Davey, R (on the application of) v University Hospitals of Leicester NHS Trust & Anor

The Claimant challenges the decision of the Defendant Coroner (“the Coroner”), made on 8 February 2013, to conduct an inquest into the death of his mother, Mrs Doreen Davey, without a jury. Mrs Davey died on 7 February 2011 in Glenfield Hospital, Leicester, for which the Interested Party NHS Trust (“the NHS Trust”) is responsible.

Before me, Stephen Cragg QC has appeared for the Claimant; Andrew Sharland for the Coroner; and Ben Bentley for the NHS Trust. At the outset, may I thank each for his helpful contribution.

The relevant law is uncontroversial.

At the time of the Coroner’s decision, section 8(3) of the Coroners Act 1988 provided, so far as material to this claim:

“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…”.

Section 8(4) provided a broader ground, namely where it appears to a coroner that there is “any reason for empanelling a jury”; but the Claimant does not place any reliance on that provision.

The requirements of section 8(3) were considered by Hallett LJ in her decision dated 21 May 2010 following the pre-inquest hearing on 26-30 April 2010 prior to the inquests into the London bombings of 7 July 2005, at [148]-[160]. As Hallett LJ was sitting as a Deputy Assistant Coroner, what she then said was not formally binding on the Coroner, nor is it formally binding upon me; but the propositions she set out in that decision were formulated after a full review of the authorities and full argument, and are accepted both generally and by both Counsel before me as a correct and indeed authoritative summary of the law. I gratefully adopt them.

The legal principles relevant to this claim are as follows.

Section 8 of the 1988 Act was repealed by the Coroners and Justice Act 2009. By section 7 of the 2009 Act, an inquest must be held without a jury, unless the death was in identified circumstances not relevant in this case, or, by subsection (3):

“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.

Mrs Davey was born on 12 July 1926. In 2009, she was referred to the cardiology outpatient clinic at Glenfield Hospital, suffering from breathlessness and chest pains, and, later, exertional dysponea and fatigue. She was diagnosed as suffering from severe symptomatic aortic stenosis (i.e. the narrowing of the aortic heart valve, restricting the flow of blood through the heart), peripheral vascular disease (i.e. the narrowing of the arteries, usually by the build up of fatty deposits or atheroma on the arterial walls), type 2 diabetes and hypertension. There was no previous history of myocardial infarction, but she had suffered several years of angina and two strokes.

In August 2010, she underwent a coronary angiogram, which revealed obstructions to three arteries, and she had stents fitted. She was also referred for consideration of surgery to repair or replace her aortic heart valve. Without such surgery, her prognosis was very poor: it was considered that her symptoms, already severe, would worsen as would her already poor quality of life – and there was a substantial risk that she would suffer a myocardial infarction, and that such an event could be fatal. Because of her age, the seriousness of her heart and vascular condition, and her history of strokes, open-heart surgery involving access through the chest (a sternotomy) was considered too high risk, the 30-day mortality risk being estimated at over 50%. However, an alternative and physically less traumatic procedure has been developed for those for whom open heart surgery is not clinically feasible, namely transcatheter aortic valve implantation (“TAVI”), in which a self-expanding replacement valve is delivered to the heart by a catheter through the blood vessels usually transfemorally, i.e. with access via the femoral artery in the upper leg. Glenfield Hospital was one of the pioneering hospitals for the procedure, although it has now been approved in many countries and is performed at several hospitals throughout England. The procedure has a risk of morbidity within 30 days of the operation of 5-10%.

Following meetings at which the available procedures and risks were discussed, Mrs Davey was admitted to Glenfield Hospital on 6 February 2011. She was reviewed and informed consent obtained. It is uncontroversial that she was issued with a TAVI leaflet explaining the risks, and those risks (including a 5-10% risk of death) were also explained to her by one of the surgical team, Dr Mohammed Habib Jeilan. He discussed with her the risk that she would require a pacemaker, the risk of trauma to the aorta and heart, the risk of the contrast affecting her kidneys, and the risk of stroke and heart attack. She indicated that those risks had been explained to her previously, and she consented to the operation having understood the risks involved as explained to her. Given the very poor state of her heart, and the alternatives open to Mrs Davey, that is entirely understandable.

