England and Wales High Court (Administrative Court) Decisions

HIGH COURT OF JUSTICE

		33 Bull Street, Birmingham.
		10th December 2013

HIS HONOUR JUDGE ROBERT OWEN Q.C:

1. This is a renewed application by the claimant, Mr. Richard Davey, for permission to proceed with his claim for judicial review of the decision of Her Majesty's Coroner for Leicestershire, dated 8^th February 2013, whereby the Coroner refused to empanel a jury for the purposes of the inquest into the death of the deceased, Mrs. Doreen Davey, the claimant's mother.
2. The Coroner's reasons for her decision are set out in the decision letter dated 8^th February 2013 which runs into six pages. The reasons as given by the learned Coroner are to be found at the bottom half of page four (and middle of page 5) namely; first, there was currently no evidence of any systemic failure; secondly, the evidence from the treating clinicians did not suggest any system failure; thirdly, the evidence suggested that the deceased died as a consequence of a recognised complication during the TAVI procedure (that is, transaortic valve implantation - a procedure which was devised or pioneered at the hospital where the operation was being carried out). Fourth, that in this case there was nothing raised by the evidence (that is, in effect, the short statements provided by the clinicians concerned) which suggested a failure of any system. On page 5 the Coroner expressed the opinion that the evidence suggested an individual failure but no analysis, however succinct, or explanation for that view is offered.
3. Thus, on the available evidence the Coroner observed that the case was, she thought, at its highest, one of individual failure, not systemic failure. Accordingly the learned Coroner determined that the duty under section 8(3)(d) of The Coroner's Act 1988 was not triggered.
4. Section 8(3)(d) reads as follows:

"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 and the safety of the public, or any section of the public, he shall proceed to summon a jury in the manner required by subsection 2 above."

5. The first three and a half pages of the decision letter sets out in detail the legal framework in respect of which nothing arises for present purposes.
6. The learned Coroner correctly identified the relatively low but nonetheless clear threshold which had to be overcome in order to trigger the duty under section 8(3)(d); that is, it was not necessary to establish that the circumstances which might recur (about which the claimant complains) actually caused the deceased's death (see pages three and four of the decision letter which summarises the judicial guidance). The prospect of recurrence required for the section to be triggered was low, that is, a possibility - a real as opposed to a fanciful possibility - of recurrence. If the circumstances are such that it is possible that the continuation of the state of affairs identified may be prejudicial to the health and safety of the public, in the present case suggest a systemic failure then the subsection will be triggered. If the circumstances suggest an individual failure then the subsection is unlikely to be triggered. Of course, each case must be decided on its own facts.
7. So far as the basis of the decision complained of is concerned, it appears the learned Coroner considered the statements provided by the clinicians and proceeded on the basis that those clinicians did not suggest a system failure and that, according to the opinion of at least one or more of those clinicians, the deceased died "as a consequence of a recognised complication during the TAVI procedure."

However, what complication exactly is alleged to have been relevant as a cause, or contributory cause, of the death of the deceased is not identified, nor indeed is the individual said to have been responsible for the failure nor the particular evidence upon which the learned Coroner did give weight.

8. The learned Coroner correctly concluded however that the duty is not triggered merely on the basis that the possibility of a systemic failure might emerge during and in the course of an inquest at which a jury had been empanelled. That is, this duty is not to be triggered for the purpose of permitting some form of fishing expedition to see whether or not 'something might turn up' at the inquest.
9. The Coroner rejected the argument put forward by Mr. Davey that the question which required to be addressed with the benefit of a jury was; what percentage of the public, whilst undergoing this procedure, had been affected either by death or by serious injury? If that was the sole point to justify the proposed empanelling of a jury then the learned Coroner was right in rejecting it.
10. In this case the question which arises is whether it is arguable that the learned Coroner's decision was plainly wrong in the sense that it is open the criticism that it is either unreasonable, or irrational, and/or fails properly to give adequate reasons so as to enable the parties clearly to understand the basis for that decision.
11. In this particular case the procedure in question was undertaken by a team of five doctors. First, Professor Spyt, Professor of Cardiovascular Surgery, and at the Glenfield Hospital a Consultant Cardiac Surgeon. He does not identify his particular role, but it appears from the other statements that he was an assistant operator at the time in this operation.
12. Second, Dr. Jan Kovac , a Consultant Cardiologist. He was the primary operator, that is, the TAVI interventionist. He described Dr. Spyt as the "assistant operator".
13. Third, Dr Derek Chin, a Consultant Cardiologist, who performed the transesophageal echocardiography.
14. Fourth, Dr. Johan Bence, a Consultant Cardiothoracic Anaesthetist, who conducted the anaesthetic during the operation.
15. Finally, Dr. Mohammed Jeilan, a Cardiology Specialist Registrar, who has provided an informal unsigned statement. He was also an assistant operator, along with Professor Spyt, who was not involved in the latter part of the procedure, but was involved during the post operation discussion and explanation with the claimant's sisters in the course of which there was some mention, according to Dr. Jaylan, of the possibility of there being some kind of unidentified trauma to the heart during that procedure.
16. The Coroner's letter dated 20^th April 2012 to the deceased's family starts as follows:

