Mrs Justice Andrews:
INTRODUCTION
- This is a claim for professional negligence brought against the Claimant's former solicitors, Leigh Day.
- The Claimant, Mrs Shaw, is the daughter of the late Mr William Ewan, who died aged 86 following an operation at Glenfield Hospital, Leicester on 26 September 2007. Mr Ewan had undergone a newly developed "keyhole" surgical procedure known as transcatheter aortic valve implantation ("TAVI") or percutaneous aortic valve replacement ("PAVR"). I shall refer to it as "TAVI". The procedure involved the insertion of a prosthetic aortic valve into the aorta via the femoral artery. It was intended to be used for patients who by reason of age or infirmity (or both) were not deemed suitable to undergo open heart surgery. During the operation, immediately following the insertion of the valve, a hole or tear developed in the aorta through which a substantial amount of blood haemorrhaged into the pericardium, leading to a cardiac tamponade. Despite post-operative attempts to stabilise the situation, Mr Ewan suffered a cardiac arrest. He died in the intensive care unit shortly thereafter.
- An Inquest was ordered into the circumstances of Mr Ewan's death. In April 2008 Mrs Shaw instructed Leigh Day to represent the interests of Mr Ewan's family at the Inquest. She subsequently instructed them in clinical negligence proceedings taken against the University Hospitals of Leicester NHS Trust ("the Trust") and a consultant interventional cardiologist, Dr Jan Kovac, who was Mr Ewan's treating consultant and one of the lead surgeons in the team who performed the TAVI procedure. I will refer to the history of the clinical negligence proceedings later in this judgment.
- At all material times, the partner in Leigh Day who bore the overall responsibility for the care and conduct of these matters was Miss Anne Winyard, who had more than 25 years' experience as a specialist practitioner in the field of clinical negligence. I heard evidence at trial from Mrs Shaw and from Miss Winyard, who is now retired.
- I also heard evidence from Sir Robert Francis QC, who was instructed by Leigh Day, in succession to Mr Owain Thomas (who was then still a junior counsel), to advise and represent the bereaved family. Sir Robert was only briefly involved. He appeared at the second of the four Pre-Inquest Reviews ("PIR") on 15 June 2009 but had to cease acting in September that year due to his appointment to chair the Mid-Staffordshire Inquiry. From September 2010 onwards, the family were represented by Mr Neil Garnham QC, (now Mr Justice Garnham) who appeared at the third and fourth PIR and at the Inquest itself. Mr Garnham, as I shall continue to call him, also settled the original Particulars of Claim in the clinical negligence claim. He did not give evidence in these proceedings. None of the counsel instructed by Leigh Day has been (or could have been) the subject of any criticism by Mrs Shaw.
- On 21 January 2011, at the conclusion of the Inquest, which had lasted for 3 weeks, the jury returned a narrative verdict. It concluded that Mr Ewan's death was the unintended consequence of a therapeutic procedure and that he had been informed of the risks of the TAVI procedure, including that of death, before he agreed to undergo surgery. The jury found that the valve which had been used was 26 mm in size and that the clinical response to the haemorrhage and cardiac arrest was appropriately managed. It decided that the cause of the damage to Mr Ewan's aorta which had led to the catastrophic bleeding could not be identified. It concluded that the medical cause of death was (i) heart failure following cardiac tamponade complicating percutaneous aortic valve replacement and (ii) coronary atherosclerosis.
- Mrs Shaw was dissatisfied with the outcome of the Inquest. Besides the claim for clinical negligence, she commenced proceedings for judicial review, which she pursued as a litigant in person despite being advised by Mr Garnham and Leigh Day that there was no real prospect of success. The claim for judicial review was dismissed by a Divisional Court comprising Burnett J (as he then was) and HM Chief Coroner; and the Court of Appeal refused a renewed application for permission to appeal that decision following an oral hearing before the full court in February 2014: [2014] EWCA Civ 294. It held that the Inquest had fully complied with the requirements of Article 2 ECHR and that the Coroner "had left no legitimate stone unturned". In paragraph 29 of her judgment, with which the other members of the court agreed, Hallett LJ said she hoped that now those proceedings had concluded, Mrs Shaw could 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. She also expressed the hope that Mrs Shaw could now complete the grieving process. Sadly, that hope proved futile. The present claim against Leigh Day was issued on 8 April 2014.
- A solicitor will only be held to have been professionally negligent if he or she fails to act in accordance with the standard of reasonable care and skill expected of a solicitor receiving those instructions, taking into consideration any relevant specialist expertise. Put simply, that means that the solicitor has failed to do something that any competent solicitor would have done; or else has done something or given advice that any competent solicitor would not have done or given. Where a matter is entrusted to a solicitor and a range of reasonable decisions or actions could have been taken by a solicitor who is so instructed, there will only be a breach of duty if it can be established that the solicitor's behaviour fell outside that range. It is not enough to show that a different solicitor may have taken a different view or a different course, let alone that the client felt that the solicitor could have done more. That is why the court will rarely hold a professional to be in breach of duty in the absence of assistance from a suitably qualified expert who can explain why in his or her opinion the acts or omissions complained of fell below the standard of professional competence that would have been expected in those circumstances. No expert evidence was called in this case.
- Of course, not every case of professional negligence requires expert evidence to support it, and there may be cases where the breach of duty is obvious, for example where it is possible to demonstrate, by reference to established authority, that the wrong legal advice was given, or where the solicitor fails to issue proceedings within the limitation period that would otherwise have had a realistic prospect of success. However, this is not such a case.
- An inquest is an inquisitorial rather than an adversarial process. Whilst interested persons have the right to make submissions at any PIR as to the scope of the inquiry, what evidence should be adduced, and what witnesses should be called, the final decision on all such matters is taken by the Coroner. So long as appropriate representations are made, the legal representatives of an interested person cannot be held in breach of duty to their client if the Coroner determines that certain evidence is not to be admitted or precludes a certain line of questioning from being pursued. That is exactly what happened here.
- One of the real difficulties that has arisen, not only in the course of the trial but in the action as a whole, has been trying to ascertain why the matters complained of by Mrs Shaw are said to have amounted to a breach of duty, let alone a breach of duty which has caused her to suffer a recoverable loss. Indeed, it is one of the more extraordinary features of this case that Mrs Shaw was constrained to concede in cross-examination that there was no evidential basis (whether cogent or otherwise) for any of the propositions that she criticised Leigh Day for not having pursued (or pressed the Coroner to pursue) either at the Inquest or in the clinical negligence proceedings.
- In their final written submissions, the Defendant's counsel Mr Whitting QC and Ms Boon said that "neither from the opening, nor from the evidence of the Claimant, nor from the cross-examination of the Defendant's witnesses, did it become any clearer what the nature of the complaints are, still less how they translate into any actionable damages." I regret to say that this is fair comment. More than once during the trial I had to ask Mr Berkley QC, who represented Mrs Shaw, to articulate precisely what it was alleged that Leigh Day should have done which they did not do, and, just as importantly, why that behaviour allegedly fell below the requisite professional standard. The answers generally left me none the wiser.
- In a letter to Mrs Shaw of 2 April 2008, in answer to Mrs Shaw's initial request for help, Miss Winyard said that "an inquest is an important fact gathering opportunity that can often greatly assist the family by answering the many questions that they have after the unexpected death of a family member". "Often" is not the same as "always", and by accepting Mrs Shaw's instructions to represent Mr Ewan's family at the Inquest, Miss Winyard was not promising that she or her firm would obtain those answers. She had no legal obligation to obtain them. At most, she was obliged to act in accordance with the standards of a reasonable, competent professional in seeking to obtain those answers at the Inquest, bearing in mind that the ambit of inquiry at an inquest is a matter for the Coroner.