On 7 February 2011, the procedure was carried out by a team including several consultant cardiologists: the primary operator, Dr Jan Kovacs; two secondary operators namely Professor of Cardiovascular Surgery Tomasz Spyt, and Dr Jeilan; and Dr Derek Chin, who operated the echocardiography device and generally monitored the procedure. Dr Johan Bence, a consultant cardiothoracic anaesthetist, was the anaesthetist. They were supported by theatre technicians and catheter lab nurses.

The procedure at first appeared to go well. However, after the delivery wire had been inserted into the native aortic valve, and at about the time that valve was expanded by means of a balloon valvuloplasty, Dr Chin reported cardiac tamponade, i.e. an increase in fluid accumulating in the pericardium, which is the cavity between the heart muscle and the pericardial sac in which that muscle lies. This acute effusion of fluid into the pericardium, at a rate so great that the pericardial sac cannot expand quickly enough to accommodate it, causes compression of the heart itself. A pericardial drain was inserted, but continuous blood loss was still noted. A decision was made to transfer Mrs Davey to theatre for open heart surgery, which was performed immediately.

This involved opening up the pericardium, which released the pressure there. However, on inspection of the aorta walls, there were no signs of perforation (or, indeed, any lesion or other sign short of a perforation) and the origin of the bleeding could not be identified. The substantive operation was completed, with the removal of the excess muscle from the intra-ventricular septum, and the excise of the native aortic valve and its replacement with a prosthetic valve. The bleeding appeared to subside, and the general condition of the patient appeared good: and so the chest was closed, although a drain was retained.

However, within half-an-hour, because of continued effusion from the pericardial cavity, the chest was reopened. Again, the heart was inspected for the possibility of wall lesions, but none was found. The bleeding was treated with coagulation products, and, when the bleeding appeared to be under control, the chest was again closed and the delivery system was removed from the leg. But that closure was followed by a sudden drop in the patient’s blood pressure, and so the chest was once more opened. Again, no bleeding point could be identified. The patient was resuscitated, but continued to lose blood, despite efforts to stem that flow. Mrs Davey continued to deteriorate, and she sadly died at 8.45pm.

In a statement dated 11 February 2011, prepared for the Coroner, Prof Spyt confirmed that cardiac tamponade had developed during the procedure, but no bleeding point could be identified. He proposed the cause of death to be recorded as “aortic stenosis (operated)”. However, some members of Mrs Davey’s family (including the Claimant) did not accept that that was the cause of death, because, they said to the Coroner, they (notably the Claimant’s sister) had been told that Mrs Davey died because the aortic valve had been pierced during the procedure.

Because of the family’s concerns and the close temporal proximity of the operation and the death, the Coroner ordered a post-mortem. It was conducted by Dr R Harrison at the Leicester Royal Infirmary on 15 February, the pathologist submitting her report on 28 February 2011. She reported that there were no identifiable areas of trauma or perforation, and therefore she considered that there was no evidence that the operation contributed to the death. She noted that the heart was severely diseased, the areas of infarction were transmural and the tracking of the haemorrhagic areas to the epicardium (i.e. the outer layer of the heart muscle, which forms the inner layer of the pericardium) could be seen, i.e. the bleeding could be tracked back to the heart muscle itself. She considered that this explained the pericardial haemorrhage, in terms of a myocardial infarction unconnected to the operation, the infarction occurring either in the very earliest stages of the operation or (because acute myocardial infarctions are usually not visible for 24 to 72 hours) at some time before the operation had started. Later, she confirmed that the only rupture she could find to explain the bleeding was the one apparently relating to the myocardial infarction itself. In her view, there was thus a natural cause of death.

