High Court must reconsider lab’s application for ‘blind review’ of cervical smear slides

Clinical Pathology Laboratories Ltd has made similar applications in several case

A laboratory’s application for orders which would allow it to carry out a “blind review” of a woman’s cervical smear slides must be reconsidered by the High Court, the Court of Appeal (COA)has ruled.

Clinical Pathology Laboratories Ltd (CPL) has made similar applications in a number of other cases by women suing over alleged misreading of their cervical smear slides and the COA findings will impact on the High Court’s treatment of those applications.

In a judgment this week, the COA said Mr Justice Kevin Cross, who manages cervical cancer litigation in the High Court’s personal injuries list, erred in his reasons for refusing CPL’s pre-trial application in the case of a woman suing it, the HSE and other laboratories over alleged misreading of smear slides taken in 2010 and 2013. She was diagnosed with cervical cancer in 2014.

Giving the COA judgment, Mr Justice Seamus Noonan noted CPL said it wanted a “blind review” to eliminate possible “hindsight bias” by its experts when examining the woman’s slide.

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A blind review involves examination of slides from which any markings made by the original cytoscreeners have been removed after those original slides, with any markings, have been digitally imaged and examined by experts for plaintiffs.

‘Controversial’

Mr Justice Noonan said an assertion by her lawyers that blind reviews are of little or no evidential value is “to say the least, controversial”.

There is significant controversy about the value of “blind reviews”, about how such reviews should be conducted, the impact of hindsight bias and related matters, he said.

The Supreme Court had not resolved those issues in its judgment in the case of Ruth Morrissey and nor could they be resolved in a case management application such as this, he said. They must be resolved at trial on the basis of expert evidence adduced.

In this case, the woman’s lawyers opposed removal of markings, arguing that markings by original screeners are the only evidence recorded of what was evidenced on that slide by them. Their removal would amount to irreversible and unwarranted destruction of that physical evidence for a blind review that is in itself “of little or no evidential value”, it was claimed.

CPL argued there could be no actual prejudice to the plaintiff by removing markings as her expert had examined the original slide and where digital imaging of the slide would be undertaken, creating a permanent record of all markings on the slide before their removal.

Counsel for the plaintiff had admitted during argument he could not identify, at this juncture, any specific prejudice to the woman by removing the markings provided those steps were taken.

Erred

Mr Justice Noonan held Mr Justice Cross erred in agreeing with lawyers for the plaintiff that CPL must show “special and exceptional” circumstances before a “blind review” order is granted.

He said the High Court erred in finding that a non-binding protocol for management of patients slides, previously agreed between parties to cervical cancer litigation and lodged in court in early 2019, meant original slide markings could only be removed, on foot of court order, in special and exceptional circumstances.

A blind review order may be granted if an applicant produces appropriate admissible evidence and if the High Court is satisfied, following a balancing exercise, that the order would not prejudice the plaintiff, Mr Justice Noonan held.

Because CPL had not provided satisfactory evidence to warrant a blind review order when it made its application, having only provided an affidavit from a solicitor who advised CPL considered a blind review would be a “good idea”, the appropriate order for the COA to make now is to remit the application to the High Court, he said.

That would provide an opportunity for the High Court to reconsider the matter in light of such further evidence as the parties may wish to adduce, he said.

Mary Carolan

Mary Carolan

Mary Carolan is the Legal Affairs Correspondent of the Irish Times