Emma Friedman, mother of 13 year old Andy, on the failed Epilim litigation against Sanofi-Aventis. Emma took the drug when pregnant to prevent epileptic fits. She was one of 100 families that sought  compensation for their children and the action collapsed earlier this year within weeks of the court hearing after a six-year fight. The families were suing over a range of claims for birth defects such as spina bifida, heart damage, cleft palates, deformed hands and feet – some claims are in the region of £6m – which they argued were the result of the children’s mothers having taken an anti-epilepsy drug when pregnant. ‘Andy is 13 years old now with a mental age of a three year old.’ Read her blog here.



Author: Jon Robins

Jon is editor of the Justice Gap. He is a freelance journalist. Jon’s books include The First Miscarriage of Justice (Waterside Press, 2014), The Justice Gap (LAG, 2009) and People Power (Daily Telegraph/LawPack, 2008). Jon is a journalism lecturer at Winchester University and a visiting senior fellow in access to justice at the University of Lincoln. He is twice winner of the Bar Council’s journalism award (2015 and 2005) and is shortlisted for this year’s Criminal Justice Alliance’s journalism award

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My son Andy was part one of a group of 100 children who received a substantial amount of legal aid – £3.25million in total – to sue the pharmaceutical company Sanofi Aventis over serious birth defects known as Fetal Valproate Syndrome caused by mothers taking an anti-epilepsy drug known as EPILIM during pregnancy. It is Andy’s experience and the financial implications to the state that I wish to discuss.
EPILIM contains Sodium Valproate which is used to control epileptic seizures and mental health conditions. It is widely accepted by clinicians as an excellent drug for the control it gives patients. The side effects are shocking and are now listed in the patient information leaflets.
In one study (Cummings et al) released this year it showed that almost four out of 10 (39.6%) of children born to mothers taking EPILIM had ‘evidence of mild or significant developmental delay’. Andy is 12, autistic with a mental age of 3 and a severe speech impediment. You can read about Andy here and hear my talk about him here. Andy is disabled for life. He will never live independently and we reckon he will cost the state at least £5million.
Legal aid was withdrawn because what is known as the FACs litigation (Fetal Anti-Convulsant Syndrome) was seen as having a low probability of success in court. The reason for that is (I’d argue) that the Consumer Protection Act and the EU Product Liability Directive is inadequate. The legal concepts ‘defect’ and ‘causation’ are not defined clearly enough.
Families together with the charity the Organisation for Anti-Convulsant Syndrome and solicitors have worked together trying to reinstate funding. In my view, there are several reasons why we weren’t successful.
‘Big Pharma’ invests in the state and our banks. They have influence in the NHS, think tanks, national charities, research laboratories and universities so it is not necessarily in the state’s best interest to upset them. The media has been reluctant to report for fear of legal action against them by Sanofi Aventis.
MPs tabled an Early Day Motion (EDM 1035) to reinstate funding but this was never debated and the justice secretary Ken Clark said he has no power over the decisions of the Legal Services Commission which runs the legal aid scheme in England and Wales as they are independent. Why hasn’t the LSC been held to account for the millions of pounds squandered on pharmaceutical claims that haven’t been granted funding to enter court? If the EPILIM cases are good enough to be granted £3 million, surely they should go to court? It seems bizarre to spend so much much money and yet not have the issues thrashed out in a court of law?
We applied for a judicial review of the decision to withdraw legal aid but funding was denied by the Legal Services Commission. We were unable to challenge the decision made by the LSC and we as parents were unable to raise the funds needed to pay for the review ourselves.
The absence of legal aid means a case like ours can’t achieve access to justice. Our children can’t have their day in the courts. EU and UK law is not strong enough for a ‘no win, no fee’ lawyer to take a case on because they can’t get the insurance to cover other sides’ costs if they lose. In the US lawyers are acting for claimants with birth defects who were exposed to DEPAKOTE which contains Sodium Valproate. Claimants, I’m sure get, will win compensation in the same way that US VIOXX Claimants were compensated when English claimants were not.
Loss of faith
I have found it intimidating challenging the LSC, government and the fourth largest drug company in the world. I have always tended to trust those in government to look after the needs of the vulnerable. To take them on hasn’t been a comfortable experience. These children have been damaged. I have become sceptical of all government decisions and have lost trust in those elected to represent us. This makes me sad.
There is no happy ending. I worry that Andy will be abused and neglected when I die with no one to look after him and disability services being cut drastically. In America the Food and Drug Administration has issued warnings. No such warning has been given in the UK. Why? I think British Banks and the UK economy are too dependent on Big Pharma investment for the government to upset them. How many of us have £10 million if a medical or surgical procedure causes irreversible damage and you lose your job, your house and there is no free legal advice to help you with debt, litigation, provision of services, housing and marriage breakdown. How will you manage and what will it cost the state?


Author: Emma Friedmann

Emma is the mother of 13-year-old Andy, this week. She took Epilim, manufactured by Sanofi-Aventis, when pregnant to prevent epileptic fits. ‘Andy is 13 years old now with a mental age of a three year old,’ she said. She was involved in a legal action against Sanofi-Aventis which was discontinued this year.

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  • Steve Lee November 10, 2011 3:57 pm

    I genuinely believe that the fact that ordinary citizens will now find it impossible to challenge global corporates through the law is not just an unfortunate consequence of the Legal Aid ‘reforms’, but that this is one of the motivating ideas behind the agenda.

  • phil August 26, 2014 2:26 pm

    we are now suing both the GP and the NHS, this is a much more likely way to get a result. In 2004 NICE guidelines state that a dose of no more than 1000mg a day should be taken while in pregnancy and if at all possble a change of medication altogether would be preferable, if you have been taking sodium valproate befor this time you wont have much of a chance but the effects are now well documented so try a different approach.There are thousands of women out there who simply do not know about the dangers of taking this stuff while pregnant.
    You have a 40% chance of having a child born with severe defects when taking sodium valproate.

    • emma friedmann November 22, 2015 10:34 pm

      Hi Phil,

      How is your claim progressing? I would be very interested to hear of other’s legal experiences.

  • emma friedmann November 22, 2015 10:53 pm

    A lot has changed since I wrote this article back in 2011. I read Bad Pharma by Ben Goldacre and got a better understanding of the pharmaceutical industry and who does what.

    I had given up on Justice and UK Democracy so put my effort into preventing this from happening to others. I started emailing the MHRA. Networking with other parents and journalists. Attending seminars. Took part in a documentary: Sodium Valproate – The Cost. Gave media interviews. All available on YouTube.

    Regulation, adequate warnings and changes to prescribing practice were what was needed to prevent further cases of FACS and enable women and doctors to make an Informed Choice on treatment options.

    A full summary of our successes are on the FACSaware website.

    I’m on Twitter and Facebook @emmafriedmann @facsaware

    I hope that one day my faith in British Justice can be restored.

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