The reasonable steps required to obtain informed consent in screening for Down’s Syndrome

In a recent judgement delivered on 8 October 2019 in Mordel v Royal Berkshire NHS Foundation Trust [2019] EWHC 2591 (QB), Mr Justice Jay had to consider some interesting consent issues regarding NHS antenatal screening for Down’s Syndrome (trisomy 21).

The claimant, Edyta Mordal, was pregnant with her first child. As the Judge explained early on in the judgement and by way of background:

“2. …For some time now pregnant mothers have been offered in the NHS routine screening for Down’s syndrome in the first trimester, usually at around 11-13 weeks. This screening has two elements: first, an ultrasound scan of the foetal neck area – this is what is known as the nuchal translucency test or “NT”; and, secondly, a blood serum test of the mother (a double test, i.e. of Beta hCG and PAPP-P) is carried out – in this particular trust on the same day. The result from this combined test yields a statistical risk factor which serves to inform subsequent decision-making. Any result higher than 1:150 is regarded as “high risk” and the mother should then be offered diagnostic testing.

 3. Second trimester screening can also be offered to the mother but only if the first trimester screening has not taken place. The precise circumstances which might trigger the offer are not agreed by the parties, but the test in question is not performed by ultrasound and is limited to blood serum. On this occasion four blood components are examined, and the procedure is known as the “quadruple test”. As with the combined test, this is no more and no less than a screening procedure and cannot yield any certainty. The latter is attained only if the mother proceeds to diagnostic testing of DNA following the taking of foetal or placental blood and/or tissue via a needle placed through the abdominal wall, a procedure which entails a risk of miscarriage of up to 2%.

 4.… The NHS must offer screening for Down’s syndrome but maternal informed choices must be respected…”

The facts of the case are relatively straightforward and are summarised in the judgment (paragraph 5). On 23 June 2014, the claimant attended the community midwife at her GP’s surgery for the booking appointment; she “accepted” all six of the standard screening tests, including combined screening. She was booked in for her NT scan on 22 July, at which time she attended the Royal Berkshire Hospital to undergo the scan. There was a dispute between the claimant and the sonographer as to exactly what happened at that appointment. There was no dispute, however, that the latter completed on the ultrasound report: “Down’s screening declined”. No NT scan was carried out. The overall condition of the fetus was checked by ultrasound, with the due date being ascertained more precisely and corrected in the records. The taking of blood, which was the second part of the combined test, was also not carried out, consistent with the claimant having declined Down’s screening. On 11 August, the claimant returned to see the same midwife and the quadruple test was not offered. The claimant underwent a fetal abnormality scan at around 20 weeks’ gestation, which was unremarkable. After a Caesarean section, baby Aleksander was delivered safely.

Having recited the facts, the Judge then summarised the issues he had to consider as follows (paragraph 6):

“(1) (a) Did the sonographer offer Down’s Screening on 22^nd July 2014; and, if she did, what exactly did she say? (b) did the claimant appear to decline the offer; and, if she did, what exactly did she say?

(2) Did the sonographer discharge her duty to the claimant in terms of obtaining the latter’s informed consent?

(3) If the answer to (1)(a) and (b) is “yes” and (2) is “no”, was it in fact the claimant’s wish not to undergo Down’s screening on this occasion?

(4) Did the midwife discharge her duty to the claimant on 11^th August 2014 in not exploring why the combined test had not been carried out?

(5) If the answer to (4) is “no”, would the claimant have informed the midwife pursuant to the exploration that ex hypothesi the latter should have conducted that she wanted Down’s screening (i.e. the quadruple test)?

(6) In the event that the answer to (3) is “no” and/or to (5) is “yes” (on the assumption that either or both of these questions arise), would the claimant have consented to invasive testing and a termination of pregnancy?”

The Judge then referred to some relevant guidance, namely the NHS document Antenatal Screening – Working Standards for Down’s Syndrome Screening, 2007 and a NICE Clinical Guideline published on 26 March 2008, Antenatal Care for Uncomplicated Pregnancies. In addition to these, the Judge mentioned the defendant’s own document, Down’s syndrome Screening Policy, November 2012 edition (which had been amended after the claimant’s son’s birth).

In discussing the legal framework in the case, the Judge then identified the importance of Bolitho, in that expert opinion must be “responsible, reasonable and respectable, and logically based”, as well as Montgomery. Significantly, the Judge referred to ARB v IVF Hammersmith [2018] EWCA Civ 2803, in which the Court of Appeal had overturned his own judgment, which had been in favour of the defendant clinic, on the basis that the clinic’s practice was illogical. As the Judge stated (paragraph 19), this decision was pertinent because:

“… it vouches that a system which does not entail the taking of reasonable steps to ensure that relevant consent is informed may be regarded – subject always to a host of other considerations – as irresponsible, unreasonable and unrespectable even if there may exist expert evidence to support it”.

The Judge concluded on the factual evidence that, in answer to the first issue posed, which were matters of fact, the sonographer (Ms Bracher) had offered Down’s screening (which was against the claimant’s recollection) and the claimant had declined it; he determined the sequence of events as follows (paragraph 55):

“(1) Ms Bracher, having introduced herself, asked “Do you want the screening for Down’s syndrome?”

