1,470+ Women Sue Pfizer Over Depo-Provera Brain Tumors as FDA Issues Warning

Mass Litigation Grows as Brain Tumor Link Confirmed

At least 1,470 Depo-Provera lawsuits have been consolidated into federal multidistrict litigation (MDL 3140) in the Northern District of Florida, with women claiming the popular birth control shot caused dangerous brain tumors called meningiomas [2]. The litigation continues to expand rapidly, with 248 new cases added between November and December 2024 alone [17]. Additional hundreds of cases are pending in state courts, including 332 plaintiffs in Delaware, 78 in New York, and others across multiple states [2].

Landmark Study Reveals 5.5x Higher Brain Tumor Risk

A groundbreaking 2024 study published in the prestigious British Medical Journal (BMJ) found that women who used Depo-Provera for at least one year were 5.5 times more likely to develop meningioma brain tumors compared to non-users [3]. The risk dramatically increased with longer exposure periods - women who received 10 or more Depo-Provera injections faced nearly a four-fold increase in meningioma risk [3]. Another 2025 study reported substantially increased risk of intracranial meningiomas among Depo-Provera users compared to women taking oral contraceptives [3].

FDA Finally Acts: Warning Label Added After Decades

In December 2024, the FDA approved a critical label change for Depo-Provera to include warnings about meningioma risk [1]. The updated label now states: "Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long-term use. Monitor patients on Depo-Provera CI for signs and symptoms of meningioma. Discontinue Depo-Provera CI if a meningioma is diagnosed" [2]. This regulatory action came after years of mounting scientific evidence and growing litigation pressure.

Devastating Symptoms Plague Thousands of Women

Meningiomas can cause severe neurological symptoms that dramatically impact quality of life, including persistent headaches, blurred or double vision, numbness or tingling in the face or limbs, seizures, memory or cognitive changes, and balance or coordination problems [4]. These typically non-cancerous but slow-growing tumors form on the membranes surrounding the brain and spinal cord [2]. Experts believe Depo-Provera may promote meningioma development because some of these tumors can grow when exposed to hormones [3].

Legal Claims Focus on Failure to Warn

The consolidated lawsuits primarily center on two key legal theories: failure to warn and design defect claims [2]. Plaintiffs allege that Pfizer knew or should have known about the risks of hormone-sensitive tumors like meningiomas but failed to update the drug's warning label in a timely or sufficient manner [2]. The lawsuits claim Pfizer misled doctors, patients, and the FDA about Depo-Provera's link to meningiomas [2]. Prominent law firms involved in the litigation include Simmons Hanly Conroy, Morris James, The Lanier Law Firm, Sokolove Law, and Rueb Stoller Daniel [2].

Pfizer Fights Back with Preemption Defense

Pfizer is aggressively defending the litigation by arguing that federal law preempts the plaintiffs' claims because the FDA had previously rejected a proposed label change [2]. The company maintains that Depo-Provera "remains an important treatment option for women seeking to manage their reproductive health" [5]. A key federal preemption hearing was held in September 2024, with the court requiring parties to resolve legal arguments about Pfizer's preemption defense by October 2024 [2]. This legal strategy could potentially shield Pfizer from liability if successful.

Settlement Predictions Range from $100K to $500K+

While no Depo-Provera verdicts or settlements have been reached yet, legal experts estimate individual lawsuit settlement amounts could range between $100,000 and $500,000 or more, depending on individual circumstances [5]. Factors influencing potential settlement values include the severity of the tumor, impact on the plaintiff's quality of life, cost of medical treatment, and whether individuals suffered long-term or permanent damage [5]. In 2021, Pfizer paid nearly $2 million to settle a Canadian Depo-Provera class action over bone density loss, demonstrating the company's willingness to resolve litigation [5].

Critical Timeline for Affected Women

The first bellwether trials in the Depo-Provera litigation are expected to begin mid-2025 [2]. Expert disclosures and depositions on general causation are scheduled for late 2025 and early 2026 [9]. Women who used Depo-Provera and later developed meningiomas should be aware that each state has different filing deadlines for pursuing legal claims [9]. The litigation affects women who used Depo-Provera, particularly those with extended periods of use, as the risk appears to increase with longer exposure [4].

What This Means for Women's Health

This developing litigation represents one of the most significant challenges to hormonal contraceptive safety in recent years. The scientific evidence linking Depo-Provera to brain tumors, combined with the FDA's recent warning label addition, validates the concerns raised by thousands of affected women. As the MDL process continues, the outcomes could establish important precedents for pharmaceutical companies' obligations to warn patients about long-term risks of hormonal medications. Women currently using or considering Depo-Provera should discuss these findings with their healthcare providers to make informed decisions about their reproductive health options.