- Mrs Shaw failed to obtain answers to all the questions that she wanted answered, and is unhappy with those answers that she did obtain. Having in consequence failed to achieve the closure that she sought, Mrs Shaw has convinced herself that someone must be to blame. She cannot accept that an Inquest will not always succeed in laying to rest all the concerns of the family of the deceased, and that this situation may not be anyone's fault. Although, like other judges before me, I have great sympathy for Mrs Shaw's desire to get to the truth of what happened to her father, that is the position here.
- Whilst I have no doubt that Mrs Shaw genuinely feels that Leigh Day let her down, and I reject the suggestion that these proceedings were brought for a financial motive, the simple fact is that there is no legitimate basis for criticism of their performance of their retainer in this matter. They carried out their instructions diligently and competently. The vague assertions that appear in the Claimant's statements of case and which were elaborated on by Mr Berkley in oral and written argument come nowhere near establishing any fault or failing on their part that could be properly characterised as a breach of their professional duties, let alone one that caused any actionable loss.
THE FACTUAL BACKGROUND
- The witnesses and the court were referred to copious documents, including transcripts of the four PIR and of the Inquest itself, from which the history of the matter was relatively easy to discern. There has been little, if any, real factual controversy.
- Early in 2007 Mr Ewan went to see his GP complaining of breathlessness. The GP referred him to a cardiologist, who examined him in May 2007 and diagnosed that he was suffering from aortic valve disease. He referred Mr Ewan to Dr Kovac for consideration of whether he might be a suitable candidate for the TAVI procedure. Unbeknown to Mr Ewan and his family at the time, Glenfield Hospital was among a number of medical centres that had been taking part in clinical trials of the prosthetic valves that were to be used in the procedure, which were manufactured by a company trading as "CoreValve". Regulatory permission for a 5-year clinical trial had been granted by the Regional Ethical Committee as recently as 22 January 2007.
- On 12 June 2007 Mr Ewan underwent an echocardiogram which was interpreted as indicating that his aortic valve was "heavily calcified with restricted opening and visually moderate to severely stenosed (sic) with aortic annulus ranging from 20-24 mm." That diagnosis was subsequently confirmed following a coronary angiogram. Dr Kovac advised Mr Ewan's GP that the aortic stenosis was "visually moderate to severe", and that, while the size of the annulus was slightly on the border for available sizes of implantable prostheses "angiographically there does not seem to be a contraindication for valve implant." Mr Ewan was duly placed on the waiting list for TAVI. At that time, it was planned to use the larger of the two CoreValve prosthetic valves, which was 29mm in size. On 25 September 2007 Mr Ewan was admitted to the hospital, and on the following day he underwent the procedure in the catheter laboratory, with the tragic consequences that I have already described. He had been only the fifth patient to undergo the TAVI procedure at Glenfield Hospital after its participation in the practical aspects of the clinical trials had ceased.
- Mrs Shaw was devoted to her father and was devastated by his death, for which she was initially inclined to blame herself, because she had financed his private medical treatment. She was understandably anxious to discover precisely what had happened, and whether any steps could or should have been taken to have prevented it. She was prepared to pay whatever it took to obtain advice and representation at the Inquest from a firm of solicitors who had expertise in representing families of the deceased at inquests. That is why she approached Miss Winyard to seek her advice and assistance. Leigh Day's hourly rates were high even by today's standards, let alone those of ten years ago, but Mrs Shaw told them "the costs are truly irrelevant. I want at the very least a correct verdict at the Inquest". By this she meant a verdict in accordance with the established facts, rather than any specific verdict (such as death by misadventure).
- Among the questions that Mrs Shaw wanted to be answered were the following:
i) Was Mr Ewan correctly assessed as suitable for the TAVI procedure?
ii) Was the CoreValve still at a developmental stage?
iii) Was Mr Ewan unwittingly part of a clinical trial?
iv) What was the size and precise model of valve inserted?
[this was not as straightforward to answer as it might have been, because the actual valve that had been used in Mr Ewan's operation had apparently gone missing after the post-mortem]
v) What was the cause of the perforation of the aorta which led to Mr Ewan's death?
- It is no part of an inquest to attribute any blame for the deceased's death. The scope of the inquiry is limited to ascertaining the identity of the deceased, where and when he died, and in what circumstances he died. Mrs Shaw was so advised, not only by Leigh Day but by the Coroner at the very first PIR. However, as Miss Winyard explained to Mrs Shaw, an inquest can be a useful fact-gathering exercise which, in an appropriate case, may form a sufficient foundation for bringing legal proceedings in due course. Miss Winyard and Sir Robert Francis both acknowledged in their evidence that whenever solicitors and counsel are instructed to attend an inquest in a medical disaster, in the background there will almost inevitably be some thought given to whether disclosed information would lead to an ability to bring an action for clinical negligence, if that is what the client wishes to do. However, that is very much a secondary consideration.
- As a starting point, Miss Winyard told Mrs Shaw that Leigh Day were going to obtain a full set of Mr Ewan's medical records and to instruct an expert consultant cardiologist who was familiar with the TAVI procedure to assist them in preparing questions that could be put to relevant witnesses at the Inquest. Mrs Shaw was content to follow that course, in reliance on Leigh Day's advice. She was aware that the role of any experts they decided to consult was purely advisory. Their function was to provide information to her legal advisers which would enable them to make informed submissions to the Coroner as to the scope of the Inquest and the relevant issues and documentation, and to assist them in formulating the lines of questioning they might take of any witnesses whom the Coroner decided to call. It was not intended to seek the Coroner's permission to call any of those experts to give evidence at the Inquest. It is not the normal practice of a Coroner to allow interested parties to call their own experts.
- Following the initial PIR in July 2008, and in accordance with the plan communicated to and approved by Mrs Shaw, a report was obtained from Dr Stephen Brecker, a consultant interventional cardiologist at the London Teaching Hospital who was familiar with the TAVI procedure. Mrs Shaw was satisfied that Dr Brecker was asked to address all the relevant issues in his instructions. As the TAVI procedure was so new at the time, the pool of experts with the requisite knowledge about it was a relatively small one. Therefore, it was hardly surprising that, although he worked at a different hospital, Dr Brecker knew Dr Kovac and the CoreValve product well. In fact, it transpired that Dr Brecker had been invited to observe the operation on Mr Ewan, though in the event he had been unable to attend.
- Dr Brecker was able to give an informed explanation of what the procedure entailed, which would obviously have some bearing on the assessment of a patient's suitability to undergo it. He agreed with the diagnosis of aortic stenosis but pointed to the "highly unusual" feature of a small gradient across the aortic valve. Despite this, he said that whilst opinions as to whether to perform TAVI on Mr Ewan might differ, there would have been a responsible body of cardiologists who would have undertaken the TAVI procedure on him. Dr Brecker said he believed that the CoreValve was a superior product to the only alternative make of valve that could have been used. He explained that although the original plan had been to use a larger sized valve on Mr Ewan, the final decision as to the size of valve was routinely taken at the last minute, during the operation. Having considered the evidence, he advised that it was the smaller 26mm valve which had been used (advice that proved to be correct). It was Dr Brecker's opinion that the most likely cause of the perforation to the aorta was the guide wire that had been used.
- Dr Brecker was unable to express an opinion as to the adequacy of the clinical response to the emergency when it occurred, as this was outside the scope of his expertise. The expert instructed to assist Leigh Day in exploring that issue was Professor Monty Mythen, a consultant anaesthetist. Professor Mythen was not critical of those aspects of Mr Ewan's care that were within his remit, but he did raise queries on aspects of the case that he acknowledged were outside his area of expertise. These included whether the extent of Mr Ewan's aortic stenosis was mild and not moderate to severe. That was a legitimate avenue for exploration, as the imaging and other clinical information could be interpreted as indicating that the aortic stenosis was not as severe as Dr Kovac had diagnosed. On the other hand, Mr Ewan's post-mortem report had demonstrated that the stenosis was worse than any of the pre-operative imaging had shown. Mr Ewan was also symptomatic, which was a relevant consideration when deciding whether he should undergo the procedure.
