The case of Negus concerned a clinical negligence claim brought in respect of aortic valve replacement surgery. The case hinged on expert opinion as to whether the operating surgeon had been negligent in using a smaller mechanical valve.
In Negus, a claim was initially brought by Tracey Negus, concerning an aortic valve replacement surgery performed by Mr. Sabetai, a consultant cardiothoracic surgeon for the defendant trust on the 29th of January 2020. During the operation, a 19mm mechanical valve was implanted. It was the Claimant’s case that the decision to utilise a 19mm mechanical valve was negligent and a larger sized valve should have been implanted, irrespective of the subsequent need for an aortic root enlargement (ARE). In addition, it was alleged that there was a failure to properly advise TN as to the risks arising from the implantation of a smaller valve, and of the need for, or risk of, an ARE. Following the death of TN, the claim was pursued by the Claimants as executors of TN’s estate.
On the 18th of March 2015, TN underwent re-do surgery at King’s College Hospital during which an ARE was undertaken and a larger, 23mm valve inserted. There were difficulties during the re-do operation and TN experienced post-operative complications. Following discharge, the Claimant’s condition deteriorated, leading to heart failure on the 29th of January 2020. It was the Claimant’s case that the re-do operation, and TN’s subsequent deterioration and death, would have been avoided if an ARE had been performed on the 5th of March 2014 with a larger valve implanted. Quantum had been agreed subject to determination of liability.
The issues for Mrs. Justice Eady to consider were:
With regards to (i) it became clear that the real issue between the parties was whether the defendant had acted in breach of the duty he owed to TN in failing to carry out an ARE so as to accommodate a valve that was larger than the 19mm valve implanted. After hearing both experts give evidence on this point, Eady J accepted that the decision not to perform an ARE was “an entirely logical view, balancing the benefits and risks in TN’s case” (para 72), accepting Mr. Sabetai’s reasoning that it was “doubtful whether performing an ARE would allow him to insert a larger valve” (para 72). As such he held it was not negligent to implant the 19mm mechanical reduced valve during surgery on the 5th of March 2014.
Eady J found Mr Sabetai’s concerns were borne out by the subsequent surgery and in considering (iii), concluded that TN would most probably have suffered the same complications in the event that an ARE had been performed on the 5th March 2014 (para 85). As to (iv), he was not satisfied that the difficulties that necessitated the re-do surgery were caused by the size of the valve fitted on the 5th March 2014, as opposed to “possible tissue overgrowth or mechanical failure, which would better explain the gap in time before TN began to experience adverse symptoms” (para 91).
Concerning (ii), the test in question was whether a “reasonable person in TN’s position would be likely to attach significance to the risk, or whether Mr. Sabetai was, or should reasonably have been, aware that TN would attach significance to it. Eady J accepted that Mr. Sabetai was “under a limited duty to warn TN of the possible risk that he might need to undertake an ARE during the valve replacement operation (para 78), but was not under a duty to explain the various possible choices that would be made intraoperatively, which included the make, design and size of the implant, and whether to undertake an ARE. As such he held that there was no duty to go beyond advice that an ARE might have to be undertaken and to provide the explanation suggested by this question” (para 80). In the counterfactual, Eady J felt that had TN been so advised, it would have “made no difference to the outcome” (para 80).
Rachel Vickers QC, a clinical negligence barrister at Outer Temple commented on the case:
This case is instructive in two respects. Firstly it is a reminder of the high bar which has to be reached when criticising clinical judgment by virtue of the Bolam test. Eady J observed that the Claimant’s pleaded case (and both parties’ cardiac experts), focused on what should have been done rather than allowing for possible alternative views that might still be regarded as proper by a competent body of opinion. The surgeon gave evidence that he did not view ARE, (which was rare), as an elective procedure but one which he might have to undertake intra-operatively. He reached this view balancing competing risks and the Claimant was unable to establish that the decision making process was flawed or illogical.
Secondly, it is an interesting application of where the line falls in terms of the information to be provided to a patient so as to ensure that they are aware of any material risk involved in the recommended treatment and or any reasonable alternative or variant treatments as per the test in Montgomery. There are fine margins between information that can reasonably regarded as ‘highly technical decision-making requiring a specialist level of understanding and experience’ which in this case included the size of valve to be used and the knock on effect of this including the need for an ARE, and matters which ought reasonably to have been discussed as ‘any reasonable alternative treatment’. The decision on consent is best understood in the context of the Judge’s decision that it was reasonable for the surgeon not to regard ARE as an elective procedure.
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