Depo-Provera Meningioma Warning Update Approved by FDA, As Lawsuits Move Forward

Lawsuits being pursued by women point out that Pfizer has been aware of the Depo-Provera brain tumor risks for years, and previously provided similar meningioma warnings for users outside the U.S.

As thousands of women move forward with Depo-Provera meningioma lawsuits against Pfizer, each raising similar allegations that the drug maker has withheld information about the brain tumor risks associated with the birth control shot for decades, federal regulators recently approved a critical new warning label update for users and the medical community.

Depo-Provera was originally approved by the U.S. Food and Drug Administration (FDA) in 1992, as a long-acting hormonal contraceptive that requires a quarterly injection of the synthetic progestin medroxyprogesterone acetate. Tens of millions of women have repeatedly been injected with the birth control shot over the last several decades, believing advertisements that claimed it is safe and effective.

However, concerns about the shot’s safety began to emerge last year, following the publication of independent studies that linked Depo-Provera to an increased risk of intracranial meningioma, indicating women who received the injections faced 5.5 times the risk of brain tumors than women who did not take the birth control shot. Intracranial meningioma can cause serious, potentially life-threatening complications, often requiring brain surgery to remove the tumors and life-long medical monitoring.

Since the publication of these findings, more than 2,100 product liability lawsuits have been filed by women throughout the U.S., alleging that the drug makers knew or should have known about the potential brain tumor risks for years, yet failed to adequately warn users and doctors, depriving them of critical information that could have prevented the development of meningioma.

Depo-Provera Warnings and Precautions Update

This month, the FDA approved an updated Depo-Provera meningioma warning, which provides some of the same information that lawsuits allege Pfizer should have provided years ago.

The new drug label and medication guide 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.”

In response to the Depo-Provera lawsuits, Pfizer has claimed that it wanted to update the warning for the last several years, but that the FDA barred such a move. However, neither Pfizer nor the FDA has issued a statement regarding this latest updated label, which was revised on an unknown date in December 2025.

Since 2022, women in both Canada and the European Union have benefited from Depo-Provera brain tumor warning labels, yet that warning was withheld from women in the U.S. until this month. Despite the manufacturer’s claims it tried to have the label updated in 2023, plaintiffs indicate Pfizer knew about the problem for decades but decided it was in their interest to place profits over women’s health.

Depo-Provera Meningioma Lawsuits

After last year’s study raised concerns about brain tumor side effects, the number of Depo-Provera lawsuits filed across the U.S. grew rapidly, prompting plaintiffs to seek centralization before a single judge to avoid inconsistent rulings and duplicative discovery.

The U.S. Judicial Panel On Multidistrict Litigation (JPML) has centralized all Depo-Provera lawsuits brought throughout the federal court system in the Northern District of Florida, where U.S. District Judge M. Casey Rodgers is overseeing coordinated discovery and pretrial proceedings.

To help the parties gauge the relative strengths and weaknesses of their claims, and promote potential Depo-Provera meningioma settlements, Judge Rodgers previously instructed the parties to prepare a group of five “pilot” cases for early trial dates, which will give them a chance to see how juries respond to evidence and testimony likely to be repeated.

The label update comes just days ahead of a case management conference scheduled for December 19, where the parties will update Judge Rodgers on the status of the litigation.

According to a joint update and proposed agenda (PDF) submitted in advance of the conference, lawyers intend to update Judge Rodgers on discovery proceedings, the collection of key documents, like plaintiffs’ proof of use, and coordination involving hundreds of additional Depo-Provera meningioma lawsuits filed in state courts, including Delaware, New York, California, Pennsylvania, Illinois, Connecticut and New Mexico.

The agenda notes that earlier this month, the court gave plaintiffs a general causation expert disclosure deadline of January 1, 2026. Defendants’ general causation expert disclosures are due by February 9, 2026, with briefings on any motions to attempt to dismiss or block any general causation experts from testifying to be completed by May 29, 2026.

Judge Rodgers is expected to issue rulings on the motions in mid-2026, setting up the potential for the first Depo-Provera pilot trials to go before juries by the end of next year or in 2027.

While the outcomes of the pilot trials will not be binding on other claims in the federal or state courts, they will be closely watched by lawyers involved in related cases and could help form the basis of a Depo-Provera lawsuit settlement agreement, avoiding the need for hundreds of individual trials to be scheduled nationwide in future years.

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