- At that stage, neither expert had said anything critical about the decision that Mr Ewan was suitable for this procedure, the choice of valve, the way in which the procedure was performed, or the clinicians' response to the emergency. They had both, however, expressed some reservations about whether Mr Ewan gave properly informed consent to the procedure, and Professor Mythen had raised matters relating to cardiological features that might be worth raising with Dr Brecker. Dr Brecker's preliminary opinion would not have supported a claim in clinical negligence based on the decision taken by Dr Kovac that Mr Ewan was suitable for the TAVI procedure, or the manner in which the procedure was carried out.
- Mrs Shaw was not persuaded by Dr Brecker's views. She had conducted some research of her own into aortic stenosis on the Internet, in the light of which she became increasingly convinced that her father was not a suitable candidate for the procedure. She said as much to Leigh Day. When she found out that there had been a clinical trial at the Hospital involving the prosthetic valves, Mrs Shaw strongly suspected that her father had been part of it, and this was something that she was very keen to explore. Her initial feelings of guilt about his death had by now transmuted into increasing feelings of anger.
- Sir Robert Francis QC was instructed on 8 June 2009. Following an initial telephone consultation, he emailed to Leigh Day a possible list of issues to be tabled at the second PIR. These included:
Consent.
Was the proposed treatment experimental?
If so, were any relevant protocols and procedures followed?
What role was played by those present?
How was the aorta damaged?
Was the death caused by the procedure?
What happened following the tamponade?
What steps were taken to resuscitate the deceased?
- The second PIR took place on 15 June 2009 before the new Leicester Coroner, Mrs Catherine Mason. Sir Robert managed to persuade her to direct that the Inquest should be held under Article 2 ECHR and that there should be a jury. The list of issues which he had drawn up was also accepted by the Coroner; indeed, it proved largely uncontroversial.
- Sir Robert explained in his evidence that one feature that struck him as significant was the dearth of records and other documentation. He told the Coroner that there was evidence that Glenfield Hospital was part of a clinical trial in relation to the use of and insertion of the CoreValve, and that the family wished it to be investigated whether the clinical trial was still ongoing and the extent to which, if at all, Mr Ewan was part of it. Against that background, he made a very wide-ranging request for disclosure of documentation - as he frankly put it, to see how much he could possibly get away with. This included a request for documentation pertaining to the clinical trial (including any relevant protocols and procedures) if Mr Ewan was part of it. Having made that request, he added this:
"even if it was said that it [i.e. Mr Ewan's operation] was after the trial, we would like to see documentary evidence to substantiate that. In other words, when did the trial take place? How many patients were in it? When did it conclude? And with what result?"
- In his evidence at trial, Sir Robert's explanation for making a request for documents that would substantiate a negative, namely, that Mr Ewan was not part of the clinical trial, was as follows:
"we wanted to know whether Mr Ewan was part of a clinical trial because that was in itself relevant to whether he had been properly informed of the risks of what he was about to undergo. I would imagine we would also be interested in the outcome of the clinical trial in relation to the safety or otherwise of the device being used, remembering that at this stage we were unclear as to what had caused the catastrophic bleeding".
Sir Robert was pleasantly surprised that the Coroner directed as much disclosure as she did. In his experience, Coroners rarely acceded to submissions that they should widen the scope of their inquiries.
- Following that PIR there were further consultations with Professor Mythen and Dr Brecker, both of which Sir Robert attended; in the event, the consultation with Dr Brecker turned out to be the last involvement he had in the case. The question whether Mr Ewan's consent had been properly obtained appears to have been the main focus of attention. Neither of the experts said anything to suggest that Mr Ewan was not a suitable candidate for the TAVI procedure or that it was negligently performed. Dr Brecker suggested that, as well as Professor Mythen, a cardiac surgeon should be asked to advise about the adequacy of the clinical response to the emergency.
- Sir Robert was asked in cross-examination about a suggestion he had made in correspondence with Leigh Day that a "basic cardiologist" might be consulted. He explained that the reason for that suggestion was that there were moving images on the radiology that might require interpretation. He also had some concerns that Dr Brecker was closely associated with the procedure and with Dr Kovac, and he felt that in the light of this, someone who was used to carrying out pre-operative assessments but had nothing to do with the procedure itself could be helpful (as he put it at the time, as a "useful fall-back".) However, it was no part of Sir Robert's thinking that such an expert would be essential, let alone that an application would be made to the Coroner to call that expert at the Inquest. He pointed out that they were not proposing to ask the Coroner to call Dr Brecker.
- In February 2010, in response to the Coroner's request, the National Research Ethics Committee released certain documents pertaining to TAVI. These included the Committee's approval, subject to certain terms and conditions, of the clinical evaluation of the CoreValve prosthetic valves. For some reason the Coroner's office did not send these documents on to Leigh Day until early July 2010. That is not something for which Leigh Day could possibly be blamed and, in the event, it caused no prejudice to them or their clients in the preparation for the Inquest, as that did not take place until January 2011. Mr Garnham was not instructed until September 2010.
- The main reason for the delay in the Inquest was that the Trust had commissioned an independent report from a firm of consultants called NICHE to look into the relevant aspects of Mr Ewan's care, including the use of CoreValve, the appropriateness of the procedure and the aftercare, and whether there were any systemic failings that the Trust should be made aware of. Two experts were instructed in connection with that report, Dr Mullen, an anaesthetist, and Dr Hutchinson, an interventional cardiologist. Both these experts eventually gave evidence at the Inquest. Much of 2010 was taken up in waiting for the completion of the NICHE report, and the next PIR was postponed on two occasions because it was not ready.
- Mr Garnham QC was instructed on 27 September, and attended the third PIR, which took place before an Assistant Coroner on 20 October 2010. A few days before the PIR, Miss Winyard sent Mrs Shaw a copy of the large folder of documents from the Ethics Committee that Leigh Day had been sent by the Coroner's office in July 2010, together with some more documents that the Coroner's office had more recently sent to them. The Ethics Committee documents had arrived at Leigh Day in what Miss Winyard described as a "jumble", and she did not rearrange them before sending them on, but there were good reasons for that. She explained that the decision to keep the documents in the order in which they were received was a deliberate one:
"It is what I always did at first pass with medical records as well, because sometimes there is I'm not suggesting it was necessarily the case here sometimes there is an importance in the order that documents are produced to you in. Each document was tabbed with a numbered tab and the index and [my] commentary followed that. My main purpose, I recall when going through those documents when received, was to see what they said about whether Mr Ewan had, in fact, contrary to what we had been led to believe up until then, been one of the patients recruited into the clinical trial."
Mrs Shaw did not look at the documents until after the PIR, but there was nothing in them to support the thesis that her father had been one of the patients in the clinical trial.
- At the third PIR, the Assistant Coroner expressed doubts about whether this was an appropriate case for an Article 2 compliant Inquest. This came as no surprise to the bereaved family's legal team, who had some concerns that it might be difficult to justify the direction given at the earlier PIR. It would appear from the transcript that Mr Garnham had to work hard to maintain that position, but he succeeded. The Assistant Coroner also expressed the provisional view that the Ethics Committee documentation was unlikely to be relevant to the issues that the coroner's court would be required to determine, and that it should be available for reference purposes only. In that context there was then a dialogue between the Assistant Coroner and Mr Garnham about whether there was any evidence that Mr Ewan had been part of a clinical trial. Mr Garnham referred to a letter written by Browne Jacobsen, the Trust's solicitors, on 15 October 2010, only a few days before that PIR, stating that he had not. In the light of this, Mr Garnham stated that the family accepted the Coroner's provisional view that the documents from the Ethics Committee were unlikely to be relevant, but that they wanted to give the matter further thought.
- Ms Hardman, the solicitor representing the Trust at the PIR, elaborated on the bare denial in Browne Jacobsen's recent letter. She explained that the trial had been a multi-centre trial and that Leicester had been asked to contribute 10 patients, but in the event they contributed 13. Mr Ewan was the fifth patient to be operated on after the recruitment phase of the trial had ended in Leicester. This was all consistent with what Ms Hardman had said she believed to be the case at the previous PIR, before she had had time to check that information. Ms Hardman said that whilst there would still be follow-up on those (surviving) patients who had been part of the trial, it would take some time for the results of the trial to be collated and written up.
