We recovered compensation for volunteers who were left
permanently disfigured following a drug trial at Charterhouse
Clinical Research Unit.
On 18 June 1999, about 14 volunteers took part in a research
trial of the drug Foscan held at the Charterhouse Clinical Research
Unit in London.
Foscan is a drug being developed by Scotia Pharmaceuticals
Limited for the treatment of cancer. It is a photosensitive
agent, which is said to concentrate in cancerous tissue. When
exposed to light the drug is activated causing it to destroy cancer
cells leaving normal tissue as unaffected as possible.
The clinical trial required the participants
to be injected with Foscan and to be exposed for a 15 day period to
increasing amounts of artificial light. Blood tests were taken
during this time.
On day 15, before being allowed home, the
participants were exposed to normal daylight. If there was no
adverse reaction suffered, the patients would be
discharged. Thereafter, the volunteers were to avoid
sunbathing and lengthy exposure to bright light for three
months.
Seven of the 14 volunteers who took part in
this trial instructed us to claim compensation after they suffered
skin burns to the arm, which had been injected with
Foscan. These burns occurred following the light exposure test
performed on day 15 of the trial.
It appeared from the clients’ instructions
that the trial guidelines had not been fully complied
with. Scotia accepted that either this was the mechanism of
injury or alternatively that there had been an extravasation of the
drug.
Under guidelines governing clinical trials
produced by the Association of the British Pharmaceutical Industry,
Scotia were willing to pay the volunteers compensation providing
they demonstrated they had suffered a significant deterioration in
their health and well-being caused directly by their participation
in the study.
Any disputes were to be subject to
arbitration. The defendant raised arguments of contributory
negligence on the part of some volunteers.
The size of burns and the nature of
disfigurement suffered by volunteers varied, but it was clear that
most had been left with some permanent disfigurement, which we felt
was unlikely to be related to any non-compliance with guidelines by
the volunteers.
Following negotiations a total compensation
award of £52,600 was agreed.
For further information or if you have a clinical trials claim please call Paul McNeil on
020 7861 4019 or email paul.mcneil@ffw.com
You can discuss your clinical trials
claim with any member of our medical
negligence team on
freephone 0800 358 3848, email personalinjury@ffw.com or
complete our short enquiry form.