The Coroner contacted the family, and offered a documentary inquest without a hearing; but, although some of the family wished to proceed in that way, the Claimant did not accept that cause of death. He said that he still believed the death was due to the surgery, because they had been told that the heart had been pierced during the procedure; and, he said, he believed that the pathologist’s report was in effect a cover-up.

The Coroner proceeded to an inquest. A Pre-Inquest Review was held on 29 July 2011. After it, the Coroner decided that she wished to hear from a number of witnesses, including the doctor who had allegedly said to the Claimant’s sister after the operation that the heart had been pierced during the procedure. However, that doctor had left the hospital, and was working abroad: so Prof Spyt prepared a supplementary statement dated 26 June 2012. In it he said:

“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.”

A further Pre-Inquest Review was held on 3 October 2012. At that hearing, the Coroner set out the scope of the inquest, and explained that she would not be sitting with a jury because the case did not fall within the relevant provisions of section 8 of the Coroners Act 1988. The legal representative for the hospital trust agreed to that course. The family members were not legally represented; but none of those taking an active part in the inquest (including the Claimant) objected to it. The inquest was eventually listed, for hearing without a jury, for 12 February 2013.

On 8 January 2013, the Coroner received a letter from the Claimant dated 6 January, indicating that he considered a jury ought to be empanelled, because:

“… 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.

In the light of those further representations, the Coroner decided to hold a further Pre-Inquest Review on 29 January 2013, to reconsider the question of whether a jury should be empanelled. She allowed the Claimant further time to make written submissions on the legal authorities, which were lodged on 6 February 2013. In those he added a further reason why he contended that a jury ought to be empanelled, namely that the evidence suggested that Mrs Davey had died from a recognised complication.

On 8 February, the Coroner gave a written decision confirming that she would not be empanelling a jury to hear the inquest with her.

In her decision, the Coroner set out the function of her court by reference to section 11(5)(b) of the 1988 Act and rule 36 of the Coroners Rules 1984, namely to investigate and, if possible, answer four questions: who the deceased was and “how, when and where he came by his death”. In this case, she concluded that her task was:

“… [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.”

Having considered at some length the relevant authorities (including the decision of Hallett LJ in relation to the London bombings inquest to which I have referred), she said that, if a systemic defect were in issue and the possibility of recurrence is prima facie apparent then a coroner must summon a jury regardless of the practical problems of scrutinising the system.

However, she found:

“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. ”

Further, having considered all the circumstances, she declined to exercise her broad discretion to summon a jury under section 8(4).

Consequently, she proposed to hear the inquest alone. However, she reminded herself that:

“… [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.”

It is, of course, that decision to hold the inquest without a jury which the Claimant now challenges. Following a refusal on the papers, His Honour Judge Robert Owen QC sitting as a judge of this court gave permission to proceed at an oral renewal hearing on 14 February 2014.

The Claimant initially relied upon two, albeit related, grounds of challenge.

Following refusal of permission on the papers, in his renewed application, the Claimant abandoned Ground 2. He was right to do so. This is, and never was, a reasons case. The Coroner’s reasons are clear: in her view, there was no evidence of a systemic failure that gave rise to the obligation to sit with a jury. The real issue is whether that was a finding open to her to make. Mr Cragg, for the Claimant, submits it was not a decision any reasonable coroner could properly have made on the available evidence.

Mr Sharland submitted that the Coroner dealt with the issues raised by the Claimant as to whether a jury should be empanelled in a model way. She identified, clearly and correctly, the relevant law and approach. Before her, the Claimant (then acting in person) relied upon four matters. First, he submitted that the question that the inquest needed to address was “what percentage of the public whilst having the TAVI procedure have been affected either by death or serious injury?”. The Coroner dealt with that in the passage I have quoted (see paragraph 26 above): the question simply fell outside the scope of the inquest. Second, he relied upon the fact that two other patients had died whilst undergoing a TAVI procedure: but it is recognised that there are risks with the procedure – indeed, as I have described, the Claimant was specifically warned as to the risks – and the fact that certain patients had unfortunately died during or shortly after the procedure is not evidence at all of any systemic failure, or indeed any type of failure or fault. Third, he suggested that there could not be individual failure, only systemic, failure – because there were five consultants involved in the surgery. That is simply misconceived. Finally, he relied upon the evidence that cardiac tamponade is a recognised complication of the procedure; but, merely because there is a recognised complication of a procedure which is inevitably performed on seriously ill patients with very poorly hearts is, in itself, no evidence of a systemic failure or, again, any other sort of failure or fault.

