The process of consent for medical procedures took centre stage in clinical negligence claims in the case of Montgomery  UKSC 11 and since then, it has featured in cases much more frequently. It was a central feature in the recently decided case of Mordel v Royal Berkshire NHS Foundation Trust  EWHC 2591 (QB).
Montgomery: To re-cap
If there was any lingering doubt about it, by the time Montgomery was decided it was from that point clear that the relationship between a patient and the doctor is no longer a paternalistic one in which, in relation to consent, information regarding a procedure is imparted by the doctor and the patient consents on the basis of that information.
The concept that patients of sound mind are entitled to determine what happens to their body and decide what form of treatment, if any, to undergo was reiterated.
In considering what treatment a patient might undergo there ought to be a dialogue between the clinician and the patient in which the material risks of a procedure, or alternatives are discussed and in which the patient’s wishes and specific circumstances should be taken into account.
Mordel however demonstrates that consent is a process and that where a ‘cooling off’ period is involved for risk/benefit information to be carefully considered, it is a requirement of the next healthcare professional in the chain to be absolutely clear that the decision communicated by the patient was an informed one.
Mordel: The facts
The claimant in the Mordel case was a first time mother who attended for her booking appointment with the community midwife on 23 June 2014 at her GP’s surgery. A discussion took place regarding screening tests including screening for Down’s syndrome in two phases, first by way of nuchal translucency (NT) scanning (ultrasound scanning of the thickness of the fetal neck) , which, combined with blood testing at around 11-13 weeks’ gestation would produce a bespoke ‘risk factor’ of Down’s syndrome for that fetus. A risk of 1:150 or greater is regarded as high risk and a second phase of further tests would then be offered in the form of fetal blood sampling, amnioscentesis or chorionic villus sampling. These further tests are invasive and carry with them a potential risk of miscarriage.
The claimant, whose first language was Polish was documented to have agreed to the first phase tests for Down’s syndrome in the form of an NT scan, as well as a dating scan followed by blood testing. She was provided with reading material giving further information about the test. It seems that a discussion also took place regarding the second phase invasive tests which might be performed and the midwife noted that the claimant was ‘unsure’. She was aware that following the first phase tests being performed she would be informed of the results by letter within 2-3 weeks.
The claimant conceded that prior to the scan being performed she did not read the booklet she had been provided with (in English at her request) as she had used YouTube for information and understood the position.
The claimant attended for the scan on 22 July 2014 and, on the sonographer’s evidence would have been asked if she wanted the Down’s syndrome screening. If the answer was ‘no’ then the sonographer would proceed only with the dating scan and general checking of the baby’s wellbeing.
The claimant’s notes for this appointment record that Down’s syndrome scanning was ‘declined’. This was recorded in the digital notes by means of a drop down box. If the patient said she did not want the screening the sonographer stated she would have simply accepted the woman’s decision. As a result the NT scan was not performed, but a dating scan was. No separate blood testing was performed.
The claimant attended for a further appointment with the community midwife on 11 August 2014. At this point it would have been possible for the claimant to have undergone a different blood test, a quadruple test for Down’s syndrome if the patient had changed her mind or a misunderstanding uncovered.
The midwife however simply noted that the claimant had declined screening and the subject was not discussed. In cross examination, the midwife conceded on two or three occasions that she ought to have discussed the scan appointment and lack of Down’s testing to ensure the claimant’s wishes had been respected.
On 25 January 2015 the claimant gave birth to her son who was diagnosed as having Down’s syndrome.
The claimant was clear that she had always wanted the first phase screening and had understood it had been performed. She admitted that she had seen the ultrasound scan report, which was contained within her patient held records, and was aware it recorded that Down’s syndrome screening had been ‘declined’. Her evidence was that she interpreted this as meaning that:
Down’s syndrome first phase testing had been performed by the sonographer
The sonographer had found no evidence and so had recorded the result as negative
'Declined' to the claimant meant that the fetus was healthy and unaffected by Down’s syndrome.
The consent process
The striking feature of the consent process in this case was that it was not clear who was actually obtaining the patient’s consent in these circumstances.
The defence obstetric expert gave evidence that consent is not taken by the midwife who discussed scanning with the patient at the booking appointment, but that this was ‘an informed offer’. It was the sonographer’s duty to obtain informed consent. The difficulty with this is that whilst the NICE guidance in relation to Antenatal Care refers to the information which must be made available to pregnant women to enable them to make a decision in relation to screening, it is less clear in relation to the obligations around obtaining consent. It seems very unlikely indeed that the sonographer was aware that she was tasked with obtaining consent in these circumstances, and indeed it was specifically found that the sonographer was not trained to provide advice. Nonetheless it was found that she should have satisfied herself that:
there had been a discussion between the patient and the midwife in relation to screening;
that the NHS booklet had been provided to her and;
the patient understood the essential elements and purposes of scanning for Down’s syndrome.
It was also clear that as between the parties’ experts there was a difference in approach.
Ultimately the judge found both the sonographer and the midwife to have been in breach of their duty of care to the claimant.
It was also found that had the test been performed it would likely have revealed a high risk of Down’s syndrome, the claimant would have undergone invasive testing and would have terminated her pregnancy.
An informed decision
This case highlights the need to identify clearly when the obtaining of consent (as opposed to simple provision of information) arises in practice and to ensure that those involved in taking consent are aware of the obligation upon them and the requirements to take consent effectively. This is particularly so in relation to planned procedures where consent will be a two stage process. Those involved need to have a clear understanding of their role and the need to document the consent process effectively.
The case is surprising in the following respects:
The acceptance by the judge of the claimant’s account that on reading her notes she interpreted the scan result as indicating that all was well.
Recognition by the claimant that a letter should have been sent to her on conclusion of the screening process yet she did nothing when no letter arrived.
The case is also notable for the claimant’s admission that she did not read the booklet given to her, but looked up the tests on YouTube - a sign of the times indeed.
In short, yet again, the message to practitioners is that consent is a process and a record of a decision is insufficient . Following Montgomery, the requirement is to be able to demonstrate that the decision was an informed one.