- Thus, the factual premise upon which Sir Robert had considered the documents pertaining to the trial might have been relevant to the issues to be explored at the Inquest (i.e. Mr Ewan's participation in the trial) was not established. So far as Sir Robert's somewhat elliptical request for documents pertaining to the outcome of the trial was concerned, it was clear from what Ms Hardman said that the results were not yet available and would not be available in time for the Inquest. Mrs Shaw very fairly accepted in cross-examination that she has seen no evidence since that time to indicate that what Ms Hardman told the Assistant Coroner was wrong, save that Dr Kovac had said in his evidence at the Inquest that the number of patients in the trial at Leicester was 14 rather than 13.
- In November and December 2010 Mr Garnham had a consultation with Professor Mythen (who appears to have been the only expert in whom Mrs Shaw had any faith) and consultations with two newly instructed experts, Dr Moat, a cardiac consultant from the Royal Brompton Hospital, and Dr David Hildick Smith, an interventional cardiologist who had been instructed in place of Dr Brecker. In her instructions to Dr Hildick Smith, Mrs Winyard explained that Dr Brecker knew Dr Kovac and the CoreValve Medtronic team well, and that he did not feel comfortable in being identified or in advising Leigh Day further. In her evidence at trial, Mrs Winyard explained how difficult it had been to find a suitably qualified interventional cardiologist who was also independent, and therefore how pleased she was to have found Dr Hildick Smith. He was not as experienced in the TAVI procedure as Dr Brecker at that time, but he had performed a number of such operations and was able to provide the family's legal team with the necessary guidance to enable appropriate questioning of the witnesses at the Inquest.
- Dr Hildick Smith was asked to look at the NICHE report and comment on various aspects of it. He expressed the view that the TAVI procedure was appropriate for Mr Ewan, although he said it was not clear to him from the data provided that his aortic stenosis was sufficiently severe to warrant any intervention. He referred to the degree of the gradient and the presence of good left ventricular function, and said that these features would normally be considered to represent mild aortic stenosis only. He observed: "at this stage it is not clear to me whether the severity was adequately confirmed prior to the TAVI procedure." In the light of this and other matters, Dr Hildick Smith was doubtful whether there was sufficiently informed consent. However, he considered that the valve was correctly implanted and expressed the opinion (consistent with that of Dr Brecker) that the most likely cause of the aortic tear was wire perforation of the aortic root. He also considered that the clinical response to the emergency was appropriate.
- Unlike Dr Brecker and Dr Hildick Smith, Dr Moat did not regard the guide wire as the likely cause of the perforation of the aorta. He thought it was more likely to have been a rupture of the annulus. Thus, this was an issue on which there was a genuine and reasonable difference of opinion between three appropriately qualified cardiology experts. On the specific aspects of the case on which his opinion was being sought, Dr Moat was not critical of the performance of the clinicians in terms of their critical care of Mr Ewan in response to the emergency. Neither was Professor Mythen, who said in his final report: "I do not believe that the anaesthesia or critical care had a material effect on the subsequent outcome".
- It was against that background that the fourth and final PIR took place before the Deputy Assistant Coroner, Nigel Godsmark QC (now HH Judge Godsmark QC) who also conducted the Inquest itself. As a distinguished practitioner in the field of clinical negligence, Mr Godsmark's experience particularly equipped him for the task. He circulated an agenda on 14 December 2010 which indicated his views about the scope of the inquiry to be carried out. The following issues were identified:
i) What was Mr Ewan's condition/prognosis considered to be? What were the treatment options available to him?
ii) What information was given to Mr Ewan? What was he told about the TAVI procedure?
iii) Did the consent procedure follow Trust policy/GMC guidelines and Department of Health requirements?
iv) Mechanics of the procedure what is used and how?
v) What happened in the laboratory during the TAVI? (The Coroner said: "We will be looking to explore the hypertension and damage to the aorta and the attempts to control bleeding in the tamponade") and
vi) what was the cause or causes of Mr Ewan's death?
- The PIR took place on 17 December 2010. Mr Godsmark made his position very clear at the outset. He said:
"What I'm not going to do is give carte blanche for there to be I use that term loosely for there to be an exploration which is going to turn this into a clinical negligence trial."
Mr Godsmark indicated that he shared his predecessor's provisional view that the Ethics Committee documents were not relevant to the issues at the Inquest and that they should not go in the jury bundle, though they should be available for reference purposes. He invited submissions from anyone who disagreed with that course.
- Mr Garnham did not object to the course that the Coroner proposed. 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. That stance was entirely consistent with Sir Robert Francis's approach, namely, that the documents would only be relevant if Mr Ewan had been part of the clinical trials. Ultimately, however, and irrespective of the stance taken by Leigh Day and Mr Garnham when invited to express an opinion on the matter, the decision to exclude those documents from the jury bundle was taken by the Coroner. I cannot see how it would have been possible, in the circumstances, for Mr Garnham to have made cogent submissions that would have had any prospect of producing a different decision, because he had no basis for submitting that the documents were relevant, and neither did Leigh Day.
- Mr Garnham made an application for Professor Mythen to be called to give evidence, but that was declined on the basis that he was saying nothing materially different from the expert anaesthetist, Dr Mullen, who was already going to be giving evidence.
- Mrs Shaw accepted in cross-examination that at the time she was perfectly happy with what Leigh Day and leading counsel had done at the final PIR. She said that she took it as read that there was nothing wrong with the valve and that her father had not been part of the clinical trial. It appears that she only changed her mind about these matters because of what happened in the clinical negligence action and/or observations made by Hallett LJ in her judgment in the Court of Appeal in the judicial review proceedings, which Mrs Shaw has taken out of context. That judgment is not critical of Leigh Day (far from it); it merely points out that there was an opportunity to try and put the documents before the jury at the Inquest, and that if that opportunity was not taken by her legal advisers, it was not open to Mrs Shaw to complain that the Inquest was flawed. However, that judgment (with which the other members of the Court agreed) also made it plain that the clinical trial documents were irrelevant.
- There was some correspondence between the Coroner's office and CoreValve about the different sizes of valve that were available at the time, in which the manufacturer indicated that there were two sizes of valve and stated that Mr Ewan had been implanted with the 26mm size. Despite this, the Coroner decided that a representative of CoreValve, a Mrs Sandhu, should be called to give evidence at the Inquest. Mrs Sandhu had been present in the catheter laboratory at the time of Mr Ewan's operation.
- When the Inquest took place a few weeks later, the jury bundle contained documents that related to the suitability of the TAVI procedure for Mr Ewan and the closely related issue of informed consent. These included email exchanges in the summer of 2007 passing between CoreValve representatives and members of the surgical team, which suggested that Mr Ewan may not have met the clinicians' own criteria for the TAVI procedure just on the basis of the results of the tests that were carried out on him (though reference was also made to the fact that he was symptomatic). For example, Dr Spyt, a cardiothoracic surgeon described by Mrs Shaw as the most senior lead for the CoreValve procedure at Glenfield, and a witness at the Inquest, sent an email to Dr Kovac's registrar on 9 July 2007 saying:
"I am concerned that the above 85 year old man is being considered for TAVI. As far as I can see the aortic valve disease is mild to moderate at the most
. [it] is difficult to believe that this aortic valve is responsible for the symptoms. Please be careful."
- I accept Miss Winyard's evidence that she discussed the misgivings expressed by Dr Hildick Smith and Professor Mythen with Mr Garnham. On the basis of the information provided by the experts instructed on behalf of Mr Ewan's family, and the documents disclosed to the Coroner and put in the jury bundle, leading counsel had more than sufficient information to enable him to explore the relevant issues with Dr Hutchinson, as well as with members of the surgical team who gave factual evidence, which Mr Garnham duly did with commendable thoroughness. As the Divisional Court stated, "this was an exceptionally thorough inquest" a view that was endorsed by the Court of Appeal.
