HOW MANY MORE WOMEN WERE MISDIAGNOSED?
As young mum sentenced to death by smear test blunder gets €2.5m, claims that up to 15 more were misread too... (but the HSE doesn’t know!)
A DOZEN or more Irish women may have had cancers missed by the US firm which made the smear test blunder that has sentenced a young mother to death. Professor John Shepherd, who gave evidence in the case of Irish cervical cancer victim Vicky Phelan, said a ‘significant number’ of cervical smear tests at an American laboratory were wrongly recorded.
Up to 15 women were affected, according to an RTÉ News report – although the HSE said it didn’t know how many misdiagnoses had occurred at the lab in Austin, Texas.
But Mrs Phelan, who has been told she has less than a year to live, said Irish women can ‘no longer trust’ the CervicalCheck
programme after she settled her case with the Texas laboratory for €2.5million yesterday.
The High Court heard that the 43-year-old mother of two from Co. Limerick was given the all-clear after a CervicalCheck smear test was carried out by her local GP in May 2011. The sample had been sent by the HSE to Texas for analysis.
It wasn’t until another smear test was done in June 2014 that she learnt she was showing signs of cancer.
She underwent radical chemoradiotherapy, but was told last November that her cancer had spread to her lymph nodes.
In January this year she learnt that it was now terminal.
Her counsel, Jeremy Maher SC, explained that if the pre-cancerous cells had been correctly spotted in 2011, she would have had less than 1% of a chance of developing an invasive cancer.
To compound the error, although CervicalCheck retested her 2011 sample in 2014 and identified a mistake, she was not told about this until September 2017.
And it has emerged that cancer tests for thousands of Irish women have been evaluated at the lab using a less stringent American system, rather than the better Irish system.
Professor Shepherd said Irish women should have been tested using Irish quality control standards, even when smears are sent to the US. He suggested in court that at least ten results at the lab may have been wrong.
‘Exactly how many came to light in this particular case I can’t say but it is quite apparent that there were a significant number of smears that were misreported,’ he said last night. When asked last night, the HSE could not confirm how many women were affected by the misdaignosis scandal.
Holding back tears outside court, Mrs Phelan denounced what she said was ‘an appalling breach of trust’ and said that Irish women ‘can no longer put their trust in the Cervical Check programme’.
Mrs Phelan said that at least ten other women have been misdiagnosed. ‘Mistakes can and do happen. But the conduct of the HSE and CervicalCheck in my case, and in the case of at least ten other women we know about, is unforgivable,’ she said.
Her solicitor, Cian O’Carroll, said that using a US standard for testing Irish women has been shown to be totally unacceptable.
‘John Shepherd, who is a world expert on gynaecological cancers, was critical of the practice of sending smears to the US to be tested by their standards. It is possible of course to send smears to a foreign laboratory and require that they be tested by Irish or Royal College of Obstetrics and gynaecology standards,’ he told RTÉ Radio.
‘But that isn’t the case. They appear to be tested according to the US standard and it’s the US standard that was so strongly criticised in this case.’
Speaking last night, Professor Shepherd, said that there were other women whose smear tests had been wrongly recorded and said there was a pattern of events at the Texas lab that need to be addressed.
‘It doesn’t imply negligence to misread a test but if there’s a pattern of events that occur then the laboratory concerned has to look at its own mechanism for testing,’ he told RTÉ News.
In his evidence to the court, Professor Shepherd said that Irish women should have been tested under the higher Irish quality control standard, even if the testing is conducted in the US.
The Irish quality control and testing system for cervical cancer was created in 2010, after a lengthy consultation between leading cancer and gynaecology experts in the UK and Ireland.
The US system differ significantly from Ireland in a number of key areas, including identification and recording of screening population; recording the screening history of women; registration of smear takers; best practice for communicating with women; quality assurance monitoring and programme reporting and evaluation.
Professor Shepherd said last night that Mrs Phelan should have been told as soon as the HSE learned that that had been a mistake in Austin, Texas.
‘The error was discovered three years before she was ultimately told, which of course is unacceptable and when these errors occur its important that the women concerned are informed of that by their treating clinicians,’ he said.
Ms Phelan sobbed loudly outside court after calling for the other women whose tests were blotched to be notified.
She said that she hoped some good would come from her case, even if she soon dies.
‘To know for almost three years that a mistake had been made and that I was misdiagnosed is bad enough, but to keep that information 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, and I truly hope that some good will come of this case, and there will be an investigation into the CervicalCheck programme as a result of this,’ she said.
Mrs Phelan is now pursuing a clinical trial in Buffalo, in the State of New York, which she hopes will cure her cancer. It will cost $240,000 for one round of the treatment, an additional $100,000 per week if she gets sick and around $100,000 for accommodation for six months.
Judge Kevin Cross, who has been hearing the case, said to her: ‘I know from hearing and seeing you... that if anyone can beat this, you can.’
Mrs Phelan, a manager of the Literacy Development Centre at Waterford Institute of Technology and her carpenter husband Jim, from Annacotty, Co. Limerick,
‘We know of at least ten women’
have two children – a 12-year-old daughter, and seven-year-old son – and €700,000 of the settlement has been paid into court for them to have when they reach the age of 18. Mrs Phelan, and her husband, sued Clinical Pathology Laboratories Inc in Austin, Texas, USA, which carried out the analysis for the HSE, and allegedly wrongly gave the all-clear. The lab did not have to admit liability as part of its €2.5million settlement.
The Phelans had also sued the HSE as operators of the National Cervical Cancer Screening Programme, known as CervicalCheck, but yesterday Patrick Hanratty SC, for the HSE, gave his consent to the proceedings against the HSE being struck out, with no order for costs and no admission of liability.
A spokesman for Health Minister Simon Harris last night told the Mail: ‘I acknowledge the severe distress that this issue has caused to the patient involved, and to her family. Cancer screening programmes... aim to detect cancer as early as possible, leading to better treatment options and outcomes for patients.
‘In fact CervicalCheck has detected over 50,000 pre-cancerous changes in women since 2008. I would stress to women the importance of CervicalCheck and the HPV vaccination programme as key measures in reducing their risk of developing cervical cancer.’
Clinical Pathology Laboratories has not yet returned requests for comment.