The outline deal reached between the Health Service Executive (HSE) and the two main laboratories carrying out testing for CervicalCheck has removed any existential threat to the programme, but it also raises a fresh set of questions.
By agreeing to take on much of the risk attached to the processing of cervical smears, in terms of possible misreadings, the HSE has ensured the continuation of a programme that has helped cut the risk of women getting cervical cancer by more than 30 per cent since it was set up a decade ago.
Yet it has also landed the exchequer with an as-yet unquantified bill for the increased cost of testing since the controversy began. Liability is not being accepted for historical cases but, in future, the HSE will bear more of the burden of litigating claims made by women alleging adverse health impacts as a result of misread smear tests.
The HSE itself still does not seem to know how many women were covered by a retrospective audit which revised earlier false negative results. And it certainly cannot know what the attitude of the High Court will be to further CervicalCheck cases.
The deal between the HSE and the two labs, Quest Diagnostics and MedLab Pathology, will see the State effectively insourcing some of the work of examining smear tests and taking on more of the costs of litigation.
The agreement with MedLab, which is subject to due diligence, will see about 15 staff being offered positions in the Irish public service. Once the State takes over this operation, it will be responsible for dealing with any claims arising.
Quest will continue providing testing services but at a higher price than heretofore. The company is currently paid about €23 per slide it processes, and this is expected to almost double under the new arrangements.
Overall, the cost of examining smear tests is likely to increase by €4 million a year.
Litigation costs
As for the cost of litigation, we know that Vicky Phelan’s case against another US lab was settled for €2.5 million, but without admission of liability. In June, the late Emma Mhic Mhathúna was awarded €7.5 million against Quest and the HSE; the lab admitted liability for misreading her slides while the HSE’s admission of liability related to its failure to disclose the findings of an audit.
A number of other cases have come to the High Court in which the women have not been identified.
For every 1,000 women screened, the test will identify 15 women with pre-cancerous changes and it will miss another five. However, not all of these abnormalities will be capable of being detected.
A key issue in any future case before the courts will be whether there was negligence in the reading of slides. While large numbers of cases are said to be in preparation, it remains to be seen how many will make it to the High Court, given the complexities of reading smears and the resulting burden of proof.
In a separate controversy about symphysiotomy a number of years ago, a predicted avalanche of cases never materialised after a test case went awry. In the event, hundreds of affected women opted for the redress scheme set up by the Government.
