Doctors treating women who were wrongly given the all-clear from cancer were urged to exercise their "judgment" on whether to tell them about the misdiagnosis, documents before the High Court show.
CervicalCheck, the national cervical screening service, also advised doctors to "simply ensure the result is recorded" if any of the women affected by botched smear tests had died in the meantime, according to the solicitor for one of the women.
It is believed up to 15 women were identified in a 2014 audit of smear tests which were found to be incorrect.
One of them, Vicky Phelan, a mother of two from Co Limerick who is dying of cervical cancer, settled a High Court action for €2.5 million yesterday against a US-based clinical laboratory sub-contracted by CervicalCheck to assess the tests.
The 43-year-old took proceedings after it emerged her 2011 smear test, which showed no abnormalities, was found, in a 2014 audit of smear tests on a number of women, to be incorrect. She was diagnosed with cervical cancer in 2014 but did not learn of the review or audit until 2017.
She told the High Court she was extremely angry she was not told of the 2014 review of her smear test for another three years.
First time
Her solicitor Cian O'Carroll told The Irish Times a circular from CervicalCheck in July 2016 – two years after the audit review was carried out – advised consultants of the women affected on how to deal with them. It was the first time the doctors were notified about the misdiagnoses, according to Mr O'Carroll.
The circular read: “While we would like if you could review the women’s notes to ensure the outcome is added to her medical records, as a general rule of thumb the outcome should be communicated to the woman with a focus on the context of confronting the overall clinical scenario.
“One difficulty with the current batch of patients is that women may not have been aware of the clinical audit process. Clinicians should use their judgment in individual cases where it is clear that discussion of the outcomes of the review could do more harm than good.
“In cases where a woman has died, simply ensure the result is recorded in the woman’s notes.”
Heavily redacted
Mr O’Carroll said from heavily redacted CervicalCheck documents released to him as part of the High Court case, it appears that up to 14 more women “had been diagnosed with cancer who had previously had clear smears”.
It is not clear what dates the other misdiagnosed smear tests were carried out but “in common with our client they were not told” until much later if at all, he added.
The HSE, which has responsibility for CervicalCheck, refused to confirm or deny the number of women affected, their current conditions or why there was such a delay in informing them. Ms Phelan had also sued the HSE but the case against it was struck out.
Mr O’Carroll said after consultants were informed in 2016 about the audit review outcome, there was a series of correspondence over whose responsibility it was to inform the patients.
“The clinician saying ‘what do you mean you want me to tell this patient about the mistake, you tell her’. And, it goes over and back a few times,” he said.
Ms Phelan has never been told why there was such a delay in telling her. “I think it is reasonable to draw your own conclusion as to why CervicalCheck wanted to keep this quiet,” Mr O’Carroll said. “It wasn’t for the benefit of the patient.”
The solicitor added: “These are life changing errors. The error they decided not to tell Vicky Phelan about is the error that is killing her.
“And, if she had died, I think we can safely say they would not have told her family.”
‘Unforgiveable’
A HSE spokeswoman said since 2010, CervicalCheck reviews the screening history of every woman with a diagnosis of cervical cancer who has been previously screened.
“Currently, the reviews are carried out as cancer diagnoses are notified, and results are sent to the woman’s treating clinician to review, as soon as they are completed,” she said.
“The results of all historical reviews completed since the establishment of the programme have now been communicated in this way to the clients’ treating hospital doctor.”
The spokeswoman stressed regular cervical screening is one of the best ways to detect pre-cancerous changes early, although it is not always effective.
Speaking to reporters outside court , Ms Phelan called for an investigation into the CervicalCheck screening programme. She said while mistakes can and do happen the conduct of CervicalCheck and the HSE “in my case and the case of at least 10 other women we know about is unforgiveable” as she said they knew for three years she had been misdiagnosed and did not tell her.
“To know for almost three years a mistake had been made and I was misdiagnosed was bad enough but to keep that from me until I became terminally ill and to drag me through the courts to fight for my right to the truth is an appalling breach of trust,” she said. “I truly hope some good will come of this case and there will be an investigation in the CervicalCheck programme as a result of this.”