In pursuit of absolute confidence

A recent Supreme Court judgment underlined that the legal standard of care in medical negligence cases remains that outlined in the Dunne principles. Catherine Reilly asks legal and medical professionals for their reaction

In May 2019, a High Court judgment in a CervicalCheck case appeared to send shock waves through the medical profession and their professional bodies.

The judgment of Mr Justice Kevin Cross in Morrisseys v HSE, Quest Diagnostics and Medlab Pathology was feared as introducing a new legal standard of care that would mean every error must result in a finding of negligence. Medical bodies warned of unintended consequences, including additional unnecessary tests and procedures on patients.

If false-negative screening tests were regarded as a breach of care, this position would potentially threaten the viability of Ireland’s cancer screening programmes, it was said.

In the aftermath of the judgment, this impression was criticised by Mr Justice Cross. Reported in The Irish Times as “sounding at times emotional” in court, Mr Justice Cross said some of the commentary had been ill-informed and “hysterical”. He said people should “really read what I have said”.

In March, the Chief Justice sought to further dispel statements and concerns around the High Court judgment, in the frankest of terms.

In a Supreme Court judgment on the appeal case, Mr Justice Frank Clarke stated that anyone who had “taken the trouble” to read the High Court decision would not have reached such conclusions. Some of the more “extreme comments” were hard to reconcile with the fact that the same standard and approach were applied in the UK without its screening systems becoming unworkable, according to the Chief Justice.

Mr Justice Clarke said Mr Justice Cross had applied what was termed an ‘absolute confidence’ test based on an English case, although “it is important to understand that the trial judge was quite specific about the precise aspects of the case to which that test was to be applied”.

The Chief Justice detailed that “in the course of the oral hearing, it became clear that there was no significant dispute between the parties on this question.”

The Morrissey case

This case is first and foremost a human tragedy. Ms Ruth Morrissey, now terminally ill, was diagnosed with cervical cancer in 2014 after attending her GP with symptomatic bleeding. She participated in CervicalCheck in August 2009 (negative result reported by Quest Diagnostics) and August 2012 (negative result reported by Medlab Pathology).

After Ms Morrissey’s diagnosis, her sample results were upgraded on audit. The results of this audit were not communicated to Ms Morrissey by the HSE until mid-2018, after the audit activity entered the wider public domain through the case of Ms Vicky Phelan.

In the High Court, Mr Justice Cross found there was no doubt that the cells on the 2009 slide were atypical glandular cells (AGC)/atypical glandular cells of undetermined significance (AGUS) and a reasonably competent screener at the relevant time should not have failed to see what was on the slide.

While concluding that abnormalities were visible on the 2012 slide, which suggested a categorisation of AGUS/AGC cells, Mr Justice Cross held that these cells were not easily distinguishable from other normal cells and thus that a screener exercising reasonable care could have failed to identify same.

However, it was also held that the failure to test the 2012 slide for adequacy in accordance with the ThinPrep method (the method utilises a liquid-based technique that replaces the direct smear method of the conventional Pap screen) was negligent and in breach of duty. The “negligent misreading” of both the 2009 and 2012 slides were found to have caused the entirety of the Morrisseys’ claims for injuries and loss.

Judgment was given in favour of the Morrisseys, against all three defendants, with damages in the sum of €2.1 million awarded (€10,000 in nominal damages were awarded against the HSE over the non-disclosure of audit results). The defendants appealed liability, although the State guaranteed the award to the Morrisseys.

In March, the Supreme Court dismissed the appeals, except that of Medlab in relation to the award of damages for loss of service. It also found the HSE was not vicariously liable for the negligent acts of the laboratories but held it had a non-delegable duty in respect of patients accessing CervicalCheck.

The 221+ CervicalCheck patient support group welcomed the Supreme Court judgment. “We are relieved and pleased for Ruth, who has had to bear the worry of the appeal on top of the burden of serious illness. Her courage and fortitude have been validated.”

