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US diagnostics company involved in CervicalCheck scandal posts record profits despite ongoing litigations

US diagnostics company involved in CervicalCheck scandal posts record profits despite ongoing litigations

High Court records show four cases have been filed so far this year by women in actions against the HSE and Quest Diagnostics. Dozens of lawsuits against the labs involved, and the HSE, have been initiated since 2018.

But the money the US firm set aside to help cover claims is dwarfed by the profits it has been making – $649m in the first nine months of this year alone.

More than 200 women in Ireland, including the late Vicky Phelan, were diagnosed with cervical cancer after being initially told their smear tests were clear. More than 20 have died.

Abnormalities on the tests were missed by labs in the US that the HSE had hired to analyse samples for the national CervicalCheck programme, which was set up in 2008.

Quest Diagnostics handled about 45pc of the 3.1 million tests provided by women in the programme. Of the 221 affected women, 162 had either not been told or were incorrectly informed about the results of a later clinical audit of their tests that had revealed cancerous cells.

In Ms Phelan’s case, the outcome of a 2016 audit was sent to her consultant. By that time, she had already been treated for cervical cancer, having been diagnosed in 2014, and was cancer-free.

She was told by her consultant in 2017 that CervicalCheck had been in touch and had carried out an audit of her 2011 smear result, which had been reported at the time as normal. However, the audit felt it to be an incorrect result and was, in fact, in keeping with squamous cell carcinoma. She was diagnosed with terminal cancer in 2017.

Ms Phelan sued the HSE and US firm Clinical Pathology Laboratories, securing a €2.5m settlement in 2018. She died in 2022 at the age of 48, leaving behind a legacy that included exposing the scandal and being a driving force for change in screening programmes.

Another woman, Emma Mhic Mhathúna, secured €7.5m in damages the same year in her case against the HSE and Quest Diagnostics. She died later that year, age 37.

In 2018, then director general of the HSE, Tony O’Brien, resigned from his role and the Government launched a scoping inquiry.

Dr Gabriel Scally, a UK health expert who undertook the review, found there were serious shortcomings in governance and expertise and failures across the entire cervical screening programme.

“The problems uncovered are redolent of a whole-system failure,” he said in his report.

“While the US labs behind the scandal have made settlements with some of the women affected, litigation is continuing in many cases.

Releasing quarterly results this week, Quest Diagnostics said it had made a $226m profit in the three months to the end of September and $649m in the first nine months of the year.

Its revenue for the first nine months of 2024 rose to just over $7bn, from $6.7bn in the first nine months of 2023.

“The company is subject to a series of individual claims brought by persons in Ireland related to allegations stemming from pap smear screening services performed by the company,” the company said in its third-quarter results.

“In general, claimants have alleged that the results of certain pap smear screening tests performed by the company and other providers, pursuant to a programme coordinated by the Irish government, were incorrect for individuals who were later diagnosed with cervical cancer.

“The Irish government and an independent scoping inquiry commissioned by the Irish government found that the company’s performance of its screening services for the Irish cervical cancer screening programme were in accordance with both Ireland’s requirements and international standards.”

Quest Diagnostics told its shareholders that it had settled claims made by certain individuals, is a party in multiple lawsuits and may be served as a party in additional lawsuits.

“The company does not believe that the resolution of existing or future claims will have a material adverse effect on its financial position or liquidity, but the ultimate outcomes of these claims are unpredictable and subject to significant uncertainties,” it wrote.

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