Shaw v HM Coroner for Leicester City & South Leicester

The applicant is the daughter of Mr William Ewan who died on 26 September 2007 at Glenfield Hospital Leicester aged 86. He was plainly much loved. Mrs. Shaw wishes to appeal the Divisional Court's refusal to entertain her application for judicial review of the inquest into her father's death.

Mr Ewan died in the following circumstances: in 2007 he was diagnosed with a defective heart valve. He suffered from aortic valve stenosis, a progressive disease which can prove fatal. Treatment may be by open heart surgery, but that carries obvious risks for anybody, let alone the elderly. An alternative treatment was undertaken in Mr Ewan's case and it was relatively new in 2007. It has become known as TAVI, standing for Transaortic Valve Implantation. The procedure involves placing an artificial valve into the defective valve via a catheter in the femoral artery.

During 2007 Glenfield Hospital conducted a trial of the procedure. Mr Ewan's cardiologist, a Dr Fitzpatrick, referred Mr Ewan to Glenfield to see if there was anything they could do for him. Mr Ewan was seen by Dr Kovac, the specialist, on 12 June 2007. He underwent an angiogram on 28 June 2007.

On 25 September 2007, the Glenfield doctors having satisfied themselves that Mr Ewan was suitable for the TAVI procedure, he was admitted. The procedure was performed under general anesthetic. If Mr Ewan was not part of the TAVI trial, as Mrs Shaw believes he was, he was certainly one of the first patients at Glenfield to undergo TAVI after the trials had been concluded.

Shortly after the new valve had been fitted, Mr Ewan began to bleed from his aorta. It was decided to open his chest to determine the source of bleeding. Doctors did their best to stem the blood flow, and insert drains. Mr Ewan was then transferred to the intensive care unit, but, sadly, died not long after his arrival.

Over the next three and a quarter years up to the time of the inquest, an investigation took place into his death. Mrs. Shaw would argue that that investigation was not sufficiently wide ranging and thorough. One of the reasons for the delay in holding the inquest itself was the backlog in work which confronted the Leicester City coroner, Mrs Mason on her appointment. When she realized her other commitments would prevent her from conducting the inquest herself, she appointed a deputy, a Ms Casey to conduct the inquest. Ms Casey then had to stand down and another coroner had to be appointed.

Mrs. Shaw instructed an experienced firm of solicitors, Messrs Leigh Day, to represent her in connection with the inquest. They in turn instructed leading counsel Mr Robert Francis QC. He appeared at a number of pre-inquest reviews. He was succeeded by Mr Neil Garnham QC, who appeared at the final pre-inquest review on 17 December 2010 and then throughout the inquest itself. Mrs. Shaw now represents herself and has done before us today.

The assistant deputy coroner who eventually conducted the inquest was Mr Nigel Godsmark QC, like Mr Francis and Mr Garnham an experienced medical negligence practitioner. He sat for some 13 days between 4 and 21 January inquiring into the circumstances of Mr Ewan's death.

He agreed to conduct an article 2 compliant inquest, known today as a “Middleton Inquest”, named after the decision in R (Middleton) V West Somerset Coroner & Another [2004] 2 AC 182 in which the House of Lords set out the obligations of the fact finder for the purposes of section 11.5(b)(ii) of the Coroner's Act 1988 and rule 36.1 (b) of the 1984 Coroner's Rules. In answering the question how when and where the deceased came by his death, the fact finder must consider by what means and in what circumstances.

Mrs Shaw was anxious that the court should be reminded of the principles that would apply to a Middleton type inquest and drew our attention to R (Smith) v Oxford Assistant Deputy Coroner [2011] 1 AC 1, in which Lord Phillips of Matravers helpfully summarised in paragraph 64 the principles that apply in domestic and European jurisprudence. He said this:

The coroner put to the jury a series of nearly 50 questions relating to the circumstances of Mr Ewan's death. They included all of the obvious questions, such as who Mr Ewan was and when and where he died. There were a series of questions relating to his underlying condition, the nature of the information given to him by his first cardiologist, Dr Fitzpatrick and the information given by Dr Kovac and by Dr Kovac's registrar, Dr Jilaihawi. A number of the questions went to what was one of the most significant issues at the inquest, namely that of informed consent. Further questions dealt with what occurred at the two procedures, the fitting of the device and secondly the attempt to stem the bleeding, and also what actually caused the bleeding. The jury were unable to determine the answer to the cause of the bleeding. However, they concluded that the medical cause of death was i. heart failure following cardiac tamponade complicating percutaneous aortic valve replacement. ii. coronary atherosclerosis.

