The CervicalCheck Scandal - A Legal Analysis

Introduction

Assistant secretary at the Department of Health, Donal Devitt, said at the Hepatitis C Tribunal in 1997 that when he was first told of the infection of several Irish women by contaminated blood, instinct told him ‘that this was going to be the biggest medical disaster in the history of the state’.¹ This title, however, has been challenged by the recent CervicalCheck scandal.

A retrospective audit of cervical cancer screenings showed that 221 women’s smear test readings missed abnormalities, leading to the development of cervical cancer. The results of the audit were not disclosed to 162 of these women, 20 of whom have since died.²

Following this revelation, a number of women and their families began litigation, and an investigation was issued by the Department of Health. In this article I will discuss the findings of the Scally Report and the Phelan v HSE case to analyse the legal responsibilities and failures of those involved in the CervicalCheck scandal.

Cervical Cancer Screening

Cervical cancer is an abnormality in the cells at the neck of the womb caused by the Human papilloma-virus (HPV). This can usually be detected by taking a sample of the affected cells in a ‘pap smear’ or ‘cervical test’ and using a machine to identify the presence of HPV.³ In Ireland, the HSE, through the CervicalCheck programme, offers women aged 25 to 60 this test every three to five years.⁴ The HSE contracts with GPs to carry out the pap smear. Contracts are also arranged with a number of private laboratory companies in the United States⁵ and one public hospital in Ireland⁶ to carry out the test which then identifies if HPV is present. The results of the laboratory tests are communicated back to the women and their test-taker by CervicalCheck.⁷

In 2011 CervicalCheck issued an audit of screening results. The purpose of the audit was primarily to be used by the laboratories for educational purposes.⁸ In his report, Dr. Scally said that;

‘The CervicalCheck audit was established with laudable aims but planning, governance and documentation appear to have been inadequate. There was little or no anticipation of the challenges which would arise when results were reviewed. Participating laboratories were not given a specification of how to undertake reviews and did not do so consistently. Analysis of the results was sporadic and informal. A trend was identified regarding reviews at Quest but no adequate steps appear to have been taken to define whether this represented a genuine issue and, if so, what actions should be taken to resolve it.’

Non-Disclosure of Audit Results

Prior to 2014 CervicalCheck had no policy relating to open disclosure.⁹ The issue of disclosure was eventually discussed at a meeting of the CervicalCheck Executive Management Team in January 2016. It was decided that ‘disclosure of the outcome of the audit to the treating health professional would be the best option’.¹⁰

CervicalCheck considered that the duty of disclosure fell with the affected women’s doctors. According to Dr. Scally, this remains in keeping with international advice. The responsibility of these doctors to then disclose the results of the audit to the affected women is outlined in both HSE and Medical Council policy.

The HSE defines open disclosure in a document titled ‘Open Disclosure: National Policy’ as:

‘An open, consistent approach to communicating with service users when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the service user informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event.’¹¹

This appears to be a definitive statement of the HSE’s commitment to informing patients of medical errors accompanied by an apology. However, later on in the document this is contradicted:

‘When a clinician makes a decision, based on his/her clinical judgement, not to disclose to the service user that an adverse event has occurred, the rationale for this decision must be clearly documented in the service user’s healthcare record and this decision may need to be reviewed by the clinician at a later date, depending on the circumstances involved.’¹²

This discretionary power given to a doctor’s ‘clinical judgement’ completely overrides the previously firm commitment to open disclosure.

The Medical Council, the regulatory body of medical practitioners in Ireland, also provides a policy document in relation to open disclosure. While not a legal code, the document outlines a set of principles that all doctors are expected to follow and adhere to. It states that:

‘Patients and their families, where appropriate, are entitled to honest, open and prompt communication about adverse events that may have caused them harm. When discussing events with patients and their families, you should: acknowledge that the event happened; explain how it happened; apologise, if appropriate; and assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.’¹³

The use of the word ‘should’ rather than ‘must’ means that the individual doctor has no absolute duty to follow open disclosure.

