Two Mothers Exposed the Sodium Valproate Scandal — and the State Still Hasn't Paid

An estimated 39,399 babies have been affected by sodium valproate since the risk to foetuses was first identified — and two Lancashire mothers with no legal training spent 17 years proving it. That is the story at the centre of the newly reviewed documentary Mums v Big Pharma, which traces the campaign that exposed a scandal a reviewer compares to thalidomide in scale and suffering.

The facts of the case are unusually simple for a corporate wrongdoing story. Janet Williams had two sons with developmental delays. For years doctors told her nothing was wrong. "You truly believed that if there was something wrong or something that needed explanation, they would tell you," she says now, recalling her trust in the medical profession.

In 2009, a specialist told her, almost casually, that her sons' condition probably resulted from her epilepsy medication, Epilim — the brand name for sodium valproate. The drug, discovered in 1962, treated seizures and bipolar disorder. By the 1990s, when Williams was having her children, it was one of the most widely prescribed epilepsy treatments in the UK.

How did two mothers build the case?

Williams began distributing leaflets in her home town of Pilling, Lancashire, asking other affected families to come forward. They did. When their questions outstripped her knowledge, she researched at Manchester Central library. Her story made the news, and Emma Murphy of nearby Bury got in touch — five of whose six children had similar difficulties after exposure to Epilim.

Murphy's own summary of their starting point: "I'd just been reading women's magazines and sitting at home watching Coronation Street!"

The film runs the mothers' story alongside that of Prof Jill Clayton-Smith, a clinical geneticist in Manchester in the mid-90s who noticed a recurring cluster of features in children born to women treated for epilepsy. She presented her findings — including a 1984 US paper describing "foetal valproate syndrome" — at a conference. "It wasn't received as well as I'd hoped," she says. The male-dominated audience dismissed her data as anecdotal.

Prof David Chadwick encouraged her to run a formal study that could not be refuted. Williams's children joined it. It helped establish that sodium valproate carries:

• a 10% risk of causing physical malformations
• a 30-40% risk of causing serious neurodevelopmental disorders in those exposed

What happened to the lawsuit?

In 2011, Murphy, Williams and 138 other families launched a class action against the manufacturer, Sanofi Aventis. Then their legal aid was withdrawn after they were deemed unlikely to succeed. The lawyers formally discontinued the action.

By 2013 the families had regrouped and turned to the regulatory failure behind licensing the drug for women of childbearing age. Westminster meetings went nowhere. "We were referred to as 'bored, hysterical housewives'," Murphy says. An official asked Williams whether she understood a word. She did. "The way they dealt with us was sickening … But it drove me on," Williams remembers.

The mothers began secretly recording the meetings. In one audio clip, a voice says: "The neurologists weren't in favour of having this acknowledgment of risk … Doctors don't like being told what to do," and suggests packet warnings were unnecessary because information was available online — "Your Facebook site's great!" "The ignorance," says Williams. "The arrogance." "Bastards," murmurs Murphy.

Where was the smoking gun?

The thalidomide campaign team advised them to search the National Archives at Kew for meeting notes from the Committee on Safety of Medicines. In 2015 they found them: the CSM's response to Sanofi's own statement that the drug harmed foetuses. Warning women, the committee said, would cause "fruitless anxiety". So nobody was told.

The reviewer's verdict on that decision is blunt: this is where medical misogyny, "a cancer in the system that corrupts everything it touches, inexorably leads."

What does this change for the families?

So far, very little in material terms. There was a government review, handwringing, and a promise of state compensation two years ago. None of the estimated 20,000 affected families has received a payment. The documentary's closing argument — and the review's — is that the campaign itself is what has held the system to account so far, and that the compensation promise remains untested until the first payment lands.