The facts leading up to 31 year-old Savita Halappanavar's death in Galway University Hospital on 28 October 2012 are now to be the subject of an official HSE enquiry. In Ireland, 'HSE' means the Health Service Executive, which is responsible for the delivery of healthcare services in the State - not the Health and Safety Executive.
Ms Halappanavar's demise sounds grim: denied an expedited delivery during a miscarriage at 17 weeks, with a non-viable pregnancy, and complaining of severe pain, she was apparently told: "this is a Catholic country" and "we can't do anything." Such a reaction to a patient in dire straits appears woefully inept. Her subsequent collapse and death could be seen as an illustration of the Latin tag "res ipsa loquitur" (the thing speaks for itself).
The case has caused Ireland international embarrassment. No one knows exactly what went on, or whether the family's account of events is denied or accepted by the professionals involved. Perhaps more worryingly, for anyone at risk of miscarriage in that part of the world, the enquiry into what went wrong will take three months, which begs the question: how do we know this isn't going to happen to somebody else, in the meantime?
So what interim safeguards have been put in place to prevent a repetition of this tragedy? We are not allowed to know, because the Irish Medical Council, which regulates doctors, will not disclose if it is looking into a doctor's practice (even if it is looking into a doctor's practice). The hospital is keeping schtum. All we can do is to scour the internet for guidance on the subject. Fortunately, the HSE and Institute of Obstetricians & Gynaecologists in Ireland produced a Clinical Practice Guideline on Management of Early Pregnancy Miscarriage in April this year. This applies to first trimester miscarriage.
This is a sensible document, adapted from the Green-top Guideline No. 25 of 2006 produced by the Royal College of Obstetricians and Gynaecologists. Its Key Recommendations include the following:
"4. At all times women should be supported in making informed choices about their care and management. Adequate explanations supplemented with written information should be given.
5. Surgical management of miscarriage should be offered to women who make a specific request, women who change their mind during the course of conservative or medical management, women who have heavy bleeding and/or severe pain, when gestational trophoblastic disease is suspected or if infected intrauterine tissue is present."
Reading this guidance, which could not be clearer, one cannot help wondering how Ms Halappanavar's reasonable request for an expedited delivery could conceivably have been refused. If the hospital considered it could save the pregnancy, that would be different, but according to the husband no one expected this baby to survive, let alone survive normally.
Anyway, assuming that Galway University Hospital has staff who had read the Guideline, the issue boils down to two simple questions: were those involved in Ms Halappanavar's care familiar with it (they must have been), and why didn't they think it appropriate for her case? It seems strange to withhold termination from a woman at 17 weeks, when termination on request is recommended for first trimester miscarriage.
They could hardly argue that they considered it in her best interests not to follow it, if this was causing her unnecessary distress. If she and her husband had been given a copy, they would have seen straightaway that her wishes should be respected.
It really shouldn't take three months to come up with an answer to these short points, even making allowances for the fact that professional indemnity insurers and their lawyers will be hovering in the wings.
But as I have suggested, the worrying question for other pregnant women in Ireland is: will this hospital be following the guideline from now on? And are there other maternity hospitals which are not following the guideline? Pregnant women unfortunate enough to be miscarrying would do well to access a copy, just in case.
There are weighty human rights considerations at stake. One of the state's obligations under Article 2 of the European Convention on Human Rights (the right to life) is "to put in place a legislative and administrative framework designed to provide effective deterrence against threats to the right to life": see Oneryildiz v Turkey (2004) 41 EHRR 20 (§ 89); Osman v United Kingdom (2000) 29 EHRR 245(§ 115).
This is a wide-ranging duty, which includes requiring the state not to deny healthcare to individuals which it has undertaken to make available to the population generally (Cyprus v Turkey [2001], no. 25781/ 94, § 219); to make regulations compelling both public and private hospitals to adopt appropriate measures for the protection of patients' lives, and to have an effective independent judicial system allowing for the cause of a patient's death to be determined, and for those responsible to be held accountable (Calvelli v Italy [2002], no. 32967/96, § 49).
One of the issues to be explored, having regard to the State's duty under Article 2, is whether a prosecution should follow. It is extremely rare, but not unknown, for doctors to be prosecuted. On 25 November 2010, the Medical Defence Union (MDU) reported that it had helped 18 members with manslaughter investigations in a clinical setting between 2000 and 2010, with just 5 cases progressing to trial and 3 doctors being convicted. Dr Devlin of the MDU was quoted as saying: "In many cases the fatal mistake leading to a manslaughter investigation is a combination of human error, system breakdown or failure at a higher management level. But individual doctors can still be singled out for blame." It should be emphasised that the threshold for a prosecution is much higher than "ordinary" negligence resulting in civil liability: it requires such a disregard for the life and safety of others as to amount to a crime. In this case, the hospital may say either that treatment met accepted standards, or that death was unforeseeable and so unavoidable.
Other aspects of patients' rights arise under Articles 3 (the prohibition on inhuman and degrading treatment) and 8 (the right to physical and moral integrity) of the European Convention. The European Court of Human Rights has been taking Poland to task in a series of extremely critical rulings under these heads, involving women whose access to a lawful termination of pregnancy was obstructed by doctors and hospitals: Tysiąc v. Poland, no. 5410/03, 20 March 2007; R.R. v. Poland, no. 27617/04, 26 May 2011; P & S v Poland, no. 57375/08, 30 October 2012.
In P & S the Court said:
"99. ...the Convention is intended to guarantee not rights that are theoretical or illusory but rights that are practical and effective (see Airey v. Ireland, 9 October 1979, § 24, Series A no. 32). .... once the State, acting within its limits of appreciation, adopts statutory regulations allowing abortion in some situations, it must not structure its legal framework in a way which would limit real possibilities to obtain an abortion."
In that case, which concerned a teenage victim of rape, the Court decided that Article 3 was breached, in part because "pressure was exerted on her by the chief doctor who tried to impose her own views on the applicant." The Court also noted that "the approach of the authorities was marred by procrastination, confusion and lack of proper and objective counselling and information..."
The problem which Ireland now faces is that Ms Halappanavar's Convention rights under Articles 3 and 8 appear to have been breached, as well as her right to life. She was in a position of great vulnerability, yet she seems to have been treated deplorably. This has generated widespread public concern, even anger. Understandably, her family are devastated, and require an explanation. It remains to be seen just how forthcoming the medical authorities in Ireland are prepared to be.