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Hormone Pregnancy Test group litigation – successful strike-out of claims against pharmaceutical manufacturers and the UK Government

Hormone Pregnancy Test group litigation – successful strike-out of claims against pharmaceutical manufacturers and the UK Government

Robert Dickason of Outer Temple Chambers and Leigh-Ann Mulcahy KC of Fountain Court Chambers acted for the Secretary of State for Health and Social Care in litigation arising from the use of hormonal pregnancy test (HPT) tablets taken to diagnose pregnancy in the 1950s-1970s.

In this group litigation, over 200 claims were issued against the pharmaceutical manufacturers of two HPTs (Primodos and Amenorone Forte), as well as against the Government on the basis that it was responsible for safe regulation of HPTs in the 1950s-1970s. The claimants maintained that HPTs taken during pregnancy had caused them to suffer congenital malformations, miscarriage and/or stillbirth.

Previous litigation brought in the 1970s-80s had also sought to prove that HPTs caused congenital malformations, but had to be discontinued in 1982 shortly before trial on the basis that there was no real prospect of proving causation.

The synthetic hormones contained in HPTs remain in widespread use internationally, including for the treatment of gynaecological conditions and as part of the combined oral contraceptive pill. Any indication that these hormones could be unsafe in pregnancy would be of profound importance in modern medicine. However, a detailed review by the Commission on Human Medicines between 2015 and 2017 concluded that the available scientific evidence did not support a causal association between HPT use and adverse outcomes in pregnancy.

Following service of Generic Particulars of Claim, the defendants applied to strike out the claims, contending that the claimants had no real prospect of proving that HPTs had caused the range of injuries alleged, contrary to the conclusions reached by the Commission on Human Medicines. Notwithstanding the developments in science and medicine in the intervening decades, the claimants were no more able to prove causation today than they were in 1982.

On 26 May 2023, following a 4-day hearing, the High Court granted the defendants’ applications and struck out the claims. Mrs Justice Yip concluded that, on all the evidence before her, the claimants had been unable to demonstrate an arguable case on causation and hence that it would be an abuse of process to permit the litigation to continue.

Read the full judgment

A link to the judgment Wilson and Others v Bayer Pharma AG and Others [2023] EWHC 1280 (KB) is available to view here.

Find out more

Robert Dickason is consistently ranked as a leading junior in clinical negligence in both Legal 500 and Chambers & Partners.

He acts for patients, Trusts, private providers and individual clinicians alike in civil claims and at inquests. His practice spans the full clinical spectrum. He is instructed in the most complex liability and quantum disputes. He has particular expertise on matters of causation and in clinical negligence cases involving members of the Armed Forces or public law aspects. He was appointed to the Attorney General’s B Panel in 2020 (formerly C Panel).

To find out more on Robert, contact Paul Barton on +44 (0)20 7427 4709 or Ben Fitzgerald on
+44 (0)203 758 4759.

News 2 Jun, 2023


Robert Dickason

Call: 2007

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