Primodos Litigation Lawsuit

Primodos Litigation

The Primodos litigation concerns a hormone product sold by the German pharmaceutical company Schering AG and used by women in the 1960s and 1970s. Pregnant women in several countries who took Primodos alleged that the drug caused severe birth defects in their children. Litigation in the 1980s ended inconclusively, with the proceedings discontinued with the court's approval, and the scientific question has since been revisited by UK regulators and independent review bodies.

Product and manufacturer

Primodos was a hormone-based product made by Schering AG, a German company that was later acquired by Bayer AG. It was first made available for sale in the United Kingdom in 1959 and was withdrawn from sale there in 1978. The best-known form was a hormonal pregnancy test: two pills containing norethisterone (as the acetate) and ethinylestradiol that induced menstruation in women who were not pregnant, so that the presence or absence of bleeding indicated whether the user was pregnant. The product was also used by pregnant women, including for morning sickness, and a similar hormonal pregnancy test was in use in Germany over the same period.

The alleged defect and the harm

In the 1960s, research by Isabel Gal at Queen Mary's Hospital for Children reported a link between exposure to the drug and severe birth defects in babies. A review by the UK's Committee on Safety of Medicines in the 1970s concluded that the product should not be used by pregnant women. The families of affected children alleged that the hormone combination was responsible for the disabilities their children suffered, rather than the pregnancy itself.

Litigation

In the 1980s, litigation was brought over these claims. This record does not list a court or a docket number for the proceedings. The case was resolved as a dismissal: the proceedings were discontinued with the court's approval, without a final adjudication on the merits, and the record does not assign a specific resolution year. The result left the scientific and legal questions open.

Aftermath

Regulatory and scientific review of the product continued long after the litigation. In 2014, the Medicines and Healthcare products Regulatory Agency reviewed the studies performed to date and assessed the evidence for adverse effects as inconclusive. In November 2017, an expert working group of the UK Commission on Human Medicines concluded that there was no causal association between Primodos and severe disabilities in babies, and it recommended that families who had taken a hormone pregnancy test and experienced an adverse pregnancy outcome be offered genetic testing to establish whether a different underlying cause existed.

The controversy also left a dispute over the archival record. A Schering memo cited by later reviewers stated that the senior investigator of the regulatory review had destroyed the material on which his investigation was based, allegedly to prevent individual claims from using it.

In 2020, the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege, reported that avoidable harm had resulted from the use of Primodos. It recommended that the government issue an apology to the families affected and that the manufacturer recognise what had happened and make ex-gratia payments to those who had suffered.