“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”
“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.”
“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.”
“[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…”