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Sodium Valproate – the way forward for claims and compensation | Medical Negligence and Private Damage Weblog | Kingsley Napley

Sodium valproate (model names embody Epilim and Depakote) is a drug to deal with epilepsy, bipolar dysfunction and migraines which, if taken in being pregnant, is related to a big threat of beginning defects and developmental problems usually generally known as Fetal Valproate Syndrome (FVS).

Given the breadth of the signs of FVS, it could be a few years in some situations earlier than it’s clear that an individual is affected by this. Unsurprisingly, longstanding issues in relation to this medicine have resulted in comparisons with the Thalidomide scandal.

A 2022 investigation by the Instances reported that docs knew in 1973 that the drug posed a threat to unborn infants and stated that some 50 years and an estimated 20,000 disabled infants later, it was nonetheless being prescribed to pregnant girls.

Current proof additionally reveals that, since April 2018, 315 females on a register of valproate customers underneath the age of 54 have been prescribed the drug throughout their being pregnant. Right here I take a look at the state of affairs because it stands now and the long run for acquiring compensation for many who have been harmed.

The information are harsh – if sodium valproate is taken in being pregnant, as much as 4 in 10 infants are susceptible to developmental problems and roughly one in 9 are susceptible to beginning defects. These can embody spina bifida, malformation of the limbs and facial and cranium malformations.

The Hughes Report

Affected person Security Commissioner Henrietta Hughes has this month printed a report recommending a publicly-funded redress scheme for these affected. This follows a report from the Unbiased Medicines and Medical Units Security Overview in 2020 known as ‘First Do No Hurt‘. This detailed that there had been inadequacies involving healthcare suppliers, regulators, skilled our bodies and pharmaceutical producers. The report concluded that it had taken far too lengthy for critical motion to be instigated to cut back the numbers of girls who take valproate throughout being pregnant whereas being unaware of the dangers.  

Issues have continued regardless of rising steerage and laws through the years. For instance, the Nationwide Institute for Well being and Care Excellence (NICE) printed pointers in 2004 on informing sufferers of ‘childbearing potential’ concerning the dangers. Additionally, prescription necessities have been tightened by the Medicines and Healthcare merchandise Regulatory Company (MRHA) in 2018 when it set out that valproate shouldn’t be utilized in a girl in a position to have youngsters with out there being a Being pregnant Prevention Programme (PPP) in place.

The Hughes report discovered that hundreds of kids who have been uncovered to valproate now have studying and bodily disabilities with many being unable to dwell impartial lives. Ms Hughes means that underneath a redress scheme there needs to be interim funds to eligible folks – adopted by potential additional payouts underneath a ‘Most important Scheme’.

New Laws

The MRHA have now produced a public assesment report wherein they set out recommendation that no-one underneath the age of 55 needs to be began on valproate until two specialists independently take into account and doc that there isn’t a different efficient or tolerated remedy. Guidelines have been additionally launched in 2023 to make sure sufferers obtain their medicine within the producer’s authentic full packs which show all related warnings.

Authorized claims

A authorized declare by a bunch of affected households towards the drug producer, Sanofi, issued in 2004, was discontinued in 2010 after funding was terminated by the Authorized Providers Fee. This left many uncompensated for very vital accidents.

The Hughes report refers to there being some progress in France in relation to a category motion towards Sanofi. Nevertheless, the report states that (additionally in relation to pelvic mesh) ‘it appears unlikely that for both product we are going to see giant scale group actions in England’.

Medical Negligence Claims

Medical negligence claims – these referring to failures in medical care slightly than actions towards product producers – will stay attainable for some, together with probably the place there was a failure by a physician both to supply correct data, or to prescribe valproate appropriately. Claims can also be attainable towards pharmacists, for instance if appropriate warnings weren’t in place on the medicine field or the proper leaflet was not enclosed with the medicine.

Ms Hughes says in her report that limitation durations have been a hurdle to some attempting to carry authorized motion. I’d strongly advise anybody who considers that they could have a declare however are outdoors the usual limitation interval for a medical negligence case to hunt recommendation from a specialist solicitor since there would possibly nonetheless be a means ahead.

Ms Hughes additionally factors out {that a} new ‘claims gateway’ has been arrange on NHS Decision’s (NHSR) web site in relation to valproate medical negligence claims. NHSR is the physique which offers with claims towards the NHS. The location units out another process to a normal authorized declare, whereby instances are assessed by solicitors performing for NHSR. In the event that they take into account that the authorized take a look at for medical negligence has been met then a suggestion could also be made with out the necessity for Court docket involvement.

As an skilled medical negligence solicitor performing solely for claimants, I’ve issues about reliance on such another ‘gateway’. Clearly NHSR appointed solicitors shouldn’t have an obligation of care to behave in the very best pursuits of unrepresented Claimants.  NHSR appointed legal professionals solely have an obligation to their very own consumer and to the courtroom. Solely a solicitor appointed by the household / the injured occasion can correctly advise the injured occasion on all acceptable points, together with the worth of their declare. A specialist Claimant solicitor will get hold of the entire skilled proof wanted to succeed in the very best end result and in addition have the ability to cut back the stress for claimants by advising them clearly and supporting them all through the method of a authorized declare.

Reflections on a redress scheme

Finally, Ms Hughes doesn’t have the mandatory authority to arrange a redress scheme. The choice is one for the Authorities. Clearly there are giant numbers in want of compensation. Nevertheless, the Hughes report recognises that such a scheme might lead to awards of much less monetary worth than these which could possibly be awarded by the Court docket in a profitable authorized motion.

A scheme which makes a contribution in direction of the losses that individuals have suffered will not be equal to an award of damages in a profitable authorized declare whereby the Court docket will endeavour to place an injured individual, as far as attainable, within the place they’d have been in with out the negligence. For my part, a redress scheme would nonetheless present some much-needed assist for these with no obvious authorized choices.


When you’ve got any questions, please contact James Bell in our Medical Negligence and Private Damage group. 



James Bell is the top of our Medical Negligence and Private Damage follow and joined the agency in 2023 from Hodge, Jones & Allen. He has undertaken medical negligence instances for over 20 years.


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