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Government review ordered: Primodos, Sodium Valproate, vaginal mesh

Product liability lawyer welcomes medical product review

Pills on table

22 February 2018

During yesterday's Prime Minister’s Question Time, Theresa May announced that the government is ordering a review into how UK authorities responded to potential health issues arising from three different medical products either currently or historically marketed within the UK. The products which will form part of the government’s review were identified as:
 
  • Primodos – a hormone based pregnancy test used widely in the UK between 1953-75 which campaigners allege has caused birth defects in their children
  • Sodium Valproate – a drug to control epilepsy, marketed in the UK since the 1970s and still available, that is alleged to have caused physical and cognitive birth defects in children born to mothers using the drug at the time of conception
  • Vaginal mesh – a medical device, still available in the UK, allegedly associated with extreme pain and damage to internal organs of patients who undergo implantation.
 
All three products have been in the news recently as a result of the harmful side effects caused to individuals using the products, or in the case of Primodos and Sodium Valproate the potential harm caused by these drugs to their unborn children.
 
Baroness Julia Cumberlege will head up the review process.
 
Boz Michalowska, product liability partner at Leigh Day commented: "Although the exact remit of the review is, as yet, unclear, we welcome the government’s decision to review the response of UK authorities to the reporting of adverse health effects associated with Sodium Valproate, Primodos and vaginal mesh.

"All three products were cleared by the MHRA, or its historic equivalent, and yet all are alleged to have caused harm in users or their unborn children. Clearly there are questions to be answered about the responsiveness of the UK’s regulatory bodies, and the steps that can be taken moving forward to better assist those affected by these products. It is vital for the safeguarding of all consumers in the UK that the government is responsive to campaigners and other groups who raise concerns about a product, transparency and rigour need to be at the heart of all of the government’s action when it comes to the clearance of medical  products in the UK".
 
All three products have been the subject of recent regulatory interventions: In respect of vaginal mesh, the UK government is currently in the process of carrying out an audit of the numbers of women in the UK with vaginal mesh implants: Regarding sodium valproate, the European Medicines Association is currently examining whether warnings about risks to unborn babies from the mother's use of sodium valproate are strong enough: Whilst last year the Commission on Human Medicines reviewed evidence concerning a causal link Primodos and birth defects and miscarriages after carrying out an inquiry.
 
It is understood that one of the objectives of the newly announced government review will be to assess whether or not a public inquiry is warranted into the way in which these products were cleared for usage in the UK.


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