"I write to inform you that disturbingly information has now been received from the solicitors representing the defendant suggesting that there may be a connection between events that took place during the procedure and the cause of death. I am reliant on doctors sharing with me all information in their possession relevant to my inquiry. I fear that on this instance they may have fallen short of their professional obligations."

The information received at that time is not identified or presently before the Court. The Coroner did have in her possession at that time, however, a report to Her Majesty's Coroner from Professor Spyt, dated 11^th February 2011. This report fails clearly to identify what exactly happened during this procedure and at best is consistent with the Coroner's belief prior to April 2012 that there was apparently nothing to connect the events which took place during that procedure and the cause of the deceased's death. The terms of that report need not be reiterated for present purposes. It does not appear, however, to be comprehensive or to deal with the material matters.

Be that as it may, following that letter the defendants duly provided to the Coroner witness statements from the clinicians involved. Professor's Spyt's supplementary statement is dated 26^th June 2012. He refers to the pathologist's report of the 22^nd February 2011 and the pathologist's supplementary letter, dated 29^th March 2011, which are not presently before this Court.

17. In this statement the Professor refers to cardiac tamponade which is said to be a rare but recognised complication of this particular procedure. He qualified that statement by stating that often there is a leak which is self-sealing.
18. The Professor identified the fact that the post mortem report concluded:

"Mild cardial infarction."

But, as the evidence revealed, that could not have been the cause for otherwise it would have been evident to those concerned and would be shown on the ECG by way of example.

19. He refers to a build-up of 'fluid' which is not identified. According to the Professor it was not possible to identify the source of that fluid. His statement goes on to state:

"With hindsight it may be that a wire had caused a small lesion which produced the leak."

That explanation, as such, is couched in very careful terms at paragraph 30 of the earlier report.

