Vivienne Wallace v Health Service Executive and Sonic Healthcare (Ireland) Ltd and Medlab Pathology Ltd and Clinical Pathology Laborotories Incorporated
| Jurisdiction | Ireland |
| Judge | Mr. Justice Noonan |
| Judgment Date | 11 May 2021 |
| Neutral Citation | [2021] IECA 141 |
| Date | 11 May 2021 |
| Court | Court of Appeal (Ireland) |
| Docket Number | Record Number: 2021/29 Record Number: 2021/24 High Court Record Number: 2019/4939P Record Number: 2021/25 High Court Record Number: 2018/10201P Record Number: 2021/26 High Court Record Number: 2018/6277P Record Number: 2021/27 High Court Record Number: 2018/9078P Record Number: 2021/28 High Court Record Number: 2018/6513P |
[2021] IECA 141
Noonan J.
Faherty J.
Collins J.
Record Number: 2021/29
High Court Record Number: 2018/6109P
Record Number: 2021/24
High Court Record Number: 2019/4939P
Record Number: 2021/25
High Court Record Number: 2018/10201P
Record Number: 2021/26
High Court Record Number: 2018/6277P
Record Number: 2021/27
High Court Record Number: 2018/9078P
Record Number: 2021/28
High Court Record Number: 2018/6513P
THE COURT OF APPEAL
Negligence – Blind review – Special or exceptional circumstances – Appellant seeking leave to remove all markings from the respondent’s slides for the purpose of carrying out a blind review – Whether the trial judge was in error in holding that there was a requirement for the appellant to establish exceptional or special circumstances in order to obtain the leave of the High Court to remove the markings
Facts: The plaintiff/respondent in the first proceedings, Ms Wallace, was one of a number of plaintiffs who instituted proceedings in the High Court arising out of the operation of the State’s CervicalCheck Screening Programme. She alleged that the defendants were negligent, inter alia, in failing to properly consider and interpret her cervical samples and reporting them as normal when they were in fact abnormal. The fourth defendant/appellant, Clinical Pathology Laboratories Incorporated (CPL), sought leave from Cross J to remove all markings from Ms Wallace’s slides for the purpose of carrying out a “blind review”. Cross J refused the application. This appeal to the Court of Appeal was one of a cohort of six appeals. It was treated as the lead appeal which governs the others. The primary ground of appeal was that the trial judge was in error in holding that there was a requirement for CPL to establish exceptional or special circumstances in order to obtain the leave of the court pursuant to para. 4 of “Final Protocol 25 January 2019” (the Protocol) to remove the markings on the slide.
Held by Noonan J that the trial judge was in error in requiring CPL to demonstrate special or exceptional circumstances. Noonan J held that the trial judge was also in error in suggesting that it was not necessary to remove the markings to conduct a blind review. Noonan J held that there may be forms of blind review that can be undertaken without removing the markings but the removal of the markings is an absolute pre-requisite for the form of blind review that CPL wished to have carried out. Noonan J held that even though the judge was wrong to dismiss the application on the basis that he did, Noonan J agreed with the argument advanced for the plaintiff that there was no sufficient evidence before the trial judge that should have entitled CPL to the order sought.
Noonan J held that the appropriate course was for the Court of Appeal to set aside the order of the High Court and remit the applications to that court to be reconsidered in the light of such further evidence as the parties may wish to adduce. Noonan J’s provisional view was that Ms Wallace should be entitled to the costs of the appeal and of the application in the High Court.
Applications remitted to High Court.
JUDGMENT of Mr. Justice Noonan delivered on the 11th day of May, 2021
. The plaintiff in the first named proceedings above, Ms. Wallace, is one of a number of plaintiffs who have brought proceedings arising out of the operation of the State's CervicalCheck Screening Programme. Ms. Wallace underwent a smear test on the 14th September, 2010 and again on the 17th July, 2013. Both tests were reported as normal. In October, 2014, Ms. Wallace was diagnosed as having cervical cancer. In these proceedings, she alleges that the defendants were negligent, inter alia, in failing to properly consider and interpret her cervical samples and reporting them as normal when they were in fact abnormal.
. When a cervical sample is taken for screening purposes, it is ultimately placed on a pathology slide which is examined by expert technicians known as cytoscreeners or cytologists. The National Screening Programme was operated by the first defendant via cytoscreening services provided at laboratories operated by the second, third and fourth defendants. The cervical sample, when received by the laboratory, is prepared for analysis by being placed in a pathology slide which covers the biological material with a glass covering. The slide is examined under a microscope at different resolutions and any abnormalities are noted by the screener marking the slide by highlighting the areas of abnormality with different types of markings. In 2010, the National Screening Programme required screening by two cytoscreeners, in turn. Further to their respective analyses, the slide may or may not be marked by one or both of them. In Ms. Wallace's case, for example, the screening carried out is evidenced by the presence on the slide of one red and one blue marking referable to the original screening.
. In cases where there was a subsequent diagnosis of cervical cancer, the slides of the women concerned were reviewed in a Cancer Audit Review (CAR). During the course of this review, further markings were applied to the slides highlighting other areas of concern identified by the reviewers in the CAR. In the Wallace case, for example, the CAR is evidenced by the presence of eleven black circles and one half circle on the slide. Consequently, many of the slides show two sets of markings, those applied by the original cytoscreeners and those applied in the course of the CAR. In many cases, there is a third set of markings applied in the course of a later review conducted by the Royal College of Obstetricians and Gynaecologists.
. A significant number of women, including the plaintiffs in these six appeals, have instituted proceedings in the High Court arising out of their participation in the CervicalCheck Programme in circumstances similar to Ms. Wallace. This litigation has been managed by the judge with responsibility for the management of the High Court Personal Injuries List, Cross J., who was also the trial judge in the leading case Morrissey v HSE [2019] IEHC 268, [2020] IESC 6.
. During the course of managing this litigation, an issue arose concerning the manner in which patient slides were to be dealt with.
. The slides reside in the laboratories where they were originally analysed for the screening programme. Each plaintiff's original slides require to be reviewed and analysed by experts advising that plaintiff, giving rise to the necessity for a procedure to be in place which provides for the transfer to and return from those experts of the relevant slides. A debate ensued between the parties as to how this objective could best be achieved and Cross J. heard argument and submissions for the purpose of devising a protocol that would apply to all cases. The final product of that process of engagement is designated “Final Protocol 25 January 2019” (“the Protocol”). This document was approved by Cross J. and directed to be lodged in court.
. The Protocol provides for the manner in which slides are to be made available to plaintiffs and after examination returned to the relevant laboratory. The Protocol also provides for digital imaging of the slides before release. The focus of the applications the subject of these appeals is Clause 4 of the Protocol which provides as follows:-
“4. Any existing markings, save for the cancer audit markings, are not to be removed or any new markings applied to the slide(s) without the prior approval of the court. Unless otherwise agreed between the parties in writing, the removal of the cancer audit markings can only occur following the review of the slide by the expert engaged by the requesting patient or legal representative of the patient or deceased patient and on the basis that, any removal of cancer audit markings will only be undertaken by the relevant laboratory contracted to the HSE/NSS. It is acknowledged by the HSE/NSS that if a patient or their representative requests the removal of such markings, the HSE/NSS will procure their removal by the contracted lab as soon as practicable. Prior to the removal of any such markings, the laboratory in question will be required to image the slide(s) in accordance with paragraph 8 below.”
. As appears from the foregoing, the cancer audit markings on any given slide may be removed without a court order subject to the terms of clause 4. However, any other markings, such as the markings...
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