The President of the Royal College of Surgeons said a judge’s ruling in a case concerning the cervical check scandal could throw the future of the Irish cancer screening programmes into doubt.
It comes after Mr Justice Kevin Cross awarded €2.1 million in damages to Ruth Morrissey and her husband Paul over consecutive misreading of smear tests under the CevicalCheck programme in 2009 and 2012.
In making his award, Mr Justice Cross said a standard of ‘absolute confidence’ should be enshrined in the screening programmes so that the possibility of delivering false negative results could be eliminated.
“A slide should not be classified as negative unless the screeners had absolute confidence that it was so,” he said.
RCSI President Kenneth Mealy responded: “Cancer screening plays a very important role in protecting people’s health, reducing incidences of cancer and detecting cancer early. Many hundreds of patients with breast, cervical and colorectal cancers have had better outcomes in Ireland because of our national cancer screening programmes.
“It is, however, important to recognise that all cancer-screening services have limitations that lead to false positive and false negative results. False positive results can lead to patients being ‘over-treated’ for benign and pre-cancerous lesions or small cancers that might never lead to clinical harm.
“False negative results refer to missed cancers which result in delayed diagnoses and have clinical consequences for patients. Each screening programme must strike a balance between both scenarios so that, on balance, cancer outcomes are improved.
“We are concerned that the standard of ‘Absolute Confidence’ mentioned in the judgment by Mr Justice Cross will be impossible to attain and may have multiple unintended consequences including additional unnecessary tests and procedures on patients who do not have cancer.
“All screening tests are associated with a small number of false-negative results and the Irish screening programmes are no exception. Despite operating to the highest possible standards, cancer screening programmes expect a certain number of such cases each year. There are published international rates for anticipated interval cancers and Irish screening programme performing in line with international best standards will have a similar false negative screening rate.
“We are concerned that if false negative screening tests are regarded as a breach of care, this position will potentially threaten the viability of the Irish cancer screening programmes altogether, to the great detriment of the Irish public.”
Mr Mealy added: “This will also impact on the more vulnerable members of society who often present later for care with these conditions and those who cannot afford to pay for private screening.
“The implication of this judgment will have a grievous impact on our ability to detect cancer and will result in poorer outcomes for many patients.
“We urge the Government to respond to the Cross judgment in a manner that allows cancer screening to continue saving lives. We also urge all of our partners in healthcare to work together to restore and enhance public confidence in cancer screening.”
There are currently three cancer screening programmes run under the HSE’s watch – for breast, cervical and bowel cancers – as well as retina screening for people with diabetes who may develop issues with their eyesight.
Limerick woman Ruth Morrissey (37) attended routine screenings under the CervicalCheck screening programme in 2009 and 2012.
Her smear tests were then sent to two US laboratories and later received a letter informing her that there were no abnormalities found in her readings.
In 2014, after developing symptoms, she was told she had developed cervical cancer, and an audit of the lab’s readings found more than 221 women, including Morrissey, had received false negatives following their tests.
It sparked controversy and concern among women who expressed their lack of confidence in the screening programme at the time.
Campaigners Vicky Phelan and Emma Mhic Mhatúna were among the women affected who took court cases, but settled their actions for an agreed amount with the HSE and the labs involved.
Morrissey’s case was the first case in which the complainant did not settle and heard a ruling from the judge.
The judge said the Limerick woman “would have been spared the pain and distress of what followed” had she not received a false negative.