A Wigan woman is hoping a bid to ditch hormone pregnancy test damages claims at the High Court will fail

The drugs, including Primodos, were given to women to test if they were pregnant from the 1950s until the late 1970s and are alleged to have been responsible for serious birth defects.

A group of claimants, which currently stands at 172, is suing Bayer Pharma, Schering Health Care, Aventis Pharma and the Government in a bid for compensation.

At a five-day hearing in London which started this week, lawyers for the drug companies and the Department for Health began a bid to have the case thrown out, arguing the claimants have “no real prospect of success” at a trial.

The defendants argue there is no evidence of a “causal association” between the hormone pregnancy tests (HPTs) and the harm suffered by the claimants.

Lawyers for the claimants said in court documents that they regard the evidence being relied on by the defendants as “unconvincing”.

The claimants contend they have evidence, are gathering further evidence from experts, and that the process is ongoing.

Speaking outside court ahead of the hearing, Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), said she was hopeful the group would “get justice” for the “thousands of children who have been damaged by hormone pregnancy tests”.

Ms Lyon, from Wigan, whose daughter Sarah Wilson was born in 1970 with a severe limb deformity, with half of her arm missing just below the elbow, said the group has had a “hard road” to get to this point, having fought since the association was set up in 1979.

She said: “To try to get to court with a medical negligence case is exceptionally difficult for two reasons: one, the drug companies fight it hard, and two, in this case the Government are actually colluding with the drug companies to fight as well and ask for our case to be struck out.

“So it is very, very difficult, but we have the evidence, we have both physical and scientific evidence, so I feel very confident that the judge will rule in favour of this going to a full trial.

“The Government is colluding with the drug companies to stop our case … and I find that reprehensible because what they are not doing is looking after families, they are looking after the drug companies.”

Addressing the court, Charles Gibson KC, on behalf of Bayer and Schering, told Mrs Justice Yip that the claims are “bound to fail, speculative and an abuse of the legal process”.

He also said it would not be “viable” for the case to proceed as the claimants have been unable, since the claims were filed in 2019, to secure funding or full legal representation.

Mr Gibson said at the start of the hearing that he will make “robust submissions” on the legal aspects of the case, but added: “We of course entirely recognise and have great sympathy for the claimants and recognise the great hardship they have endured and continue to endure, and nothing I say is intended to detract from that.”

He said the claims were an attempt to “re-litigate” proceedings against the pharmaceutical companies which were dropped in 1982.

At that time, the judge hearing the case set a hurdle for any potential future legal action to overcome, which was that there had to be a “scientific revolution or marked change in circumstances”.

Mr Gibson said scientific investigations over the past decade have “unanimously concluded” that it has not been established that HPTs cause congenital defects.

He said claimants have not shown they are able to overcome that hurdle or have a “real prospect of success” on the issue of whether the drugs caused the harm.

The barrister said in court documents: “They have already been afforded very generous time to do so. It is now three and a half years on and the claimants’ position is worse, having lost their solicitors.

“The abuse in this case strikes to the very heart of the claim – namely its lack of viability.

“The administration of justice would not be served by permitting a claim to proceed any further which is bound to fail, even on the claimants’ own evidence.

“There is only one proportionate response to those circumstances and that is to strike out the claim.

“It would be unjust for the defendants to continue to be put to the burden and expense of continuing to face these claims, claims which have been threatened and pursued at various times over the past 40 years.

“There has also been very significant scientific enquiry over the past 10 years into the question of a causal association between HPTs and congenital anomalies.

“This litigation cannot replicate that amount of scientific enquiry. Those enquiries have unanimously concluded that a causal association between HPTs and congenital anomalies has not been established.”

Lawyers for the Government said in court documents that there is no evidence put forward by the claimants of a causal link between the drugs and the harm suffered by them.

Leigh-Ann Mulcahy KC, representing the Government, said: “The (defendant) recognises at the outset that the individual claimants in this litigation have faced, and continue to face, real difficulties in everyday life as a result of their (or their family member’s) congenital malformations, and that they believe those malformations to have been caused by HPTs.

“This (document) is not intended in any way to minimise those difficulties or beliefs, but instead to assist the court to understand the (defendant’s) position in relation to the applications which it is required to determine.”

Lawyers for Aventis also argue that, having regard to the “clear and unequivocal scientific evidence”, the claimants are not able to overcome the hurdle and are “bound to fail on causation”.

Geraint Webb KC, for Aventis, said in written arguments that the company “recognises that the individual claimants in this litigation have a genuine and strongly held belief that they have suffered injury as a result of an HPT”.

He added: “Nothing in this document is indented to belittle or underestimate the difficulties which have been faced by the claimants or the strength of such feelings.”

Primodos first became available in the UK in 1959, with a user taking a pill on two consecutive days, and if women had a “withdrawal bleed” a few days later this meant they were not pregnant.

It was withdrawn from the market in 1978 after concern that it may have been responsible for congenital malformations, miscarriages and stillbirth in some cases, the court was previously told.

In July 2020, a review chaired by Baroness Cumberlege concluded there had been “avoidable harm” caused by Primodos and “opportunities were missed” to withdraw it from the market.

The Government apologised to women harmed by medical procedures and drugs examined by the review.

Baroness Cumberlege’s report said that “from 1967, hormone pregnancy tests should no longer have been available” due to the “suggestion of increased risk”.

The review also concluded that alternative pregnancy tests had become available and “the expression of any concern about risk should have led to action by the regulator. Failure to act meant that women were exposed unnecessarily to a potential risk”.

The healthcare system does not know how many people took an HPT such as Primodos, the review said.

ACDHPT has estimated that 1.25 million people took the drugs and thousands of families have allegedly been affected, though some may be unaware.

Campaigners have claimed that Primodos tablets were 40 times the strength of the contraceptive pill.

They alleged that the use of the medicine in early pregnancy has caused a range of lifelong impacts such as limb defects, spina bifida, congenital heart defects or developmental and learning problems.

It has also been claimed that the use of the drug led to miscarriages or stillbirths.

The Cumberlege review stressed that the scope of the inquiry was not to determine a causal association between HPT use and physical malformations but examined the UK’s decision making around the drugs in the healthcare system.

When HPTs first became available, the regulatory framework that guides medicines was not in place, with rules introduced after the thalidomide scandal.

The hearing is due to conclude on Tuesday next week and Mrs Justice Yip is expected to give her decision at a later date.