Victims of three medical products that caused ‘avoidable harm’ still awaiting redress

The dark granite block in a children’s cemetery in Bristol tells an incomplete story: “Trelissa Whitbread, born 3rd of Feb 1988. She lived 2 hours.”

Deborah Mann has not returned to the grave of her firstborn for 30 years but today has come with her daughter, Branwen, to tell her the story. “It shouldn’t have happened,” she says quietly.

Ms Mann had four pregnancies. Her first two children, Trelissa and Kaverne, died shortly after birth. Ms Mann believes their deaths were caused by an epilepsy drug she was taking called sodium valproate, prescribed by her GP.

After a long gap she would go on to have two more children, both girls, who were diagnosed with what is now recognised as foetal valproate syndrome, which has left them with life-long physical and neurological problems.

Ms Mann tells Sky News: “I asked so many questions and was told ‘this is just the way things are.’ It can’t be the way things are when you lose two babies. How can it be the way things are?”

Five years ago, valproate was among three medical products including the pregnancy test drug Primodos and medical device pelvic mesh, that were found to have caused “avoidable harm” to patients.

The report was clear that valproate could cause lifelong disabilities to the children of mothers taking the drug when pregnant.

The independent review, chaired by Baroness Julia Cumberlege, strongly criticised the industry and regulators and made a series of recommendations, including the creation of a redress scheme for victims in all three groups.

On valproate, it stated: “Nothing can undo the harm that has been done to these individuals, but steps can be taken to make their lives easier.”

20,000 children exposed to drug while in womb

Five years on there is still no such scheme for any of the campaign groups. In the week of developments in the Post Office scandal and infected blood, here is another scandal no less significant.

An estimated 20,000 children were exposed to sodium valproate while in the womb.

UK regulator the MHRA says an increased risk of neonatal loss is not currently a recognised adverse reaction, but it does warn of a range of congenital problems caused by the drug that are increasingly likely the higher the dose.

Sky News has also seen a study from 1972 which shows high doses of sodium valproate could be embryo-lethal in rats. At times Ms Mann was being prescribed 5,000mg, which is double the highest recommended dose.

Ms Mann worries about the future of her surviving children. She says of the government: “It’s financially better to pretend they don’t even exist. So many children are harmed, so many children that will not have their needs addressed as they grow older.”

At the time of birth her eldest daughter Rhonwen’s medical records state “valproate levels caused foetal and patient damage,” which included deafness.

Daughter worries about being a mother as she can pass condition on

Ms Mann wasn’t initially told about the cause of her daughter’s problems, even when she was pregnant with her next child Branwen.

The 29-year-old told Sky News: “I have tight ankles, tight legs, tight hips and I have a weak lower back. I have to wear splints every day to be sure I can keep walking, and I have to do exercises every day. I have autism, Asperger’s syndrome.”

She goes on to list a series of brain problems that must be scanned every two years, “to make sure nothing’s grown or moved.”

She was bullied at school for her appearance, and she worries about being a mother as she can pass the condition on to her children.

She said: “I feel very let down by the government. I feel let down by the people who promised they would help us, that they will help ensure that we have a better quality of life.”

‘Somebody at last had listened’

Others the Cumberlege review wanted to get redress for “avoidable harm” were children born with malformations after their mothers used the drug Primodos.

These hormone-packed pills were prescribed as a pregnancy test to thousands of women in the 1960s and 70s and are alleged to have caused a range of malformations to babies, from shortened limbs to heart defects, which the manufacturer denies.

Lead campaigner for the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), Marie Lyon, told Sky News: “Our families were utterly overjoyed that somebody at last had listened, and Julia Cumberlege did a thorough review. Our expectations were wow! This is it now. An apology from the health secretary, all these years and we’ve finally got there, and then nothing.

“Five years and may I say, five years and 31 deaths. That’s how many of our members have died since that report was published in 2020 and we’ve still not received justice. It’s a disgrace.”

Baroness Cumberlege also recommended the government create a redress scheme for women left debilitated by pelvic mesh implants.

‘The government are dragging their feet’

Kath Sansom, founder of the Sling The Mesh campaign group, told Sky News: “There are women in there who can’t walk any more, who need a stick or a mobility scooter – they’ve lost jobs, marriages, pensions. Some have had to sell their homes, and it feels really unfair that we are still waiting for a reply on redress.

“The government are dragging their feet. We keep being told that they are working on it at pace – but the phrase within the group is – a snail’s pace.”

The Department of Health and Social Care said: “The harm caused by pelvic mesh continues to be felt today” and “we are fully focused on how best to support patients and prevent future harm.”

“Health Minister Baroness Gillian Merron met patients affected and has committed to providing a further update.”

Government considering recommendations

The government says it is considering the recommendations by the patient safety commissioner last year for a redress scheme, but it’s notable there is no timescale and no reference to the harm caused by valproate or Primodos in their statement.

Dr Alison Cave, chief safety officer at the Medicines and Healthcare products Regulatory Agency (MHRA), said: “Patient safety is our highest priority and no one should stop taking valproate without seeking advice from their healthcare professional.

“Valproate is a highly teratogenic medicine and there is evolving evidence for harms in males, which is why the Commission on Human Medicines (CHM) recommended new regulatory measures to reduce the known harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in male.”

Sanofi, manufacturers of sodium valproate, told us: “We have always worked closely with the MHRA and fully met all our legal and regulatory obligations in relation to valproate which is an essential medicine used to treat a serious and potentially life-threatening condition.

“Sanofi has at all times provided information regarding valproate that reflects current knowledge as approved by MHRA.

“We are committed to working with all concerned stakeholders to continue educating about the risks and precautions for the appropriate use of valproate.”