The number of lawsuits filed has tripled to over 1300 since May
New US peer-reviewed study adds to body of research confirming link between use of Depo-Provera and increased risk of brain tumours
- 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.
- 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 contraceptives3,4.
- In a recent case management order, Judge M. Casey Rodgers instructed law firms to file their claims as soon as possible.
PENSACOLA, Fla.–(BUSINESS WIRE)–A hearing in the Depo-Provera legal action against Pfizer Inc. (NYSE:PFE) will take place on Monday, 29 September at 9:00am CT in the United States Courthouse in Pensacola, Florida. The hearing will address oral arguments from the plaintiffs and defendants concerning the issue of pre-emption. The pre-emption defence is common in drug litigation. It involves the drug manufacturer arguing that they cannot be sued for failure to warn under state law, because changes to a drug warning label are governed by federal law and the FDA. The pre-emption defence asserts that the FDA rejected its request to add a tumour warning to the drug’s label, pre-empting any state law claims that it failed to warn consumers and physicians. The plaintiffs argue that Pfizer’s pre-emption defence fails because the company’s request to the FDA was too broad, because it grouped Depo-Provera with other lower dose hormonal contraceptives, and this led to the FDA’s decision not to approve a tumour warning on the drug’s label in the USA. Also, according to a UN 2022 family planning report, 247 million worldwide are on hormonal contraceptives5,6.
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 and the Preterm Infant Nutrition Products Liability Litigation against Abbott Laboratories and Mead Johnson, owned by Reckitt Benckiser. Virginia Buchanan, Partner at Levin Papantonio, is the court-appointed co-chair of the Plaintiffs’ Executive Committee and member of the Trial Committee and Chris Paulos, Partner at Levin Papantonio, is the court-appointed liaison counsel for Plaintiffs.
Virginia Buchanan, Partner at Levin Papantonio and court-appointed co-chair of the Plaintiffs’ Executive Committee and member of the Trial Committee, said: “This hearing strikes at the core of whether women injured by Depo-Provera will have their day in court. Pfizer is attempting to avoid accountability by invoking a preemption defense, yet there are serious questions about whether it ever provided the FDA with the full picture. Preemption was never meant to serve as a shield for drug companies that fail to warn patients adequately. Thousands of women living with meningiomas deserve the chance to have these issues fairly considered by the courts.”
“A new U.S. study published this month in the peer-reviewed Journal of the American Medical Association once again highlights the increased risk of meningioma in women who have used Depo compared with other hormonal contraceptives. Despite this addition to the long-existing and growing body of evidence, Pfizer has continued to disregard the heightened and unnecessary risk associated with its injectable Depo-Provera and has consistently failed to take reasonable steps to alert patients and their physicians to this very real danger.”
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 Journal7 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. A study by Griffin et al. in September 2024 confirmed the findings of this study8. A further study published on 29 June 2025 in Expert Opinion on Drug Safety by Frey et al. found that use of Pfizer’s Depo-Provera (DMPA) by women of childbearing age for more than one year is associated with a 3.5-fold increased risk of developing an intracranial meningioma, compared with the use of certain combined birth control pills9. The study analysed 114 million individuals in total, including 72,181 DMPA users and 247,180 users of the combined oral contraceptive pill. Most recently, a large retrospective population-based cohort study by Xiao et al. published in JAMA Neurology10 on 2 September 2025 analysed data from more than 61 million women in the US. The study observed a 2.43-fold increased risk of meningioma in women who had used DMPA for four years or longer, or who began treatment after the age of 31, compared with women using other hormonal contraceptives (excluding DMPA) and non-users of contraceptives.
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 has acknowledged its awareness of the risks linked to long-term use of the drug and added warning labels in Canada, the UK and Europe.
At least one US 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-Provera11.
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.
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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 The pill, injectables and the implant. Excluding IUDs.
6 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.
7 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.
8 Griffin RL. The Association between Medroxyprogesterone Acetate Exposure and Meningioma. Cancers (Basel). 2024 Sep 30;16(19):3362. doi: 10.3390/cancers16193362. PMID: 39409982; PMCID: PMC11482550.
9 Frey C, Sodhi M, Fatehi M, Kezouh A, Etminan M. Use of medroxyprogesterone acetate and risk of meningiomas: a comparative safety study. Expert Opinion on Drug Safety. 2025. https://doi.org/10.1080/14740338.2025.2526787 Accessed 8 July 2025.
10 Xiao T, Kumar P, Lobbous M, et al. Depot Medroxyprogesterone Acetate and Risk of Meningioma in the US. JAMA Neurology. 2025. doi:10.1001/jamaneurol.2025.2629. Accessed 10 September 2025.
11 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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