QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL |
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B e f o r e :
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Janet Birch |
Claimant |
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- and - |
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University College London Hospital NHS Foundation Trust |
Defendant |
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Grahame Aldous QC (instructed by Hempsons) for the Defendant
Hearing dates: 14-24 July 2008
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Crown Copyright ©
para | |
INTRODUCTION | |
Background | 2 |
1. Mrs Birch at Watford General Hospital | 3 |
2. Transfer to Queen Square Hospital | 9 |
3. Decision for catheter angiography | 14 |
4. The consent form | 20 |
5. Catheter angiography is performed | 24 |
6. Mrs Birch's stroke and its aftermath | 28 |
THE EXPERT EVIDENCE | 32 |
1. The "rule of the pupil" and the risk of an aneurysm | 34 |
2. Cavernous sinus pathology and its likelihood | 37 |
3. Catheter angiography v MRI | 38 |
4. Risks of stroke from angiography | 49 |
5. Risk benefit analysis and the "pathways" | 50 |
ISSUE 1: NEGLIGENCE | 53 |
1. The law | 54 |
2. The claimant's submissions | 56 |
3. Was Queen Square negligent? | 62 |
19. ISSUE 2: CONSENT | 71 |
1. The law | 72 |
2. Disclosing comparative risks | 75 |
3. Causation | 80 |
CONCLUSION | 82 |
Mr Justice Cranston :
INTRODUCTION
BACKGROUND
(1) Mrs Birch at Watford General Hospital
"PAINFUL PUPIL-SPARING RIGHT III PALSY. Plan:
(i) URGENT MRI ? exclude:
- POST-com [artery] aneurysm.
- CAVERNOUS SINUS PATHOLOGY.
(ii) Please let me know outcome of scan."
(2) Transfer to Queen Square Hospital
"Thank you for accepting this 55 year old lady who presented with a gradual onset headache behind the right eye. She has a painful third nerve palsy and was seen today by Dr Giovannoni who felt that a posterior communicating aneurysm or cavernous sinus pathology need to be ruled out. CT – NAD [no abnormalities detected]."
It went on to indicate that she had been a diabetic of twenty years. There was nothing in the letter about Professor Giovannoni's recommendation for an urgent MRI. However, some sixteen pages of the Watford notes accompanied Mrs Birch, including Professor Giovannoni's plan, when she arrived at Queen Square on late Friday night, the 20th. She was admitted to a Neurosurgical ward. Mrs Birch was first seen by the senior house officer that evening. He noted a history of "right-sided eye headache" with associated vomiting and nausea. There was a decrease in vision in the right eye, which was painful. She had never had this before. Her diabetes was noted. He thought the right side of her face was puffed up. He noted that she had had a CT scan, which was normal and had a painful third nerve palsy. Professor Giovannoni's differential diagnosis was noted. The plan was review by the specialist registrar to consider an MRI scan or an angiogram in the morning. (The notes read "For R/V by SPR? MRI? ANGIO MANE [in the morning]: NBM [nil by mouth] from midnight").
i) Dr Andrew McEvoy, who at the time was a specialist neurosurgical registrar at Queen Square. In 2003 he was considered by his superiors to be an able young doctor, a view subsequently confirmed by his appointment as a consultant neurosurgeon at Queen Square;
ii) Mr Neil Kitchen, a consultant neurosurgeon at Queen Square, the senior of the three consultants there with a sub-specialist interest in problems such as the aneurysm which Mrs Birch might have had. Mr Kitchen is clearly an outstanding figure in this field, with an international reputation;
iii) Dr Al-Jeroudi, a general radiology registrar, at the time an on-call locum at Queen Square. He is now a consultant radiologist at West Middlesex University Hospital; and
iv) Mr Stefan Brew, a consultant neuroradiologist at Queen Square.
(3) Decision for catheter angiography
"WRSPR (McEvoy)
Admitted with 1/52 history headache
Right orbital headache
Ptosis since 4/7
GCS 15/15
BP 180/80
Pulse 70 regular
O/E pupil sparing right third nerve palsy
Plan for angiogram today ? discuss with radiographer and on-call radiologist for 11.30am today. Thank you. Dr Young SHO.
