Trial Date Has Been Set in MDL against Pfizer for Depo-Provera Overseen by Levin Papantonio
- Number of Lawsuits Increases Fivefold to Over 2,100 Since May
- FDA Approves Brain Tumour Warning
- Global pharmaceutical company Pfizer Inc. (NYSE:PFE), manufacturer of contraceptive injection Depo-Provera (DMPA), is facing a Multidistrict Litigation (MDL No. 3140) in the USA being brought on behalf of women who developed an intracranial meningioma, a type of brain tumour, after using Pfizer's Depo-Provera.
- 2,132 women in the US have filed lawsuits against Pfizer, representing a fivefold increase since May.
- A link between Depo-Provera and a type of brain tumour was found in peer-reviewed studies, and lawsuits allege that Pfizer did not warn about this risk.
- This litigation followed a study by EPI-PHARE (Roland et al.) published in March 2024 in the British Medical Journal, which found that women who had used the Pfizer contraceptive injection Depo-Provera1 for more than one year were 5.6 times more likely to develop an intracranial meningioma.
- An estimated 74 million women globally receive Depo-Provera injections according to a 2019 UN study2. Also, according to the UN, 247 million worldwide are on hormonal contraceptives34.
- The FDA approved a warning label change in December for Pfizer's contraceptive injection Depo-Provera, adding a brain tumour warning.
At a Case Management Conference in the Multi District Litigation against Pfizer Inc. (NYSE:PFE), the Honorable M. Casey Rodgers set a date for the first Trial, which will take place in December 2026, as more than 2,100 women pursue litigation alleging Pfizer failed to adequately warn patients despite long-standing knowledge of the risk.
The hearing took place within days of the The US Food and Drug Administration (FDA) approving a label change to Pfizer's contraceptive injection Depo-Provera, adding a warning about the risk of intracranial meningioma, a type of brain tumour.
These cases have been filed across the Depo-Provera Multidistrict Litigation and the New York and Delaware Litigations against Pfizer. The fivefold increase in filings since May reflects the number of individuals who have reported serious harm to their health and subsequently identified an association between their use of Depo-Provera and a diagnosis of intracranial meningioma.
One of the law firms appointed to the Plaintiff's Executive Committee responsible for overseeing the MDL is Levin Papantonio, which has helped to secure more than $80 billion in jury verdicts and settlements against some of the world's largest corporations, including Johnson & Johnson, BP, Dupont, 3M, Merck and big tobacco. The law firm is currently acting for plaintiffs in the Talcum Powder Litigation against Johnson & Johnson (NYSE:JNJ) and the Preterm Infant Nutrition Products Liability Litigation against Abbott Laboratories and Mead Johnson, owned by Reckitt Benckiser (LON: RKT).
Virginia Buchanan, Partner at Levin Papantonio and court-appointed co-chair of the Plaintiffs' Executive Committee and member of the Trial Committee, said: "Following the decision by the FDA to approve a brain tumour warning for Depo Provera and the Judge setting the first trial date for December 2026, women around the country are a few steps closer to demanding the accountability from Pfizer that they deserve.
The long-overdue warning label approved by the FDA underscores the validity of these women's claims against Pfizer. As one of the world's largest pharmaceutical companies, Pfizer would have known exactly how to investigate safety signals and update warning labels, but they did not. Instead, women and their doctors were not given the information they needed to make informed choices about their health and many have gone on to suffer from life threatening injuries as a result."
This legal action follows multiple studies linking Depo-Provera use and intracranial meningiomas. In March 2024, a study by EPI-PHARE (Roland et al.) published in the British Medical Journal5 found that women who had used Depo-Provera for more than one year were 5.6 times more likely to develop a meningioma compared with non-users, using data from over 108,000 women aged 18 to 70. The links was confirmed by other studies including Griffin et al. in September 2024, Frey et al. in June 2025 and Xiao et al. in September 2025 that analysed data from more than 61 million women in the US.
The lawsuits allege that Pfizer was aware of the link between these birth control injections and brain tumours and that they failed to adequately warn of the risk and promote safer alternatives. Pfizer knew of the risks linked to long-term use of the drug and added warning labels in Canada, the UK and Europe long before the FDA action in the United States.
At least one law firm is also investigating a shareholder legal action against Pfizer's Board of Directors for potential breaches of fiduciary duties to Pfizer's shareholders in connection with the Company's marketing and sale of Depo-Provera6.
Notes to editors
About Levin Papantonio
Levin Papantonio is one of the leading plaintiff law firms in America. The firm has successfully represented more than 100,000 clients harmed by corporate negligence and misconduct and has helped to secure more than $80 billion in jury verdicts and settlements against some of the world's largest corporations, including Big Tobacco, BP, Dupont, 3M and Merck.
1 Refers to Depo-Provera 150 mg/ml formulation.
2 United Nations. Department of Economic and Social Affairs, Population Division. Contraceptive use by method 2019: data booklet. 2019. https://www.un.org/development/desa/pd/sites/www.un.org.development.desa.pd/files/files/documents/2020/Jan/un_2019_contraceptiveusebymethod_databooklet.pdf Accessed 25 April 2025.
3 The pill, injectables and the implant. Excluding IUDs.
4 United Nations, Department of Economic and Social Affairs, Population Division. World Family Planning 2022. 2022. https://www.un.org/development/desa/pd/sites/www.un.org.development.desa.pd/files/files/documents/2023/Feb/undesa_pd_2022_world-family-planning.pdf Accessed 24 September 2025.
5 Roland J, Weill A, Ricordeau P, et al. Risk of intracranial meningioma in women using medroxyprogesterone acetate: nationwide cohort study. BMJ. 2024;384:e078078. https://www.bmj.com/content/384/bmj-2023-078078 Accessed 10 September 2025.
6 Berger Montague PC. Investigation Alert: Berger Montague PC Investigates Pfizer Inc.'s Board of Directors for Breach of Fiduciary Duties (NYSE:PFE). 2025. https://www.ktsm.com/business/press-releases/cision/20250603DC02450/investigation-alert-berger-montague-pc-investigates-pfizer-inc-s-board-of-directors-for-breach-of-fiduciary-duties-nyse-pfe/ Accessed 7 July 2025.
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