QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT IN BIRMINGHAM
Priory Courts, 33 Bull Street Birmingham |
||
B e f o r e :
____________________
THE QUEEN on the application of RICHARD DAVEY |
Claimant |
|
- and - |
||
HM CORONER FOR LEICESTER CITY AND SOUTH LEICESTERSHIRE |
Defendant |
|
- and - |
||
UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST |
Interested Party |
____________________
Andrew Sharland (instructed by Leicester City Council Solicitor) for the Defendant
Ben Bentley (instructed by Browne Jacobson LLP) for the Interested Party
Hearing date: 25 November 2014
____________________
Crown Copyright ©
Mr Justice Hickinbottom:
Introduction
The Law
"If it appears to a coroner, either before he proceeds to hold an inquest or in the course of an inquest begun without a jury, that there is reason to suspect…
…
(d) that the death occurred in circumstances the continuance or possible recurrence of which is prejudicial to the health or safety of the public or any section of the public,
he shall proceed to summon a jury…".
i) The first step is for the coroner to determine the scope of the inquest. Only then can there be an assessment of the applicability of section 8(3)(d).ii) Although section 8(3)(d) is on its face in mandatory terms (… he shall proceed to summon a jury…"), a coroner has a judgment to make ("If it appears to the coroner… that there is reason to suspect…") in respect of which he or she has a margin of discretion.
iii) "Reason to suspect" is a low threshold for the triggering of the obligation to empanel a jury, "suspicion" for these purposes being a state of conjecture or surmise arising at the start of an investigation in which obtaining a prima facie proof is the end (Hussein v Chong Fook Kam [1970] AC 942 at page 948).
iv) The relevant section of the public, whose health and safety might be prejudiced, need not be substantial.
v) For the subsection to apply, the prospect of recurrence is low, being just the possibility of recurrence and not a higher chance.
vi) It is not necessary to establish a causative link between the relevant "circumstances" and the deceased's death. It is only necessary to show that the death occurred in circumstances the continuance or possible recurrence of which is prejudicial to the health of any section of the public.
vii) Every case must be decided on its own facts. However, if the circumstances that are prejudicial to the health and safety of the public suggest a system failure, subsection (d) is likely to be triggered; but, if the circumstances suggest an individual failure, it is unlikely to be triggered.
viii) Whether a jury should be empanelled under this provision is a matter for the coroner, subject only to the usual public law grounds of challenge in this court.
"An inquest into a death may be held with a jury if the senior coroner thinks that there is sufficient reason for doing so."
There is no saving provision for section 8 of the 1988 Act; and so, if a coroner has now to consider whether an inquest should be with or without a jury, the provisions of section 7 of the 2009 Act apply.
Factual Background
"5. Cardiac tamponade is a rare but recognised complication of the TAVI procedure. Most often the leak of blood into the pericardial cavity is small and seals itself. Sometimes percutaneous drainage of the pericardial sac is required and only rarely is it necessary to perform emergency sternotomy.
6. The pathologist concluded that Mrs Davey suffered a myocardial infarction. She suggested this occurred 24 to 72 hours prior to her death. If this was the case, it would have been most likely evidence in ECG recordings and in intra-procedural echocardiography and also apparent clinically.
7. The first we knew of the problem was when the fluid began to accumulate. At the time we were unable to identify a source for the bleed. I was unable to identify the source of the leak at subsequent open heart surgery and I note the pathologist was unable to identify any bleed point at post mortem.
8. With the benefit of hindsight I think it is likely that the wires used during the procedure have caused a small lesion to the wall of the vessels resulting in a leak. I did mention at paragraph 30 of my first report dated 11 February 2011 that I inspected the heart for any possible LV (left ventricular) perforation. That was because I considered it a possible explanation for the bleed.
9. The concept of a ventricular rupture as occurred in this case is difficult to explain and understand even for experienced medical practitioners in this specialist field but we do know that unfortunately it is a recognised complication."
"… the question that needs to be addressed is what percentage of the public whilst having the TAVI procedure have been affected either by death or serious injury""
He stated that he knew of two: his mother and another patient. On 16 January, the Claimant wrote again, identifying a third individual whom, he said, had died having a TAVI procedure.
