreed that amputation was not the only option for the Claimant (2/495). In answer to the question "What would have been the result had the limb been salvaged?", the experts agreed that there would have been little or no knee extension, or a permanently stiff knee if arthrodesed. The Claimant would, however, have retained a full sensate lower leg and foot, full ankle movement and the ability to weight bear. There would have been extensive scarring on the leg and abdomen or back (donor site scarring), with weakness of the abdominal wall and bulging if a rectus abdominis-based flap were used. An abdominal incisional hernia can also occur after removing the rectus abdominis muscle (2/495).
- Mr Stone accepted in cross-examination that it was not appropriate for him to comment on A&E management, nor was it appropriate for him to comment on orthopaedic management. He accepted that whether a muscle is completely dead or can possibly be revived must depend on what the orthopaedic surgeon sees and what view he comes to with his clinical experience. He did not suggest that an orthopaedic surgeon would be negligent in not involving a plastic surgeon in a debridement.
- Mr Stone said that the decision to amputate is a multi-disciplinary process. Mr Hand received input from the plastic surgeon, Mr Evriviades. He accepted that once all muscles had been removed from the thigh there was a difficult balancing exercise. He did not disagree that there were two options for the Claimant.
- Mr Parkhouse said that the extensive muscle debridement of the thigh resulting in complete loss of the extensors would have posed a very major reconstructive challenge which he believed would have been wholly unsatisfactory from a functional point of view (para 3.9 of his report).
- With regard to the view of the microbiologists as to when radical debridement should have been performed, Mr Parkhouse observed that microbiologists can view the hurly burly of the world through the window of a laboratory.
(D) Microbiology
- Dr Rothburn gave evidence for the Claimant and Dr Dryden for the Defendant. Dr Rothburn's report dated 8 May 2013 is at 2/359. Dr Dryden's report dated 22 September 2012 is at 2/388. They had a meeting on 8 August 2013 which led to joint statements dated 15 August 2013 (2/399-405).
- They agreed that the infection affecting Mrs Jones' right leg was caused by Group A Streptococcus. They also agreed that the sore throat was the probable source of bloodstream spread seeding the leg (answers 2.1 and 2.2).
- They agreed that a medical microbiologist should be involved when invasive Group A Streptococcus infection is suspected and that in the event of a suspected diagnosis of invasive Group A Streptococcus infection their advice would be to take blood cultures and other investigations but not to delay the administration of effective intravenous antibiotics and also to perform emergency surgical debridement and other organ support as required (answer 3.2). They agreed that antibiotic treatment should have been started at the latest at the time of surgery (answer 3.3). They agreed that in necrotising infection the earlier tissue debridement is performed less extensive the spread (answer 4.1).
- Dr Rothburn said that the Group A Streptococcus infection in the Claimant's throat probably spread twelve hours before the leg pain started. By the time she arrived at QAH she had established infection. He said that on the balance of probabilities the condition was there by 1400hrs or so on 20 July. Dr Dryden said that the clinical signs clearly pointed to necrotising fasciitis by 2300hrs on 20 July (para 3.8 of his report at 2/396). This was, he said, a surgical emergency. He said that none of the evidence that Dr Rothburn gave did he disagree with. However he added that the Claimant was not septic until 2300hrs on 20 July. Prior to that, he said, the diagnosis was very unclear.
Discussion and findings of fact
(1) Allegation 1: negligent delay in getting the Claimant to theatre
- Mr Michael Kent QC, for the Claimant, identifies six issues of fact that he submits require determination in relation to this allegation. They are as follows:
i) Was the Claimant capable of full weight bearing on her right leg after her arrival at QAH at 1036hrs?
ii) Did the Claimant or her husband mention the sore throat?
iii) Are the clinical notes wholly reliable?
iv) When and by whom was compartment syndrome considered as a possible or actual diagnosis?
v) When was a compartment syndrome first established in fact?
vi) When was a dangerous infection suspected as a cause of the Claimant's symptoms?
I shall consider each in turn.
- Full weight bearing: Dr AJP who saw the Claimant on 20 July at 1130hrs noted "FWB" (full weight bearing) twice; first in the history (4/492); and second, on his examination (4/493). Dr V noted that she was "able to weight bear" (2/215). Dr Bolland noted that at 1920hrs the Claimant was "able to weight bear" (2/216). A note made at 2055hrs states that she "remains in pain but slight (sic) comfortable at present" (3/218).
