In Negus v Guy’s and St Thomas’ NHS Foundation Trust [2021] EWHC 643 (QB), the High Court considered whether an NHS Trust was responsible for the Claimant’s death, where it was alleged that during cardiac surgery a 19 mm mechanical valve was implanted instead of a larger valve. The Claimant underwent a further operation a year later, during which a larger valve was inserted but from which she never fully recovered. Eady J held that the initial operation was not negligent, as the decisions made by the Consultant Cardiothoracic Surgeon were a reasonable exercise of his professional judgement and would be supported by a responsible body of cardiothoracic surgeons.

Background

The Executors of the Claimant’s estate sought damages relating to aortic valve replacement surgery undertaken in March 2014. The Claimant argued that insertion of a 19 mm mechanical value was negligent as a larger sized valve should have been used, even though that would have required the more complicated and higher risk procedure of an aortic root enlargement (ARE). In March 2015, re-do surgery was undertaken involving the more complicated ARE procedure to insert a larger 23 mm valve. However, difficulties arose during and after that operation and the Claimant never fully recovered. She died of heart failure on 29 January 2020.

The Issues

The issues for the court to consider were:

  1. Was it negligent to use a 19 mm mechanical valve during the first surgery?
  2. Was it negligent for the consultant not to have explained that in order to implant the largest possible valve the need for an ARE might arise, a more complicated and higher risk procedure? If the Claimant had been so advised, would she have still chosen to undergo the operation?
  3. Would the complications that the Claimant suffered during the second surgery also have occurred had the consultant attempted to implant the larger valve in the initial operation?
  4. Were the cardiac dysfunction requiring re-do surgery and the Claimant’s subsequent death on 29 January 2020 due to the initial failure to implant a 21 mm valve?

The Decision

With regard to the first issue, the Court took the view that the decision to use a 19 mm valve at the first surgery was a reasonable exercise of the surgeon’s judgement. Eady J performed a very careful analysis of the expert evidence from which it became clear that the surgeon was faced with a difficult decision made during the course of the procedure. It became clear in evidence that whilst the Claimant’s expert might have taken a different view, the Surgeon’s assessment that performing an ARE involved greater risks and might not achieve any benefit was reasonable – applying the Bolam test – having regard to various factors including the age of the Claimant, and various aspects of her anatomy only visible at the time of the operation.

As to the second issue, the Claimant’s expert was of the opinion that she ought to have been warned of the risk of having to undergo a possible ARE procedure as a separate part of consent but the operating surgeon claimed that this decision fell within general consent as to “procedures necessary to save life or prevent serious harm to health.” Eady J found that in these particular circumstances, where the surgical decisions as to process rested heavily on the situation uncovered at the time of surgery, there was a limited duty upon the surgeon to warn the Claimant of the possibility of an ARE. However, this was clearly not a scenario where the patient could be presented with a choice to be made as so much was unknown prior to the procedure and many relevant factors would only become clear during the surgery itself, so Eady J concluded that it was false to present this as a simple “bilinear choice of treatment“. 

Eady J was also satsified that there was no basis for her to conlcude that any breach of duty in respect of an absence of warning of the possibility of ARE would not have made any difference. In particular, the court accepted that in this scenario the Court would only have resulted in the Claimant leaving it to the Surgeon “to exercise his professional judgment as required during the operation“.

In light of the above the court did not need to consider issues 3 & 4 but the court did so concluding that any attempt to implant a larger valve in March 2014 (necessitating ARE) would most likely have led to the same complications as the Claimant suffered during the surgery in March 2015. The court also considered the cause of the re-do surgery and found that circumstances and influences other than the size of the valve could have been at play; for example, possible tissue overgrowth or mechanical failure. This would provide a better explanation for the delay before the Claimant started to experience adverse symptoms after the initial operation. The judge was “not satisfied on the balance of probabilities that the need for the re-do surgery was caused by the size of the valve fitted during the initial operation“.

Expert Evidence

This case demonstrates the central importance of expert evidence in this type of case and the importance of ensuring that experts are properly appraised of the applicable legal tests in a given case and apply those tests to the opinion they express. Eady J made some interesting comments on the evidence from the cardiothoracic experts whose opinion was key to the dispute. Whilst she acknowledged the high standards and professional judgement of both experts, she had concerns that this led the experts to lose sight of the test to be applied. By way of example, the Defendant’s expert referred to the ARE procedure as a ‘procedure now relegated to the history books’, a view that the judge found was not shared by all reasonable bodies of opinion. Similarly, there were times when the views expressed by the Claimant’s expert were based on his own opinion on a subject, as to how he thought things should be done, thus not allowing for the possibility that alternative views might still be recognised as being proper, by a competent, reasonable body of opinion.

Perhaps recoginsing that this was a case where the experts might not have had the Bolam test at the forefront of their minds, Eady J emphasised the following:

“Thus, whilst respect is to be afforded to the views of experts in a particular field, the determination of breach of duty in clinical negligence cases remains firmly a matter for the court. Negligence will only be established if the treatment undertaken was outside the range of professional opinion, but that is subject to the court being satisfied that the views within that range are capable of withstanding logical analysis.“

Eady J was clear in her acknowledgement of the intricacies of surgery of this type and the decisions that needed to be made in the moment by the experienced surgeon undertaking the operation. The need for re-do surgery was not in itself indicative of a failure in the initial operation and the lack of a successful second attempt at inserting a larger valve and performing an ARE in fact had fatal consequences. Eady J emphasised that whether there has been a breach of duty is a matter for the court and expert opinion is there to assist not decide. Logical analysis of such professional opinion must be undertaken.

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