Should patients be informed of material risks involving technical decisions?
Negus and Bainbridge v Guy’s and St Thomas’ NHS Foundation Trust [19.03.21]
This claim concerned an aortic valve replacement and whether the patient should have been provided with further information in respect of the valve sizes available to be inserted and possible associated treatments.
The patient in this case underwent surgery, performed by a consultant cardiothoracic surgeon at St Thomas’ Hospital on 5 March 2014. Surgery involved the implant of a 19mm mechanical valve. The patient later experienced cardiac dysfunction, requiring revision surgery which was carried out at King’s College Hospital on 18 March 2015. Revision surgery entailed a larger 23mm mechanical valve being inserted along with an aortic root enlargement. The patient suffered complications during her post-surgery rehabilitation and continued to deteriorate after the surgery in March 2015; sadly, she died of heart failure on 29 January 2020.
During the consultation with the consultant cardiothoracic surgeon employed by the defendant Trust (the Consultant) on 7 February 2014, the patient was advised in relation to the various risks associated with an aortic valve replacement and the types of valves (mechanical or tissue prosthetic) that could be used. As referred to at paragraph 17 of the judgment, the patient in this matter “having been a nurse, had some knowledge of the different types of valve”.
The claimants’ case
The claimants (the executors of the estate of the deceased) contended the use of a 19mm mechanical valve during the surgery in 2014 was negligent and a larger sized valve ought to have been used, alongside an aortic root enlargement being performed. It was argued that the surgery on 18 March 2015, the subsequent deterioration and the patient’s death would have been avoided had a larger valve been used and aortic root enlargement been performed in 2014. The claimants also alleged the patient was not properly advised in respect of:
- The risks/benefits associated with the implantation of various valve sizes; and
- The possibility of performing an aortic root enlargement and its associated risks.
Having considered the parties’ respective expert evidence, Mrs Justice Eady found the Consultant’s decision to implant a 19mm valve and not to perform an aortic root enlargement was not negligent.
Both parties’ experts agreed the size of the valve could not be determined pre-surgery and it must be decided intra-operatively by using a sizer to determine the best fit. As such, the Consultant was unable to have a meaningful discussion with the patient prior to the surgery with regards to the size, particular brand or design of the valve to be implanted. Mrs Justice Eady was also content with the professional judgement exercised by the Consultant as to the choice of valve and agreed such a decision would need to be made intra-operatively.
On the issues of consent and in keeping with the test adopted in Montgomery, Mrs Justice Eady found there was a failure to advise the patient that there was a possible risk of an aortic root enlargement being performed. However, the Judge also found there was no duty to patients to advise why an aortic root enlargement may need to be performed, nor the various choices of valve that might arise intra-operatively. Mrs Justice Eady held this was best determined by the professional judgement of surgeons during the operation.
Mrs Justice Eady’s judgment indicates there is a line to be drawn between clear choices that can be set out prior to surgery and choices made by surgeons which require professional judgement to be exercised intra-operatively. Given the number of variables involved in aortic valve replacement, it was not incumbent on the Consultant to discuss each possibility that could arise during surgery and what the patient’s preference for those possibilities were.
The extent to which patients are owed a duty to be informed of all material risks will always turn on the facts in each case.
This case clearly demonstrates that there will be circumstances where there will be choices that need to be made intra-operatively, and those choices are best left to the professional judgement of surgeons rather than patient preference.