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Campaigners who believe their babies were harmed by a pregnancy drug have returned to the High Court for the first time in over 40 years.
Over 100 claimants are attempting to rekindle their case against the manufacturer of the drug Primodos after their first attempted litigation collapsed in 1982.
They are also attempting to sue the Department of Health for failing to properly regulate the drug after concerns arose about it in the scientific community in the late 1960s.
The government apologised to the families in 2020 after an independent review team found the drug had caused "avoidable harm".
However, three years on, the government is attempting to "strike out" the families’ claim in court, alongside lawyers representing the manufacturer.
Charles Gibson KC, representing pharmaceutical company Bayer, argued that the claimants’ case was "bound to fail" and therefore should not be granted a full hearing.
He said there was no new evidence since the previous trial collapsed other than submissions that were "wholly speculative and demonstrably flawed".
He also said the claimants had been given extra time to demonstrate how they would fund their legal action.
"The brutal fact remains, despite generous time, they have been unable to do so," he added.
The claimants – who started a crowdfunding page last year – admit they still do need extra time for this.
But they will argue they have strong new evidence of an association between the drug and malformations to babies in the womb.
Primodos was a hormone packed drug used in the 1960s and 70s for regulating a woman’s mensural cycle – then adapted and promoted as a pregnancy test – that would trigger a woman’s period if she was not pregnant.
The alarm about the drug was first raised by scientist Isabel Gal in 1967.
Her research suggested a higher number of babies with spinal defects had been born to women who had used the pregnancy test drug Primodos.
But it remained on the market for years until further studies pointed to a link with other abnormalities in the foetus, and a warning appeared on the packet in 1975 saying it must not be taken unless it was certain the patient was not pregnant.
Campaigners and Sky News have in recent years uncovered more evidence of a link between the drug and birth defects – including archives in Berlin suggesting the British regulator found there was a significant risk to the foetus, but he had destroyed all the material on which his investigation was based.
In 2019, victims gave evidence to an independent review which a year later concluded the drug had caused "avoidable harm" and recommended redress be paid to the victims.
The health secretary at the time, Matt Hancock, apologised to the victims.
Despite the apology, three years on, there’s been no compensation and lawyers are trying to strike out their claim.
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Marie Lyon, a mother who used Primodos, has fought for decades for recognition from the government and the manufacturer that hundreds of children were affected by the drug.
Outside court, she said: "We were quite positive when we saw the apology on Sky News.
"But when we went back to the government and said ‘you’ve apologised, what are you going to do about it? Our children need to be cared for’, the response was: ‘Oh no, we didn’t apologise because we felt we’d done anything wrong, we just apologised because it had taken so long to listen to your concerns’.
"And I just found that mealy-mouthed. It was a PR thing."
Health Secretary Steve Barclay told Sky News: "There is a court case on that, so it’s important that one allows the legal process to follow its course, so you wouldn’t expect ministers to comment on issues that are before the court.
"But Baronness Cumberlege obviously made a series of recommendations; we’ve been working our way through to implement those. We’ve been taking her report extremely seriously."
The manufacturer Schering, now owned by Bayer, said: "Bayer denies that Primodos was responsible for causing any congenital anomalies in children, miscarriages or stillbirth.
"Since the discontinuation of the legal action in 1982, Bayer maintains that no significant 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 anomalies.
"In 2017, the Expert Working Group of the UK’s Commission on Human Medicines published a detailed report concluding that the available scientific data from a variety of scientific disciplines did not support the existence of a causal relationship between the use of sex hormones in pregnancy and an increased incidence of congenital anomalies in the newborn or of other adverse outcomes such as miscarriage."
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