HSE v O'Sullivan

• Jurisdiction: Ireland
• Judge: Mr. Justice O'Donnell,Mr. Justice Woulfe,Ms. Justice Elizabeth Dunne
• Judgment Date: 10 May 2023
• Neutral Citation: [2023] IESC 11
• Docket Number: S:AP:IE:2022:000057
• Court: Supreme Court

Between/

Ray O'Sullivan

Applicant/Respondent

and

The Health Service Executive

Respondent/Appellant

[2023] IESC 11

O'Donnell C.J.

Dunne J.

Charleton J.

Baker J.

Woulfe J.

S:AP:IE:2022:000057

AN CHÚIRT UACHTARACH

THE SUPREME COURT

Health care – Healthcare professional – Allegation of misconduct – Investigation and disciplinary process – Appeal against grant of mandamus

Facts: The respondent had been accused of misconduct in his role as a healthcare professional, following allegations of insertions of catheters in the vaginas of certain patients without consent. An investigation was launched, and disciplinary proceedings resulted in a proposal that the respondent would be removed from his employment. The High Court had dismissed the respondent’s application for leave to seek judicial review, but the Court of Appeal had overturned that dismissal on certain grounds. Leave to appeal was granted by the Supreme Court in [2022] IESCDET 79.

Held by the Court, that the appeal would be allowed. Dunne J. was satisfied that the decisions to suspend the respondent and ultimately terminate his employment were lawful, Braganza v BP Shipping Limited [2015] UKSC 17; [2015] 1 WLR 1661 applied. O’Donnell C.J. and Woulfe J. also handed down judgments in the matter.

Judgment of Mr. Justice O'Donnell, Chief Justice delivered on 10 May, 2023.

Introduction

1 . I fully agree with the comprehensive and careful judgment of Dunne J. in this matter. In circumstances where these proceedings have already generated a comprehensive judgment in the High Court ( [2015] IEHC 282, Unreported, High Court, Barr J., 27 April, 2021), a very thorough judgment in the Court of Appeal ( [2022] IECA 74, Unreported, Court of Appeal, Noonan, Faherty and Murray JJ., 25 March, 2022), and two detailed judgments in this Court, I am reluctant to add anything further to the analysis. However, while there is no substantial dispute as to the facts concerned, and an agreement as to the applicable legal test, there remains sharp disagreement between the judgments in this case. This seems to indicate a wider problem regarding litigation in respect of disciplinary proceedings, particularly those involving professional people or those occupying senior positions. Certainly, the time it has taken to resolve the question of whether a suspension on full pay effective from 6 August, 2019 in respect of incidents which occurred on 4 and 5 September, 2018, does not suggest a process that is clear, efficient, or satisfactory from the point of view of anyone involved. It is perhaps appropriate therefore, to offer some further reflections on the legal issues which can arise and have been particularly exemplified in this case.

The Facts

The Feasibility Study

2 . The facts of this case have been set out in the judgment of Dunne J. and with some further additions, and observations in the judgment of Woulfe J. It is not necessary, therefore, to rehearse them in detail. I am also conscious of the fact that the parties had resolved their differences prior to the hearing of this appeal, and that this appeal was allowed to proceed to address issues of more general importance, particularly to the respondent to the proceedings, the HSE (“the respondent”). Professor O'Sullivan (“the applicant”) is in the rather invidious position that his conduct, which I imagine, indeed hope, he by now no doubt sincerely regrets, has become a focus of intense scrutiny and in what has become something of a test case, and he would no doubt wish to be able to get on my his life without the notoriety of being the subject of a leading case on suspension for misconduct. In fairness to all concerned, I will attempt to refrain from characterising this case in any more emotive or inflammatory language than is necessary for the identification and resolution of the net legal issues.

3 . For present purposes it is, I think, sufficient to set out the following account of the facts, which do not now appear to be in dispute. On 4 and 5 September, 2018, gynaecological procedures were carried out on five women in St Luke's Hospital in Co. Kilkenny under the supervision of the applicant. The patients were under the care of the applicant, who was a Consultant Obstetrician Gynaecologist and were scheduled to undergo a hysteroscopy procedure, which involves the insertion of a small light guided camera attached to a small tube into the vagina to permit examination of the internal wall of the vagina. In the course of carrying out the respective procedures, what was termed as a ‘feasibility study’ was carried out on the direction of the applicant by his Registrar and Senior House Officer, which involved the placing of a balloon catheter and a pressure pad connected to a tube inside the entrance of the five patients' vaginas. This was ostensibly for the purpose of commissioning a further study, which the applicant claimed would lead to the development of more effective equipment for conducting gynaecological examinations.

4 . A number of features of the study bear mentioning. Informed consent had not been sought from the respective patients for the study to be performed. The equipment used in the study were not purchased by the hospital but privately by the applicant himself. Hospital management and the wider healthcare team in the hospital was not aware of the study, nor was ethical approval sought by the applicant to carry it out. Furthermore, no record of the study was entered in the patient notes but rather data appears to have been collected on a mobile phone and subsequently deleted.

The Doran/Brennan Report, the SAR report and correspondence concerning the study

5 . As a result of concerns expressed by members of the nursing staff, who had witnessed the procedure but similarly had not been informed of the study, the matter was brought to the attention of the general manager of the hospital, Ms. Anne Slattery, who directed that the clinical research cease immediately. The matter was also brought to the attention of Professor Mary Day, the then Chief Executive Officer of Ireland East Hospital Group, who immediately commissioned a report from Professor Peter Doran, the Director of UCD Clinical Research and Ms. Sinead Brennan, a Group Director of Quality and Patient Safety (“the Doran/Brennan report”). Professor O'Sullivan was notified of this by letter of 27 September, 2018 and interviewed for the purposes of the Doran/Brennan report. It is clear that the focus of the report was the research study. The key questions identified in the letter of 27 September, 2018, sent to Professor O'Sullivan and which was signed by Professor Day and Kevin O'Malley, Clinical Director of the Ireland East Hospital Group, were as follows:-

The source of the letter and its contents illustrate both the seriousness with which the matter was being addressed and the lack of information then available about the detail of the procedure.

• (i) “Is there a written protocol for the study?

• (ii) Have you received ethical approval?

• (iii) Have any measurements/results been recorded and if so who has been given the results?

• (iv) Are there external parties involved?”

6 . The Doran/Brennan report was delivered dated 1 October, 2018. It concluded, inter alia, that the trials had not been conducted in accordance with the ethical principles having their origin in the Declaration of Helsinki of 1948. The conclusion was stated as follows:-

“… The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, primarily addressed to doctors but intended for wider adoption by all research team members. The declaration acknowledges that medical research is important to generate new knowledge, but also states this goal can never take precedence over the rights and interests of individual research subjects.

The declaration sets out a number of principles aimed at providing guidance to research activity. It is our conclusion that this study has not met a number of these principles including, but not limited to[:]

Principle 22. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

Principle 23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins.

Principle 25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.

Principle 26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspect of the study.

Principle 35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

This study was not done in line with requirements. Ethical approval was not obtained, nor an exemption granted. Patient consent was not obtained. The classification of the study as a pilot or a feasibility is of no consequence. As the study involved additional procedures patient consent should have been obtained, to provide the five ladies in question, and the 20 planned with the opportunity to autonomously decide on their participation. By not seeking consent the patient's wishes were not considered”.

These conclusions have not been challenged. They were undoubtedly serious and necessarily reflected upon the applicant as the person responsible for the study and, therefore, for the breaches identified.

7 . At the same time, Ms Slattery...