- Mrs Shaw complained that the jury was not told that the valve had only recently received CE approval and was still at the "bench testing" stage, or that the clinical investigations were still ongoing, but neither of those matters was relevant to the issues the jury had been asked by the Coroner to decide. As the Court of Appeal found, the efficacy of the device was not a legitimate line of inquiry at the Inquest, because there was no sound evidential basis to suggest it was. That remains the case.
- Mrs Sandhu gave evidence at the Inquest that the 26mm size valve was used in the procedure, and she was able to confirm this by reference to the packaging and the bar code on it. The serial number for the product on the packaging was CRSP3640, which tallied with the make and model number on the CE certificate of conformity of the smaller valve. There was no factual basis on which that evidence could have been challenged, and by its findings, the jury plainly accepted it. As the Court of Appeal observed in the judicial review proceedings, the jury made a clear finding of fact, on the basis of good evidence, as to exactly which valve was used. The evidence in that regard was all one way.
- Dr Kovac gave evidence at the Inquest. His factual description of where the guide wires were placed tended to negate the theory that a guide wire used in the operation was the cause of the perforation to the aorta. That evidence plainly played a role in the inability of the jury to decide what the cause was.
- Apart from the question of informed consent, the jury's answers to the many questions posed to it by the Coroner were entirely consistent with the opinions expressed and the advice given by the medical experts to the bereaved family's legal representatives. As Mrs Shaw accepted when it was put to her by Mr Whitting, neither at the time of the Inquest nor in the seven years since, has there been any expert evidence that:
a. Mr Ewan was not a suitable candidate for the TAVI procedure;
b. The CoreValve product was unsuitable for Mr Ewan;
c. There was any defect in the CoreValve used in the procedure (or that it was unsafe or had not obtained the necessary CE approval prior to use);
d. The TAVI procedure was performed incompetently;
e. The aortic tear was caused through clinical negligence.
- Whilst Mrs Shaw was disappointed with the outcome of the Inquest, in its immediate aftermath her focus turned to the clinical negligence claim. A protective claim form had been issued on 23 September 2010. Mr Garnham circulated a draft Particulars of Claim on 28 February 2011. At a subsequent lengthy and detailed consultation with Mrs Shaw on 3 March 2011, Mr Garnham explained why he had only felt able to advance a claim for negligence on the basis of a failure to obtain informed consent, and why there was no evidential basis for alleging that the procedure itself had been carried out negligently.
- The Particulars of Claim were served by Leigh Day on 20 April 2011 and the Defence was served on 17 June that year. On 28 June, a CPR Part 36 offer of settlement in the sum of £34,000 was made on behalf of both Defendants, which remained open for acceptance until 19 July 2011. Miss Winyard advised Mrs Shaw that this offer should be accepted, having discussed the matter with Mr Garnham. However, she rejected that advice. Leigh Day took no further material steps on Mrs Shaw's behalf in the clinical negligence action, though they only came off the record on 3 February 2012.
- In February 2014 the claimant instructed her current solicitors, Pearsons, who successfully applied to amend the claim in the clinical negligence action. The relevant amendments were of a relatively minor nature, elaborating on the issue of informed consent and adding an allegation that, following the damage to the aorta Mr Ewan should have been taken to theatre or placed on a bypass machine - though it was not pleaded that the failure to do either of those things was causative of his death. It was never alleged in the clinical negligence action that the valve was defective or unsuitable for use on Mr Ewan, or that the procedure had been performed incompetently. The new solicitors instructed two new experts, one of whom, Dr Wilmshurst, was a cardiologist, so they had access to further expert advice as to whether there were additional grounds for criticism of the Trust or Dr Kovac. They also obtained three separate orders for specific disclosure against the Trust.
- An order for disclosure was made against CoreValve on 4 May 2015. The very next day, the Trust indicated that it was not going to continue to defend the claim. Judgment was entered against it on 2 July 2015. Dr Kovac continued to defend the claim, but eventually, on 22 October 2015, he too consented to judgment being entered against him. On 28 October 2015, HH Judge Platts awarded Mr Ewan's Estate damages in the total sum of £15,591, of which £5000 comprised damages for pain, suffering and loss of amenity. This was well below the level of the Part 36 offer and therefore Mrs Shaw was only awarded her costs to 19 July 2011 and had to pay the Defendants' costs from that point onwards. An appeal brought by Mrs Shaw against the Judge's refusal to make a discrete award of damages for the failure to obtain informed consent was dismissed by the Court of Appeal.
- Despite the fact that she had failed to beat the Part 36 offer and suffered the anticipated adverse costs consequences, Mrs Shaw saw the capitulation of the Trust and Dr Kovac as vindication. In her evidence, she referred to the fact that it had been pointed out to her by Miss Winyard that because her father's last hospital bill had not been paid, the Trust might seek to set that sum off against any sum it had to pay his Estate (though in the event it did not). Had she accepted the Part 36 offer, and if that had happened, the net amount recovered would have been less than the £15,591, without a finding of liability. In her own mind, therefore, Mrs Shaw had done better by continuing with the proceedings in the face of the advice she had received, even though the consequences were exactly as she had been warned.
- Mrs Shaw subsequently issued a product liability claim against the manufacturers of CoreValve and various other parties associated with its distribution. There were five defendants in all. The claims against four of the defendants were struck out by Lavender J, and the claim against the fifth defendant was discontinued. Although there were obvious limitation difficulties, the claims were struck out because there was no viable cause of action.
- Against that background, I turn to consider the specific complaints that are made against Leigh Day in the current proceedings.
THE CLAIM FOR PROFESSIONAL NEGLIGENCE
- The claim is expressed in extremely broad terms in paragraph 33 of the Particulars of Claim:
"[Leigh Day] seriously failed in the discharge of its duties owed to Claimant and the Estate in failing to make use of the important fact gathering opportunity of the inquest to establish the facts and information regarding the treatment and the circumstances of the death of the Deceased and thereby insofar as the claim as pleaded in the clinical negligence proceedings had been based upon seriously incomplete facts and information regarding the treatment, the circumstances and the death of [Mr Ewan] prejudiced the Claimant and the Estate's interests in the clinical negligence claim. Specifically no investigations had been undertaken of or challenges made to the Hospital's and the valve manufacturers' assertions (a) that the valve had performed correctly and (b) that Mr Ewan had not been part of the trial and (c) that the clinical trial had concluded successfully in early 2007
"
- At trial it emerged that the essence of Mrs Shaw's complaint is that Leigh Day did not follow Sir Robert Francis' advice and recommendations. Specific complaints are that they did not obtain all the documentation pertaining to the clinical trials and that they failed to obtain "appropriate independent expert advice" from a cardiologist as to the suitability of the procedure for Mr Ewan and the diagnosis of severe aortic stenosis. It is pleaded that this failure resulted in inadequate instruction of Mr Garnham for the Inquest and in the clinical negligence proceedings, and a failure to ensure that all the appropriate questions were raised at the Inquest.
- Sir Robert's suggestions of various lines of inquiry was made at a very early stage in the process, before the scope of the Inquest had been determined, when both he and Leigh Day were trying to explore every possible avenue that might be relevant. That meant that as matters developed, and further information came to light, certain lines of inquiry that were initially pursued, or considered to be worth pursuing, might become redundant and so it proved with the documents pertaining to the clinical trials, once it emerged that Mr Ewan was not part of them.
- In a case such as this, the solicitor is charged with the responsibility of making decisions on behalf of the client, together with counsel, as to what material or information the legal team is going to utilise at the hearing if the Coroner so permits. Therefore, in order to establish that Leigh Day were negligent, Mrs Shaw would have to prove on the balance of probabilities that no reasonable solicitor would have taken the tactical decisions that Leigh Day took, or that a reasonable solicitor would have been obliged to have acted differently in terms of seeking to put further evidence before the jury at the Inquest.
