The latest hearing in legal action over a hormone pregnancy test blamed for causing serious birth defects is due to take place at the High Court.
More than 200 people who claim to have been caused harm by the drug Primodos, which was given to women to test if they were pregnant from the 1950s until the late 1970s, are suing Bayer Pharma, Schering Health Care, Aventis Pharma and the Government in a bid for compensation. Some of those bringing a legal challenge are expected to gather outside the Rolls Building in central London ahead of a hearing before Mrs Justice Yip starting on Tuesday.
The five-day hearing is due to cover the defendants’ bid to have the cases against them thrown out by the court without a trial. 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 It was withdrawn from the market in 1978 following concern that it may have been responsible for causing congenital malformations, miscarriages and stillbirth in some cases,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 that “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 that “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 a hormone pregnancy test (HPT) such as Primodos, the review said.
The Association For Children Damaged By Hormone Pregnancy Tests has estimated that 1.25 million 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.
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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 instead examined the UK’s decision making around the drugs in the healthcare system. When HPTs first became available, the regulatory framework which guides medicines was not in place, with rules introduced after the thalidomide scandal.
Former prime minister Theresa May has previously urged the Government to consider “redress” for Primodos victims. MPs warned earlier this year that families who have suffered “decades of hurt” after medical treatments led to avoidable harm “have waited too long” for redress or compensation.
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