Epileptics may sue over serious birth defects

LAWYERS acting for at least 13 women are considering legal action against doctors who prescribed anti-convulsant drugs during pregnancy, allegedly leading to serious birth defects.

The women, all of whom suffer from epilepsy, conceived malformed foetuses after taking the drugs. Some were able to terminate the pregnancy, but others gave birth to babies with spina bifida, kidney defects and deformed limbs. In most cases, the women complain, they were never told by their doctor of the risks of taking the drugs in pregnancy.

Anti-convulsant drugs used to control epilepsy, such as Epilim and Tegretol, have been known since 1967 to carry a risk of birth defects. Department of Health and British Medical Association guidelines clearly state that, in almost all cases, doctors should discuss the risk of drug side-effects with patients.

Stephanie Moore, 27, is among 13 women whose cases are under legal investigation. In October 1990 she had her first pregnancy terminated at 20 weeks after discovering her unborn baby had spina bifida. She was taking large doses of Epilim and Tegretol and had not been told of any risk.

Mrs Moore, a solicitor's conveyancing clerk from Rotherham, South Yorkshire, was prescribed the drugs by a consultant neurologist when her epilepsy was diagnosed in 1988. 'Before I became pregnant, I visited my consultant with my husband and said we had decided to start a family. He just said it was fine,' Mrs Moore said.

The spina bifida was not discovered until late in the pregnancy and Mrs Moore decided to have an abortion. 'On the day I went in for the termination, I took my epilepsy tablets with me and put them on the bedside table.

'A young doctor, probably a trainee, came in and seemed rather horrified when she saw them. I can't remember her exact words, but I got the impression that I should not have been taking it.'

It was only later that Mrs Moore discovered that there was a known link between the drugs and birth defects. 'It is impossible to say now whether I would still have got pregnant if I had known. But I think I should have been told. The whole experience has been so upsetting that at the moment I don't feel I want children.'

Martin Brodie, director of the epilepsy research unit at Glasgow University, said the risk of anti-convulsants causing birth defects was well known, especially to epilepsy specialists. 'In my opinion, a doctor has got to discuss this with a patient. A woman who wants to become pregnant is entitled to have a say,' he said.

Dr Brodie pointed out that the risk of an abnormal pregnancy was small and had to be balanced against the possibility of an epileptic fit, which might lead to the death of mother or baby.

However, many epilepsy sufferers take a 'cocktail' of anti- convulsants which significantly increases the risks. If a pregnant woman is taking one anti-convulsant drug there is about a one-in-100 chance of a birth defect. If she is taking two different anti-convulsants the risk rises to six in 100; with three drugs it is one in 10, and with four drugs it is one in five. Twenty per cent of epileptics take more than one drug.

As well as spina bifida, recognised side-effects of anti-convulsants used in pregnancy include children born with congenital heart disease, cleft lip or palate, and malformations such as crooked fingers or odd features.

Guidelines issued by the Department of Health in 1990 say patients are entitled to information 'in a way they can understand' about proposed treatments, possible alternatives and any substantial risks, so they can make a balanced judgement. The British Medical Association and the Medical Defence Union, which represents doctors in legal actions, gives similar advice.

However, if any of the cases comes to court some doctors are expected to argue that they were right to withhold information because of the danger of causing stress and anxiety in pregnancy. A ruling by Lord Bridge in the House of Lords in 1985 also suggested that how much a doctor told a patient might be a matter of clinical judgement.

Sanofi, maker of Epilim, and other drug companies list the known side-effects of anti- convulsants in approved medical publications. In some cases, the makers print warnings on packets. New EC regulations will make it obligatory to include clear information sheets with drugs.

Ten solicitors representing the women have commissioned preliminary investigations from medical experts to establish if there is a prima-facie case against either the doctors or drug companies.

