QUEEN'S BENCH DIVISION
MANCHESTER DISTRICT REGISTRY
B e f o r e :
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MRS GABRIELE SHAW (as Personal Representative of the Estate of William Ewan (deceased)) |
Claimant |
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- and - |
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LEIGH DAY (A FIRM) |
Defendant |
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John Whitting QC and Elizabeth Boon (instructed by Womble Bond Dickinson (UK) LLP) for the Defendant
Hearing dates: 9-11 July 2018
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Crown Copyright ©
Mrs Justice Andrews:
INTRODUCTION
THE FACTUAL BACKGROUND
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?
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?
"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?"
"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.
"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.
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?
"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.
"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."
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.
THE CLAIM FOR PROFESSIONAL NEGLIGENCE
"[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 "
The "basic cardiologist"
Documents relating to the stage of development of the CoreValve
The make and size of valve used in the TAVI procedure
No complaint to the GMC
No claim made against the Trust under Article 2 of the Human Rights Act
Failure to advise Mrs Shaw in respect of a claim against the valve manufacturer
CONCLUSION