Both the HSE and the Medical Council are contradictory in their apparent support of open disclosure with the absence of any absolute requirement to disclose error.

It is thus unsurprising that there was confusion and misdirection when it became apparent that women had not been correctly diagnosed.

Disputes between a number of doctors and CervicalCheck broke out following the issue of letters detailing results of the audit in February 2016. The disputes concerned whether the women should be informed at all, and who should be responsible for delivering the news to the women. That the woman herself might have a say in the matter was not discussed.¹⁴

Vicky Phelan & Jim Phelan v HSE & CPL Inc

Correspondence showing an example of such a dispute has been made public through the case brought by one woman affected by the audit. Vicky Phelan began litigation after it became apparent her 2011 smear test result was incorrect. She was diagnosed with cervical cancer in 2014, but was not informed of the review or audit until 2017.¹⁵

This case was the first of a number brought against CervicalCheck and the laboratories contracted to carry out smear tests. The main issues in these cases were allegations that the smear tests had been negligently read and a failure to disclose to the women and their families the results of audits carried out on the smear tests when cervical cancer had been diagnosed.¹⁶

Ms. Phelan’s claims for aggravated and exemplary damages against the HSE were denied and the case struck out.

A settlement was made without admission of liability for €2.5 million against Clinical Pathology Laboratories Inc, the US firm which had carried out the test for HPV.

Assigning Liability

Though this case was successful in securing financial compensation and bringing public attention to the issue, it did not solve the question of liability.

The Minister for Health announced in December 2018 that, on the advice of Mr Justice Charles Meenan in his Report on an Alternative System for Dealing With Claims Arising From CervicalCheck, an independent statutory tribunal to deal with claims arising from the CervicalCheck scandal will be set up in the near future. The aim of this tribunal will be to assign liability and seek redress. Until the results of such a tribunal are published, we must use the advice Mr. Justice Meenan to investigate potential liability.

In his Scoping Inquiry Dr. Scally explains that there will always be a margin of error involved in cancer screening – results known as “false negatives”.¹⁷ Thus, a number of women will always be reported as having no evidence of HPV in their cells. This does not indicate negligence on behalf of the laboratories carrying out the test. Mr. Justice Meenan says that ‘for a woman – or her family to establish negligence evidence would have to be given from a suitably qualified expert that the reading of the smear fell below the appropriate standard required. Thus where a woman develops cervical cancer following a false negative this is not, of itself, sufficient to prove negligence.’¹⁸

The contracts between CervicalCheck and the US laboratories contain indemnity clauses which cover false negatives, as well as dispute resolution mechanisms.¹⁹ There may be issues between CervicalCheck and the laboratories that are not covered by the indemnity where liability may be assigned.

With regard to the liability of CervicalCheck and individual doctors for non-disclosure, Mr. Justice Meenan’s assertion that ‘the legal right of a patient to be informed of the result of an audit is the subject of some legal debate’²⁰ is salient, as evidenced by the contradictory policies I have discussed. The withholding of the results of the audit from these women is incontrovertibly morally wrong, but it will be up to the tribunal to establish if it was legally wrong.

Conclusion

It is clear from the cases and reports I have discussed that there must be a statutory duty of open disclosure for both individual doctors and the organisations under which they operate. An absence of definite policy on open disclosure has led to years of argument and uncertainty, causing irreversible distress, upset and anger. A requirement for women affected by CervicalCheck to undertake legal proceedings to establish their medical record is unacceptable, and will no doubt have serious implications for their trust in the medical profession. I sincerely hope an independent tribunal will be established as soon as possible, so that women and their families may have their cases heard in a sensitive, dignified, and timely manner.

Note from the Editorial Board: this article was amended on the 16th of October 2023 to correct factual inaccuracies that were present in the article at the time of publication.