Incredible advances in interventional treatment in utero have been made in recent years. Some babies who previously would not have survived the pregnancy are now born healthy. Some who would have survived but with significant disability have seen their prospects of a healthy life greatly improved. As can be expected with cutting-edge treatment however, the benefits also come with risks.
Brisbane doctors recently performed the first Australian in utero surgery on a foetus with spina bifida. Dr Jay Wellons, one of the American neurosurgeons who travelled over for the surgery, stated “the risks are, let’s face it, death, but this is where we work on the edge of death.” At 24 weeks of gestation the surgeons made an incision in the mother’s abdomen, lifted the uterus and filled it with fluid so that the foetus floated upwards, and were then able to repair the spinal defect prior to closing the mother up and allowing the pregnancy to continue. Compared with surgery performed after birth, the in utero surgery is associated with better outcomes and it is hoped that it can be more widely carried out in Australia and New Zealand in the future.
Another radical procedure, pioneered in the ‘noughties, is a technique called fetoscopic tracheal occlusion (FETO). FETO is now being used at specialist centres around the world to treat congenital diaphragmatic hernia in utero (around 1 in 4000 pregnancies are affected). Where the hole in the diaphragm is large, the foetal lungs are not able to develop properly and in most cases this means stillbirth or death shortly after birth. Now a balloon can be inserted and filled within the trachea, which pushes the diaphragm downwards and allows the lungs the opportunity to grow. Once this has occurred the balloon is deflated and removed and the baby is delivered normally. Whilst not every foetus can be saved by performing FETO, around 60% now are.
Whilst these developments are wonderful news to so many families, health providers should be aware of the specific legal issues that pioneering in utero procedures may raise:
- If a foetus dies in utero, it has no legal status and hence there is no capacity for a claim to be brought on its behalf. Most claims for death in utero will of course be brought by the mother, and in some cases the father as well, for psychiatric damage. These can be substantial depending on the level of impairment.
- The Coroner has no jurisdiction to investigate a death in utero or a stillbirth, however as soon as a baby shows any sign of life, however brief, the Coroner’s jurisdiction is triggered.Where there has been an in utero medical intervention and the baby dies after birth, the Coroner may well feel this removes the death from the category of ‘natural death’, even if there was a ‘natural’ but potentially fatal underlying condition that the foetal intervention sought to remedy. Health providers must therefore remain aware of the possibility of Coronial examination of the treatment.
- If a foetus is damaged in utero and lives, but with a disability attributable to negligence in providing the treatment rather than the underlying condition, s/he will be able to sue the health provider. New techniques are often riskier, not having been widely practiced, and longer-term outcomes may be unknown. These things may lend themselves to an increased litigation risk.
- In the event a claim in negligence is brought against a health provider in respect of such pioneering treatment, there may be difficulty in obtaining supportive expert evidence simply because there may be very few others who are undertaking the same procedure. This would not necessarily be fatal to the defence of a claim, however it may render it more difficult.
Steps that can be taken to reduce the possibility of a successful claim include obtaining clinical ethics committee approval, peer and medical director support, and ensuring the consenting procedure is extremely thorough. If the treatment is being provided pursuant to a clinical trial this may also assist in the defence of a claim as the regulation of trials is very stringent and can often withstand much scrutiny when proper consent procedures are in place.