BALLYDAVID, Ireland — One of America’s largest labs reached a 7.5 million euro ($8.76 million) settlement on Thursday with an Irish woman who says it mistakenly cleared her of cancer years ago. She is just one of more than 200 women in Ireland found to have been misdiagnosed in a screening program that involved two American labs.
Emma Mhic Mhathuna, who just won the big battle, is still fighting for her life.
“I’m 37, learning about the process of dying,” she said. “It’s not fair for children to have to go through that process.”
The single mother of five was diagnosed with cervical cancer in 2016. But she says she would have had a better chance of survival if New Jersey-based Quest Diagnostics hadn’t missed the warning signs on her earlier screening tests.
Over the past decade, Quest, along with Texas-based Clinical Pathology Laboratories (CPL) and an Irish lab, processed smear tests for Ireland’s Health Service. A government audit in 2014 found that the labs mistakenly cleared 209 women in Ireland who were later diagnosed with cervical cancer. Since then, 18 of those women have died. But most of the women affected were never told, until one of them, Vicky Phelan, discovered a page from the audit in her medical file in January.
“‘Jesus,’ I said, ‘Mom, I actually had cancer in 2011,'” Phelan said. “It wasn’t just pre-cancer. It was cancer.”
“That was the day I contacted solicitors and decided I’m going to take this further,” she added.
She was the first to go to court, and in April reached a roughly $3 million settlement with Ireland’s Health Service and CPL.
“My settlement will mostly be spent on buying me time and for paying for clinical trials to keep me alive, and to allow me to spend more time with my children,” Phelan said after the case was settled.
Since Phelan went public with her case, dozens of other women, including Mhic Mhathuna, have sued the two labs. Attorney Cian O’Carroll is representing more than 60 of them, including five who are terminally ill.
“In quite a number of cases we’re looking at, there are multiple errors,” he said.
O’Carroll also believes women in the United States who use the labs should be concerned because “not only did they get the tests wrong, but they got them very, very wrong.”
The controversy has sparked anger across Ireland, where rallies have been held in support of the women affected, and many people have accused their government of withholding information about the audit. The Irish government has set up an inquiry to find out what happened.
“We need to receive full explanation as to why there was such a high level of misdiagnosis,” said Caoimhghín Ó Caoláin, a member of the Irish parliament who warned against outsourcing the tests to the U.S. years ago. “I wish I was 100 percent wrong, but sadly that’s not the case.”
CPL and Quest, which says it serves half of all doctors and hospitals in the U.S., did not respond to requests for an interview. But in a statement, CPL said “no screening program is 100% effective,” adding, “we adhere to the highest clinical standards.”
The College of American Pathologists, which helps inspect and accredit American labs, told CBS News it is now investigating CPL because of the misdiagnoses in Ireland. It said it is not, however, looking at the Quest lab in Teterboro, New Jersey, which processed Mhic Mhathuna’s tests.
The Centers for Medicare and Medicaid Services (CMS) is a federal agency in the Department of Health and Human Services that regulates lab testing on people in the United States. When CBS News asked the agency if it is investigating CPL and Quest over the controversy in Ireland, a spokesperson said, “It’s CMS policy not to speculate on ongoing or forthcoming survey activities.”
The spokesperson added that there is no federally set “error rate” for processing cervical cancer tests in the United States, adding, “each laboratory is free to design and monitor error rates for their own facility.”
Mhic Mhathuna said on Friday that her settlement and an expected letter of apology from Quest will bring her some comfort. But that doesn’t change the fact she is still going to die.
“There’s no cure for me in Ireland,” she said, “so I’m hoping to reach outside Ireland so that someone might be able to help me stay alive.”
A Facebook page has been set up for the women in Ireland who were misdiagnosed.