Primodos 2023: The Fight for Justice Continues for the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT)

A five-day hearing is scheduled to take place at the Royal Courts of Justice from May 2nd to May 9th, 2023, which marks a significant milestone in the civil litigation case related to Primodos. This demonstrates the unwavering determination of the affected families to pursue justice despite facing adversity. Nevertheless, the Department of Health and Social Care (British government) and German pharmaceutical company Bayer have filed applications to strike out the court proceedings. They contend that the plaintiffs' statement of case discloses no reasonable grounds for bringing or defending the claim regarding Primodos, a hormone pregnancy test alleged to have caused harm.

 

Lord Markham, the Parliamentary Under Secretary of State at the Department of Health and Social Care, has confirmed that the department has applied to strike out a claim made by a group of individuals who allege that hormone pregnancy tests caused them harm. This decision was influenced by the findings of the Expert Working Group’s report on hormone pregnancy tests, which was published by the UK's Commission on Human Medicines in November 2017.

 

Bayer, a multinational pharmaceutical and biotechnology company, has claimed that no new scientific evidence has emerged to contradict their prior assessment of the safety of Primodos, a drug manufactured by Schering which they acquired in 2006. According to a company spokesperson, this lack of new scientific knowledge means there are no reasonable grounds for litigation or a need to defend against a claim.

 

It appears that both Bayer and the Department of Health and Social Care are relying on a report by the Expert Working Group set up by the Medicines and Healthcare Products Regulatory Agency to support their strike out applications. This report in question, issued in November 2017, concluded that there was no scientific evidence to support a causal link between the use of hormonal pregnancy tests like Primodos and adverse outcomes such as miscarriage, stillbirth, or congenital anomalies.

 

It is important to note, however, that this report has been subject to criticism and controversy. This is because it was explicitly not within the remit of the Expert Working Group to make official recommendations or conclusions. Several have argued that the Expert Working Group did not consider all of the available evidence and that the report's conclusions were influenced by industry interests. Some members of parliament have even labelled the findings as a "whitewash." Others have pointed out that the report's scope was limited and did not fully address the concerns of those who believe that Primodos and similar drugs may have caused harm.

 

The Expert Working Group was referred to as an "Independent" group in a press release by the UK's Commission on Human Medicines, even though it was established by the Medicines and Healthcare Products Regulatory Agency, which is sponsored by the Department of Health and Social Care. This is significant because the department has a history of allowing Primodos to be sold on the British market, despite concerns about its safety. This clear potential for conflicts of interest raises serious questions about whether the Expert Working Group has the agency to conduct an objective and impartial investigation independently from government influence.

 

Back in 1982, the legal team representing the families discontinued their legal action, believing that it was unlikely to prove that Primodos was responsible for the alleged congenital abnormalities. After the discontinuation, the case was left open, and the judge made it clear that the plaintiffs were free to pursue the case again if new evidence linking Primodos to birth defects emerged, which is what they claim has happened. Therefore, the British government and Bayer's attempts to strike out the case should be rejected because of the emergence of new scientific evidence.

 

On July 8th, 2020, the Independent Medicines and Medical Devices Safety Review published its report First Do No Harm. The independent review spanned a period of two years and involved an extensive analysis of evidence, encompassing written material, oral hearings and personal testimonies, among other sources, to draw its conclusions and formulate recommendations. The review made nine recommendations and proposed 50 actions for improvement, including the establishment of a Redress Agency and Schemes to cover the cost of care.

 

In a press release, Baroness Julia Cumberlege, the chair of the Independent Medicines and Medical Devices Safety Review, acknowledged that the healthcare system had failed to fulfil its first duty of ‘doing no harm’ to patients. The report emphasised the need for changes in the healthcare system to ensure that patients receive the best possible care and that the system is held accountable for any harm caused to patients. This admission of failure, along with the proposed recommendations and actions, was a departure from the previous report by the Expert Working Group.

 

During the Oral Hearing Sessions of the Independent Medicines and Medical Devices Safety Review on November 27th, 2018, Professor Carl Heneghan brought several issues to the committee's attention regarding the Working Group Report's findings. Professor Heneghan is the Professor of Evidence-Based Medicine in the Department of Primary Care Health Sciences at the University of Oxford.

 

He identified several concerning omissions and errors in the report. One of them was that the report combined two completely different treatments, namely oral contraceptives and hormone pregnancy tests. Additionally, the report was not constructed using systematic review methods and did not use standard methods for appraising quality. Sensitivity analysis was also not carried out. Finally, the report's draft version contained a meta-analysis that provided a pooled relative risk in the forest plots, which was omitted from the final report.

 

Professor Heneghan is a seasoned researcher with over a hundred systematic reviews under his belt. He conducted a systematic review and meta-analysis on Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis. This study has undergone peer review and is indexed on PubMed.