The jury's overall conclusion was that Mr Ewan's death was the unintended outcome of a therapeutic medical procedure. They concluded that he was suitable for the TAVI procedure, that he was aware of the nature of the procedure and of the risks and gave his informed consent.

No doubt all too aware of Mrs Shaw's feelings on the subject, (as am I), the jury added a sympathetic rider to their verdict. They stated they were “driven to the conclusion” that there was no fault on the part of those who treated her father.

Before the Divisional Court, consisting of Burnett J and His Honour Judge Peter Thornton QC, Chief Coroner, Mrs Shaw sought to quash the inquisition on a number of grounds and secure an order for a fresh inquest. Her original grounds for judicial review contained little of substance. However, no doubt appreciating how emotionally charged these proceedings are for her, the court focused on her lengthy amended grounds served in October 2011. These were summarized by Burnett J as

Overall, Mrs Shaw complained that there was an inadequate investigation into her father's death, both in domestic law terms and in accordance with the state’s obligations under Article 2 of the European Convention on Human Rights. These complaints were considered in turn and comprehensively dismissed by Burnett J, which whose reasoning the Chief Coroner agreed.

Mrs Shaw then attempted to obtain permission to appeal on a large number of grounds. These were refused on paper by Sir Richard Buxton. She amended her grounds and appeared before Aikens LJ at an oral hearing. He was troubled by just two aspects of her proposed appeal and decided, rather than refuse her permission to appeal on all of the grounds, to refer them to this court for a hearing on permission to appeal with appeal to follow if necessary. Mrs Shaw accepted at the beginning of this hearing that she was restricted, therefore, to arguing that she was entitled to permission to appeal on two issues.

First, she placed reliance on the alleged failure of the assistant deputy coroner to investigate the relevance of the Ethics Committee documentation, which she submits was a fundamental flaw in the inquiry. She argues that the documents were fundamentally relevant and should have been included for the jury's consideration. The documents demonstrated that this was a trial of an untested uncertified medical device. Both domestic and European law imposes stringent conditions for the approval of medical devices, without which she submitted they should not be used. The documentation would have established that the trial had been mismanaged and had demonstrated a number of inadequacies on the part of the device. She also submitted that the documentation was relevant to the issue of how many of the valves were used in the trial. Overall it may have affected the jury's consideration to a significant extent.

Second, she argued that documents relevant to the issue of informed consent and the suitability of the procedure for an elderly vulnerable patient like Mr Ewan were not placed before the jury. If the trial was mismanaged and deaths had occurred as a result, as she alleged, and her father had been informed of this he would not have given his consent. Without this information his consent was not informed.

Despite the restrictions to which I have just referred, Mrs Shaw amplified her written amended grounds of appeal to us, arguing that the Divisional Court had made a number of errors, including on the timetabling of the inquest, incorrectly assuming that her father was not part of the TAVI trial, and that all trials for surgical procedures are necessarily carefully planned and monitored. There were, in fact, systemic failings and had the jury known of them, they may well have formed a different view of whether or not this was an appropriate procedure to conduct on her father. She felt the Divisional Court did not understand her complaints about the Ethics Committee documentation. She insisted that she never received the whole file and that even a cursory glance will prove that the key documents are missing from the schedule produced by her solicitor. The jury never saw, therefore key documents for example those detailing the number of patients in the trial and the serious adverse event schedule, all of which went to the question of informed consent and causation of death.

She submitted that the Divisional Court wrongly concluded that the death of trial patients was unconnected with the TAVI procedure and misunderstood the number of valve sizes available and its significance. However, she abandoned an application to rely upon fresh evidence in the form of a report from a Dr Wilmshurst, cardiologist, obtained after the Divisional Court hearing on the basis it was now too late. Had she not done so, I would have refused to receive it n any event; it was not only too late, it was based on an incomplete knowledge of the facts and arguably, in a number of passages, lacked the objectivity of an expert report prepared for the court.