"… [to] conduct an investigation into the circumstances relevant to Mrs Davey's death and how it came about. This will include what risks specific to her and the TAVI procedure were know at the material time. However, I will keep my line of inquiry under review as evidence is received and heard."
"In this case there is currently no evidence of any system failure.
The evidence from the treating clinicians does not suggest any system failure.
The evidence suggests that Mrs Davey died as a result of a recognised complication during the TAVI procedure.
…
[The Claimant] suggests that the question that needs to be addressed is 'what percentage of the public whilst having the TAVI procedure have been affected either by death or serious injury?' Such a question falls outside the scope of this inquest. That question would require an audit of all TAVI procedures. That is not the purpose of this court.
In this case there is nothing raised by the evidence that I have seen that suggests a failure of any systems. In my view, on the evidence that I have seen, the case is, at its highest, one of individual failure. For the above reasons, I am of the view that I do not have a duty pursuant to s8(3) to hold the inquest with a jury. "
"… [I]f the evidence that I have seen and based my decision on changes before or even during the course of the inquest, then I still have the power to reconsider whether to summon a jury at any time during the proceedings."
The Grounds of Challenge
Ground 1: The Coroner's erred as a matter of law in basing her conclusion on the premise that there was no evidence of systemic failure: there was such evidence before her, namely evidence that something can go wrong with the TAVI procedure which, although unidentified and apparently unidentifiable by the naked eye, is a recognised complication of the procedure and one which can lead to the death of the patient.
Ground 2: In any event, the Coroner failed to give adequate reasons for her conclusion that there was no reason to suspect systemic failure: she did not explain why, in the light of that evidence, that low threshold had not been crossed.
i) I have already dealt with the evidence of Prof Spyt. He found no physical evidence of any perforation or even lesion in the heart valve, and no bleeding point, but he appears to have discounted a myocardial infarction because of the absence of any indication on the echiocardiogram and other monitoring equipment used during the procedure of such an event having occurred. On balance, he considered the cardiac tamponade was caused by a guide wire making a small lesion inside the heart valve, which resulted in the leak into the pericardium.ii) Dr Kovac (in paragraph 16 of his statement of 25 June 2012) said:
"We cant say and would not be able to say exact place where wire caused perforation and we were not sure where it was in the cath lab, we could only see fluid accumulation as per Dr Chin statement, which is indeed recognised and one of the more frequent complications which are clearly mentioned in info sheet and consent."That, said Mr Cragg, at least implicitly appeared to recognise that guide wire perforation of a valve sometimes occurs in practice.iii) Dr Chin, uniquely, said that, during the search for the source of fluid, the delivery wire was noted to be embedded in the wall of the heart but the wall was not pierced; and this was (he said) made known to the operating team at the team (paragraph 5(g) of his statement of 11 May 2012).
iv) Dr Bence said, again uniquely, that the source of the bleeding was identified and controlled (paragraph 26 of his statement of 17 May 2012). Dr Bence was the anaesthetist, and his evidence that the source of the bleeding was identified (denied by all of the cardiologists) appears simply wrong.
v) Dr Jeilan considered that the most likely cause was trauma caused by the inflation of the balloon in the native valve (undated report to the Coroner). This was enough, Mr Cragg said, to raise a suspicion of circumstances that might recur, arising from a systemic failure inherent in the procedure.
vi) Mr Cragg also relied upon the evidence of Dr Nicholas Moore. He is the CMG Medical Director for the NHS Trust, and was not directly involved with the care of Mrs Davey. In his statement of 28 February 2014 – of course, well after the Coroner's challenged decision – he says that, in Mrs Davey's case, there is simply no evidence of any perforation of the valve, and a lesion short of perforating could not account for leakage through to the pericardium (paragraphs 3-6). He says that the wires used are soft-ended, and are incapable of piercing tissue as a lay person may suppose (paragraph 7); and there appear to be no reported cases of such an event happening. He accepts that bleeding during the TAVI procedure is a recognised complication, but, in the few cases where it occurs, it is generally not life-threatening and can resolve naturally through clotting (paragraph 9).
That is the evidence of the healthcare professionals, upon which Mr Cragg relies.
Observations
Conclusion