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
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