- Mr Bolland in his evidence said that the Claimant reported that she could weight bear and that on examination she was able to stand on the leg. He said that he would have wanted to see for himself that the Claimant could stand on her leg. He added that if she had said she was in great pain he would have noted that.
- Mrs Jones said in her evidence that she could not remember anything from the time she arrived at QAH (see para 34 above). Mr Jones does not deal with the weight bearing issue in his witness statement. He said in his evidence that Dr AJP was wrong in noting that she was full weight bearing. He remembers that she was in a chair at that point.
- I accept the evidence of Mrs Jones as to the pain that she was experiencing before she arrived at QAH and the problems that caused when travelling in the van (see paras 8 and 34 above). However I find on the balance of probabilities that it was not reported by the Claimant or her husband to the doctors at QAH that she was unable to weight bear without pain. Mr Heyworth said in cross-examination that each doctor would want to establish whether the patient was fully weight bearing for himself. It may be, as Mr David Evans QC, for the Defendant, suggests that there is a confusion of terminology and weight bearing is a matter of degree. However I accept the notes of Dr AJP, Dr V and Mr Bolland as being accurate. I find on the balance of probabilities that the Claimant was capable of full weight bearing on her right leg after her arrival at QAH.
- In any event I accept, on the evidence, that the weight bearing issue is irrelevant in causation terms. The evidence of Professor Atkins, which I accept, is that although an inability to weight bear would have indicated that the Claimant was "less well", it would not have assisted the diagnosis, led to Mr Richards seeing the Claimant any earlier or led to an earlier decompression procedure.
- Sore throat: Mr Kent refers to the history of the sore throat being well documented in the GP and out of hours notes and suggests it cannot be that the Claimant or her husband were reluctant to mention this matter, in particular because they were alive to the potential significance of the symptom in the light of their daughter's recent meningitis which had started with a sore throat. However there is no mention of the sore throat in any of the clinical notes before about 2100hrs on 20 July when the general surgeon saw the Claimant (3/218).
- The Claimant said in her evidence that she could not remember anything about any of these events after admission to A&E and before she woke up following the amputation. Mr Jones was sure that he had mentioned the sore throat to each and every doctor. However the absence of any mention in the clinical notes by any doctor of a sore throat before the entry at about 2100hrs leads me to the conclusion that Mr Jones is mistaken about this. Mr Bolland's evidence was that if a sore throat had been mentioned he would have noted it. I prefer Mr Bolland's evidence on this point to that of Mr Jones.
- In any event the Accident & Emergency experts agree that even if the sore throat had been overlooked this did not affect the referral. The orthopaedic surgeons agree that mention of a sore throat would have made no difference to the management of the Claimant because there would have been nothing to link it with necrotising myositis (Answer 7 at 2/336).
- The reliability of the clinical notes: for the reasons I have given I consider the clinical notes to be reliable on the two principal issues in respect of which they are challenged, namely whether the Claimant was capable of full weight bearing and the sore throat.
- Consideration of compartment syndrome as a possible or actual diagnosis: Mr Kent invites the finding that compartment syndrome was "suspected" from 1130hrs on 20 July and it was never thereafter excluded, though there was a question as to how far it had progressed, and it was belatedly recognised by the orthopaedic surgeons from not later than 2300hrs.
- Dr AJP had at 1130hrs on 20 July noted compartment syndrome as an outside possibility ("??? Compartment syndrome" (4/492)). At 2000hrs the general surgical registrar had considered there was a "right thigh developing compartment syndrome" (3/218). At 2100hrs Mr Stenning had noted "clinically not acute compartment syndrome yet, secondary to spontaneous rhabdomyolysis" (3/218). At 2245hrs Mr Bland noted "clinically a compartment syndrome" (3/219).
- Mr Bolland's examination of the Claimant at 1920hrs did not suggest to him that she had a compartment syndrome (see para 40 above). Mr Richards said that his overall impression after the case was presented to him by Mr Bolland was that it did not sound as if she had established compartment syndrome (para 48 above).
