Pharmaceutical giant Pfizer Inc. is facing mounting legal pressure as litigation over its long-acting contraceptive Depo-Provera intensifies in U.S. federal courts. The drug, used by millions of women worldwide for birth control, is at the center of claims linking prolonged use to the development of meningiomas, a type of brain tumor that can cause serious neurological problems.
More than 1,200 lawsuits have now been consolidated into a federal multidistrict litigation (MDL) before Judge M. Casey Rodgers in the Northern District of Florida. The cases allege that Pfizer knew of the potential risks but failed to adequately warn patients and healthcare providers.
Allegations of Concealed Risk
Plaintiffs claim that long-term exposure to Depo-Provera’s active ingredient, medroxyprogesterone acetate (MPA), increases the likelihood of developing meningiomas. Several studies in recent years have suggested a possible link between high-dose hormonal contraceptives and tumor growth.
A 2025 study published in Expert Opinion on Drug Safety reported that women who used Depo-Provera for more than a year faced a 3.5-times higher risk of developing a meningioma compared to users of common oral contraceptives. An earlier 2024 study in The BMJ estimated the risk could be even higher—around fivefold.
“These tumors can be debilitating,” said a Florida-based attorney representing multiple plaintiffs. “Our clients were not warned of the risk, and the science now shows there was reason for concern years ago.”
Pfizer’s Defense: FDA Rejection
Pfizer maintains that it acted responsibly and that its hands were tied by regulators. The company argues that it proposed an updated warning label about the potential tumor risk in late 2023, but the U.S. Food and Drug Administration (FDA) declined to approve it, citing insufficient evidence.
Because of that decision, Pfizer contends that the lawsuits are preempted by federal law—meaning the company could not legally alter its label without FDA authorization. “Pfizer could not have unilaterally changed its warnings,” the company stated in a court filing reviewed by Reuters.
Attorneys for the plaintiffs counter that Pfizer’s proposed label was too vague, lumping Depo-Provera together with unrelated hormonal contraceptives, which led the FDA to reject the update. They argue that a narrower, drug-specific warning could have been approved and should have been pursued.
Legal Process and Next Steps
The MDL, created in February 2025, aims to streamline pretrial proceedings by consolidating common evidence and witness testimony. Judge Rodgers has selected five pilot cases—often called bellwethers—to test key legal and scientific issues before the broader pool of claims moves forward.
Discovery and expert testimony are underway, with Pfizer’s summary judgment motion—based largely on its preemption defense—pending before the court. A ruling is expected later this year and could determine whether the majority of cases proceed to trial or are dismissed.
Meanwhile, the number of claimants continues to climb. Attorneys say they are fielding new calls each week from women who used Depo-Provera and later developed meningiomas. Similar lawsuits are also being investigated in Australia and the United Kingdom, where regulatory agencies have already updated product labeling to include tumor warnings.
Scientific Debate and Regulatory Scrutiny
At the heart of the case lies an ongoing debate about causation. While meningiomas are typically noncancerous, they can cause seizures, vision problems, and other severe symptoms. Scientists caution that a correlation between Depo-Provera and tumor risk does not necessarily prove causation—but the mounting research has drawn global attention.
In contrast to European regulators, the FDA has not required Pfizer to add a brain-tumor warning to the U.S. Depo-Provera label. The agency has stated it continues to monitor emerging data.
High Stakes Ahead
Legal experts say the Depo-Provera MDL could become one of the most consequential pharmaceutical mass torts since the Johnson & Johnson talc litigation. If Pfizer’s preemption defense fails, the company may face mounting settlement pressure. If it succeeds, many claims could be thrown out.
“The outcome will hinge on whether the court believes Pfizer had the ability—and the duty—to warn,” said a legal analyst following the case. “This decision could set a major precedent for drug manufacturers nationwide.”
For now, both sides are preparing for a long fight, as thousands of women await answers—and potential accountability—from one of the world’s largest drugmakers.
