Depo-Provera Lawsuits Surge Past 1,300 as Plaintiffs Take On Pfizer

Case Overview: More than 1,300 lawsuits accuse Pfizer of failing to warn Depo-Provera users about the risk of developing meningiomas.

Who's Affected: Women across the U.S. who received Depo-Provera injections and later developed brain tumors.

Court: U.S. District Court for the Northern District of Florida

What began with fewer than 100 women has now become a wave of more than 1,300 lawsuits tied to Depo-Provera, Pfizer’s injectable contraceptive. 

The consolidated litigation in the U.S. District Court for the Northern District of Florida alleges the company failed to warn patients that using the drug could raise the risk of developing meningiomas, a type of brain tumor.

The growth of the case has been rapid. When the lawsuits were first combined in February, just over 70 plaintiffs were involved. Since then, filings have multiplied as more women came forward with claims of injury. 

Judge M. Casey Rodgers, who is overseeing the case in Pensacola, has required each plaintiff to submit proof of both drug use and injury, yet the docket continues to expand.

A key hearing on September 29 will decide whether these claims survive or whether federal law blocks them.

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Pfizer Argues FDA Rejected Label Warnings on Brain Tumor Risks

Pfizer and its affiliates Pharmacia LLC and Pharmacia & Upjohn Co. LLC argue that their hands were tied by the U.S. Food and Drug Administration (FDA). The company points to late 2023 studies suggesting a possible link between Depo-Provera and meningiomas. 

After reviewing the data, Pfizer says it submitted a request to add a warning label, but the FDA declined the proposed change. According to Pfizer, once the FDA denies a label change, courts have consistently ruled that failure-to-warn claims cannot proceed. 

The company also contends that any suggestion of a design defect is off the table because the FDA had already determined the drug was safe as marketed.

Plaintiffs Say Pfizer Misrepresented FDA’s Response to Shield Itself

The plaintiffs tell a different story. They argue that the FDA did not reject a warning outright. Instead, the agency asked Pfizer to revise its proposal and resubmit it because the request was too broad, applying to an entire category of contraceptives rather than Depo-Provera specifically.

By framing the FDA’s response as a final denial, plaintiffs say Pfizer misleads the court. They argue that allowing this type of defense would give drugmakers an incentive to submit half-hearted proposals to regulators, knowing that an incomplete warning request could later be used to shield them from liability.

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What Happens Next

The September 29 hearing in Pensacola could prove decisive. If Judge Rodgers accepts Pfizer’s preemption argument, the vast majority of cases could be dismissed. If she sides with the plaintiffs, the litigation will move into its next phase, where both sides present expert testimony on whether Depo-Provera can cause meningiomas.

Deadlines are already set for late October to begin that phase if the case proceeds. At that point, medical studies, epidemiological research, and patient histories will become central to the arguments.

Separate California Case Seeks Medical Monitoring for Patients

Beyond the Florida litigation, Pfizer also faces a proposed class case in California. Filed by Makisha Greeno, the lawsuit seeks to represent California residents who received at least four Depo-Provera injections or its generic equivalents.

The California complaint names Pfizer Inc., Pharmacia & Upjohn Co. LLC, Prasco Labs, Greenstone LLC, and Viatris Inc. as defendants. Like the Florida litigation, it alleges that the companies knew for years about the potential risk of brain tumors but continued to sell the product without clear warnings.

The plaintiffs in that case are not just seeking damages. They are also pushing for a medical monitoring program that would give impacted patients access to regular screenings.

Why the Litigation Matters

The Depo-Provera lawsuits raise questions about how far a drug company’s duty to warn extends when the FDA has not signed off on label changes. They also highlight a growing debate about whether federal preemption shields pharmaceutical manufacturers too broadly.

Patients and their families say they were left in the dark about risks tied to long-term use. Pfizer insists it followed the rules and that regulators, not the courts, have the final word on drug safety warnings.

Case Details

• MDL: In re: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation
• Case Number: 3:25-md-03140
• Court: U.S. District Court for the Northern District of Florida

Plaintiffs' Attorney:

• Christopher Seeger (Seeger Weiss LLP)
• Bryan Aylstock (Aylstock Witkin Kreis & Overholtz PLLC)
• Ellen Relkin (Weitz & Luxenberg P.C.)

Have you or someone you know used Depo-Provera injections? Learn more about how to file a Depo-Provera lawsuit here.