- I find that there was no actual diagnosis of compartment syndrome until Mr Bland saw the Claimant at 2245hrs. Dr AJP had raised the possibility of there being a compartment syndrome at 1130hrs, but for the reasons given by Mr Bolland and Mr Richards they considered that she did not have compartment syndrome. The first clinical note that, in my view, indicates the real possibility of compartment syndrome was that made by Mr Stenning at 2100hrs.
- Compartment syndrome first established in fact: I accept Mr Richards' evidence that this was not until he examined Mrs Jones at 0200hrs on 21 July (see para 53 above).
- The plastic surgery expert witnesses agreed that "the Claimant developed a compartment syndrome that could/should have been diagnosed on the basis of the clinical signs and the elevated creatinine kinase at 1520hrs" on 20 July (2/494). Mr Kent invites me to accept this evidence because this is a matter of medical science which is as much within the province of the plastic surgeons as within that of orthopaedic surgeons. I reject this submission. The diagnosis of a compartment syndrome is for an orthopaedic surgeon, not a plastic surgeon. Mr Richards gave his reasons for his assessment that the Claimant had not developed a compartment syndrome by 1520hrs on 20 July (see para 57 above). I accept that evidence.
- Dangerous infection suspected as a cause of Claimant's symptoms: Mr Kent observes by reference to Mr Bolland's clinical note at 1920hrs (3/217) that "he was on to the possibility of an infective process". There was then no review by an A&E doctor until 2245hrs. The first mention specifically of a dangerous infection is in the ITU notes made at 0305 and 0306hrs on 21 July by Dr Chan and Dr McQuillan (4/864-5). The "Gram stain" results were phoned through at 0505hrs (4/865).
- Mr Kent submits that there were inexplicable and negligent delays in the treatment of the Claimant: in aggregate they amount to delay of over 16 hours between her arrival at QAH and her being taken to theatre. Within that time there was a period of nearly 11 hours after her arrival up to 1920hrs when she was seen by only two doctors, Dr AJP and Dr V. At 1920hrs she was reviewed again by the orthopaedic team but no reference being made to the absence of any intervening review by general or vascular surgeons. Thus began what Mr Cottingham described as "the strange game of ping-pong" during which Mr Bolland referred her to the general surgeons who referred her back to Mr Stenning who, it seems, left her in A&E at 2100hrs where she remained until Mr Bland saw her at 2245hrs.
- Mr Kent submits that the essential point about delay in this case is that all the usual alternative explanations for the Claimant's severe symptoms were serially excluded (and should have been eliminated from the investigation by lunchtime on 20 July at the latest). That left, he submits, a leg developing ischaemia with several clues that this was an infective process. The need to take her to theatre in good time on Sunday afternoon if only for an exploratory operation to take samples was, he suggests, obvious.
- The difficulty for Mr Kent with these submissions and for the Claimant with the allegation of delay is the agreed expert evidence. Mr Cottingham and Mr Heyworth agree that the A&E management was reasonable. The material points made in the joint report of the A&E consultants are set out at para 78 above.
- I do not find Mr Cottingham's explanation for writing his letter of 8 October 2013 to the Claimant's solicitors and his reasons for departing from the joint report to be satisfactory. Where the views of Mr Cottingham conflict with those of Mr Heyworth I prefer the views of Mr Heyworth who considers that the A&E management was reasonable.
- It was Mr Heyworth's evidence that at 2245hrs on 20 July the A&E consultant acted reasonably in transferring the Claimant to the resuscitation room and requesting orthopaedic review. I did not understand Mr Kent in his closing submissions to submit to the contrary. In any event I accept Mr Heyworth's evidence on this point.
- The joint report of the orthopaedic experts essentially provides a complete answer to the Claimant's case against the orthopaedic surgeons in respect of the allegation of delay. They agree that the management of the first orthopaedic review at 1200hrs was not negligent; assuming the orthopaedic note to be accurate, the second orthopaedic review by Dr Bolland at 1920hrs was not negligent; assuming the orthopaedic note to be accurate Dr Stenning's management at 2100hrs was appropriate; and assuming the orthopaedic note to be accurate, the orthopaedic management recommendation made by Mr Richards at 2300hrs was appropriate (generally see para 85 above).
- I do not find Mr Baird's explanation for writing his letter of 20 October 2013 and departing from the joint report to be satisfactory. The evidence of Professor Atkins was that the orthopaedic management, including the time taken before the decision to decompress in the first operation, was reasonable. I prefer the evidence of Professor Atkins in this regard to that of Mr Baird.
