Damages for drug trial injuries 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.
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