British families lose compensation offer for Primodos pregnancy test | Drugs

An attempt by more than 100 British families to seek compensation for birth defects they believe were caused by the Primodos hormonal pregnancy test has been rejected by the High Court.

The families, who believe their babies suffered from a series of drug-induced birth defects, hoped to revive a civil suit against the manufacturer after a previous attempt in 1982 failed. However, Judge Yip ruled that ‘there wasn’t enough new evidence to show a causal link between the tests, used until the 1970s, and birth defects, and families therefore had no real chance of success at their request.

“There was no scientific revolution, or anything like it,” she said in a written judgment released Friday. “There remained insufficient evidence [in 1982] to demonstrate a causal association. This is still the case today. »

Primodos was a hormone drug used between the 1950s and 70s to regulate a woman’s period, which was later licensed and promoted as a pregnancy test. If she was pregnant, the drug would induce a period and no bleeding was a positive result. However, concerns were raised in 1967 by scientist Isabel Gal, who found that a higher proportion of mothers whose babies had birth defects had used the tests. The test remained available until the 1970s and it was not until 1975 that pregnancy became a contraindication to the use of the drug.

Several studies have since suggested evidence of a link and the Cumberlege review, published in 2020, concluded that the drug had caused “avoidable harm” and recommended that compensation be paid. Matt Hancock, the then health secretary, issued an apology to the victims, although the government did not subsequently act on the recommendation to draw up a reparations plan.

Manufacturer Schering, now owned by Bayer, denies that Primodos is responsible for birth defects, miscarriages or stillbirths.

Speaking after the judgment, Marie Lyon, president of the Association for Children Damaged by Hormonal Pregnancy Tests, said: “I am deeply disappointed, but the result was not unexpected. It’s just a bump in the road and our journey continues.

“I am convinced that justice will eventually be served, but not today.”

Lyon, whose daughter was born with an arm that did not form below the elbow after taking the pills while pregnant, dismissed the suggestion that the latest scientific evidence was insufficient to show harm. “We have new evidence and are awaiting further studies to show that these components cause harm,” she said.

Professor Carl Heneghan, a clinical epidemiologist at the University of Oxford who led a systematic review of Primodos in 2018, said: “It is unacceptable that those advocating for justice regarding the effects of hormonal pregnancy tests on birth defects were not allowed to have their case heard in court.

“There are misconceptions about using epidemiological evidence to prove causation that should be addressed in court. But a lack of financial resources has made it impossible for defendants looking to spend their day in court.

“This is a concerning obstacle to obtaining justice, and it will only make it harder for people to seek revenge for wrongs in the future.”

In a statement, Bayer said: “Since the court action was discontinued in 1982, Bayer maintains that no significant new scientific knowledge has been produced that would call into question the validity of the previous assessment that it there was no link between the use of Primodos and the occurrence of such birth defects.