The National Maternity Hospital (NMH) has won its challenge to the Minister for Health's decision to set up an inquiry following the death of a woman during surgery for an ectopic pregnancy at the hospital .
The High Court's Mr Justice Charles Meenan ruled the Minister had no reasonable basis for directing an inquiry under Section 9 of the Health Act arising from the May 2016 death of Malak Thawley (34).
An agreement between the Minister and the NMH of the need for a further review should be followed up so the lessons learned from this tragedy can be applied across the health service “and such a tragic event avoided in the future”, he stressed.
He expressed condolences to Ms Thawley’s husband Alan and family on their “tragic loss”. Mr Thawley previously settled a negligence action against the hospital over his wife’s death.
The Minister had in November 2017 directed a Section 9 inquiry by the Health Information and Quality Authority (HIQA). A Section 9 inquiry requires a reasonable belief of a “serious risk” to the health or welfare of patients at the hospital.
The far-reaching implications of such a decision were “self-evident” for patients, medical staff and others, the judge said. He ruled the assertions on the issue of patient safety “stand up to no analysis”.
The Minister, before directing the Section 9 investigation, did not carry out any investigation of his own but claimed to rely upon the NMH’s internal report into Ms Thawley’s death, a HSE report on the matter and medical evidence at a coroner’s inquest, he said.
It was clear the findings, recommendations and conclusions of those reports were not properly considered by the Minister and no regard was given to the sworn evidence at the inquest, he held.
No reasonable grounds
In light of those reports and their recommendations, it could not be said that “reasonable grounds” for a Section 9 inquiry existed.
If the Minister considered there was such a serious risk, he took no steps to direct the hospital to counter that, the judge also noted.
The Minister accepted the “serious risk” he claimed to have identified in the NMH also exists in hospitals across the health service, he said. It was “irrational and unreasonable” for the Minister to direct a Section 9 investigation into this hospital where the practices being inquired into exist, without any ministerial intervention, in many other hospitals across the health service.
Patient safety must be a priority for the Minister and, if the Minister had a belief of serious risk, it was “inconceivable” he would not have directed the NMH to take all necessary steps to eliminate that. It would not have been acceptable to await the outcome of the inquiry before doing so.
He noted the NMH report found three key causal factors for Ms Thawley’s death - vascular injury of the aorta during laparoscopy, delay recognising that injury and delay in commencing surgery and resuscitation.
The report made numerous detailed recommendations to address those, to be considered for implementation not just at the NMH but at a national level.
The HSE report had also concluded the NMH report complied with the relevant guidelines.
Having considered the evidence,he ruled the grounds for the Section 9 investigation fell short of the grounds required and the briefing notes prepared for the Minister reflected the deficiencies identified.
The Minister, or his officials, stated on numerous occasions the inquiry would be a “learning exercise” and practices being inquired into were not unique to the NMH and were practiced across hospitals in the health system, he said.
Ice not relevant
The Chief Medical Officer, Dr Tony Holohan, had cited "pressing issues" arising from the facts of Ms Thawley's case required further investigation.
These included the NMH decision to commence surgery at a particular time, the passing of 20 minutes between blood being requested and transfusion being commenced, the fact relevant vascular instruments were not on site but had to be brought from other hospitals and procuring of ice from a nearby pub.
The evidence at the inquest was the decision on surgery was taken by a doctor during consultation with the consultant on call and the Chief Medical Officer had no issue with that; the transfusion of blood and cross-matching were not issues in the events which ended in Ms Thawley’s death and getting ice was not relevant to her death in any way, the judge said.
Hospitals are under a direction not to have ice on site because of fear of infection, he said.
If these were specific issues of patient safety, once would have expected an immediate direction to the hospital to implement the necessary changes but there was “no such direction”.
Dr Holohan accepted no country in the world has a standard of having on site consultants at all times, he said.
There was no evidence the procedure followed in Ms Thawley’s case would not be followed in other cases, he said.
Apply the learning
HIQA has set up a monitoring programme advising all maternity hospitals which would cover various issues the Minister had identified as being a problem within the NMH and wider health service, he noted.
Neither the reasonable grounds nor the “serious risk” identified by the Minister were communicated to the hospital despite its repeated requests for those, he also found.
The HSE report concerning Ms Thawley’s death had stated the potential for learning from some patient safety incidents is “so great”, or the consequences to patients, families and carers, staff or organisations so significant, these incidents warrant a “comprehensive response”, he noted.
In the case of the tragic death of Ms Thawley, there has been such a response but it is “now necessary to apply the learning,” he said.
