by Claire Long July-16-2020 in Healthcare Law
The case of Mordel v Royal Berkshire NHS Trust [2019] EWHC 2591 (QB) is one of the most illuminating judgments regarding the question of informed consent to emerge in recent times. Although as a judgment of the English High Court it is not binding in Ireland, it is likely to be considered as persuasive by the Irish Courts when faced with cases regarding informed consent, particularly in respect of the extent to which there is an obligation on practitioners to explore a patient’s reasons for agreeing to, or declining, a particular treatment or course of action.
1. Background
i. Antenatal screening system
The NHS conducts routine screening for Down's Syndrome in the first trimester of pregnancy. This screening has two elements: a nuchal translucency test, which is an ultrasound scan of the foetal neck area, and a blood serum test of the mother. The result from the combined test provides a statistical risk factor, which the patient can then use to inform subsequent decision-making about whether they will opt to have a definitive, diagnostic test, which unfortunately carries a risk of miscarriage.
Second trimester screening can also be offered in the NHS system, but only if first trimester screening has not occurred. Four blood components are examined, and the test is known as the “quadruple” test. This is a screening, and not a diagnostic test. A diagnostic test which offers certainty, for example, an amniocentesis or CVS, entails a risk of miscarriage of up to 2%.
ii. Ms Mordel’s treatment
The Claimant attended her booking appointment with the community midwife at her GP surgery. It was her first pregnancy. The Claimant is Polish and the trial judge, Mr Justice Jay, described her English as being “good but far from excellent”.
At the booking appointment, the Claimant was given information to read about the nuchal translucency scan and a discussion also occurred regarding the second phase tests (i.e. the diagnostic/invasive tests which carry a risk of miscarriage) which could be performed. The midwife recorded in the notes that the Claimant was “unsure” about pre-natal diagnosis/CVS/amniocentesis.
The Claimant attended the Royal Berkshire Hospital to have the nuchal translucency scan carried out as part of the first trimester screening. The sonographer could not recall the consultation but gave evidence that it was her usual practice to ask whether the patient wished to have the screening for Down's Syndrome. If the patient said no, the sonographer said she would say that she was not carrying out the screening and was simply performing the dating scan, checking the baby and making sure that the dates were correct. The Court found that the Claimant did not respond when the sonographer said this to her. The sonographer selected “Down’s screening declined” from a drop-down menu in the computerised medical records.
The Claimant went on to have a further appointment with the community midwife. At that stage, the Claimant could still have undergone the quadruple test and it was her case that this should have been offered at the appointment with the community midwife. The midwife noted in the medical records that the Claimant had declined screening and the subject was not discussed. The Claimant underwent a foetal anomaly scan at 20 weeks gestation, which was unremarkable. The Claimant's son was subsequently born and diagnosed as having Down’s Syndrome. The Claimant sued the Trust for clinical negligence.
2. Legal Issues
i. Offer of screening
Ultimately, there was a conflict of evidence between the sonographer and the Claimant. The Claimant’s primary case was that she had agreed to antenatal screening at her booking appointment and that she had not been asked by the sonographer whether she wanted the screening when she attended for the nuchal scan. She said that she had read her medical notes after the appointment and had read “Down’s screening declined” as meaning that the sonographer had carried out the test and all was well, i.e. that declined meant that the baby did not have Down's syndrome. The Claimant had not submitted this account in her written statement.
It was the NHS Trust’s case that the Claimant was offered and had declined the test at the appointment for the nuchal scan and that this was substantiated in the contemporaneous medical record. The Claimant’s secondary case was that she did not understand the sonographer’s question and that there was therefore an absence of informed consent.
ii. Decision
The Court held that the Claimant wished to undergo Down's Syndrome screening, that the sonographer breached her duty of care on the day of the nuchal translucency scan, and the midwife did not discharge her duty to the Claimant at the later appointment, when there was no exploration of the Claimant’s apparent rejection of antenatal scanning, given she had initially indicated at the booking appointment that she wanted this. This meant that the opportunity for the Claimant to have the quadruple blood test was missed. The Court held that had a screening test been performed, it would likely have revealed a high risk of Down’s Syndrome, the Claimant would then have undergone invasive testing and would ultimately have decided to terminate her pregnancy (as the Claimant said she would have done).
The Claimant’s primary case in fact failed, with the Court accepting that that the sonographer did ask the Claimant whether she wished to have the screening for Down’s Syndrome. The judge found that that the Claimant failed to understand the sonographer’s question, that her “unreflective response” was to say "no" and that in the heat of the moment, she had failed to process the question and everything that ensued subsequently resulted from that. There were difficulties in the Claimant’s case, in that she accepted that she did not read the leaflet she was provided (which she was content to accept in the English language rather than a Polish version) and her position was that she had watched Youtube videos on the subject instead. She also conceded that she was aware that the results of the screening would be sent to her but she did not receive a letter.
iii. Informed Consent
However, the judge considered that the sonographer’s question had been “somewhat abrupt” and she should have done more “to lay the ground properly”, to guard against the risk that she and her patient were at cross-purposes and/or that the patient was not listening to her properly. It was considered that the sonographer needed to go further, given the Claimant had provisionally accepted screening for Down's syndrome, and the sonographer should have asked whether she still wanted it; and in a case where she had rejected it, the sonographer should have sought confirmation that her understanding of what the patient understood was correct.
iv. Patient’s level of understanding
The judge considered that the Defendant had overstated the difficulty in exploring a patient’s level of understanding without appearing to undermine her right to choose, which will be a key concern for practitioners in this particularly sensitive scenario. The judge was of the opinion that it is not the patient’s reasons for acceptance or rejection of a treatment decision which require to be unpicked, but rather a “gentle exploration” is required of the patient’s state of mind, conducted for the limited and specific purpose of checking that she understands what is entailed. It is interesting that the Court was not swayed by what could be considered understandable reticence to probe a patient’s decision or indication of which path they wished to follow; the judge considered that “respect for patient autonomy is scarcely undermined by sensitive inquiry”.
3. Import of the Mordel Decision
Arising from Mordel, the following are key issues to be considered in the context of eliciting truly informed consent:
- According to Mordel, the mere provision of the relevant information to the patient does not in and of itself demonstrate informed consent. The clinician must make sure that the patient understands the information, that they are aware of the potential risks of any treatment and that they understand the options available to them. Some probing may be necessary to establish that the patient has truly understood and is not simply being ‘swept along’;
- Where there is any doubt as to a patient's comprehension of language, then a translator or interpreter should be consulted and the medical records should clearly state the difficulties in comprehension, and that a translator has been engaged before proceeding;
- Consideration should be given to asking the patient to repeat the content of the discussion back, to include the patient's rationale for opting to take a certain course of action which should be clearly evidenced in the medical records;
- Where a discussion is conducted with a patient, the content of that discussion should be recorded. Particularly in a scenario where there is an auto-populated field or drop down box, a narrative should be added if at all possible. It is advised that hospitals and clinics review their record systems and address any issues in this regard to allow narrative to be entered by the clinician in the medical records.
Whilst the extent to which Mordel is followed in this jurisdiction remains to be seen, the issues highlighted in the decision and addressed above serve as timely reminders to obstetric clinicians, midwifery staff and sonographers addressing informed consent issues on a daily basis.
Back to Full NewsShare this article:
About the Author
Claire Long
Claire is an associate solicitor in the Healthcare team at Hayes solicitors. She specialises in defending medical negligence actions against hospitals and individual healthcare practitioners. Claire is committed to providing healthcare professionals with advice to support them through the litigation process, and dealing with claims expeditiously.