HSE ‘primarily liable’

According to the State Claims Agency (SCA), the appeal on behalf of the HSE related to the “issues of absolute confidence and primary and vicarious liability”. The Agency informed the Medical Independent (MI) it welcomed the Supreme Court’s “clarification” of the position in relation to the absolute confidence test.

“The Supreme Court reaffirmed that the Dunne principles are the only applicable test for the determination of professional negligence,” outlined an SCA spokesperson.

The Supreme Court “also clarified that the level of conviction required for a cytologist to declare a cervical smear test as negative is specific to the interpretation of cervical smear slides and does not have wider application to other clinical negligence cases”, according to the SCA.

The SCA acknowledged that the Supreme Court found that the HSE “in the manner in which it adopted and promoted CervicalCheck, could be assumed to have undertaken responsibility for the scheme, irrespective of whether actual screening or other elements of the scheme were to be performed by others, and was therefore primarily liable for any negligence which might be found against the laboratories”.

The Supreme Court overruled the High Court’s finding that the HSE is vicariously liable for the actions of the laboratories, added the SCA.

‘Myth’ of medical certainty

Dr Cliona Murphy, Chair of the Institute of Obstetricians and Gynaecologists (IOG), RCPI, informed MI that it “noted” the judgment of Mr Justice Clarke. “It confirms that screeners must have absolute certainty in the adequacy of the smear. While the legal issue appears settled, the IOG have some concerns about the content of the judgment,” added Dr Murphy, who said the IOG noted the use of the phrase ‘the all-clear’ or ‘clear smear’ a number of times.

“As clinicians, this is troubling and perpetuates the myth of medical certainty. This is echoed by a cytotechnologist in his evidence — ‘Well, this is something that — so absolute confidence for me, as a scientist, absolute confidence is very hard to have because, I mean, generally in science, you generally say the evidence supports this or doesn’t support that.’” “As clinicians, we are taught not to say ‘all-clear’. All tests have false-negatives and false-positives.

In the setting of screening, where the aim is to reduce population morbidity and mortality, the reason for repeated interval testing is that it increases pick-up. “The current coronavirus pandemic highlights the issue of medical uncertainty that has to be tolerated. The current coronavirus test has 15 per cent false-negative — sampling error, timing, viral load, all vary the pick-up.”

Commenting more broadly on medical negligence issues, Dr Murphy said the “ever-increasing litigation in Ireland”, compared to other countries, has to be questioned. We spend far more on litigation than we do on training. Obstetrics and gynaecology accounts for a huge proportion of the medico-legal payout annually.

“Parents have an agonising and exhausting journey to access financial supports through the legal system that is unedifying. Surely all children with cerebral palsy deserve support to achieve some quality-of-life, not just those whose lawyer can find a sentinel event on a retrospectively reviewed CTG (foetal heart tracing)?

“Countries which have adopted ‘no fault compensation’ include Denmark, Sweden, New Zealand and Finland. With increasing evidence that medico-legal concerns affect speciality choice, it is something that should be considered.”

Dr Rob Hendry, Medical Director at Medical Protection, welcomed the “clarity” provided by the Supreme Court in confirming that the Dunne principles remain the legal test for medical negligence.

However, he described as “debatable” whether the High Court decision on the legal standard of care should have caused confusion, although “the fact is that it did”. The standard of care is a matter for expert evidence and this remains the position, he outlined.

According to Dr Hendry, use of the terminology ‘absolute confidence’ in the High Court decision “attracted a lot of attention and often conflicting views on what this meant for future cases”. He said many practitioners had “understandably expressed concerns”.

“There can be genuine differences of opinion between competent professionals reading the same slide, even applying a test of ‘no doubt’,” he said.

On behalf of the The Academy of Clinical Science and Laboratory Medicine, Ms Marie Culliton said the “clarification” from the Supreme Court was welcome. “It would be standard practice in Ireland that any screener would not call a smear negative or un/satisfactory if they had any doubts. In practice, difficult cases would be circulated among colleagues and a consensus agreed.

“No measurement in a clinical laboratory is ever considered to be ‘absolute’, as all are subject to uncertainty from a number of sources; pre-analytical, analytical and post-analytical variables, in addition to clinical variability. It would not be standard practice to equate ‘no doubt’ with ‘absolute confidence’.”

