A 38-year-old woman with incurable cancer has received an apology in court from the HSE over the "failings" that occurred in two smear tests which "led to" her diagnosis.
The apology was read out in the High Court as Leona Macken and her husband Alan settled their legal action against the HSE, arising from what they said were failures in the CervicalCheck screening programme in 2016 and 2020.
The High Court heard how Ms Macken, a mother of two young daughters, now has incurable metastatic cancer.
The court heard how the hair stylist from Dublin was diagnosed with stage three cervical cancer in June 2023 and underwent radical surgery followed by postoperative chemoradiotherapy.
Despite intensive treatment, recurrence of her cancer was diagnosed in March 2025 and has advanced to stage four.
Medical expert evidence that was given as part of Ms Macken's case indicated that her 2016 and 2020 smear tests by Quest Diagnostics should not have been reported as negative and concluded that the delay in identifying pre-cancerous abnormalities directly resulted in her developing cervical cancer.
A letter was read to the court from Fiona Murphy, Chief Executive of the National Screening Service, who stated that on behalf of the HSE and the National Screening Service, she wished to apologise to Ms Macken, her husband Alan, her children and extended family.
"I wish to express our deep regret to you and your family and acknowledge the many challenges that you have faced as a result of your diagnosis."
An undisclosed settlement was made for damages.
The "courage" of Ms Macken was commended in what was described in court as a "truly tragic case".
Mr Justice Paul Coffey said he was pleased that the case was concluded in "a timely way".
Speaking outside the court afterwards, Ms Macken welcomed the apology made "after two misdiagnosed smears".
"I've been fighting this since 2023. I knew that things didn't add up," she said as she sought information on her smear tests following her cancer diagnosis two years ago.
"We are told to trust the process. Something is not working in the system," she said. "Something needs to be fixed. It's not good enough."
She also highlighted the toll this has had on her family saying she does not know what her daughters' future is going to look like because of this.
Errors were 'negligent and unacceptable', says solicitor
Her solicitor Cian O'Carroll said Ms Macken's case is tragic but could have been avoided as he outlined the "negligent errors".
He said while there will always be errors of a certain type in the National Screening Programme, in Leona's case, they were "negligent and unacceptable".
Speaking on RTÉ's Six One News, Mr O'Carroll said it is a "complete falsehood" that there has been an improvements in the way women are told about mistakes in their smear tests.
He said: "The point she was making today was that, standing outside the High Court in Ireland seven years on from when Vicky Phelan stood in the exact same spot, effectively nothing had changed.
"She was still complaining of similar errors, but ones that have now occurred two years after Vicky.
"Also like Vicky, she was not told of any failures in her screening."
Mr O'Carroll said it was "a very big burden" for Ms Macken to pursue the case.
"To take it on when you have been told that your cancer is now spread beyond the point where it is untreatable and that the time you have left is limited - that is an enormously difficult thing for a person to do," he said.
However, he said Ms Macken felt her diagnosis "didn't fit" with receiving two normal results in 2016 and 2020.
Mr O'Carroll said: "In the absence of any audit in this country now, which was shut down in the wake of Vicky Phelan's remarkable case and the scandal that she uncovered in 2018.
"She had no choice but to go to solicitors and seek to have her screening investigated."
He added Ms Macken "would never have found out that her smears were negligently misread and that she was effectively losing her life due to that negligence, if she had not made her own inquiries".
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