- I reject Mr Cottingham's characterisation of the referral between specialities in a multi-disciplinary team context, as in this case, as "ping-pong". The Claimant's underlying condition was very rare and her presentation was not specific. I accept the evidence of Mr Heyworth and Professor Atkins that the diagnosis was unclear. Professor Atkins noted that "a compartment decompression of the thigh is a very major surgical undertaking and spontaneous compartment syndromes of the thigh are quite simply vanishingly rare" (2/318, para 6.39). Mr Bolland's examination of the Claimant at 1920hrs effectively excluded compartment syndrome at that time. It was Professor Atkins' evidence that the Claimant did not have a compartment syndrome until her circulatory collapse at 2300hrs. It was in these circumstances that the Claimant was kept under observation in the A&E observation room and was seen by different specialities when her condition changed. Once the decompression was planned at 2300hrs Mr Richards intended to operate as soon as the Claimant was stabilised.
- I accept Mr Evans' submission that Professor Atkins' comment in his report (at para 7.17 in 2/323) exposes the wisdom of hindsight approach:
"A thigh compartment decompression will inevitably lead to disfigurement and exposes the patient to a risk of infection and all the risks of major surgery. It is all too easy with the eye of retrospect to suggest that this major surgical intervention should have been carried out earlier, however a degree of caution is needed before submitting patients to major invasive surgery with all its attendant risks and sequelae."
Allegation 2: inadequate remedial surgery carried out at first and second operations
- Mr Kent raises two factual issues: (1) was necrotic tissue visible to Mr Richards at the first operation? (2) Was necrotic tissue left in situ at the second operation? I shall deal with each in turn.
- Whether necrotic tissue was visible at the first operation: the operation note (3/225) refers to "dead-looking oedematous muscle". In evidence Mr Richards said that was a reference to grey/"dubious" tissue that might revive later.
- Whether necrotic tissue was left in situ at second operation: the operation note (3/227-8) refers to "oedema ++ Necrotic fat". It continues: "Only concern is fat and skin as to whether this needs to be removed". Mr Kent submits that these notes indicate a decision not to remove some necrotic tissue including fat.
- Mr Richards explained that the operation he carried out at 0320hrs on 21 July was to "decompress" the muscle compartment by making incisions down each side of the thigh and to take a tissue biopsy from the right thigh in order to obtain a definitive diagnosis, because he did not know what the diagnosis was even though the Claimant was deteriorating and her pain was worsening. He saw "dead-looking" muscle which had "reduced vascularisation" (para 9 of his witness statement) but he did not know that he was dealing with an infection by necrotising myositis even though that was a possible diagnosis.
- Professor Atkins stated in his report (at para 6.50 in 2/319) that it is "well known to every surgeon undertaking compartmental decompression, that muscle which looks dead may in fact be viable" and can recover when the blood supply is restored after decompression. Mr Baird agreed that it was a matter of clinical judgment for Mr Richards having regard to what he saw when he opened the thigh. He also agreed that there was a high threshold for cutting out thigh muscle and weakening the leg when the surgeon feels it has a chance of recovery and he does not know he is dealing with necrotising myositis.
- Dr Dryden in his report stated that "an early decision to explore and debride is the cornerstone of treatment" (para 3.6 in 2/396); and Dr Rothburn and Dr Dryden were agreed that in the event of a suspected diagnosis of invasive group A Streptococcus infection their advice would be "to take blood cultures and other investigations but not to delay the administration of effective intravenous antibiotics … and also to perform emergency surgical debridement and other organ support as required" (2/403).
- However in their joint report Professor Atkins and Mr Baird agreed that measurement of the compartmental pressures, decompression of the compartments and taking samples for culture and sensitivity was appropriate management (answer 23). They were further agreed that if there was obvious dead muscle, this should have been debrided at this primary procedure. If the clinician judged the muscle to be dubious, it would be reasonable to retain it, since when decompressing a compartment syndrome, apparently dubious muscle may recover (2/343).
- I accept the evidence of Mr Richards that there was not obviously dead muscle. I accept that he judged the muscle to be dubious. In those circumstances, having regard to the agreed evidence of Professor Atkins and Mr Baird which I accept, it was reasonable to retain it.
