The core assertion — that children suffered avoidable harm because their mothers continued taking sodium valproate during pregnancy without being properly informed of the risks, despite those risks being known to the healthcare system — is directly confirmed by two major official UK reviews (the Cumberlege Review/First Do No Harm, 2020, and the Hughes Report, 2024) and by government medicines safety guidance. 1. **Valproate causes harm during pregnancy**: This is established medical fact. The UK government's own guidance states that up to 4 in 10 babies exposed to valproate in utero are at risk of developmental disorders and approximately 1 in 10 at risk of birth defects. NHS guidance confirms sodium valproate "can cause birth defects and problems with your child's learning and behaviour." 2. **The harm was "avoidable"**: The Hughes Report (February 2024, commissioned by the Department of Health and Social Care and produced by the Patient Safety Commissioner) explicitly uses this exact language, stating that the purpose of the recommended Interim Scheme is to offer patients "an initial, fixed sum in recognition of the avoidable harm they have suffered as a result of system-wide healthcare and regulatory failures." 3. **Doctors knew the risks and patients were not informed**: The Independent Medicines and Medical Devices Safety (IMMDS) Review, chaired by Baroness Cumberlege and published in July 2020 ("First Do No Harm"), found conclusively that: - "Sodium valproate has been licensed in the UK since 1972. It was known from the very beginning that it is harmful to unborn children. No one disputes that." - "Women told us that when pregnant and controlling their epilepsy with Sodium Valproate, they were never told that their unborn baby could be seriously damaged." - "Health professionals do not inform them of the risks, regulators have not done enough to make them do so." - A dedicated section of the review is titled "'I was never told' – the failure of informed consent." - Surveys cited in the review found that 18–20% of women taking valproate were unaware of the risks in pregnancy, and 28% said they had not been informed. The Cumberlege Review recommended the government issue "a fulsome apology on behalf of the healthcare system to the families affected by... sodium valproate," confirming the systemic nature of the failure. Sources: - GOV.UK, "Valproate – reproductive risks" — https://www.gov.uk/guidance/valproate-reproductive-risks - NHS, "Pregnancy, breastfeeding and fertility while taking sodium valproate" — https://www.nhs.uk/medicines/sodium-valproate/pregnancy-breastfeeding-and-fertility-while-taking-sodium-valproate/ - The Hughes Report: Options for redress for those harmed by valproate and pelvic mesh (Patient Safety Commissioner, February 2024) — https://www.patientsafetycommissioner.org.uk/wp-content/uploads/2024/02/Redress-Report_.pdf - IMMDS Review, "First Do No Harm" (July 2020) — https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf - House of Commons Library, "Pelvic mesh and sodium valproate" — https://commonslibrary.parliament.uk/research-briefings/cbp-10487/