In the quiet corridors of U.S. federal courts, a profound reckoning is unfolding for one of the world's largest pharmaceutical companies. As of January 2026, more than 2,100 women across the United States have filed lawsuits against Pfizer, alleging that the company's long-acting contraceptive injection, Depo-Provera, caused them to develop intracranial meningiomas — benign but often life-altering brain tumours. These cases, consolidated into a multidistrict litigation (MDL) in the Northern District of Florida under Judge M. Casey Rodgers, represent a growing chorus of voices demanding transparency, accountability, and justice for what plaintiffs describe as decades of withheld information about a serious health risk.
Depo-Provera, first approved by the FDA in 1992, is a popular injectable birth control method administered every three months. It delivers medroxyprogesterone acetate (MPA), a synthetic progestin that mimics progesterone to prevent ovulation and thin the uterine lining. The shot has been a go-to option for millions of women — with CDC data showing that 1 in 4 sexually active U.S. women have used it at some point, and roughly 2 million using it annually — thanks to its convenience and effectiveness. Yet, beneath this widespread reliance lies a troubling shadow: emerging scientific evidence linking prolonged use to an elevated risk of meningiomas.
The catalyst for the current wave of litigation was a March 2024 study published in the British Medical Journal by EPI-PHARE researchers. Analyzing data from over 108,000 women, the study found that those using Depo-Provera for more than one year were 5.6 times more likely to develop an intracranial meningioma compared to non-users. Subsequent research, including large-scale analyses in 2024 and 2025 involving millions of women, has reinforced this association, with some reporting risks up to 3.5- to 5-fold higher than with other contraceptives.
Meningiomas grow slowly along the meninges — the protective membranes surrounding the brain and spinal cord. While typically benign (non-cancerous), they can cause devastating symptoms: severe headaches, seizures, vision or hearing loss, neurological deficits, and even death if they compress critical brain structures. Treatment often involves invasive brain surgery, radiation, or ongoing monitoring, with procedures risking permanent damage to nearby tissues.
Plaintiffs' central allegation is stark: Pfizer knew or should have known about this risk for years — potentially decades, given studies linking progesterone derivatives to meningiomas dating back to the 1980s — but failed to adequately investigate, warn patients, or update labelling in a timely manner. The complaint accuses the company of wilful neglect, claiming it "conspired and acted in concert to ignore relevant safety concerns" and deliberately avoided long-term safety studies for chronic users. This failure to warn, they argue, deprived women and their doctors of the information needed to weigh risks against benefits or choose safer alternatives.
Pfizer's defence has centred on regulatory pre-emption: the company claims it first identified the link in 2023, promptly sought FDA approval to add a meningioma warning in early 2024, but was initially rejected (the FDA cited insufficient evidence from observational studies alone). Pfizer resubmitted in June 2025, and in December 2025, the FDA approved the change. The updated label now states: "Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long-term use." Pfizer argues this shields it from liability for earlier claims, as federal oversight pre-empts state-law failure-to-warn suits.
In late 2025, Judge Rodgers rejected Pfizer's motion to dismiss, paving the way for trials. In early January 2026, following a case management conference, she set the first bellwether trial for December 7, 2026 — a pivotal "test case" that will hear one plaintiff's claims, with subsequent trials for four others potentially following every 60 days if no settlement emerges. Bellwether outcomes often guide global resolution strategies in mass torts like this.
The litigation's momentum is undeniable. As of January 2026, the federal MDL includes between approximately 1,470 and 1,859 pending cases (with totals nearing 1,775–2,100 including state filings), and numbers continue to climb rapidly — a fivefold increase in some periods since mid-2025. Additional suits proceed in state courts (e.g., Delaware, New York, California), and experts predict the total could reach 5,000–10,000, with potential damages in the billions.
Beyond causation and warnings, deeper questions linger. International regulators in Canada, the UK, and Europe added meningioma warnings earlier (as early as 2022–2024), raising why U.S. patients waited longer. Some critics point to potential conflicts, noting former FDA officials with Pfizer ties. The FDA's initial rejection and eventual approval after "additional evidence" (including major studies) underscores the tension between regulatory caution and public health urgency.
For the women at the heart of this story — many facing surgeries, radiation, vision loss, or permanent neurological impacts — the fight transcends compensation. It is about informed choice in reproductive health, where a widely used, affordable option carried hidden hazards. As Virginia Buchanan, a lead plaintiffs' attorney, stated: "This is a critical women's health issue... It's critical to have something that is safe."
The December 2026 trial will not resolve every claim, but it will test the evidence: internal Pfizer documents, adverse event reports (over 43,000 in FDA's FAERS database, many serious), expert testimony on causation, and the company's response to safety signals. A strong plaintiff verdict could accelerate settlements; a defence win might narrow the field.
In the broader context, this case highlights recurring themes in pharmaceutical litigation — the balance between innovation, profit, and safety; the lag between scientific signals and regulatory action; and the power of collective action when individual voices feel unheard. As 2026 unfolds with monthly status conferences, expert challenges, and discovery battles, the Depo-Provera MDL stands as a stark reminder: when trust in medicine is tested, the courtroom becomes the arena where truth is sought, and accountability demanded. For millions of women who trusted a shot to control their futures, the outcome could redefine how risks are communicated — and who pays the price when they are not.