- At the second operation the orthopaedic surgeons are agreed that the exact amount of tissue to be removed was "a matter of fine clinical judgment" and that this has been "reasonably judged" (answer 27 in 2/343). They agreed that "appropriate debridement was undertaken" (answer 12.1 in 2/353).
- I reject the allegation that there was any negligent delay in not undertaking the second operation until 2210hrs on 21 July. I accept Professor Atkins' evidence that the decision to stabilise the Claimant between the first and second operations was reasonable and that the timescale between the two operations was reasonable for the reasons he gave (see para 86 above).
Allegation 3: negligent advice as to available reconstructive options once necrotising myositis had been overcome leading to an unnecessary through-knee amputation
- It is not suggested that a proper consent was not taken from the Claimant. The original pleaded allegation was that it was wrong to advise an amputation and that other options, in particular limb preservation, should have been considered and discussed (para 32(q) of Particulars of Claim in 1/10). In paragraph 33 of the Particulars of Claim (1/11) the allegation is put as follows:
"Had full and appropriate consideration been given to the viability and future of the Claimant's right leg, she would not and should not have been advised that it should be amputated."
- The allegation that it was wrong to recommend a through knee amputation was abandoned by Mr Kent in opening. The orthopaedic experts in their joint statement agreed that in weighing up the various options which were available to Mrs Jones and advising her as to what the best reconstruction was the clinicians had exercised their clinical skill appropriately and that it was not mandatory to advise her to retain her leg (answer 31). They further agreed that a through-knee amputation with modern prosthetic reconstruction was an appropriate procedure (answer 32) (and see generally answers 31-35 and answer 13.1). That left the two issues of fact identified by Mr Kent in his closing submissions to be determined. First, what advice was given to the Claimant about the options, when and in what circumstances? Second, what option would the Claimant have gone for if properly and fully informed?
- Mr Evans summarises the Defendant's case as follows: the option of limb salvage was considered and discussed, but for wholly justifiable reasons, Mr Hand's and Mr Evriviades' strong preference and therefore recommendation was for an amputation and given that there was some urgency to cover the vasculature and bone of the empty anterior thigh compartment it was reasonable to counsel the Claimant in these terms (see para 50 of Defendant's closing submissions).
- The amputation was not carried out as an emergency procedure, however the orthopaedic surgeons agreed "that a multi-disciplinary approach had been employed and that the attending clinicians had come to an appropriate decision concerning the best reconstructive option for Mrs Jones, taking into account the clear urgency of reconstruction in view of the exposed femoral vessel and bone". (Answer 13.1 [2/354]).
- Mr Evans acknowledges that the ITU notes are not as clear as they might be and that the system for entry of notes by ITU staff, not orthopaedic surgeons, was not ideal. Nevertheless, in my view, the entries plainly support the Defendant's case.
- During the days leading up to 4 August 2008 the Claimant was suffering from periods of confusion, she was at times delirious, paranoid and confused. During that period discussion of options was conducted in the main with her husband and family. Mr Jones said in his evidence in chief that he remembered a discussion with Mr Evriviades about amputation and that during that discussion they discussed fusion of the knee. In his witness statement at paragraph 38 (1/118) he refers to a conversation with Mr Evriviades on 28 July. Mr Jones also accepted in cross-examination that the "pros and cons" of leg fusion or amputation were discussed (see also his witness statement at paragraph 39). He said the advice that he was given led him to think that amputation of the leg was indeed the best option (see para 42 of his witness statement).
- Clinical notes for 31 July record that Dr Hatfield, the rehabilitation consultant, "discussed through knee and transfemoral amputation with patient's husband and sister" (4/795); and at 2325hrs there is the following note (written in retrospect) (4/797):
"The family are in favour of an amputation as they do not think that her level of functioning will be as good with a fused leg. Her sister has nursing background and they have done their own research as well as taking on board what the surgeons have said.
They asked what would happen if Karen was refusing an amputation. I said that currently she was not competent to make those decisions …."
- A clinical note for 3 August at 1014hrs (4/816) notes that the Claimant is "recovering from paranoia, hallucinations". At 1354hrs there is a further note (4/817):
"She still doesn't really understand what's happened to her leg or remember what is going to happen on Tuesday (through-knee amputation). Her husband asked us to go through this with her again tomorrow."