- As to the question of what loss was said to have been caused by the alleged negligence, Mr Berkley realistically accepted that he would have been in evidential difficulties if he had had to prove that if further evidence had been placed before the jury, it would have given different answers to the questions that the Coroner asked it to answer. However, he put Mrs Shaw's case on the basis of the loss of a chance. He submitted that because Leigh Day failed to discharge their duty, Mrs Shaw was deprived of the opportunity to achieve the closure and peace of mind that she made it clear from the outset that she was seeking and was willing to pay for.
The "basic cardiologist"
- The first specific complaint is that no attempt was made to instruct a "basic cardiologist" who was independent of the TAVI procedure to advise regarding the extent of the aortic stenosis and Mr Ewan's suitability to undergo the procedure. In his opening note, Mr Berkley had suggested that expert evidence about "whether Mr Ewan was a suitable candidate for the TAVI procedure - that is to say, whether or not his pre-existing condition was severe or only moderate
was only obtained in 2015 in the course of the clinical negligence proceedings". That is factually incorrect, and demonstrably so. In his final written submissions, Mr Berkley modified the complaint as follows: "nothing was done to assess suitability by a truly independent cardiologist until the instruction of Dr David Hildick Smith on 30.11.2010. Given the vested interests and the relative ease with which such evidence could have been obtained it was negligent of Leigh Day not to have obtained such evidence well in advance of the Inquest and to have pressed the Coroner to admit such evidence".
- Whatever way the complaint is put, I reject it as being without justification. Leigh Day ensured that the issue of Mr Ewan's suitability to undergo the TAVI procedure was before the jury and they obtained sufficient expert evidence from appropriately qualified cardiologists to enable Mr Garnham to explore that issue thoroughly and appropriately at the Inquest, which he duly did.
- As I have already observed, Sir Robert Francis never regarded the views of a "basic cardiologist" as essential. He thought such an expert might be useful as a means of assisting him to interpret the moving images, and possibly as a fallback (someone whose opinion could be used to check Dr Brecker's views) because of concerns he had about Dr Brecker's independence. The question for the court is whether it was a breach of Leigh Day's professional duties to fail to instruct a less specialised expert cardiologist to advise on aspects of the case relating to the patient upon which the expert they did instruct was suitably qualified to express an opinion, simply because of concerns that the more specialist expert might be too closely associated with the procedure itself to be willing to express criticism of it. Plainly it was not.
- When it was originally intended to instruct an expert cardiologist to advise, Leigh Day told Mrs Shaw that they intended to instruct someone who had knowledge of the TAVI procedure, which was both a reasonable and sensible approach. That is why Leigh Day instructed Dr Brecker. It is important to bear in mind that the sole reason why there were concerns about Dr Brecker's independence was that he might have a vested interest in negating or playing down criticisms of the procedure itself or of the valve that was used in it or of the practitioners who carried out the procedure. The accuracy of the original diagnosis, whether the patient met the medical criteria for surgical intervention, and what other treatment options were available to him, are separate issues from issues concerning the novelty, safety and risks of the procedure itself. Dr Brecker's perceived lack of independence which might have affected his ability to give impartial advice on those issues, cannot possibly have impaired his ability, as an experienced cardiologist, to interpret the tests and radiological images or to offer an impartial opinion on the extent of Mr Ewan's aortic stenosis.
- Although it may not have been necessary to consult an interventional cardiologist on those issues, it was a reasonable approach to use the same expert cardiologist. The fact that Mrs Shaw was not prepared to accept Dr Brecker's opinion because she latched on to the concerns expressed by Professor Mythen, whom she liked and trusted, but who was not a cardiologist, does not mean that Dr Brecker was not qualified to express it or that someone else should have been approached, let alone that a failure to approach another expert to give a second opinion would fall below the standards to be expected of a competent solicitor. The ease of finding a "basic cardiologist" is no reason to criticise the failure to instruct one, if it was unnecessary to do so, or if the view that it was unnecessary to do so was reasonably open to the solicitors at the time, which it was.
- However, even if there had been any doubt about that, Leigh Day acted appropriately upon the concerns expressed by Professor Mythen with regard to the diagnosis, and they also addressed concerns about Dr Brecker's perceived lack of independence. That is why Dr Hildick Smith came to be instructed, and he was able to give an independent view on these issues, among others. Although Mr Berkley had put the claim in writing in the manner quoted in paragraph 67 above, in the course of his final speech I specifically asked him whether it was accepted that despite being an interventional cardiologist with experience of the TAVI procedure, Dr Hildick Smith was independent for these purposes. I was concerned to clarify this, because Mrs Shaw, in the course of her evidence, had displayed extreme distrust in any expert who was in any way shape or form associated with TAVI and had suggested that Dr Hildick Smith and even Dr Moat were not independent. Mr Berkley's answer was that "he raised serious questions about suitability which would have emerged had someone like Dr Wilmshurst been instructed earlier." I took that to mean yes, or at least a concession that the hypothetical "basic cardiologist" would have expressed a similar opinion to Dr Hildick Smith.
- There was more than sufficient time for Leigh Day and Mr Garnham to act on Mr Hildick Smith's advice in preparation for the Inquest. When I pointed that out and queried on what basis Leigh Day were to be criticised, Mr Berkley was driven to submitting that if the same information had been obtained in an expert report at an earlier stage and shown to the Coroner "he would have put the question of suitability at the top of the agenda and there would have been more searching and vigorous enquiry about it." There is no evidential basis for that submission. There is no reason to suppose that the timing of Mr Hildick Smith's expert advice made the slightest difference to the thoroughness of the inquiry; and suitability was on the top of the agenda.
- There is no suggestion that anything in the disclosed documentation or in the experts' advice that suggested that Mr Ewan's aortic stenosis was less severe than Dr Kovac diagnosed was not picked up by the bereaved family's legal team prior to the Inquest and appropriately explored at it. The jury bundle contained the email exchanges prior to the operation which suggested that there was some doubt within the surgical team itself about whether Mr Ewan should undergo the procedure and that Dr Kovac made the final judgment call. Mr Garnham was perfectly well equipped to explore both the extent of the stenosis and Mr Ewan's suitability to undergo the TAVI procedure at the Inquest, as he did. No other documents emerged after the Inquest, in the course of the clinical negligence trial for example, that would have strengthened Mr Garnham's hand on these points had they been disclosed earlier, but even if something had emerged later, Leigh Day would not have been legally responsible for the fact that it was not produced in response to the Coroner's directions. The jury had all the materials before it that it needed to be able to reach an informed view on those matters, and it did so. This complaint is wholly groundless.
Documents relating to the stage of development of the CoreValve
- The next complaint is that Leigh Day failed to seek to persuade the Coroner to put documentation before the jury pertaining to the testing, evolution and development of the CoreValve (including the documents from the Ethics Committee and one of the protocols for the trials, which was not then available because it was only disclosed by the Trust in the course of the clinical negligence action). However, such documentation falling into that category as had been disclosed in consequence of the Coroner's previous directions was available to the jury, if they wished to refer to it. Mr Godsmark did not regard it as relevant to the issues that the jury were asked to decide, nor did Mr Garnham, and that view was not only reasonable but, in my judgment, right. As Mr Whitting pointed out, Mrs Shaw has never been able to demonstrate that it was relevant.
- The question of what documentation should be put in the jury bundle or made available to the jury was ultimately a matter for the Coroner. At the second PIR, the Coroner had made a wide-ranging order for disclosure of documents, some of which turned out to be irrelevant to the issues that were put before the jury because it was established prior to the Inquest that Mr Ewan was not part of the clinical trial. If and to the extent that it is suggested that it was professionally negligent of Leigh Day to accept the Coroner's provisional view that the documents should not go in the jury bundle, and that they should be available for reference purposes only, and that they should have instructed Mr Garnham to press for its inclusion in the jury bundle, I reject that suggestion. It was at least within the range of reasonable views that was open to solicitors in their position. The same view had been expressed at the third PIR by a different Coroner, and very sensibly Mr Garnham had said that he and the family wanted time to consider the position; the decision to accept the Coroner's view was taken after an adequate time for reflection and it was a reasonable decision in the circumstances.
