The Court of Appeal has set aside a High Court refusal to let Clinical Pathology Laboratories Incorporated (CPL) remove markings from CervicalCheck slides for a proposed blind review, and sent the applications back for reconsideration on further evidence.
In a judgment delivered on 11 May 2021, Mr Justice Noonan said the High Court was wrong to require “special or exceptional circumstances” before allowing removal under the case management protocol. But the Court of Appeal also rejected CPL’s position that removal should be allowed on request unless a plaintiff showed prejudice. The default under the protocol is that markings remain unless the court permits their removal.
The six appeals concerned proceedings brought by women, and in one case two plaintiffs, arising from the State’s CervicalCheck screening programme. The lead appeal was brought in the case of Vivienne Wallace, who had smear tests in 2010 and 2013 reported as normal and was diagnosed with cervical cancer in 2014. She alleges the defendants negligently failed to identify abnormalities. Those allegations were not determined in this appeal.
The slides carry markings made during original screening, and may also carry marks added during a later Cancer Audit Review or review by the Royal College of Obstetricians and Gynaecologists. The protocol allows Cancer Audit Review markings to be removed under specified conditions, but requires court approval to remove other markings. CPL sought permission to remove all markings on Ms Wallace’s slides to reproduce the conditions of the original screening and limit hindsight bias.
CPL relied on an affidavit from its solicitor, who said the company believed removal would help present expert evidence and that imaging would preserve a record. Ms Wallace’s solicitor objected that original screeners’ markings were the only recorded evidence of what they observed. At the appeal hearing, her counsel said he could not then identify specific prejudice if the proposed imaging steps were taken.
The Court of Appeal said an applicant must provide appropriate, admissible evidence explaining why the default should be changed. Expert evidence must set out the proposed steps and explain how the defence could suffer a real risk of prejudice without them. The court must also consider countervailing circumstances, including actual or anticipated prejudice to the plaintiff. The appeal court said the merits of different forms of blind review and the controversy over hindsight bias are matters for trial, not this interlocutory application.
The court found the solicitor’s affidavit was not a sufficient evidential basis for CPL’s request. It set aside the High Court order and remitted the applications for reconsideration, with further directions on affidavits left to the High Court. No order granting permission to remove the markings was made. The Court of Appeal gave a provisional view that Ms Wallace should receive the costs of the appeal and High Court application; CPL had 14 days to seek a supplemental hearing on costs.