£22,000 awarded after experimental drug use

Clinical trials for an experimental drug treatment for a bladder condition led to compensation of £22,000 being awarded to a 57-year-old woman for physical and psychological injuries.

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Clinical trial injury claims

Injury details

The claimant suffered from significant bladder problems and was referred by her GP to a gynaecology clinic at hospital. The clinic prescribed her medication.

Three months later she returned to the clinic. She could not tolerate the medication so further tests and investigations were carried out over a six month period. Following cystoscopy and biopsy of her bladder she was diagnosed with a cystocele.

The claimant suffered from poor bladder compliance and sensory urgency. She was referred for botox injections to the bladder. The treatment was not approved by the National Institute for Health and Clinical Excellence except as an experimental procedure.

Three months later the treatment was carried out. Following the treatment the claimant suffered complications. She was unable to empty her bladder normally and required insertion of a catheter.

The claimant suffered further problems including infection, being prescribed antibiotics and being seen on five further occasions.

Two months after the treatment her GP requested a second opinion. An appointment was made with a consultant urological surgeon for three months later.

The consultant criticised the treatment the claimant had received, stating the catheter had been used for far too long. The implications of the treatment had not been discussed with the claimant. The original complaint had not been treated as botox treatment was not a recognised treatment for the condition.

Seven months after fitting the catheter was removed. The claimant was referred for treatment from the urology and pain management teams.

Two months later she was discharged from urological care but remained under the care of the pain management team.

The claimant continued to suffer from the problems she had been originally diagnosed with. A consultant psychiatrist had diagnosed her with an adjustment disorder due to the effects of the experimental treatment. She had become anxious, depressed and socially isolated.

After removal of the catheter the lady's emotional symptoms improved but some anxiety remained and her social life was affected.


Clinical negligence was alleged insofar as the experimental treatment was recommended despite not being an effective cure.

The claimant's risk factors had not been taken into account leading to increased risk of complications. She had not been given adequate information to make an informed decision as to consent.

The hospital had not removed the catheter within recommended time limits causing significant pain and suffering.

The botox injections directly caused bladder problems, as well as pain and psychological harm.

Conclusion and settlement

Liability was admitted and the matter settled without proceeding to a Court hearing.

Compensation of £22,000 was accepted by way of an out of Court settlement.

£15,500 of the damages was attributed to "pain, suffering and loss of amenity."

The remaining £6,500 related to expenses incurred and interest.

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