- Although Mr Berkley suggested in his closing submissions that the fact that clinical trials were continuing in other centres besides Leicester at the time when Mr Ewan's operation took place was relevant to the inquiry at the Inquest irrespective of whether he was a patient within the trial or not, because it suggested that the product was still at an experimental stage and not yet ready to be used on the general public, that analysis had played no part in Sir Robert Francis' thinking when he asked for the disclosure. Sir Robert regarded documents pertaining to the trials as relevant only if Mr Ewan was part of them; that was an entirely reasonable stance to have taken and Leigh Day cannot be criticised for adopting the same stance.
- Sir Robert explained that the disclosure he had requested even if it was said by the Trust that Mr Ewan was not part of the trials was really aimed at ascertaining the results of the trials, because that might provide some information relevant to the issue of informed consent. By the time of the third PIR it was clear that the results were still some way off and thus no such documents would have been available. There was therefore nothing to be gained by pressing for such disclosure. Leigh Day had no evidence to contradict the Trust's categorical assurance, given in Browne Jacobsen's letter of 15 October 2010 and reiterated by Ms Hardman at the third PIR, that Mr Ewan was not a patient within the trial at Leicester. The fact that the clinical trial was still continuing in other centres besides Leicester, because this was a multi-centre trial, would have been an insufficient basis for taking issue with what Browne Jacobsen said in that regard.
- Mr Berkley criticised Leigh Day for not challenging the Trust's assertions and pressing the Coroner for further disclosure about Mr Ewan's lack of involvement in the trials but in my judgment, that criticism was both unfair and misguided. There was no material which would have enabled them to have mounted such a challenge (and even if they did, they were unlikely to have achieved anything by it). In any event, even if another firm in their position might have sought to take issue with what Browne Jacobsen and Ms Hardman said, it was not unreasonable for Leigh Day to have accepted it. There was no breach of duty in this regard either.
- Leigh Day could not possibly be held responsible for the time it took the Trust to disclose the documents, or for any failure by the Trust to disclose any document or documents concerning the clinical trials, such as the protocol to which I have referred, that only came to light in the clinical negligence proceedings. Nor could they be held responsible for any delay by the Coroner's office in sending the documents on to them. Since Leigh Day, not the lay client, had the conduct of matters relating to the Inquest, the fact that Miss Winyard did not send the bundle that she had received to Mrs Shaw until shortly before the fourth PIR, because she had been systematically going through the documents, evaluating them and making notes about them, is not a basis for legitimate criticism either.
- Mr Berkley referred to the fact that Mrs Shaw continued to be haunted by the concern (or suspicion) that her father was being experimented on. That is not something for which Leigh Day can be held legally responsible. It emerged in the course of the evidence that this lingering concern is based on only two matters, the fact that the trial did not end in other centres until 2008, and the Trust's submission to judgment in the clinical negligence proceedings which, in Mrs Shaw's mind, amounted to an acceptance that Mr Ewan had been part of the trial in Leicester after all. Apart from those matters, Mrs Shaw conceded that even after disclosure in the clinical negligence proceedings, in which the Trust and Dr Kovac had expressly denied that Mr Ewan participated in the clinical trials, she had no evidence that he did.
- The claim in clinical negligence was never pleaded on the basis of a complaint that Mr Ewan unwittingly took part in a clinical trial of the valve. In the context of the overarching complaint that he had not given his informed consent to the TAVI procedure, it was initially pleaded by Mr Garnham that Mr Ewan had not been told that the procedure was a difficult or complex one, or that the valve had been designed for clinical investigations to assess its safety and that those clinical investigations had only recently commenced. After Pearsons took over the case, the aspects of the Particulars of Claim relating to lack of consent were amended to add the allegation that the Trust "failed to obtain Mr Ewan's consent to participate as a patient in the clinical investigations." The phrase "clinical investigations" seems to me to be deliberately vague, and it is wide enough to cover any clinical investigations into how the valve performed in post-trial operations. However even if that phrase were to be construed as a reference to a formal clinical trial, at the very most the Trust's submission to judgment amounts to an acceptance of the pleaded fact that such consent was not obtained. It does not amount to an acceptance that Mr Ewan was a patient in the trials or that there were any such clinical investigations involving him (as those facts were never pleaded).
- In any event the Trust's acceptance of liability for failing to obtain Mr Ewan's informed consent to the TAVI procedure, which came some years after the conclusion of the Inquest, is no basis for criticising the way in which Leigh Day handled the matter before and at the Inquest. Mr Berkley submitted that it was not known whether or not, upon more vigorous inquiry and questioning, the Trust would have been willing to concede at the Inquest that that was the stage at which the product was developed and that was the state of the product when it was inserted into Mr Ewan, because that line of inquiry and investigation was not effectively pursued at the Inquest, and Mrs Shaw had to take clinical negligence proceedings in order to establish those facts. However, all the matters pertaining to the issue of informed consent that were ultimately pleaded in the clinical negligence case were thoroughly and vigorously pursued at the Inquest by Mr Garnham.
- I am also satisfied, on the basis of her exhaustive pursuit of claims against anyone and everyone that might possibly have had some liability for what happened to her father, that Mrs Shaw would have pursued the Trust in clinical negligence proceedings come what may. There was no causative link between anything done or omitted to be done by Leigh Day in connection with the Inquest and the decision to sue the Trust and Dr Kovac.
- In my judgment there is no basis for the suggestion that the tactical decisions that were taken by Leigh Day regarding the lines of inquiry and investigation to be pursued at the Inquest and the documents that they agreed should go before the jury fell outside the scope of reasonable decisions that were open to them consistently with their duties to their client. The criticism of them on this ground, too, is completely unjustified.
The make and size of valve used in the TAVI procedure
- One complaint that was made, and never formally abandoned, though it was not pressed by Mr Berkley in his final speech, was that Leigh Day failed to achieve an answer to the question which size and model of valve had been used in Mr Ewan's procedure. That complaint was utterly without foundation. The question was asked and answered by the jury, and the evidence in support of Mrs Sandhu's confirmation that it was the 26mm valve was more than sufficient to allay any concerns that it may have been the larger valve. Her evidence confirmed what Dr Brecker had already advised was the likely position. There was no material that would have enabled Leigh Day or Mr Garnham to undermine that evidence. It was plainly not negligent to have failed to mount such a challenge in the absence of any evidence to suggest that Mrs Sandhu was mistaken.
No complaint to the GMC
- Mrs Shaw contends that Leigh Day did not make a complaint to the GMC (despite the fact she never instructed them to do so) or advise her to do so, and that this was a breach of duty. Mr Berkley accepted that this complaint did not feed into any claim for pecuniary loss, and just formed part and parcel of what Mrs Shaw alleged was a general failure by her solicitors to do what was required of them.
- Miss Winyard's attendance note of her very first telephone conversation with Sir Robert Francis records Sir Robert as observing that it was "a classic case for complaint to the GMC". Miss Winyard's recollection was that she did discuss the possibility of making such a complaint with Mrs Shaw as early as 26 June 2008 and that this arose on subsequent occasions; Mrs Shaw categorically denied this.
- I do not need to resolve that difference of recollections because in my judgment there is no substance in this complaint irrespective of whether the possibility of making such a complaint was discussed with Mrs Shaw or not. The short and simple answer to this aspect of the claim is that it was no part of Leigh Day's retainer to make such a complaint or to advise the client on it. That was a matter for the client to pursue independently. The remark made by Sir Robert in the course of an early discussion with Miss Winyard did not trigger an obligation on her part to advise the lay client to make such a complaint.