Mr Cian O’Carroll, solicitor for the Morrisseys, told MI that the HSE had actively generated unrest around the standard of care element of the High Court judgment.

According to Mr O’Carroll, the HSE “summoned” senior clinicians to a meeting after the High Court judgment, and a plan was formulated to react to the decision. This led to a lot of media publicity, much of which predicted an “Armageddon for screening”, stated the solicitor (the HSE told MI “we are not aware of any such activity”).

Early in the High Court trial, according to Mr O’Carroll, all of the parties were informed by Mr Justice Cross that he would want written submissions on a series of questions, including the standard of care, at the end of the proceedings.

“And reference was made right from the start to this English case of Penney Palmer and the absolute confidence test in that case,” said Mr O’Carroll. “Every expert witness had that ‘absolute confidence’ phrase and reference to that particular case put to them throughout the trial, and when it came to writing submissions, the HSE declined to make a submission on absolute confidence… and that very point became the centrepiece of their hysterical reaction [after the judgment].”

Meanwhile, the SCA informed MI it was managing 165 active claims in relation to alleged cervical cancer misreporting, as of 19 March last. “This total includes 25 psychological injury claims from members of the families of the women concerned.

As of this date, the SCA was managing 14 active claims in relation to alleged breast cancer misreporting. It had received no claims in relation to bowel screening as of this date.” The spokesperson said the number of claims related to CervicalCheck “has continued to increase through the first quarter of 2020”.

However, BreastCheck-related claims do not show a similar trend.

Mr O’Carroll said he is acting for approximately 60-to-70 people in regard to CervicalCheck. He said it was “difficult to see” the advantage for clients of accessing the CervicalCheck Tribunal (which is not yet established) rather than the courts. He said the State put forward a tribunal in the context of the failure to commit to a promise that women would not have to endure a court process.

The State has said the tribunal will be less adversarial than the current court process due to the adoption of pre-hearing protocols and case management procedures.

While it is being established with the intention of being less adversarial, Mr O’Carroll said he doubted this would be the case. “It is not what people ordinarily understand to be a tribunal. It was given that name, I think certainly not by the judges involved in it, but by the legislature and by the promoting Minister for Health because it made it sound fluffy and patient-focused, or patient-centred.”

He said it should be abolished and replaced by a new tribunal that does “not involve confrontation with the laboratories”, which should instead be pursued by the State, as happens anyway. “It will be the same as the High Court, only the media will not be allowed in. Maybe it is the media who put manners on everybody and made it less confrontational in the High Court. I certainly don’t think these defendants are going to be ‘nicer’ when they are behind locked doors.”

The 221+ group said it expects the tribunal will be more private and quicker than the High Court but “have no expectations of it being less adversarial”.

Applying the Penney Palmer approach

The High Court judge in the Morrissey case placed particular reliance on the decision of the English Court of Appeal in Penney, Palmer & Canon v East Kent Health Authority. This case also considered the allegedly negligent misreading of smear tests by cytology screeners.

In the High Court, Mr Justice Cross said the legal standard to be applied on the issue of the liability of the defendants is the Dunne test. Questions of fact, however, “are for my decision on the balance of probabilities”.

The questions of fact include what was to be seen on the individual slides. Accordingly, as in Penney Palmer, Mr Justice Cross said the correct approach was to determine:

(i)   What was to be seen on each slide;

(ii)  Whether a reasonably competent screener at the relevant time could have failed to see what was on the slide; and (iii) Whether a reasonably competent screener in the light of what he or she should have observed, could have treated the slide as negative.

Questions (ii) and (iii) above and any issues as to adequacy are to be decided in the light of the ‘absolute confidence’ test and thereafter, the test for negligence is as stated in Dunne. Justice Cross said absolute confidence was the screener’s practical duty in relation to their analysis of what was on the slide and the adequacy of the sample, and the legal issue was whether they had carried out that duty in accordance with the Dunne principles.

