Ireland Investigates Cervical Cancer Screening Scandal

DUBLIN — The Irish government announced Monday that it was opening an official inquiry and setting up phone help lines and emergency testing after it emerged that a publicly funded smear test program had mistakenly cleared at least 208 women who later received diagnoses of cervical cancer.

The 208 women received false negatives between 2010 and 2014. At least 17 of these women have since died, Irish officials said, although they added that they could not confirm the causes of death.

Prime Minister Leo Varadkar said Monday that he was “very angry” and “saddened” by the case. He said the government would investigate what he described as “appalling communication failures” and examine the testing process.

The government is contacting all affected, including survivors of the 17 deceased women, to inform them of the mistaken tests and of a 2014 review that identified the lapses but did not become public until recently. The government is also considering a plan to automatically compensate those survivors, so their families do not have to go through the courts.

The scandal came to light last week when it emerged from court proceedings that a U.S. company to which some tests had been outsourced, Clinical Pathology Laboratories of Austin, Texas, had reached a settlement worth 2.5 million euros (about $3 million) with Vicky Phelan, 43, a terminally ill woman from County Limerick.

In 2011, Phelan was given a negative result after a smear test taken that year was negative, but a second test done in 2014 revealed a diagnosis of cancer. Her previous negative test was then reviewed, in accordance with standing procedure, and was found to have in fact strongly indicated the presence of cancer.

“If she had been diagnosed in 2011, there would have been a 95 percent chance of a cure,” said her lawyer, Cian O’Carroll. “Instead she is left with what is now an incurable cancer.”

In 2014, a review found that 208 women had received false negative results since 2010, but only 46 of those women were informed.

Phelan only learned of the earlier false result in September. In January, she was told she had only six months to a year to live.

Dr. Grainne Flannelly, clinical director of the government-run CervicalCheck program, which provides free smear tests to women between 25 and 60, resigned over the weekend.

“I am sorry that recent events caused distress and worry to women,” she said in a statement. “I have decided to step aside to allow the program to continue its important work.”

Emails released in the Phelan case showed that the CervicalCheck program had advised some doctors not to tell their patients about the 2014 review, arguing that finding out about the false negatives would not affect their current treatment.

In addition, there was a dispute between the program and the doctors over whose responsibility it was to inform the affected patients.

In all, some 1,400 women developed cervical cancer after previously testing negative in smear tests during the 2010-2014 period. In most of those cases, the earlier tests were found to have been correctly conducted and analyzed — the cancer had developed later — but in the 208 identified cases, reviews of the earlier tests found clear signs of cancer that had been missed. The women in the 208 cases should have been referred for full diagnostic testing.

O’Carroll, the lawyer for Phelan, said that the Health Service Executive, the Irish government body that oversees the screening program, and CPL, which were joint defendants in her case, had pursued a prolonged and aggressive defense, demanding that she prove she had suffered actual loss from the delayed diagnosis, and making her spend three days in court before they settled. He also said that they had also tried to get her to accept a confidentiality agreement as part of the settlement, but that she had refused. The company did not respond to requests for comment.

“This is a very hard thing to do when you are literally dying, and you are being told that the case will take weeks in court and there will be no chance of a settlement,” O’Carroll said. “She said, ‘I don’t care what happens, I’m not going to agree to a confidentiality agreement.’ If she had, none of this would have come out.”

Phelan told Irish radio presenter Ray D’Arcy last week that she hoped to leave much of her settlement to her husband and two children, and use the rest to access experimental treatments that might prolong her remaining time with them.

It was not clear if the Texas company was the only one associated with the 208 mistaken test results, as Irish smear tests have at times been outsourced to a number of companies.

An emergency help line for women who are worried about the reliability of their smear tests went online Saturday morning, and was reported to have received several thousand calls in the first few days.