Depo-Provera Brain Tumor Lawsuit To Be Prepared for Trial by December 2026

Decision comes days after FDA approves new Depo-Provera label warnings, alerting users to the risk of intracranial meningioma.

The U.S. District Judge presiding over all federal Depo-Provera brain tumor lawsuits has called for the first of five proposed bellwether “pilot” cases to be ready for trial by early to mid-December 2026, the rest of which will be scheduled in 2027.

Depo-Provera is a long-acting hormonal contraceptive originally approved by the U.S. Food and Drug Administration in 1992, which involves a quarterly injections of the synthetic progestin medroxyprogesterone acetate to prevent pregnancy.

Given the widespread belief that it was safe and carried few serious side effects, the birth control shot has been received by tens of millions of women over the last several decades. However, Pfizer and generic manufacturers now face more than 2,100 product liability lawsuits brought by women throughout the U.S., who say the manufacturers failed to provide adequate warning that Depo-Provera side effects were linked to brain tumor risks.

The litigation began to emerge early last year, following the publication of independent studies linking Depo Provera to meningioma risks, which found that women who received the injections faced a 5.5 times higher risk of developing brain tumors compared to those who did not use the drug. Intracranial meningioma can cause serious, potentially life-threatening complications, often requiring brain surgery and lifelong medical monitoring.

While hundreds of cases are filed in state courts such as New York, Delaware and California, all federal claims have been consolidated into a Depo-Provera brain tumor lawsuit MDL, or multidistrict litigation, where U.S. District Judge M. Casey Rodgers is presiding over coordinated discovery and pretrial proceedings in the Northern District of Florida.

When assigned the litigation, Judge Rodgers immediately had the parties begin preparing for a series of five “pilot” cases to go before juries, to help parties gauge the relative strengths and weaknesses of their claims.

On December 19, lawyers met for a case management conference with Judge Rodgers, who then released a case management order (PDF) on December 21, calling for the parties to meet with the Special Master to set a case-specific discovery and trial schedule for the Pilot cases. Judge Rodgers indicated she wanted the first case ready by December 7 or 14, 2026, with the rest of the trials scheduled to begin in January 2027.

The judge announced that the first case to go to trial will be one filed by Donna Toney (PDF) of Florida, who indicates she suffered vertigo, dizziness and hearing loss due to a brain tumor caused by her birth control injections, resulting in the need for brain surgery. However, Judge Rodgers indicated she is open to the parties selecting another case if they do not think that one would be ready or appropriate for the first trial.

New Depo-Provera Brain Tumor Warning

The conference was held just days after the FDA approved an updated Depo-Provera brain tumor warning, which adds new language to the drug’s label alerting users to the risk of intracranial meningioma, indicating patients should be monitored for signs of brain tumors and that Depo-Provera should be discontinued if a meningioma is diagnosed.

In response to the warning update, Judge Rodgers told Depo-Provera lawyers at the status conference that they should prepare supplemental briefings on how the new label changes will affect the litigation in the near future, and what impact it should have on her consideration of Pfizer’s motion for summary judgment based on federal preemption. She heard oral arguments over the motion in late September 2025, but has not issued a ruling.

The briefings and label changes will also likely have a significant effect on general causation hearings that will be held in May 2026, which are designed to determine if plaintiffs can scientifically prove that Depo-Provera injections can cause the development of brain tumors.

If the litigation clears the preemption and general causation hurdles, the pilot trials will be closely watched to see how juries respond to evidence and testimony that would likely be repeated in thousands of cases if the litigation is not otherwise resolved. However, if no Depo-Provera brain tumor settlement agreement is reached, Judge Rodgers may remand the remaining claims back to their originating District Courts for individual trial dates.

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