Two mothers from the North West say the government has seriously failed in its duty to protect families, after a medicine prescribed to thousands of women was linked to lifelong disabilities in their children.
Sodium Valproate is used to help those with epilepsy but an independent review in 2020 confirmed what campaigners had suspected for decades: that it caused "avoidable harm" in babies whose mothers took the medicine while they were pregnant.
Up to 20,000 people have been affected by what is now known as foetal valproate spectrum disorder (F.V.S.D).
It is a condition which can include physical malformations, autism and developmental delays.
The use of the drug is now meant to be carefully controlled - but campaigners warn that women on the medication are still being allowed to become pregnant without being sufficiently warned of the risks.
And unlike with other medicine scandals - such as thalidomide - there is still no compensation scheme for affected people or their families.
'We were told it was safe': What is the sodium valproate scandal?
Sodium valproate is an effective drug used to treat epilepsy, which was licensed in 1973 - but as early as the 1980s reports of babies born with deformities began to surface.
After decades of parents and medical practitioners raising safety concerns, a 2020 review concluded that thousands of mothers and babies had been exposed to "avoidable harm".
One of the women prescribed the medication without being warned of the risks was Emma Murphy from Greater Manchester.
All five of her children have F.V.S.D and have been affected in various ways, with diagnoses of cerebral palsy, incontinence, deafness, speech and language delay, valgus foot, and sensory processing disorder.
"It's quite devastating really, to be told that a medication you were prescribed was not safe, and there was no warnings whatsoever with that", Emma said.
"You trust your doctors. We took that medication, and we know it wasn't our fault, we've proved that now, but it doesn't take that feeling of guilt away, to watch your children struggle every day. It's hard."
'These are stories I will take to my grave': The Cumberlege Review
In 2020, an Independent Review led by Baroness Cumberlege examined the health service's history with sodium valproate.
Her report, "First Do No Harm", concluded thousands of lives were ruined because officials failed to listen to female patients.
It set out nine recommendations for the government, including an urgent apology and improvements to patient safety and treatments.
The report also recommended that compensation be paid to those affected to help them pay for ongoing care and support those who experienced avoidable harm.
But two years on, just four of these nine recommendations have been implemented so far - and there's still no sign of any financial redress for the many thousands of affected families.
The recommendation to help people pay for ongoing care remains only "under consideration", and the government rejected the need for an independent agency to oversee any compensation.
It leaves many families who say they're facing an unthinkable future.
'What happens to our children when we're gone?': The fight for ongoing care
Janet Williams from Lancashire has spent well over a decade campaigning on behalf of thousands of families affected by sodium valproate.
She was prescribed the drug while pregnant with her two sons in 1989 and 1991 - both have F.V.S.D, and are unlikely to be able to live independently.
Janet says her two boys make her proud every day of their lives, but she also lives with the daily worry of who will care for them when she and her husband are gone.
"It's panic more than anything. I'm 57, my husbands 60. We've got another 10 / 15 years to deal with this and get things set in stone and right for them. Without that help and support they're going to really struggle."
"When I think of my boys having to go into an institution. I can't bear the thought of that happening. It feels like such a waste of a life.
"This is why our campaign is so important, because there's going to be so many children in that position."
Janet and Emma have now set up INFACT (Independent Fetal Anti Convulsant Trust) a campaign group raising awareness of F.V.S.D and urging to government to act on all of the recommendations set out in the Cumberlege Report - including compensation.
Emma says it will help families plan for the future. She said: "There's no support at the minute. You have to fight for everything. Our children have got disabilities caused by a medication.
"It shouldn't have happened. And as parents, you just worry: 'Who will be there when we're not here? Who will support our children? Will they end up in institutions?'
"All the families we represent, that is their concern daily, and it never leaves your mind."
Janet's MP, Lancaster and Fleetwood's Cat Smith, says the state owes it to women to provide adequate compensation:
The Health Secretary has told the House of Commons that "there are plans that we are looking at, and when we're ready we will come to this House".
Janet and Emma have met with a Health Minister this week, and say they will carry on speaking out for thousands of affected families.
'As we speak, more and more women are being put at risk'
INFACT is also warning that more families will be left fighting for support in the future - with some women still not being properly informed of the risks, should they get pregnant while on the medication.
According to the latest data, published in March, sodium valproate was prescribed to 247 pregnant women between April 2018 and September 2021.
It means about six babies every month are being born in the UK having been exposed to the drug.
Guidelines state that the medication should only be prescribed to women who are on a pregnancy prevention programme (where contraception is being used).
The prescription should also be given in packaging which is clearly marked with a warning label, and should come with an accompanying patient information leaflet.
However, Janet and Emma say they have spoken to multiple women who were given their drugs in unmarked chemist boxes, with no accompanying guidance.
It has a finding they found "devastating".
"This is never going to end - and that's what we want to see happen.
"We don't want to keep seeing children year after year, being harmed by something that can be avoided," Janet explains.
"To know that this is still going on, it's just a scandal".
What has the Government said?
A Department for Health and Social Care spokesperson said:
“We recognise the devastating impact sodium valproate can have on all of those affected and we are fully engaged in addressing these issues.
“Minister for Patient Safety and Primary Care Maria Caulfield recently met with Ms Williams and Ms Murphy to discuss their concerns and we are working with NHS Resolution to establish a single path for patients who wish to bring a claim.
“We have set out an ambitious programme for change in response to the Independent Medicines and Medical Devices Safety Review and we aim to publish an update on implementation progress this summer.
“Patient safety remains a priority and that is why we will be appointing the first Patient Safety Commissioner for England, to improve how the system listens to patients.
For more information
The NHS guidelines state that Sodium Valproate is a safe and effective drug for people with epilepsy who are not pregnant, and they are advised not to stop taking it unless discussed with their doctor.
It goes on to say: "It's important to get advice as soon as possible if you think you are pregnant or might become pregnant while taking sodium valproate.
"However, do not stop taking your medicine suddenly without talking to your doctor first."
Click here for more information on the Sodium Valproate pregnancy prevention programme.