HB 14.3, WBC 7.5. pH 257, INR 0.95
APPT 28, NA 135, K 4.1. U 3.4 CR70"
Dr McEvoy attributes the brevity of the notes to the fact that there were some 90 patients on the ward to be seen over the four hours so the notes for each had to be relatively brief. Maybe, he says, they were written retrospectively by the junior doctor accompanying him on his rounds. In any event there are important omissions, such as the pain on which Mr Kitchen placed some reliance as a feature demanding that an aneurysm be excluded. So by, or at this point, the possibility of an MRI had been discarded and the decision made to conduct the angiogram.
"One cannot afford to treat on the balance of probabilities, because of the risk of it being an aneurysm and the danger that if it is are both greater than the risks associated with angiography." "
That the third nerve palsy was pupil sparing in Mrs Birch's case would not have largely reassured him that this was a more benign situation than an aneurysm. She had atypical features which were consistent with an aneurysm. Diabetics could have aneurysms.
"In 2003, it would always have been my practice to proceed to an angiogram without an MRI scan or MR angiography first with a painful [third nerve palsy] and when I suspected an aneurysm … even after taking her presentation, diabetic history and age into account."
Mr Kitchen accepted that there could be an ascertainment bias in his unit, so that those like Mrs Birch could potentially be exposed to inappropriate procedures. Exclusion of an aneurysm fell within the field of neurosurgery. That was the task that had been set and in 2003 use of catheter angiography was the way to do this, with a greater degree of comfort than if MRI were to be used. It was a judgment call taking into account the advantages and disadvantages of the procedure for Mrs Birch.
(4) The consent form
(5) Catheter angiography is performed
"The patient lies on the table and the staff scrubs. The patient is draped. The patient is lying on their back. The neuroradiologist advises that he is to go into the right groin. He palpates the artery. He applies local anaesthetic. He goes into the groin with a needle into the artery. The wire is put up in the artery. A sheath is placed into the iliac artery. The catheter is then put in. The wire then goes up to the aortic arch and is then taken out. It is then necessary to get into one of the carotid arteries and then the vertebral arteries. Once the catheter is in the desired position, a small volume of contrast is injected to determine the catheter position and to ensure that the artery has not been damaged. A roadmap to show the course of the artery that is to be catheterised may be obtained to aid correct placement of the catheter. Images of that artery are then obtained. The catheter is repositioned as above into any other artery that needs to be examined. At the end of the procedure, if the neuroradiologists are happy with the images, then the catheter is taken out. The sheath is pulled out and the neuroradiologist presses on the groin to stop the bleeding and the patient is transferred back to the ward."
(6) Mrs Birch's stroke and its aftermath
THE EXPERT EVIDENCE
i) Mr M C Choksey, a consultant neurological and spinal surgeon, who is one of the two specialist neurovascular surgeons at the University Hospitals, Coventry and Warwickshire Hospital;
ii) Dr Richard Hardie, a consultant neurologist at the North Bristol NHS Trust and an honorary senior lecturer in the Faculty of Medicine and Dentistry at the University of Bristol. Dr Hardie has a special interest in stroke; and
iii) Dr Andrew J Molyneux, a consultant neuroradiologist, an honorary senior clinical lecturer at the University of Oxford and a well-known figure in the field of aneurysms.
On the defendant's side the experts were:
iv) Mr Peter J Kirkpatrick, a consultant neurosurgeon and honorary lecturer at the University of Cambridge. Mr Kirkpatrick was elected a Fellow of the Academy of Medical Sciences in 2006, in recognition of his exceptional contribution to the advancement of the subject; and
v) Dr N S McConachie, a consultant neuroradiologist at Nottingham University Hospitals NHS Trust and a noted contributor to the literature on the subject.
(1) The "rule of the pupil" and the risk of an aneurysm
"A painful third nerve palsy with pupil sparing is nearly always due to diabetes. The presumed pathology is infarction of the nerve trunk, and hence in third nerve lesions due to these causes the pupil is usually spared. … The prognosis in all instances is for complete recovery of function to occur over some 4-12 weeks. If recovery does not occur the diagnosis must be reconsidered."
There was some disagreement among the experts about the "nearly always". In a more recent publication, a commonly held clinical extension of the rule of the pupil is said to be that "a neurologically isolated complete external dysfunction and pupil spared [third nerve palsy] in a patient with vasculopathic risk factors (e.g. over the age of 50 years, diabetes, hypertension) is usually due to an ischaemic infarct of the third nerve" (Lee et al, "The Evaluation of Isolated Third Nerve Palsy …" (2002) 47 Survey of Ophthalmology 137, 141). Overall the experts agreed with this approach.