20. Finally, the Professor stated that there was a ventricular rupture, which was difficult to explain, which was a recognised complication of this procedure. It is not clear whether ventricular rupture is in fact the same thing, or the same kind of complication, as cardiac tamponade. The impression gained is that the Professor was speaking of two different events. But he might not have been.
21. Dr. Johan Bence, the Consultant Cardiothoracic Anaesthetist, provided a statement dated 17^th May 2012. According to him everything was stable until the ballooning of the aortic valve. According to Dr. Bence, speaking for Dr. Chin apparently, Dr. Chin identified fluid (which again it is not clear but appears to refer to blood) and the development of cardiac tamponade due to blood in the perocardinal space. It was as a result of that event that the deceased was taken to theatre in order to identify the cause.
22. Signs which would indicate a cardio chamber wall perforation were considered. Eventually the source was considered to be located in the left ventricle, and controlled. There was apparently one perforation. The TOE wire went through or was 'embedded' in the left ventricle wall, it appears from this statement. Cardiac arrest occurred upon closing the chest following those investigations. The description given by this professional clinician, considering that he was an eye witness, is not as clear as one might have expected at this stage.
23. Dr. Derek Chin, the Consultant Cardiologist, whose statement was dated 11^th May 2012 understood and monitored the transesophageal echocardiography. According to him a wire was noted to be embedded in the wall, that is, I assume, the left ventricle, but not apparently pierced. No further details are provided by this Consultant.
24. Dr. Jan Kovac, the Consultant Cardiologist was the primary operator. According to his statement of the 26^th May 2012 fluid accumulation is one of the recognised and more frequent complications. No further explanation is offered by him.
25. Finally, there is an unsigned, undated statement marked "Private and Confidential" from Dr. Jeilan whose involvement in this procedure stopped at the point of transfer to theatre to which I have referred. According to Dr. Jaylan the suspicion within the team was the possibility of bleeding into the aortic root may have followed trauma by the balloon and which might be the cause, from which, from their experience, it would not be possible to correct by simply implanting the TAVI. Accordingly it was unsafe to proceed and it was appropriate to take the deceased to theatre.
26. Dr. Jeilan's next involvement was subsequently in the quiet room having a discussion with the claimant's sisters when according to his statement he explained that the worry was that there may have been trauma to the heart or aorta during the balloon valvuloplasty causing a leak through possible perforation of the heart, aortic valve, ring or aorta. He says that he explained that a leak had not been found.
27. This was the state of the evidence which was before, so far as it is possible to tell on the present information, the learned Coroner.
28. The application for renewal was presented by Mr. Davey in person. He explained that given the events affecting the deceased, not least in the background of the fact that there had been at least seven other verdicts before the Coroner during 2012 involving this procedure which has resulted in the death of the patient concerned, that the threshold for empanelling a jury has been triggered in that there is sufficient evidence before this Court to show that it is arguable that something was inherently wrong with this particular procedure. By "something" I took Mr. Davey to mean – although he had difficulty in articulating himself (for which there is no criticism) – that there was something systemically wrong with this procedure.
29. Mr Davey submitted that the learned Coroner was wrong in saying that there was no evidence of systemic failure because at this stage he argued the evidence has not been fully adduced and the matter has not yet been subjected to full scrutiny and therefore it is not possible for the Coroner to come to that conclusion. Accordingly he argued that given the history of this matter the reason given is not a proper or rational reason and there was a misdirection by the learned Coroner.
30. Clearly, Mr. Davey's submission cannot be accepted in that form. The question which arises (leaving aside the adequacy of the reasons argument) is whether there is sufficient evidence to render this decision arguably wrong and that it is arguable that there is or may be a systemic deficiency within this procedure which may have caused or contributed to the death of the deceased and, if so, would or might be prejudicial to the health and safety of the public or a section of the public (those persons who may be exposed to this procedure in its present form).
31. Mr. Davey referred the Court to the seven other cases which indeed all took place between January and December 2012. According to the information submitted to the Court these concerned patients between the ages of 68 and 87. All bar one, according to the information presented to the Court, died as a result of or contributed to apparently 'a recognised complication' of this procedure, which complication was not, however, identified.
32. In dealing with the summary grounds of resistance the defendants refer to this piece of evidence at paragraph 29. In that paragraph reference is made (out of the seven cases cited) to the single case of Mr. James Craig, who died on the 1^st October 2012, who is the only person who, according to the post mortem, died of natural causes. In my judgment these summary grounds of resistance fail to grapple with this piece of evidence, namely the sheer number of other fatal outcomes involving in some way this same procedure at this hospital which was of course pioneered and devised at this hospital.
33. So far as the summary grounds of resistance otherwise are concerned, the position taken, not unpredictably, is that the learned Coroner directed herself in accordance with the appropriate test and came to a conclusion which was open to her on the state of the evidence. That is, putting it negatively, there was no evidence to suggest a system failure.
34. The difficulty with this application and case is that the evidence thus far largely comes from the clinicians themselves. They can hardly complain if an independent objective observer has some misgivings about the fullness and quality of that evidence given the understandable concerns expressed by the Coroner herself in her letter of April 2012.
