For nearly 50 years campaigners have fought for recognition that a pregnancy test drug called Primodos, given to them by their GPs, damaged babies in the womb.
Earlier this year High Court Judge Mrs Justice Yip ruled there was insufficient new evidence to support their claim, and the claimants did not have the funds nor legal representation to take their challenge further, after their solicitors dropped the case.
The case was struck out, leaving the claimants potentially liable for costs.
Now they have been sent a letter by lawyers representing the Department Of Health and drug manufacturer Bayer saying that, unless they commit to never making another claim, they will have to pay the legal bills of the lawyers used to block their joint action.
Marie Lyon, from the Association for Children Damaged by Hormone Pregnancy Tests, told Sky News: “It constitutes bullying and intimidation.
“They want us to sign a form to say we will never ever initiate any legal action in the future no matter what kind of evidence emerges.
“Otherwise, they will slap that £10m plus on our families. I am absolutely disgusted with our government – not only did they damage us initially, but now they are actually asking us to pay for it.”
The drug was given out by GPs to pregnant women in the 1960s and 70s but withdrawn from the market in 1978 after concerns were raised in the scientific community about an association between the drug and malformations.
However, the first attempted legal challenge against the manufacturers in 1982 failed.
In 2017, an Expert Working Group of the UK’s Commission on Human Medicines published a report concluding that the available scientific data did not support the existence of a causal relationship between the use of hormones in pregnancy and an increased incidence of congenital anomalies in babies.
However, the then prime minister, Theresa May felt the body of the report also contained evidence that there might be an association.
She commissioned an independent review, led by Baroness Cumberlege, not just to look at the drug but also the way in which it was regulated in the UK.
The findings of that report, published in July 2020, were highly critical of the regulatory system – and suggested Primodos should have been withdrawn from the UK market 10 years earlier than it was.
It found Hormone Pregnancy Tests caused “avoidable harm” and said the government should apologise and set up a system of redress.
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2:26
May 2023: Primodos families lose legal bid
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The government did apologise, but shortly after, the Department Of Health hired lawyers, sided with the German manufacturer, and ensured that a new the legal claim from families was struck out of the courts.
All this led to a debate in Parliament on Thursday where Mrs May told the House, that mothers wrongly felt guilty about taking the drug and damaging their babies.
She said: “This drug was given to them by their GPs, and I hope the minister will stand up this afternoon and say very clearly the women who took Primodos, whose children suffered, were at no fault whatsoever, and should not feel guilty at all. The fault lay with the NHS.”
Leader of the Liberal Democrats Ed Davey said: “This is in my view potentially one of the biggest cover-ups of a pharmaceutical outrage the world has ever seen.”
Jacob Rees-Mogg pointed to findings from a previous Sky News investigation saying: “This drug was used in South Korea, and in Germany, as an abortifacient.
“It was used to procure abortions. Well, what is a drug that will do that doing to a baby?”
Until now the government has said it has not been able to discuss issues of redress due to the legal claim against it.
The Minister for Women’s Health Maria Caulfield has offered to meet the families and in regard to the letter about legal costs said: “The letter that’s gone out to those taking part in court cases – I will look at that – because I don’t want to be in a position where people feel they cannot get justice simply because they cannot afford to do so.”
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1:38:34
Primodos: A Bitter Pill
The SNP’s Hannah Bardell blamed the failed legal action on the solicitors who pulled out of representing the claimants.
“They’ve been done over – and I am going to use my parliamentary privilege here – by a company called Pogust Goodhead,” she said.
“Now they approached the Primodos campaign, they approached them to take over the case, they then got cold feet and decided to drop the claimants and the victims when they didn’t fancy their chances of winning.
“Not only to compound that, they went on to withhold the documents that constituents like mine, Wilma Ord, had presented to them and given to them to pursue the case.
“That prevented the campaign from being able to find other legal representation and fundamentally has meant that the campaign was unsuccessful in court. That in my view is a hostile and odious move by any legal firm.”
When Sky News previously approached the legal firm with this allegation in April this year, Pogust Goodhead said: “We refute the suggestion that we are withholding information to damage this case.
“We are aware that the claimants have been provided with 1,256 pages of legal documents containing information which should assist with their search for legal representation and funding.
“We have not been notified that there is another law firm on the court record as acting for any of the individuals we represented. We are bound by a duty of confidentiality and must adhere to strict rules in relation to disclosure of any former client’s documentation.
“We poured extensive resources into this case because we care deeply about the injustice and harm caused to any victim of wrongdoing that has resulted in injury.”
The manufacturer Schering, now owned by Bayer, has always denied that their drug caused harm to babies in the womb and point to the findings of the 2017 Expert Working Group report.
It added: “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 occurrence of such congenital anomalies.”