Sodium valproate – or epilim – is taken to prevent seizures in the brain
Dozens of families who blame an epilepsy drug for causing birth defects in their children say they are devastated that legal aid to sue its maker has been withdrawn.
Women who took sodium valproate in the 1990s claim they were not given adequate warnings of possible harm.
The Legal Services Commission, which runs legal aid, has concluded the case is not sufficiently likely to succeed.
Manufacturer Sanofi Aventis denies failing to provide proper warnings.
About 80 families have begun action for damages against the firm, claiming the drug – also known as epilim – caused severe disabilities in children including spina bifida, heart damage and learning difficulties.
BBC health correspondent Adam Brimelow said the refusal of legal aid meant this action, which had been seven years in the planning, now appeared close to falling apart just days before it was due to go to the High Court.
Karen Buck and John Coyle say they were not made aware of any risks while pregnant with Bridget
Karen Buck and John Coyle, whose daughter Bridget is severely handicapped, said they were devastated legal aid had been pulled just before the case was due to be heard.
Mr Coyle, from Stanmore in north-west London, told the BBC: “As a family we feel devastated because the case has gone on for over six years and the legal aid have funded it all the way along.
“Everybody has the belief that it [the case] has a better chance of winning than not, and just everybody is devastated that the finances have been pulled.”
Bridget’s mother took an increased dose of epilim during her pregnancy in 1997/8, but said she was not made aware of any potential risks to her child.
Her daughter has spina bifida, is unable to walk or talk, is herself epileptic, and requires 24-hour care.
Mr Coyle said: “There didn’t seem to be any information available at the time Karen fell pregnant about taking epilim in pregnancy.
“I think the information has definitely improved quite a lot. They’ve become more aware and have accepted more that there are a lot of risks of problems in pregnancy with epilim, I’m not sure the drug company has accepted full responsibility.”
Sanofi Aventis said it had sympathy for the claimants but insisted it had always provided appropriate warnings.
The company said it regularly provided authorities with updated safety data.
Epilepsy is the most common serious neurological disorder affecting people of all ages, with one person in 50 expected to develop it at some time in their life.
Sodium valproate is prescribed to people with epilepsy to prevent seizures in the brain.
(from BBC News Website November 8th, 2010)
pub. November 8th, 2010