Mr Sharland says, with some force, that that deals comprehensively and conclusively with the challenge before this court. The Coroner dealt with each and every point raised by the Claimant as to why there ought to be a jury; and dealt with them, without doubt, lawfully. Thus, she did not even arguably err in law.

However, Judge Owen (before whom the Claimant acted in person, and neither the Coroner nor the NHS Trust was represented) took up points that had not been raised before, in particular that, contrary to the Coroner’s finding, there was evidence of a systemic failure in the TAVI procedure such as to found a suspicion that Mrs Davey’s death occurred in circumstances the possible recurrence of which would be prejudicial to the health of a section of the public, namely those patients who in the future are exposed to the procedure. Importantly, Mr Sharland submitted, those matters had not been raised before the Coroner, who could therefore not be criticised for not dealing with them. Her failure to deal with these new points, again, could not possibly amount to an error of law.

However, understandably, that basis of claim set out in the judgment of Judge Owen on the renewed permission application was taken up by Mr Cragg; and, as it was the basis upon which permission was granted, I propose dealing with the merits of it.

With one small exception, to which I shall come (see paragraph 37 below), in support of the proposition that the Coroner acted irrationally in finding that there was no evidence of systemic failure, Mr Cragg relied upon – and solely upon – the evidence of the healthcare professionals who were involved in the care of Mrs Davey, as follows.

Additionally, the Claimant initially relied upon seven cases in respect of which, he said, TAVI was implicated in a death at Glenfield Hospital. Save for the two I have mentioned (see paragraph 21 above), these cases were not in any event before the Coroner: as I understand it, they have been subsequently discovered by the Claimant by effectively interrogating the hospital computer in respect of references to “aortic valve replacement” in reports of deaths.

The cases are helpfully analysed in paragraph 41 of Mr Sharland’s skeleton argument. It is clear that not all of these cases concern the TAVI procedure at all, and some do not concern Glenfield Hospital. In four of the seven cases, the operation was open heart surgery, not TAVI. In another case, it is unclear whether the patient had any TAVI operation – she is recorded as dying of endocarditis – but, in any event, she appears to have died at Leicester Royal Infirmary, not the Glenfield Hospital. In the two remaining cases, women are reported as having died following TAVI surgery. In one, the cause of death is given as simply “cardiac failure”; in the other there is no specific cause of death given.

In the circumstances, Mr Cragg conceded that these cases offered very little, if any support for the Claimant’s case. He referred to just two of the cases, in which the TAVI procedure was performed, and there was evidence of an overt through puncture or perforation of a heart valve; although there is no indication as to how (or, even, if) this puncture contributed to the death, and there is no evidence at all that a guide wire caused or contributed to or was implicated in the perforation in any way.

Having considered all of this evidence and Mr Cragg’s able submissions, I am unpersuaded that the Coroner erred in law by concluding that there was no evidence before her upon which to found a legitimate suspicion that there was a systemic failure inherent in the TAVI procedure that Mrs Davey underwent. The evidence relied upon by Mr Cragg simply does not support his contention.

