Negus v Guy’s and St Thomas’s NHS Foundation Trust [2021] EWHC 643 (QB)
The facts
The claim was brought by the executors on behalf of the estate of Mrs Tracy Neill. On 4 March 2014 the Deceased underwent the implantation of a 19mm mechanical aortic valve. The Claimants alleged that a larger size valve should have been used (albeit that would have required an Aortic Root Enlargement or ARE), and that there was a failure to advise the Deceased properly as to the risks arising from the implantation of a smaller valve. The Deceased had subsequently undergone a re-do valve replacement on 18 March 2015, which required an ARE and the insertion of a 23mm valve. The Deceased ultimately developed progressive heart failure and died in January 2020.
At the relevant consultation with a consultant cardiothoracic surgeon, Mr Sabetai, the Deceased was advised as to the risks and benefits of the surgery. She agreed to proceed with an aortic valve replacement. Eady J summarised the expert evidence that the size of valve that can be implanted depended on the size of the annulus (the aperture at the root of the aorta). However, it was possible to enlarge the aortic root and implant a larger valve. Nevertheless, ARE was a very rare procedure, which was undertaken in less than 1% of aortic valve replacements. It was common ground that the size of valve to be used could not be determined prior to surgery once the aortic root had been decalcified. It was also common ground that the standard practice was to insert the largest size of valve that could be safely implanted. In any event, prior to the operation, Mr Sabetai did not discuss with the Deceased the size, particular brand or design of the valve to be implanted. He explained to the court that he would not do so as the decision as to the particular size and make of valve would have to be determined intra-operatively. Mr Sabetai further agreed that, prior to surgery, he did not discuss with the Deceased the possibility of undertaking an ARE to permit the insertion of a larger prosthetic valve. The judge accepted his evidence that this was not because he was incapable of performing such a procedure but because, whilst he had in mind the possibility that he might need to undertake an ARE, this would only be something he would do if he found it was necessary intra-operatively.
The Deceased subsequently signed a consent form with Mr Sabetai’s registrar, which included the statement that “I understand that any procedure in addition to those described on this form will only be carried out if it is necessary to save my life or to prevent serious harm to my health.” Mr Sabetai’s evidence was that he would have considered intra-operatively during the subsequent surgery whether it was appropriate to perform an ARE – if it had been so, he would considered it as a procedure falling within that description. His evidence was that, in light of his operational findings concerning the Deceased’s heart, ARE was not appropriate.
Assessment
The judge commented in respect of the expert cardiothoracic evidence that the Claimants’ case was founded on a number of allegations of negligence that in cross examination of the Claimants’ expert were “demonstrated to be based upon a particular opinion as to how things should be done, rather than allowing for possible alternative views that might still be recognised as proper by a competent, reasonable body of opinion. Whilst experts should, of course, make concessions where it is appropriate to do so, the concern in this case is that so many of the allegations levied against Mr Sabetai appear to have been based on the application of the wrong test.”
The judge’s first conclusion was that it was not negligent to implant a 19mm valve rather than to undertake an ARE and implant a larger valve – it was in accordance with a reasonable body of surgeons, and was also logical.
Her second conclusion was that, while there was a negligent failure to warn the Deceased of the potential risk that an ARE might have to be undertaken (which would double the risks), there was no requirement to have informed her that ARE was an alternative procedure. She held that Mr Sabetai’s duty to warn did not extend to:
“presenting TN with the various possible choices that might arise intra-operatively and could only properly be determined by the surgeon at that stage. The decision that Mr Sabetai had to make during surgery was not simply whether to implant a 19mm valve without undertaking an ARE, or to perform an ARE and then implant a larger valve; he had to exercise judgement at various stages of the surgery to determine what choices were open to him to achieve the best outcome for TN (what size of valve he could fit once he had de-calcified the root; what make and design of valve he should use; what outcome that could achieve; whether he could be assured of achieving a better outcome if he could insert a different, larger valve; whether any risks involved in doing so (in particular, if that involved undertaking an ARE) were justified; and so on). This involved highly technical decision-making, requiring a specialist-level of understanding and experience; it would be false to represent this as a simple or bilinear choice of treatment.”
She also held that, even if the Deceased had been informed of the possible risk of ARE, she would have still consented to surgery. Further, had she been advised that ARE was an alternative form of procedure, there was no evidential basis for thinking the Deceased would have done anything other than leave it to Mr Sabetai to exercise his professional judgment as required during the operation.
Comment
The judgment is an illustration of the problem of experts failing to appreciate the Bolam test (or potentially of their instructing solicitors failing to ensure that they understood it properly). It also is an interesting and relatively rare consideration of the circumstances in which informed consent does not require discussing highly technical matters that most patients could not reasonably be expected to grasp.
Matthew Barnes acted for the Defendant. He did not contribute to this article.