"In older patients, the major confounding source of isolated third nerve palsy is microvascular infarct of the nerve, which characteristically produces ptosis and opthalmoparesis of the four relevant extraocular muscles but spares the pupil. This ischaemic cranial neuropathy is usually associated with other systemic vascular disease and is most common in patients with hypertension, diabetes mellitus, or smoking. Typically, patients develop acute diplopia, retro-orbital pain, and headache. Pain is a common accompaniment in about 60% of cases. The pupil is not involved in the majority (70% to 80%) of patients." (Kasner et al, "Neuro-opthalmologic aspects of aneurysms" in R W Hurst (ed), Neuroimaging Clinics of North America: Cerebral Aneurysms, Neurosurgery, 1997, Vol 7, No 4, 687-689 (footnotes omitted)).
In ordinary circumstances the treatment in such cases is conservative: the patient is observed over a period to see if the problem resolves spontaneously.
(2) Cavernous sinus pathology and its likelihood
(3) Catheter angiography v MRI
(i) need catheter angiography have been used?
"It must be emphasised that these conclusions are valid only for centres which perform MRA to a high standard, when the images are interpreted by experienced neuroradiologists" (326).
"Clearly a modern CTA [computerised tomography angiography] or MRA examination will be more than adequate for many patients needs: for example, in imaging some small asymptomatic aneurysms that wouldn't be treated or in unequivocally mild carotid atherosclerotic disease. But there remain common situations, for example in subarachnoid haemorrhage, where a 90% negative predictive value for aneurysm with CTA or MRS is not good enough … [E]ven in the year 2008, for many patients with potentially life-threatening neurovascular conditions, we practitioners – and those patients – must still accept these risks to gain the potentially life-saving diagnostic information provided by the high-quality cerebral angiogram."
(ii) would MRI have detected an aneurysm?
(iii) the small aneurysm
(iv) the chance of a missed aneurysm rupturing
(4) Risks of stroke from angiography
(5) Risk benefit analysis and the "pathways"
ISSUE 1: NEGLIGENCE
(1) The law
"[A doctor] is not guilty of negligence if he has acted in accordance with a practice as accepted as proper by a responsible body of medical men skilled in that particular art … Putting it the other way round, a doctor is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view."
The gloss on this is that a court may still find that doctors are negligent, even though they have acted in accordance with a practice accepted as proper by a reasonable body of medical opinion, if it is not convinced that the body of opinion is reasonable or responsible. As Lord Browne-Wilkinson put it in Bolitho v City of Hackney Health Authority [1998] AC 232, 243C:
"[I]f, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible."
"[It] would be wrong to allow such assessment to deteriorate into seeking to persuade the judge to prefer one of two views both of which are capable of being logically supported" (at 243D).
Not only am I bound by this view but I conceive it to be eminently sensible: it would be folly for a judge with no training in medicine to conclude that one body of medical opinion should be preferred over another, when both are professionally sanctioned and both withstand logical attack.
(2) The claimant's submissions
(3) Was Queen Square negligent?
"Having read the Particulars of Claim, I remain of the opinion that should Mrs Birch had presented to any other Neurosurgical Unit within the untied Kingdom the vast majority would have proceeded directly to digital subtraction angiography if she had fallen into Neurosurgical hands for the purpose of excluding an aneurysmal cause."
Of course it is obvious both from the literature and the expert evidence presented on Mrs Birch's behalf that there was no consensus within the profession in 2003 as to the better imaging method for diagnosing aneurysms of the type Mrs Birch might have had, angiography or MRI. It may be that there has been a trend since 2003 in favour of MRI and other non-invasive techniques as the diagnostic tool of choice, as illustrated by some of the literature mentioned earlier. But the plain fact is that there was a responsible body of medical opinion in 2003 which would have taken the Queen Square decision.
ISSUE 2: CONSENT
(1) The law
"In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law, as indicated in the cases to which I have just referred, that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt" (at p59).
That statement of principle, he pointed out, was approved by Lord Steyn as part of the majority view in Chester v Afshar [2004] UKHL 41, [2005] 1 AC 134 at para 15. Lord Steyn added, in his own words, that generally speaking, in modern law medical paternalism no longer rules and "a patient has a prima facie right to be informed by a surgeon of a small, but well established, risk of serious injury as a result of surgery" (at para 16). The obvious rationale is patient autonomy and respect for the reality that it is the patient who must bear any consequences if a risk transforms itself into a reality.
(2) Disclosing comparative risks
(3) Causation
CONCLUSION