Parents who say their babies were damaged by a pregnancy test drug have warned manufacturers and the government that they are preparing to take legal action.
Lawyers representing more than 200 claimants have written letters accusing two drug companies and the UK regulators of being negligent and putting patients at risk.
The drug Primodos was given to women in the 1960s and 70s. It was made up of two pills which would induce a period in women who were not pregnant. However, many families believe that if the mother was pregnant, it damaged or even killed their children in the womb.
If successful the claim could be worth millions as the alleged victims all suffer with a variety of life-changing difficulties, including limb malformations, musculoskeletal abnormalities, heart defects and brain injuries. Some parents are also claiming still births were caused by the drug.
The proposed legal action follows a Sky News investigation in 2017 where we found documents in German archives showing manufacturers were warned by UK regulators that those using the drug had an increased risk of malformations – and that records from that study appeared to have been deliberately destroyed in order to frustrate any future legal action.
Our investigation also found the drug was being used in other countries, at higher doses, to induce abortions, and that there had been a legal settlement in the 1970s in the US against a drug made up of the same components.
Marie Lyon, from the Association For Children Damaged by Hormone Pregnancy Tests, said: My overwhelming feeling is relief that we finally have the opportunity to expose the truth about these drugs and the failures of the regulators.
We are so grateful SPG Law has chosen to represent us but unbearably sad that many of our members are no longer alive to see justice finally served.
We first started our campaign in 1978. It has taken 41 years to reach this milestone but today makes it all worthwhile. Our day in court will finally reveal the truth and allow us to move on with our lives.
Lawyers representing the families have told Sky News that they are also investigating whether GPs followed advice to destroy prescription records to protect themselves from legal action.
Recipients of the letters include German pharmaceutical giant Bayer, who took over Schering, the manufacturers of the drug Primodos. Also, Sanofi, whose predecessor company Roussel produced a similar drug called Amenorone Forte.
The manufacturers are accused of marketing the pills without establishing whether they were safe. Lawyers also say they delayed removing the drug when concerns first emerged about the risks it posed to the unborn fetus.
The claim made against the Department of Health also accuses UK regulators of not taking the appropriate steps when the potential risks of the drug first emerged.
Lisa Lunt, from SPG Law, represents the claimants.
She told Sky News: They placed the drug on to the market without any prior toxicology testing. I find that astonishing considering that this was a pregnancy test given to women and it had no therapeutic benefit whatsoever.
And when concerns were first raised about the safety of the test they didn’t act quickly enough either suspending the drug or removing it from the market.
A previous claim by families was abandoned in 1982, and a government review published in 2017 found there was insufficient evidence to show a causal association between the drug and defects to babies in the womb.
However, last year an Oxford University team led by professor of evidence based medicine, Carl Heneghan, produced an analysis of data relating to Primodos and found a clear association with several forms of malformation.
Also in 2018, Neil Vargesson, senior lecturer at Aberdeen university’s Institute of Medical Sciences, published research showing deformations to zebra fish embryos just hours after they received a dose of Primodos components.
In a statement, Bayer told Sky News it denies Primodos was responsible for causing any deformities in children.
It said: Since the discontinuation of the legal action in 1982, no new scientific knowledge has been produced, which would call into question the validity of the previous assessment of there being no link between the use of Primodos and the occurrence of such congenital abnormalities.
In response to the Oxford University research, it added: The UK (through the Medicines and Healthcare products Regulatory Agency) asked that the Committee for Human Medicinal Products, which is the main expert scientific body of the European Medicines Agency, to conduct an independent assessment of these publications.
In opinions of 2018 and 2019 respectively, these studies have been found by the CHMP to have many limitations such that it was not appropriate to treat the results as reliable.
Therefore we believe this action to be without merits and will defend our position vigorously and, if necessary, in court.
Sanofi said: The Commission on Human Medicines Expert Working Group on Hormone Based Pregnancy Tests (HPTs) concluded in 2017 that the available scientific evidence does not support a causal association between the use of HPTs during early pregnancy and adverse outcomes, either with regard to miscarriage, stillbirth or congenital abnormalities.
Sanofi heritage companies ceased the commercialisation of HTP products over 40 years ago and have no evidence that can add to the conclusions reached by the CHM Expert Working Group.