An attempt by more than 100 UK families to seek compensation for birth defects they say were caused by the hormone-based pregnancy test Primodos has been struck out by the high court.
The families, who believe their babies suffered a range of congenital abnormalities due to the drug, were hoping to rekindle a civil case against the manufacturer after a previous attempt collapsed in 1982. However, Mrs Justice Yip ruled that there was insufficient new evidence to demonstrate a causal link between the tests, which were used until the 1970s, and congenital malformations, and that as a result the families did not have a realistic chance of succeeding in their claim.
“There has not been a scientific revolution, or anything approaching one,” she said, in a written judgment published on Friday. “There remained insufficient evidence [in 1982] to demonstrate a causal association. That is still the position today.”
Primodos was a hormone-based drug used between the 1950s and 70s for regulating a woman’s periods, which was then licensed and promoted as a pregnancy test. If a woman was not pregnant they would start their period. No bleeding indicated pregnancy. However, concerns were raised in 1967 by the scientist Isabel Gal, who found a higher proportion of mothers whose babies had birth defects had used the tests. The test remained available until the 1970s and it was only in 1975 that pregnancy became a contraindication for using the drug.
Several studies since have suggested evidence for a link and the Cumberlege review, published in 2020, concluded the drug had caused “avoidable harm” and recommended compensation be paid. Matt Hancock, the health secretary at the time, apologised to the victims, though the government has not subsequently taken forward the recommendation that a redress scheme be drawn up.
The manufacturer Schering, now owned by Bayer, denies Primodos was responsible for causing any congenital anomalies, miscarriages or stillbirth.
Speaking after the judgment, Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests, said: “I’m profoundly disappointed, but the result wasn’t unexpected. It’s just a bump in the road and our journey continues.
“I’m confident that justice will eventually be served, just not today.”
Lyon, whose daughter was born with an arm that did not form below the elbow after she took the pills during pregnancy, rejected the suggestion that the latest scientific evidence was insufficient to demonstrate harm. “We have new evidence and we’re awaiting further studies to show these components cause harm,” she said.
Prof Carl Heneghan, a clinical epidemiologist at the University of Oxford, who led a systematic review into Primodos in 2018, said: “It’s unacceptable that those advocating for justice regarding the effects of hormone pregnancy tests on congenital malformations have not been allowed to have their case heard in court.
“There are misconceptions about using epidemiological evidence for proving causation that should be addressed in a court of law. But a lack of financial resources has made it impossible for the defendants seeking to have their day in court.
“This is a concerning barrier to achieving justice, and it will only make it more difficult for people to seek retribution for harms in the future.”
In a statement, Bayer said: “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.”