 

According to Professor Heneghan, the evidence indicates an association between hormone pregnancy tests and "congenital malformations, congenital heart disease, musculoskeletal, neurological and a syndrome vacterl". He submitted a report to the Independent Medicines and Medical Devices Safety Review, where he presented his findings and concluded:

Extract from Professor Carl Heneghan's report on Hormone Pregnancy Tests, submitted to the Independent Medicines and Medical Devices Safety Review  in December 2018

 

At the Oral Hearing Sessions of the Independent Medicines and Medical Devices Safety Review on November 27th, 2018, Professor Neil Vargesson, a developmental biologist from the University of Aberdeen, presented evidence from a preliminary study involving the injection of human synthetic hormones into zebrafish embryos. The study showed varying results, with high doses of the drug  causing defects in the head, brain, nervous system, blood vessels, ears, eyes, and spine, and lower doses causing more subtle damage such as smaller eyes and heart problems.

 

Zebrafish embryos were chosen for the study due to their genetic similarity to humans, sharing 70% of the human genome, with 87.5% of the common genes seen in human birth defects. The study The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafish embryos, was published in February 2018. It specifically examined the effects of the synthetic hormones found in Primodos, Norethisterone acetate and Ethinyl estradiol, and found that these components caused developmental abnormalities in the embryos. The results of the study concluded:

Extract from a study published in February 2018, The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafish embryos

 

Over several decades, numerous epidemiological studies and animal experiments have been conducted to investigate the teratogenic effects of Hormone Pregnancy Tests, including Primodos. These studies suggest that the use of such tests can potentially cause birth defects, such as neural tube closure defects, cleft lip and palate, limb defects, and cardiovascular defects in humans, as well as and brain malformations, genital malformations in fetuses, embryonic death, and abortion in animal experiments. However, it is important to take into account the historical context of some of these studies and the limitations of the technology and methods used at the time of their execution. Despite these limitations, the studies listed below offer possible connections between Hormone Pregnancy Tests, particularly Primodos, and birth defects and other health issues.

 

2010s: Heneghan. et al. (2018),  Brown. et al. (2018), Tummler. et al. (2014)

2000s: Maier. et al. (2001)

1980s: Kricker. et al. (1989), Hendrickx. et al. (1987), Joshi. et al. (1983)

1970s: Rothman. et al. (1979), Nora. et al. (1978), Janerich. et al. (1977),                                  

Gal. (1976), Greenberg. et al. (1975), Janerich. et al. (1974),  David., & O’Callaghan. (1974), Oakley. et al. (1974), Gal. (1972), Gidley. et al. (1970)

1960s: Gal. et al. (1967), Johnstone. et al. (1964)

 

The British government's attempt to strike out the litigation filed by the families affected by Primodos is further compounded by their use of public funds - which come from taxpayers - to defend their actions in the legal dispute. The use of public funds to defend their failures is highly unjust, especially considering the role of the government in overseeing healthcare and ensuring patient safety. This raises concerns about the fairness of the legal process, particularly given the obstacles that ordinary families face when pursuing legal action against powerful organisations like the Department of Health and Social Care (which is part of the British government) and Bayer (one of the largest corporations in the world).

 

In a stark contrast to the government's approach, families impacted by Primodos use have opted for a more grassroots effort to pursue justice. They have taken matters into their own hands and launched crowdfunding campaigns, with the support of the British actor and political activist Ricky Tomlinson, to raise funds and strengthen their legal representation. Two of the current campaigns include:

 

• Crowd Funder – Official 22/23 Autographed Liverpool FC Shirt.

The winner of this campaign was announced live on Facebook by Ricky Tomlinson on Sunday, April 2nd, 2023 at 7pm.

• Crowd Funder – A Collette Collinge Limited Edition Framed.

The winner of this campaign was announced live on Facebook by Ricky Tomlinson on Wednesday, March 1st, 2023 at 7pm.

 

The Primodos-affected families have been on a long and challenging journey to achieve justice spanning almost five decades. Sadly, the passage of time has also resulted in the tragic loss of many members who fought tirelessly for accountability and redress. Marie Lyon, Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, stated, "In 2014, new scientific evidence was presented to the British government. Since this time, a further 36 of our members have died waiting for the government to acknowledge responsibility."

Image information shared by Marie Lyon, Chairwomen of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), with the consent of the families of the deceased members

It is imperative that the legal system acknowledges and confronts the damage inflicted upon the families affected by the use of Primodos. This case cannot be disregarded, and those responsible for manufacturing and distributing the medication must be held responsible. The families have endured prolonged agony and hardship, and they are entitled to a just opportunity to seek reparations and legal redress. The justice system must ensure that the families impacted by Primodos have access to a clear and unbiased legal system that considers the harm they have suffered, and the necessity for accountability. The time has arrived to dispense justice and grant the affected families the closure that is rightfully theirs.

 

If you are interested in reading more about this injustice, Sharon Hartles has published several articles on the Harm and Evidence Research Collaborative blog that may be of interest:

 

Primodos: Financial redress is long overdue

Primodos, Mesh and Sodium Valproate: Recommendations and the UK Government’s response

Primodos: The next steps towards Justice

Primodos: The first step towards Justice