I shall focus as Aikens LJ intended we should do on the Ethics Committee documentation, and material Mrs Shaw obtained by way of freedom of information requests to the National Health Research Authority post the inquest. The thrust of Mrs Shaw's submission is that this material provides a very different picture from that presented to the inquest jury. The jury was led to believe that this was an exciting, proven and successful development in the field of cardiology. The truth revealed by these documents, Mrs Shaw submits, is that it was no such thing. There had been a series of ‘serious adverse events’ linked to the procedure, the trial was poorly managed and a potentially dangerous procedure was deployed on vulnerable elderly patients. There were, she argued, obvious systemic failings which should have been investigated and which may have shone light on her father's death. A more thorough investigation of the trial may have helped prevent deaths in the future.

When pressed as to why the points she now takes were not taken earlier in the proceedings, it became clear that her true complaint is with her lawyers for failing to conduct the proceedings in the way she now says was appropriate. Whatever position she or her counsel adopted before the coroner it was the coroner’s duty, in inquisitorial proceedings, to conduct a full and fearless inquiry.

I understand Mrs Shaw's concern to ensure a proper inquiry into the circumstances of her father’s death. In pursuit of the truth, she has spent many hours trawling through the documentation looking for any possible hint that the clinical trial was defective and the device unsuitable for her father. She truly believes she has found it. However, all the relevant material upon which she now relies was available to the coroner and the parties and was carefully considered at the time. Mr Garnham was alert to the possible issue of the relevance of the documents. At the pre-inquest review in October 2010 before Miss Casey, he stated that the bereaved family accepted the coroner's provisional view that the documents from the Ethics committee were unlikely to be relevant but they wanted to give the matter further thought. He also considered carefully which documents should go in the jury bundle.

When he appeared at a pre-inquest review conducted by Mr Godsmark, he informed the coroner that as far as the bereaved family were concerned the principal issues were the positioning and choice of the valve and the issue of informed consent. It was because all parties agreed, and the coroner was satisfied, that there was no issue as to the efficacy of the device that the manufacturers CoreValve took a back seat in the inquest. Mrs Shaw is therefore now trying to run a totally different argument from that pursued before the coroner and unfortunately it is based solely on her speculation and assertion.

I take her point that whatever stance adopted by the parties the coroner has a duty to ensure a full and fair investigation but he was entitled to look to them for assistance. He found it and I have no doubt that both he and counsel agreed the efficacy of the device was not a legitimate line of inquiry because there was no sound evidential basis to suggest it was.

The documentation simply does not support the interpretation put on it now by Mrs Shaw; for example the schedule of serious adverse events does not establish a causative link between the procedure and a number of deaths of patients as she asserted. Had there been any material to suggest that the procedure was unproven and too risky to be used on an elderly man, given the very thorough nature of the inquiry conducted by Mr Godsmark, I have no doubt this would have been pursued..

Even if Mrs Shaw had been able to establish that a patient had died as a result of the procedure and that the clinical trial had not been managed as it should have been, it is not clear to me, what impact that information would have had upon the jury's deliberations. The jury made clear findings of fact that her father was warned of the risks of the procedure, that he was advised as to his options and that he nevertheless consented to the operation. As for the number and size of the valves used in the trial and on Mr Ewan, the jury made a clear finding of fact, on the basis of good evidence, as to exactly which valve was used.

I am acutely conscious of how much this inquiry means to Mrs Shaw and her family. She undoubtedly genuinely believes the doctors caused her father’s death. I know how badly a bereaved person can be affected by the belief that somebody has caused and/or contributed to their loved one's death and not been brought to account. However, to my mind Mrs Shaw's claim is simply unarguable. I confess I am somewhat surprised it has got this far. In my judgment the coroner left no legitimate stone unturned. His inquiry amply met the demands of an Article 2 compliant inquest.

I can only hope that now these proceedings have concluded Mrs Shaw can comfort herself with the knowledge that no daughter could have done more or fought harder to ensure that the circumstances of her father's death were brought to light. I truly hope that she can now complete the grieving process.

For all of those reasons I would refuse the renewed application.

LORD JUSTICE DAVIS: I also would refuse this renewed application for the reasons given by Lady Justice Hallett and I do not for myself wish to add anything.

LORD JUSTICE FLOYD: I also agree that this application should be refused for the reasons given by my Lady.