If there was any room for doubt that the slide was normal and the screener ascribed a normal result to the slide, then the screener was in breach of the Dunne principles.

The Dunne Principles

Finlay CJ in Dunne v National Maternity Hospital

1. The true test for establishing negligence in diagnosis or treatment on the part of a medical practitioner is whether he has been proved to be guilty of such failure, as no medical practitioner of equal specialist or general status and skill would be guilty of if acting with ordinary care.

2. If the allegation of negligence against a medical practitioner is based on proof that he deviated from a general and approved practice, that will not establish negligence, unless it is also proved that the course he did take was one which no medical practitioner of like specialisation and skill would have followed had he been taking the ordinary care required from a person of his qualifications.

3. If a medical practitioner charged with negligence defends his conduct by establishing that he followed a practice which was general, and which was approved of by his colleagues of similar specialisation and skill, he cannot escape liability if, in reply, the plaintiff establishes that such practice has inherent defects which ought to be obvious to any person giving the matter due consideration.

4. An honest difference of opinion between doctors as to which is the better of two ways of treating a patient does not provide any ground for leaving a question to the jury as to whether a person who has followed one course rather than the other has been negligent.

5. It is not for a jury (or for a judge) to decide which of two alternative courses of treatment is in their (or his) opinion preferable, but their (or his) function is merely to decide whether the course of treatment followed, on the evidence, complied with the careful conduct of a medical practitioner of like specialisation and skill to that professed by the defendant.

HPV primary screening will be ‘tremendous advance’

CervicalCheck made the “technical transition” to human papillomavirus (HPV) cervical screening as planned on 30 March, according to the HSE. However, the screening programme is suspended amid the Covid-19 pandemic.

HIQA recommended in 2017 that changing to primary HPV testing would reduce the number of screenings each woman has in her lifetime, while providing better accuracy in detecting precancerous abnormalities and early-stage invasive cervical cancer.

Separately, in regard to when the audit process will be reinstated, a HSE spokesperson said it was awaiting the final recommendation from an expert advisory group. CervicalCheck has been the subject of numerous well-documented reviews and controversies over the past two years.

The Scally report in 2018 found serious gaps in the governance structures of the screening services. However, medical bodies have pointed out that since the establishment of CervicalCheck, the rate of cervical cancer has declined by 7 per cent year-on-year.

Women directly affected by non-disclosure of audits and misreadings have urged others to continue to attend for smears. HPV primary screening will be a “tremendous advance” for cervical screening, according to Chair of the Institute of Obstetricians and Gynaecologists (IOG) Dr Cliona Murphy.

“We can envisage — 10 years from now or less — when the vaccine curve and HPV screening curves will cross each other and a dramatic drop in high-grade CIN and the eradication of cervical cancer. “This has been the experience in Australia. Like any new advance, the clinical community will need support in roll-out.

Administrative support, communication support about the change is essential. There has been engagement with our colleagues in NWHIP [National Women and Infants Health Programme] and the IOG is represented on the clinical advisory group by Dr Nóirín Russell. Other stakeholder groups are also represented.”

Meanwhile, The Academy of Clinical Science and Laboratory Medicine said it has always been its policy that laboratory examination of cervical smears be undertaken in Ireland under the standards and governance that apply in Irish laboratories.

On behalf of the Academy, Ms Marie Culliton said it understands CervicalCheck is working to this goal. “There is investment in the development of a national screening laboratory but there will be a requirement for investment in posts, education and training for medical scientists to staff this laboratory both in the HPV lab and the cytology lab to have the future capacity.

“We welcome the recent developments at the Coombe Women and Infants University Hospital, who will be providing HPV testing to the cervical screening programme. Indeed, we congratulate the Cytopathology Department on their success in obtaining accreditation to the ISO 15189 standard for liquid-based cytology HPV testing.”

Ms Culliton said the Covid-19 pandemic has highlighted the requirement to have an expert and responsive clinical diagnostic laboratory service. “We need to invest in our medical scientists and have consultant-level medical scientists leading the service alongside the clinical consultants.”