(2) The claimant said “No”

(3) Ms Bracher said, “So we are not doing the screening then, we are just doing the dating scan and I will be checking the baby and making sure that the dates are correct”.

(4) There was no response from the claimant.

(5) The claimant was asked to lie down on the table.

(6) Ms Bracher then clicked on the box in the dropdown menu, “Down’s screening declined”, and this was not a mistake – the claimant had said “no” and nothing else…”

With respect to the second question, as to whether the sonographer had discharged her duty, the judge acknowledged that the meaning of informed consent was not sensibly in dispute, but the issue in this case was the nature of the steps which should be taken to secure such informed consent. The Judge considered that taking informed consent in the claimant’s situation was not just a matter of the sonographer taking the claimant’s decision with all the relevant information having already been provided beforehand: informed consent to the procedure still had to be provided. He considered that the sonographer had a duty to satisfy herself that the patient was consenting to the procedure about to be performed, which he said (paragraph 89):

“… in my view logically mandates: (i) checking that there has been a discussion between patient and midwife, (ii) checking that the patient has been supplied with the NHS booklet, and (iii) ascertaining by brief questioning that the patient understands the essential elements and purposes of scanning for Down’s syndrome”.

The Judge noted (paragraph 91) that, if informed consent had been taken at the booking appointment, with that decision then being communicated to the sonographer as merely a formality, the defendant would be in some difficulty (“caught between a rock and a hard place”) because, as fact, in this case the claimant had accepted and given informed consent to six tests, including NT, and as such the sonographer ought to have carried out what the claimant had already consented to; or, at the very least, “explored that the claimant’s apparent change of mind was genuine”. He also took the view that, in any event, the sonographer would remain under an obligation to ensure that the consent remained valid. On the other hand, if informed consent had not been given beforehand, which was the Judge’s analysis, it would be incumbent on the sonographer to take reasonable steps to ensure that it was given before the procedure commenced. The Judge was (paragraph 92) rather critical of the sonographer’s opening exchanges with the claimant, describing them as “a somewhat abrupt way to begin an important exchange”, even though he appreciated that sonographers “are busy, are working under time-pressures and their lists are full”.

The Judge recognised (paragraph 94) that the “modicum of exploration” that he was indicating a sonographer was duty-bound to perform might lead to question being asked by the patient that the sonographer was unable to answer; in such a situation, he would suggest a referral to a midwife for further discussion, preferably on the same day. He also noted (paragraph 95) that it was relevant that the sonographer always asked the same question regardless of what had been recorded at the booking appointment. However, the sonographer was, or should have been, aware that the claimant had previously requested screening and should have explored the apparent change in mind – she should have asked whether the patient “still” wanted the screening test: to do no more than she did was insufficient. On the sonographer’s own account, the taking of informed consent involved a short question and a short answer (“maybe 3 seconds”) and selecting an appropriate drop-down answer on a computer – the Judge concluded that this was an inadequate process.

With respect to the third issue, whether it had been the claimant’s wish (as fact) to undergo Down’s screening, an issue which was integral to the case, the Judge considered on the factual evidence that it had remained the claimant’s wish to undergo Down’s syndrome screening on 22 July and that she continued to believe at all material times thereafter that it had been carried out.

He then looked at the fourth issue, whether the midwife had discharged her duty to the claimant on 11 August 2014 in not exploring why the combined test had not been carried out. He considered the guidelines and expert evidence and, in determining that the midwife had failed to discharge her duty, concluded:

“It cannot be incumbent on the midwife to undertake lengthy inquiry or to delve into the reasoning processes and motivations of the patient, but in my judgment in a situation where the patient was booked for the combined test and did not have it, the midwife should not leave the matter there. A simple and straightforward exploration and check that what has occurred, or not has occurred, was and is in accordance with the patient’s wishes continues to place her at the centre of the decision-making process and amounts to the taking of reasonable steps to ensure that everything has gone and is continuing to proceed according to plan.”

The answer to the fifth issue, whether the claimant would have informed the midwife she wanted screening if properly asked, was “yes”, given the answer to the third issue.

Finally, the answer to the sixth question, as to whether the claimant would have undergone invasive testing and termination, was based on both expert and factual evidence: had the claimant undergone a combined or quadruple test, she would have been placed into a high-risk category (a greater than 1 in 150 chance) and would have been offered invasive testing (amniocentesis or Chorionic Villus Sampling), which would have confirmed the Down’s Syndrome.

At paragraph 150, the judge concluded:

“I have found that the claimant consistently wanted Down’s screening of her baby. The claimant did not have a principled objection to termination, and [Counsel for the Defendant] did not suggest that she did. Had she been informed that her baby had Down’s syndrome, I am satisfied that she would have proceeded to termination”.

And at paragraph 152:

“I have concluded that the claimant probably would have proceeded to invasive testing had she been told that there was a high risk of Down’s syndrome. The claimant was a relatively young mother and I think that at the end of the day the fear that she might be carrying a child with Down’s syndrome would, at least for her, have tipped the balance”.

The claimant, therefore, succeeded in establishing that the defendant had negligently failed to obtain her informed consent and failed to carry out Down’s syndrome screening. Further, the defendant’s midwife had failed to discharge her duty by not exploring why the combined test had not been carried out. Had the claimant undergone screening and subsequent invasive testing, Down’s Syndrome would have been confirmed and the claimant would have proceeded to termination.