- Mrs Shaw is an intelligent, articulate woman who was determined to leave no stone unturned, even to the extent of carrying out her own internet research so that she could challenge the advice being given to her by medical experts, and she would have known perfectly well that it was possible to make such a complaint. She did not need solicitors to tell her that, and she did not seek their advice about whether to make such a complaint. Indeed, she did make a complaint to the GMC in December 2013 against five doctors involved in the TAVI procedure and that complaint went nowhere. The GMC decided not to exercise its discretion to disapply the five-year period for making such a complaint, because it concluded that the complaint was insufficiently serious and/or did not suggest an unwarranted risk to the public. There was still time for Mrs Shaw to have made the complaint within the original time limit after Leigh Day ceased to act for her.
- No responsible solicitor would make a complaint to the GMC on behalf of a client without obtaining express instructions to do so and having sufficient ammunition against the doctor or doctors concerned. Mr Berkley was unable to identify any specific point in time at which it could be said that there was sufficient information to enable Leigh Day to make such a complaint, though he said that at the latest it would have been at the time of the clinical negligence claim. He said that it was incumbent on Leigh Day to complain as soon as they had identified that there were issues that suggested that Mr Ewan had been inappropriately treated. But all the expert evidence that Leigh Day obtained suggested the opposite. The clinical negligence claim was based solely on a failure to obtain Mr Ewan's informed consent because that was the only aspect of Mr Ewan's care about which Mr Garnham and Leigh Day felt they had sufficient information to plead a case. Mrs Shaw was so advised.
- Whilst it is possible that a complaint could have been made to the GMC that the clinicians responsible for treating Mr Ewan had failed to obtain his informed consent, thereby duplicating the issues in the clinical negligence proceedings, it was not professionally negligent of Leigh Day to concentrate on the claim for clinical negligence, which their client had formally instructed them to pursue. A complaint to the GMC would have achieved nothing more in terms of answering questions to which Mrs Shaw did not receive answers, or answers with which she was satisfied, in the Inquest. In any event they were not instructed to pursue such a complaint; if Mrs Shaw had wanted them to, she would have said so.
No claim made against the Trust under Article 2 of the Human Rights Act
- In order to bring such a claim Mrs Shaw would have to establish a systemic failure of the Trust to put in place general mechanisms, processes and procedures for protecting life, or prove that they failed to take operational steps to protect life in individual circumstances. The pleaded case is that such a claim, if brought within the clinical negligence proceedings, would have had an 80% chance of success; I have no idea of how, and on what factual basis, that evaluation could possibly have been made. In cross-examination Mrs Shaw admitted that she was unaware of the legal test, and that she had no expert evidence to corroborate the suggestion that the Trust had done either of those things.
- The 12-month period for bringing an Article 2 claim expired in September 2008, only a few months after Leigh Day were first instructed and before Sir Robert Francis became involved in the case: but the court would have had jurisdiction to disapply the time limit if it were just and equitable to do so. It is telling that Mrs Shaw's new solicitors did not tell her that it was possible for the Court to disapply the limitation period for an Article 2 claim and advise her to seek to bring such a claim in the context of the clinical negligence proceedings in which they were instructed in succession to Leigh Day.
- Mr Garnham's advice in February 2011 that, despite the fact that the Coroner had been persuaded that the Inquest had to be Article 2 ECHR compliant, there was no basis for bringing an Article 2 claim against the Trust, was conveyed to Mrs Shaw. Naturally she asserted in this claim that the advice was wrong, although when challenged in cross-examination to explain why it was wrong, she could not do so, and simply said that the reasons for that advice were never explained to her. It is difficult to understand how a client can claim that expert advice given by leading counsel is wrong if she does not know the reasons for it. However, this is an excellent example of Mrs Shaw's attitude, namely, that if an expert does not give her the advice that she wants to hear, the advice must be wrong. Mr Garnham's advice was correct, but even if there was room for more than one view (which there was not) Leigh Day was entitled to rely upon it. If such a claim had been brought, it would probably have been struck out.
- Mr Berkley suggested that the Trust's submission to judgment in the clinical negligence proceedings amounted to a sufficient basis for an allegation of systemic failures; but an acceptance that the Hospital had failed to follow the appropriate procedure for obtaining the informed consent of one patient did not come anywhere near a sufficient basis for making such an allegation. The suggestion that Leigh Day were professionally negligent in accepting leading counsel's advice and failing to seek the disapplication of the limitation period in order to bring such a claim within the context of the clinical negligence proceedings is not only ill-founded, but like many of the allegations in this case, it borders on the vexatious.
Failure to advise Mrs Shaw in respect of a claim against the valve manufacturer
- It was unclear to what extent, if at all, this allegation was being pursued but I regard it as equally hopeless. Leigh Day was not instructed in respect of such a claim, and in any event, there were no arguable grounds for bringing proceedings against the valve manufacturer. There is and was no evidence that there was anything inherently unsafe about the prosthetic valve that was used on Mr Ewan.
CONCLUSION
- None of the allegations of professional negligence that have been made against Leigh Day came even close to being established on the balance of probabilities. Indeed, I have had no hesitation in concluding that the criticisms that were made of them were completely unjustified. In the light of this conclusion, it is unnecessary to consider issues relating to quantum in any detail.
- Suffice it to say that even if it had been established that Leigh Day were in breach of duty in any material respect, the claim that there was a total failure of consideration could not possibly have succeeded. Mr Berkley realistically referred to this as an "ambitious plea", which I regard as something of an understatement; but he never received instructions to concede it. Leigh Day undoubtedly provided the services that they were engaged to provide pursuant to their retainer. A claim that the professional services which were provided fell below the standard to be expected, even if proved, does not entitle the aggrieved party to get all their money back.
- Equally, it cannot be shown that there was a partial failure of consideration. This was put forward on the footing of a claim for wasted expenditure. The first problem facing Mrs Shaw with this way of putting the case is that the contract of retainer was not divisible, save possibly in respect of the instructions given to Leigh Day to pursue the claim for clinical negligence. A claim for partial failure of consideration is not legally viable if there has been part-performance on any view of the matter, there was performance of both aspects of the retainer. Even if one were to assume that the retainer was divisible as between services provided relating to the Inquest and services provided in respect of the clinical negligence claim, it cannot be established by Mrs Shaw that some identifiable part of the consideration relating to a divisible part of it has wholly failed. None of the costs that Mrs Shaw incurred in instructing Leigh Day were wasted. She did receive the promised services, and to the high standard that she was entitled to expect, but even if they had fallen below the requisite standard that would not have given rise to a viable clam to recover back some of the costs expended on this basis.
- The costs incurred by Mrs Shaw in bringing the judicial review proceedings were not incurred in consequence of anything done or omitted to be done by Leigh Day. Those proceedings were brought contrary to the advice that they and Mr Garnham gave that proved, ultimately, to be correct. Likewise, there is no legitimate ground on which Mrs Shaw could claim to recover any of the costs that she expended in fruitless product liability litigation against the valve manufacturers and others that ended in the claims being struck out.
- As for the costs of the clinical negligence proceedings, Mrs Shaw recovered her costs up to the date on which the Part 36 offer expired, and that covered the entire period of Leigh Day's active involvement in those proceedings, so she suffered no loss in respect of the fees they charged her. If that had not been the case, she would not have been entitled to recover those costs back from Leigh Day either on the basis of a partial failure of consideration or as damages; the services to which those fees related were provided.
- If I had come to the conclusion that there had been a breach of duty which resulted in information being kept from the jury which was likely to have made a material difference to the outcome of the Inquest, I might have been persuaded to order general damages for injury to feelings, of the type that I held to be arguable in an earlier judgment in this action. However, even if those circumstances had arisen in the present case, which they did not, those damages would not have exceeded £5,000. I would not have acceded to Mr Berkley's application at the trial to make a very late amendment to remove the pleaded cap on this head of claim, given the long and tortuous history of Leigh Day's attempts to get Mrs Shaw to properly particularise her case before the trial.
- For all the above reasons the claim against Leigh Day fails in its entirety and judgment will be entered for the Defendant.