Start your day with The Independent, sign up for daily news emails
Have you tried new the Independent Digital Edition apps?
ebooks
ebooksA special investigation by Andy McSmith
  • Get to the point
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
Independent Dating
and  

By clicking 'Search' you
are agreeing to our
Terms of Use.

iJobs Job Widget
iJobs General

Recruitment Genius: Photographer / Floorplanner / Domestic Energy Assessor

£16000 - £25000 per annum: Recruitment Genius: A Photographer/ Floor planner /...

Ashdown Group: Front-End Developer - Surrey - £40,000

£30000 - £40000 per annum: Ashdown Group: Front-End Developer - Guildford/Craw...

Recruitment Genius: Customer Service Assistant

£13500 - £15000 per annum: Recruitment Genius: A Customer Service Assistant is...

Recruitment Genius: Sales Executive - OTE £35,000

£16000 - £35000 per annum: Recruitment Genius: An ambitious and motivated Sale...

Day In a Page

Not even the 'putrid throat' could stop the Ross Poldark swoon-fest'

Not even the 'putrid throat' could stop the Ross Poldark swoon-fest'

How a costume drama became a Sunday night staple
Miliband promises no stamp duty for first-time buyers as he pushes Tories on housing

Miliband promises no stamp duty for first-time buyers

Labour leader pushes Tories on housing
Aviation history is littered with grand failures - from the the Bristol Brabazon to Concorde - but what went wrong with the SuperJumbo?

Aviation history is littered with grand failures

But what went wrong with the SuperJumbo?
Fear of Putin, Islamists and immigration is giving rise to a new generation of Soviet-style 'iron curtains' right across Europe

Fortress Europe?

Fear of Putin, Islamists and immigration is giving rise to a new generation of 'iron curtains'
Never mind what you're wearing, it's what you're reclining on

Never mind what you're wearing

It's what you're reclining on that matters
General Election 2015: Chuka Umunna on the benefits of immigration, humility – and his leader Ed Miliband

Chuka Umunna: A virus of racism runs through Ukip

The shadow business secretary on the benefits of immigration, humility – and his leader Ed Miliband
Yemen crisis: This exotic war will soon become Europe's problem

Yemen's exotic war will soon affect Europe

Terrorism and boatloads of desperate migrants will be the outcome of the Saudi air campaign, says Patrick Cockburn
Marginal Streets project aims to document voters in the run-up to the General Election

Marginal Streets project documents voters

Independent photographers Joseph Fox and Orlando Gili are uploading two portraits of constituents to their website for each day of the campaign
Game of Thrones: Visit the real-life kingdom of Westeros to see where violent history ends and telly tourism begins

The real-life kingdom of Westeros

Is there something a little uncomfortable about Game of Thrones shooting in Northern Ireland?
How to survive a social-media mauling, by the tough women of Twitter

How to survive a Twitter mauling

Mary Beard, Caroline Criado-Perez, Louise Mensch, Bunny La Roche and Courtney Barrasford reveal how to trounce the trolls
Gallipoli centenary: At dawn, the young remember the young who perished in one of the First World War's bloodiest battles

At dawn, the young remember the young

A century ago, soldiers of the Empire – many no more than boys – spilt on to Gallipoli’s beaches. On this 100th Anzac Day, there are personal, poetic tributes to their sacrifice
Dissent is slowly building against the billions spent on presidential campaigns – even among politicians themselves

Follow the money as never before

Dissent is slowly building against the billions spent on presidential campaigns – even among politicians themselves, reports Rupert Cornwell
Samuel West interview: The actor and director on austerity, unionisation, and not mentioning his famous parents

Samuel West interview

The actor and director on austerity, unionisation, and not mentioning his famous parents
General Election 2015: Imagine if the leading political parties were fashion labels

Imagine if the leading political parties were fashion labels

Fashion editor, Alexander Fury, on what the leaders' appearances tell us about them
Phumzile Mlambo-Ngcuka: Home can be the unsafest place for women

Phumzile Mlambo-Ngcuka: Home can be the unsafest place for women

The architect of the HeForShe movement and head of UN Women on the world's failure to combat domestic violence