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Unlicensed use of Misoprostol for stillbirth delivery leading to catastrophic brain injury
Claimant aged 28 suffered catastrophic brain injury caused by unlicensed use of
Misoprostol
The NHS Litigation Authority defended the claim until three weeks before the case was
due to come to court
The Claimant became pregnant in 2004 and was booked for delivery at the West Cumberland Hospital maternity unit; this was her fifth pregnancy. The pregnancy proceeded unremarkably until, in August, she was no longer able to feel fetal movements. She was assessed at the maternity unit, where an intra-uterine death was diagnosed. She was re- admitted later, when intra-uterine death was confirmed and arrangements were made for her to undergo an induction of labour to deliver the foetus the same day. Prostaglandin E2 (drug name Dioprostone, trade name Prostin) is the natural prostaglandin which has been commercially available and used for induction of labour for over twenty years. Prostaglandin E2 has a relatively short half-life (duration within the bloodstream), and has been commonly used in clinical practice and licensed for the purposes of induction of labour for over twenty years. It is (and was at the time of this labour) the method recommended for induction of labour by both the Royal College of Obstetricians and Gynaecologists and the National Institute of Clinical Excellence. Prostaglandin El (drug name Misoprostol, trade name Cytotec) is a prostaglandin analogue (as opposed to a naturally occurring prostaglandin). It has a long half-life (being metabolised less quickly), and was developed and licensed as a treatment for stomach ulcers. It is not licensed for induction of labour, nor is it recommended for such purpose by its manufacturer, Searle, who issued a warning in 2000 as follows:- “Cytotec is not approved for the induction of labour or abortion. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labour, in spite of the specific contra-indications to its use during pregnancy. Serious adverse events reported following off label use of Cytotec in pregnant women include maternal or fetal death, uterine hyper-stimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.” It was specifically not recommended for induction of labour by the National Institute for Clinical Excellence and the Royal College of Obstetricians and Gynaecologists. The Royal College of Obstetricians and Gynaecologists “Induction of Labour - Evidence Based “There are safety aspects of Misoprostol that have not been fully evaluated and it is not currently licensed for obstetric use. Its use must therefore be restricted to RCT's (randomised The Claimant was not given any of the above information. The induction of labour proceeded, with the first dose of Misoprostol being administered at 10.35 am. Further doses were given during the day, and at 9.42 pm the Claimant was found in a collapsed state. She had suffered cardio-respiratory arrest, leading to catastrophic brain injury, which were caused by uterine hyper-contractility, leading to The NHS Litigation Authority arranged a settlement meeting, several months before trial, so that each side could discuss with the other the strengths and weaknesses of their respective cases. That did not achieve anything useful, we would say because the Defendant either failed to understand the enormity of what they had done, or because they hoped that the Claimant’s husband would not have the strength to fight on to the bitter end. Luckily they were wrong, if that was their view. He was brave courageous, and would not give in. As the date for the court hearing approached, the NHSLA increased its offers, first to 50%, and then, step by painful step, to a full admission. But they kept the Claimant’s husband in agony until three weeks before trial. I would love to know how they could possibly justify The NHSLA is one of the most vociferous critics of claimant personal injury lawyers who, they say, are costing the State billions of pounds in legal costs and compensation. This is the other side of that coin. Not merely the apparent waste of legal costs in a case that should have been dealt with quietly, sympathetically and humanely, but also the apparent indifference to the torture of the Claimant’s husband, who is nursing his minimally conscious wife in their small home, causing a huge impact on both him and their young family. Bill Braithwaite QC led Dr Simon Fox

Source: http://billbraithwaite.com/cases/Clinical%20pdfs/NC%20(Clin%20Neg).pdf