The claim has three components forming a causal chain: (1) doctors knew the risks of sodium valproate during pregnancy; (2) patients were not informed of those risks; and (3) this had devastating consequences for the children. **1. Doctors knew the risks** The evidence is extensive that the teratogenic risks of sodium valproate were known to regulators and clinicians for decades. Evidence submitted to the Independent Medicines and Medical Devices Safety (IMMDS) Review by patient groups documents that the Committee on Safety of Medicines (CSM), in consultation with the manufacturer, knew of the teratogenic potential as early as 1973–74. The MHRA's own drug safety updates confirm that up to 30–40% of children exposed in utero experience developmental disorders and approximately 10% have congenital malformations. Clinicians were progressively advised from 1995 onward to inform female patients of the risks, but the patient group evidence notes that information provided to clinicians was itself incomplete for many years. **2. Patients were not informed** The "First Do No Harm" report (the IMMDS Review, published July 2020) explicitly states: "We heard from women who were never told of the effect their medication for epilepsy could have on their unborn children." The report's Theme 3 is titled "'I was never told' – the failure of informed consent." Surveys cited in evidence to the Review found that in 2017, 28% of women taking sodium valproate said they had not been informed of the risks in pregnancy. Patient Information Leaflets made no reference to teratogenic risks before 1997, and until 2003 were described as "positively misleading." The CSM in 1973–74 made a deliberate decision to omit key information from packaging inserts "to ensure that there would be no danger at all of patients themselves seeing it." Even as late as 2018, an MHRA Drug Safety Update noted that 88% of surveyed patients had not signed the Risk Acknowledgement Form. **3. Devastating consequences** The consequences are well-documented: up to 40% of exposed children have developmental delays, autism, or lower IQ; approximately 10% have serious congenital malformations including spina bifida, heart defects, and limb defects. The Hughes Report (February 2024) refers to "avoidable harm" suffered "as a result of system-wide healthcare and regulatory failures," and the First Do No Harm report states that "much anguish, suffering and many ruined lives could have been avoided" had the system properly communicated the risks. **Causal assessment** The causal chain is well-established through multiple official UK reviews. The teratogenicity of sodium valproate is scientifically established. The failure to inform patients is documented through surveys, official reviews, and regulatory records. The connection between the failure to inform and the resulting harm is explicitly drawn by both the IMMDS Review and the Hughes Report, which characterize the harm as "avoidable" — meaning that had patients been properly informed, some exposures could have been prevented. The mechanism is clear: without information about risks, women could not make informed decisions about their medication during pregnancy, and children were consequently exposed to a known teratogen. The claim is strongly supported by primary official sources, including two UK government-commissioned reviews and MHRA regulatory documents. Sources: - IMMDS Review, "First Do No Harm" (July 2020), https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf - IMMDS Review, Patient Groups Evidence on Sodium Valproate, https://www.immdsreview.org.uk/downloads/Evidence/FOR%20PUBLICATION%20-%20Patient%20Groups%20-%20Sodium%20Valproate.pdf - MHRA/Gov.uk, "Valproate – reproductive risks," https://www.gov.uk/guidance/valproate-reproductive-risks - MHRA/Gov.uk, "Medicines related to valproate: risk of abnormal pregnancy outcomes," https://www.gov.uk/drug-safety-update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes - MHRA/Gov.uk, "Valproate medicines: are you acting in compliance with the pregnancy prevention measures?" https://www.gov.uk/drug-safety-update/valproate-medicines-are-you-in-acting-in-compliance-with-the-pregnancy-prevention-measures - Patient Safety Commissioner, "The Hughes Report: Options for redress for those harmed by valproate and pelvic mesh" (February 2024), https://www.patientsafetycommissioner.org.uk/wp-content/uploads/2024/02/Redress-Report_.pdf - House of Commons Library, "Pelvic mesh and sodium valproate" research briefing, https://commonslibrary.parliament.uk/research-briefings/cbp-10487/