There is within the statements of the healthcare professionals to which I have referred reference to a number of possible mechanisms for the cardiac tamponade that undoubtedly occurred in Mrs Davey’s case. There might have been a trauma to the inside of the heart valve – by inflation of the balloon or a wire – that in some way led to her severely diseased heart leaking, not perhaps by direct through perforation but possibly by allowing a leakage through a section of the heart wall weakened by the trauma. Trauma of the heart is a specific risk of which patients, including Mrs Davey, are warned. Or Mrs Davey might have suffered a myocardial infarction, as the pathologist (Dr Harrison) appears firmly to believe. Or the tamponade may have been idiopathic, i.e. without an identifiable pathogenesis. But, in any event and whatever the mechanism, there is no basis for a proper suspicion that a systemic failure caused or contributed to Mrs Davey’s death. Any evidence of TAVI procedures generally does not assist the Claimant in showing that, in his mother’s case, a systemic failure contributed to her death.

As I have indicated, it is not necessary to establish a causative link between the “circumstances” the continuance or possible recurrence of which is prejudicial to the health of a section of the public, and the deceased’s death; but nor was there any other evidence before the Coroner that in any other case there had been such a systemic failure. There is nothing in the other cases originally relied upon by the Claimant which in substance evidentially supports the contention that any of those seven patients suffered cardiac tamponade as result of a wire; or that there is any form of systemic failure inherent in the TAVI procedure. There were and are in evidence no adverse reports to any regulatory authority, here, in the USA, or anywhere else. There is no evidence from learned literature reporting any such case, even anecdotally.

In my respectful judgment, the Coroner’s decision was carefully and well reasoned. She set out the law, as Mr Cragg accepted, admirably and correctly. She well understood the task she had to perform under the statutory provisions relating to juries under section 8(3)(d) of the 1988 Act. She considered all the evidence before her, and submissions made to her (including, of course, those made by the Claimant), before coming to the conclusion that she did, namely that there was no evidence of a systemic failure in the TAVI procedure which Mrs Davey underwent at Glenfield Hospital. Having made that finding – which it was properly open to her to make – she concluded that there was no reason to suspect that Mrs Davey’s death, which she was investigating, occurred in circumstances the continuance or possible recurrence of which would be prejudicial to the health or safety of any section of the public, notably those upon whom the TAVI procedure is performed in future. She was not only entitled to come to that conclusion, but, although a matter for her, in my respectful view, on the evidence before her, her decision was inevitable and right.

In those circumstances, I must dismiss this application.

May I add two things.

First, in this application, I have been considering whether the Coroner’s decision not to empanel a jury in February of last year was right in law. In my judgment, it was. However, as the Coroner herself indicated in her decision, if and when further evidence comes forward, she has the power to reconsider her decision to sit without a jury, any such decision being made under the new provisions of the 2009 Act.

Second, without descending into the merits of the Coroner’s decision, as I have indicated, there is a mortality rate of 5-10% associated with the TAVI procedure. Although that may appear high when compared with the risks of some other surgical procedures, the TAVI procedure is by its nature only performed on individuals who are very ill with life-threatening disease of the heart. As I have described, they are usually performed on elderly patients with a poor prognosis where the risk of more traditional surgery is too great, i.e. over 50%. Even if it were shown that a particular proportion of such patients at the Glenfield Hospital died following the TAVI, as I have indicated, that would not in itself assist the Claimant’s case.

In fact, the evidence is that the 30-day mortality rate for the Glenfield Hospital was 2.5% in 2011 (i.e. one death out of 39 TAVI patients, namely Mrs Davey) and 4.5% in 2012 (two out of 45 patients), compared with a rate of 5-10% suggested in the informed consent material, 6% at Papworth Hospital and 8% at Liverpool Heart and Chest Hospital, both of which, like Glenfield Hospital, specialise in the procedure. As Mr Sharland submitted, not only is the evidence that there was no systemic failure at Glenfield Hospital in relation to cardiac tamponade and/or other adverse events in association with the TAVI procedure, but, by reference to mortality rate, the results achieved at Glenfield bear good comparison with those elsewhere.

I understand the strong feelings to which Mrs Davey’s death has given rise. She was, quite clearly, a loved mother. However, this court can only interfere with a decision of the Coroner such as this if the Coroner has erred in law. For the reasons I have given, I am quite satisfied that she has not.

Consequently, I refuse this application for judicial review.