Breda O’Brien: Independent review crucial in Baby Christopher case

A  "never event" in medicine is a preventable error so serious that it should never happen. The Merrion Fetal Health Clinic – owned by five consultants Peter McParland, Fionnuala McAuliffe, Rhona Mahony, Shane Higgins and Stephen Carroll – and the National Maternity Hospital (NMH), admitted full liability this week for a "never event": aborting a healthy baby, Christopher Joseph Kiely.

This is not just a private tragedy resulting in unending grief for Christopher's parents, Rebecca Price and Patrick Kiely. The systemic failures leading to this catastrophe must be fully examined.

The couple is calling for an independent inquiry to establish the full facts of what happened to them, how many other times this tragedy has happened, and for consistent implementation of standards to prevent it from ever happening again.

The journey to getting an admission of complete liability took two years, three months and nine days.

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Rebecca Price and Patrick Kiely pursued the truth despite their own heart-shattering grief and all the obstacles placed in their path.  Many would not have that capacity.

It is scandalous that this had to come to court because the truth could not be established any other way. It is scandalous that we do not know how many other Baby Christophers there may have been and no certainty there will not be future cases. It is scandalous that the response to this catastrophic death is so muted and that so few support the call for an inquiry.

Reporting to the Minister for Health on the failure of mediation in this case, Dr Peter McKenna (clinical director of the National Women and Infants Health Programme) made important recommendations.

Full liability

He said that both in this case and another tragic case involving the death of Malak Thawley, the Department of Health believed an independent review was required. He made the obvious point that "the independence of the review could be called into question if it was organised by the institution in which the adverse event took place".

Furthermore, the fact that the Minister as the funder of the service cannot “mandate an independent review seems inappropriate, indefensible and ultimately unsustainable”.

Legislation allowing the Minister to insist on truly independent reviews is needed immediately

Legislation allowing the Minister to insist on truly independent reviews is needed immediately. Both the former and current Minister acknowledged to the couple that the statutory inquiry procedure of the Health Act 2007 is inadequate.

There is no evidence in the documents procured by Rebecca Price and Patrick Kiely under data protection regulations that any objective systemic review or learning has happened in the NMH in the long interim period. Instead, the consistent message to Ministers, the Health Service Executive and the public was that there was nothing to see here. Yet full liability was admitted on the first day of the case.

One key error was a failure to either interpret or communicate the reliability of a non-invasive prenatal test (Nipt) carried out by Merrion Fetal Health, a private, profit-making concern operated by McParland, McAuliffe, Mahony, Higgins and Carroll.

The Merrion Fetal Health Clinic website is still advertising the Harmony Nipt which costs €430 by stating: “The test identifies in singleton pregnancies more than 99 per cent of fetuses with trisomy 21, 98 per cent of fetuses with trisomy 18, and 80 per cent of fetuses with Turner syndrome.”

High-risk result

Naturally, any parent numb with shock after a positive Nipt result for Trisomy 18 will interpret it as meaning that their child has a 98 per cent chance of having the condition. The traumatised family relies on the obstetrician to explain to them that, in fact, it means no such thing.

The couple say  their obstetrician, Prof Fionnuala McAuliffe, described the pregnancy as having a 99 per cent probability for a fatal Trisomy 18

According to the Nuffield Council for Bioethics, if you receive a high-risk result for Down syndrome (Trisomy 21) there is a one in five (20 per cent) chance that the result is wrong and your baby does not have the condition. For Edwards' syndrome (Trisomy 18) it's a three-four in five (60-80 per cent) chance. In the case of Rebecca Price, because she had normal ultrasound scans, after the Harmony positive result, there was less than one in four chance that her baby had Trisomy 18. Yet the couple say that their obstetrician, Prof Fionnuala McAuliffe, described her pregnancy as having a 99 per cent probability for a fatal Trisomy 18.

In fact, one study published in Pediatrics showed that, while a high risk of miscarriage exists, children who live until birth with Trisomy 18 may have an average lifespan of 14 days; with 39 per cent of babies living for more than a month, and 10 per cent living for more than a year.

McAuliffe performed a definitive test, chorionic villus sampling (CVS) but the couple says that they were incorrectly counselled against waiting for the final cell culture (karyotype) as it would “not show anything different”. This proved to be catastrophic. The karyotype in fact showed that Christopher was healthy.

The Price-Kiely family have called for an immediate cessation of the practice of not awaiting the results of CVS karyotype analysis in all cases where genetic conditions are suspected but there is a normal ultrasound. They have also requested an independent external review of practices and management of adverse incidents at NMH. If this does not happen, there will be other Christophers and other bereaved families.