Primodos was a hormone-based pregnancy test drug commonly used in the 1960's and 70's. However, after concerns were raised about the safety of the drug, it was withdrawn from the market but not before many women had used it.
Primodos was made up of two pills which was designed to induce a period in any woman who was not pregnant. However, for those women who were pregnant, it has been suspected for a long time that harm could be done to the foetus either resulting in the baby not being born at all or, if born, with life changing deformities including birth malformations; musculoskeletal disorders; heart defects; and brain injuries.
Suspicions about a link between such malformations and Primodos were raised as far back as 1978. A previous claim by a number of families was made against the manufacturer on or around 1982. However, due to there being insufficient evidence establishing a link between Primodos and the birth defects, the claim was eventually abandoned. Further, a Government review published in 2017 found there to be insufficident evidence of any link between Primodos and birth defects.
However, two much more recent reviews - one by Professor Carl Heneghan, Professor of Evidence based at Medicine at Oxford University and a second by Neil Vargesson, a senior lecturer at Aberdeen University Institute of Medical Science detailed information and researched data which they believe represents compelling evidence of a link between Primodos and several forms of malformation in babies.
On the strength of these reviews, a number of victims, represented by the firm SPG Law, have intimated letters of of claims to Bayer, the German pharmaceutical giant which took over Schering, the original manufacturers of Primodos. Letters have been sent out to Sanofi, who predecessor company Roussel produced a similar drug called Amenorone Forte.
Similar letters of claim have also been sent to the Department of Health accusing UK Regulators of not taking the appropriate steps to restrict or discontinue the drug at a time when the potential risks of the drug were well known. Further, lawyers representing the families are also investigating whether GPs followed advice to destroy prescription records to protect themselves from possible legal action.
Recent statements from both Bayer and Sanofi suggest they will defend any claim or court action vigorously on the basis that they do not consider that any connection between Primodos and birth malformations have been established to any meaningful extent. In such circumstances, the companies will no doubt be relying upon the information previously available at the time the claims were made in 1982 as well as, of course, the more recent Government review published in 2017.
Given the number of claimants involved and the potential value of each of the claims, it seems likely that if any such connection is to be established between Primodos and the malformations, it will have to be established by way of a lengthy trial in court. Any trial will, of course, involve a number of experts for each party presenting evidence to the court both for and against the proposition that there is a sufficient connection made between malformations and Primodos.
The obvious advantage, of course, of raising a class action on behalf of many claimants (and indeed there may well be other claimants out there not part of any action at the moment) is that the funding of such an action can be shared between many people. Undoubtedly, any action will be expensive but clearly the rewards of being able to establish such a claim will be significant for those involved in such an action. Watch this space.
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