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Vicky Phelan Vicky Phelan via GoFundMe

US laboratory wanted confidentiality clause in Vicky Phelan case

A UK expert will lead the inquiry into the CervicalCheck controversy.

Updated at 5.45pm

THE US LABORATORY at the centre of the cervical cancer screening controversy in Ireland sought a confidentiality clause in the legal challenge brought forward by Vicky Phelan.

The CervicalCheck scandal came into the public eye last month when Phelan, whose cervical cancer is now terminal, settled a High Court action against the HSE and
Clinical Pathology Laboratories (CPL) for €2.5 million over incorrect smear test results from 2011.

Ciaran Breen, Director of the State Claims Agency (SCA), spoke to the Oireachtas Finance Committee about the case today.

Breen described the situation as “tragic”, noting it “has had dreadful consequences for Ms Phelan and her family”.

“I want to assure the committee that, at every stage of our involvement in this case, we have been acutely aware of the consequences, trauma and pain Ms Phelan and her family have suffered, and continue to suffer.

“In carrying out our statutory role in managing this case, we have been mindful of the need to ensure that, wherever possible, nothing we did would add to the suffering of Ms Phelan and her family.

“In managing personal injury litigation taken by persons against the State, we never forget that our work frequently involves the management of difficult, complex and traumatic cases taken by persons who have suffered injury, sometimes of a catastrophic nature.”

Breen noted that the SCA had a role in Phelan’s case because one of the parties she took a case against was the HSE, which is one of the agency’s clients. The case was also taken against the US laboratory that carried out her smear test, CPL.

“We managed the case on behalf of the HSE but the US laboratory had separate legal representation and a separate legal strategy,” Breen stated.

“The primary legal issue in the case centred on the alleged misreading of Ms Phelan’s original smear test. The US laboratory accepted that legal liability for this issue rested with it alone and that the HSE was not legally responsible for the misreading.

As part of the US laboratory’s defence of this issue, its lawyers sought a confidentiality clause that would have restricted Ms Phelan from disclosing details of the settlement of the case.

Breen added that the SCA opposed the use of a confidentiality clause in the case.

“Our view is that the US laboratory’s insistence on a confidentiality clause was a significant factor in the failure of the attempt to resolve the claim through mediation.

“Mediation is our preferred route for resolving cases of this nature as it would have eliminated the need for court hearings or a contested court action,” Breen stated, noting that 98% of all cases managed by the SCA are resolved without the need for a contested court hearing.


Meanwhile, the Cabinet has been discussing the terms of reference of the scoping inquiry into the CervicalCheck scandal.

Health Minister Simon Harris also informed the Cabinet of his intention to appoint a new HSE board and introduce legislation to allow this.

RTÉ News is reporting that ministers Finian McGrath, Michael Ring and Katherine Zappone told their Cabinet colleagues that Tony O’Brien, Director General of the HSE, should step down amid the growing controversy.

The scoping inquiry will commence this week and engage directly with Phelan and any other woman affected who may wish to have an input.

Speaking today, Harris said the investigation will be led by Dr Gabriel Scally, an expert from the UK. Dr Scally has had a distinguished career as a senior public health doctor and advisor with the UK Department of Health, as well as the NHS, and is currently the President of Epidemiology and Public Health section of the Royal Society of Medicine.

Dr Scally has also asked an international expert in women’s health, Dr Karin Denton, Consultant in Cellular Pathology North Bristol NHS Trust, to provide assistance in undertaking this review.

“We’ll be appointing a UK-based medical expert and gynaecologist to come to Ireland to try and ascertain answers to these very important questions,” Harris told reporters.

He said that Phelan would be informed of the progress of the inquiry.

Dr Scally arrived in Ireland today and will immediately begin his work. He will report back by the end of next month, setting out his findings, according to the Department of Health.


Over the past two weeks, more information has continued to emerge about the controversy whereby women were told that they had normal smear test results in error. While not a test for cancer, a smear test that results in an abnormal reading can warrant further investigations to test for the presence of cancer.

It has since emerged that more than 1,500 women who developed cervical cancer did not have their cases reviewed by CervicalCheck.

The scoping inquiry due to be discussed by ministers today will independently establish the facts surrounding the controversy, including details of the non-disclosure to patients relating to CervicalCheck clinical audits and the management and level of knowledge of various parties including, the HSE and the Department of Health.

It will also examine the tendering, contracting, and operation of the labs contracted by CervicalCheck. Over the last week, it has emerged that three labs carry out smear test reviews – two are in the US, while the third is in Ireland.

Separately, there will be an international expert panel review led by the Royal College of Obstetricians and Gynaecologists, and the British Society for Colposcopy and Cervical Pathology. This will review the results of screening tests of all women who have developed cervical cancer who participated in the screening programme since it was established.

The Department of Health said this will provide independent clinical assurance to women about the timing of their diagnosis and any issues to their treatment and outcome.

As noted about, it’s intended that the inquiry will report to Harris in June.

The minister also brought his plans on mandatory open disclosure to Cabinet today. It is understood it is Harris’ intention to prioritise this, with a view to having it passed through the Oireachtas as quickly as possible. Harris believes this is the most practical legislative response to recent events.

The HSE’s CervicalCheck freephone helpline (open from 9am to 6pm every day) can be contacted on 1800 45 45 55 (from Ireland) or +353 21 4217612 (outside Ireland). More information can be read here.

With reporting by Christina Finn  

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