35. Furthermore, one only has to look at the statements, which appear to be carefully drafted, if not defensive. My concern arising out of the evidence before this Court, which I assume was the same evidence before the Coroner, is that too much weight appears to have been given to the fact that none of these treating clinicians have openly identified or suggested systemic failure. That said, the fact remains that it appears that in the course of this operation the left ventricular wall was or might have been significantly damaged, if not outrightly perforated, so as to produce the bleeding in question.
36. Furthermore, it appears to be the case that none of these doctors apparently were able it seems properly to identify the source of the bleeding, yet one of the doctors is able to identify the location of the contact between the wire and the left ventricular wall. However, the fact is that there is no real explanation before the Court, nor was there before the Coroner, as to how that fatal outcome resulted.
37. My concern is that it is arguable that this decision fails properly to give a reasoned explanation for the decision in question. I am concerned by the absence of any analysis of the statements which were before the Coroner and their failure collectively or individually to provide a full or rational explanation for the fact of the damage to the ventricular wall and why that damage was attributable (if it be suggested, in fact, by the clinicians) to individual error rather than by system error. That is, the very nature of this procedure created the (arguably) unacceptable risk of piercing or trauma to the ventricular wall and/or in circumstances where the operating clinicians are unable to anticipate and avoid or reduce the risk of such piercing or trauma.
38. I am further concerned that the alleged 'recognised complication' which is said to be the cause of the deceased's death has not been identified by any one of the doctors concerned or, indeed, the Coroner herself in her decision letter. It is not clear what was the exact 'recognised complication' which is said to have been relevant in this particular case. I refer to the reference by the Professor to a cardiac tamponade, and then to ventricular collapse, rupture and so on. It is not clear to the Court in these circumstances on what basis the learned Coroner could come to the conclusion referred to or, in any event, why or how that conclusion was arrived at.
39. In short, I am satisfied that it is arguable at least that this decision was wrong and fails adequately to identify, on a reasoned (or any) basis the correctness of this decision.
40. Furthermore, I am satisfied that in all the circumstances this is an issue which deserves full argument before the Court rather than be summarily treated in the way in which it has been hitherto.
41. It is in these circumstances that I am persuaded, albeit not for the reasons or grounds specifically advocated by Mr Davey that it would be appropriate to grant permission for this matter to proceed before a Judge for full argument. The decision is not adequately explained or reasoned; it is arguable that the evidence is consistent with and reveals a systemic as opposed to individual failure; the paucity of detail provided by the clinicians and the fact of the damage to the ventricular wall during the operation without explanation allows for the argument that the procedure itself created the very risk of damage which arose and thus the failure might be regarded as systemic, not individual.
42. It in these circumstances that permission is granted. The directions which I make are as follows: the defendant, and any other person served with a claim form, who wishes to contest the claim, or support it on additional grounds, must file and serve detailed grounds for contesting the claim, or supporting it on additional grounds, and any written evidence, within 21 days after service of this order. In particular the defendant should consider whether they wish to file any further and if so what evidence in order to state in plain and unambiguous terms: (a) the cause and site of the bleeding in question; (b) when and how that bleeding was occasioned; (c) when and by whom it was identified; (d) what if any steps were taken and when and by whom to seal that leak; (e) what recognised complication it is said applied to this particular case and how it caused or contributed to the death of the deceased. Finally, whether any and if so what step has been taken, and if so when, to modify the TAVI procedure further so as to reduce the risk, or avoid the risk, of perforation by wire during this procedure.
43. Secondly, any reply and any application by the claimant to lodge further evidence must be done within 14 days after service of the detailed grounds contesting the claim. In particular the claimant should give consideration to the terms of this Judgment and recognise that the main points he has pursued hitherto, by way of specific points, were not in fact appropriate and rather his generalised point that, as it were, 'something was wrong' with this procedure in the circumstances requires clarification.
44. Next, the claimant must file and serve a hearing bundle not less than four weeks before the date of the hearing of the judicial review. The claimant must liaise with the representative of the defendants who may wish to accept the burden of providing an appropriate bundle themselves so as to ensure that the bundle is presented to the Court in a full and proper order. Whether or not that bundle should include each of the documents referred to in this Judgment, but not presently before the Court, together with the relevant medical records, is a matter for consultation between the parties.
45. Next, the claimant must file and serve a skeleton argument not less than 14 days prior to the hearing of the judicial review.
46. Next, the defendants and any interested party must file and serve their skeleton argument, if any, not less than seven days prior to the hearing of the judicial review.
47. In the event that either party wishes to present to the Court any authority then the parties must file an agreed bundle of authorities not less than three days before the hearing of the judicial review.
48. This matter will then be listed for hearing for two-and-a-half hours. Counsel for the defendant is to provide a written time estimate within seven days of this order if he or she disagrees with this direction.
49. I have given full reasons having regard to the absence of the defendants and interested party, the fact that there may be additional information available which has not been made available to the court for whatever reason and the fact that the reasons for granting permission differ from those advanced by the claimant, a litigant in person.

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Signed: (Christine Kriehn)

5790/H4476