- Mr Hand said that whilst through-knee amputation was his recommendation, no decision had yet been made. On 4 August there are notes which include the following:
"01.03 [4/821]
Definitive thru knee amputation Tuesday
Improving confusion and paranoia
08.21 [4/823]
Drs have spoken with Karen and her husband and she has seen the pictures of her leg. Karen has spoken with the physio about prosthetic limbs and the consequences of above and below knee amputation. Karen is naturally angry with her situation but appears to be starting the processes involved in resolving her altered body image."
09.26 [4/823]
Lesley Wilbourn, physio
"…Alert, appearing to take in all information and appropriate responses – very upset following discussions explaining need for amputation, but appears to understand fully.
…
Asked by Karen later following long discussion with medical staff to chat generally about what rehab will entail and what she might eventually hope to achieve – chatted about format of rehab …"
14.41[4/825-6]
Dr Chan SpR
"Written in retrospect.
Discussion with Karen and her husband this morning about the events that have led to this point. Karen has no recollection of what has happened to her and we ran through this together. I have stressed the severity of her illness and the fact that at one point she was close to death. We talked about the current situation and the impending definitive surgery tomorrow. We have briefly talked about the surgical options, although I have stated that I am not the surgeon and therefore not the expert on this, - either an amputation through the knee or the other option of an arthrodesis.
Karen appears to have taken this in and wishes to think a little. I have said that I will talk to her later.
Mr Hand and Mr Demetrius are both at Haslar today and are unlikely to be able to come and speak to her today, although both will be in tomorrow and will keep her informed of a time."
16.31 [4/827]
A note written by Dr Kikari, an SHO on ITU refers to a discussion between Mr Hand (orthopaedic surgeon) and the family.
"Situation discussed with family, option of amputation versus limb salvage discussed.
Family and patient agree with preferred option of through-knee amputation.
All aware that unlikely to go without any complications at all. Patient consented, complications explained."
- Despite the note which indicated Mr Hand was at the Haslar Hospital on 4 August he did in fact attend the QAH that day. I accept his evidence that he was one of the doctors present at a meeting with Mrs Jones at 0821hrs (see para 65 above). I also accept his evidence with regard to the discussion that he had with Mrs Jones that afternoon (see para 66 above). These events must have been very distressing and traumatic for her; she is not now able, she said, to recall anything after she arrived at QAH and before she woke up after the amputation. However I am satisfied that there was the discussion that afternoon about which Mr Hand has given evidence and that he did discuss the options of amputation and limb salvage with her.
- The consent form (3/356) records the Claimant's final consent at 1631hrs after this discussion to "right through-knee amputation, soft tissue reconstruction (using skin and muscle from right leg plus/minus split skin grafts)". The intended benefits are "to regain soft tissue cover of thigh with view to improving mobility".
- The consent form also records that the patient has the right to change her mind at any time even after signing the form (3/357, para 1).
- Finally, there is the evidence of Mr Evriviades (see paras 67-76 above). He is not noted as being present at the discussion with the Claimant on 4 August. I think the probability is that he was not. Mr Jones accepts that he had a discussion with Mr Evriviades (see para 38 above). It is not clear when he had the discussion that he said he had with Mrs Jones.
- I consider Mr Evriviades to be an honest and truthful witness and I am satisfied that he did have the discussion with Mrs Jones about which he gave evidence (see paras 70-72 above). The probability is that he had it on a day shortly before the operation on an occasion when she was lucid. However as it is not clear precisely when he had that conversation I have not taken it into account when reaching my decision on this issue.
- I am satisfied, on the basis of the evidence of Mr Hand, the clinical notes and the consent document that Mr Hand did have a discussion with Mrs Jones on 4 August about the pros and cons of the options, and that she was properly and fully informed about the options at a time when she was in a fit state to understand the implications of what she was being told.
Conclusion
- In my judgment, for the reasons I have given, (1) there was no negligent delay in getting the Claimant to theatre; (2) there was no inadequate remedial surgery carried out at the first and second operations; and (3) there was no negligent advice as to available reconstructive options once necrotising myositis had been overcome, leading to an unnecessary through-knee amputation. The Claimant was properly informed of the options. This was an anxious and difficult case for all involved, as Mr Evans observes. The consequences for Mrs Jones have been tragic, but I am satisfied that the treatment she received was not negligent. Accordingly this claim fails.