Depo-Provera litigation grows to 1,300 plaintiffs who claim Pfizer hid brain tumor risks

Depo-Provera lawsuit overview:

• Who: More than 1,300 plaintiffs have joined a multidistrict litigation (MDL) against Pfizer.
• Why: The plaintiffs claim Pfizer failed to warn about the link between its hormonal contraceptive Depo-Provera and brain tumors.
• Where: The Depo-Provera litigation is pending in Florida federal court.
• How to get help: If you were ever diagnosed with one or more brain tumors after using Depo-Provera, you may be eligible to join a Depo-Provera class action lawsuit investigation.

The number of plaintiffs in a multidistrict litigation alleging Pfizer failed to warn consumers about a potential link between brain tumors and its contraceptive injection Depo-Provera has surpassed 1,300, with additional filings expected before a key federal preemption hearing on Sept. 29.

The litigation began with just over 70 plaintiffs when the cases were consolidated in February in the U.S. District Court for the Northern District of Florida. Since May, the figure has tripled despite U.S. District Judge M. Casey Rodgers requiring each plaintiff to provide proof of injury and use of the drug.

The plaintiffs face a significant test at the upcoming hearing in Pensacola, Florida, where Pfizer will argue that federal law preempts their claims. Pfizer contends it sought U.S. Food and Drug Administration (FDA) approval to update the Depo-Provera label to warn of tumor risks, but the agency rejected the proposal.

Pfizer, along with related entities Pharmacia LLC and Pharmacia & Upjohn Co. LLC, says it attempted to warn consumers after reviewing late 2023 epidemiological studies suggesting an association between Depo-Provera and brain tumors called meningiomas. 

According to the company, courts have consistently ruled that failure-to-warn claims are preempted when the FDA denies a labeling change. Pfizer further argues that any design-defect allegations are “clearly preempted,” since the FDA had certified the product as safe and would need to approve any modification.

Plaintiffs dispute Pfizer’s warning efforts

The plaintiffs argue that the FDA never rejected an adequate warning of meningioma risks because Pfizer’s proposal was too broad, covering an entire class of contraceptives without strong scientific backing. They note the FDA’s response letter merely asked Pfizer to revise the warning and resubmit it, indicating the agency’s decision was neither final nor legally binding.

They say that allowing Pfizer to avoid liability on preemption grounds could encourage drugmakers to submit inadequate warning proposals to shield themselves from lawsuits.

A ruling favoring Pfizer could end most of the MDL. If the judge sides with the plaintiffs, however, the case will proceed to general causation, with initial deadlines already set for late October.

The Depo-Provera lawsuits cite years of medical evidence suggesting that progesterone, synthetic progestins and particularly Depo-Provera may contribute to the development of meningiomas. Plaintiffs allege Pfizer failed to investigate these risks for decades despite mounting data.

If you or a loved one were diagnosed with one or more meningiomas and used the birth control, you may be eligible to join the Depo-Provera litigation.

The plaintiffs are represented by Christopher Seeger of Seeger Weiss LLP, Bryan Aylstock of Aylstock Witkin Kreis & Overholtz PLLC and Ellen Relkin of Weitz & Luxenberg P.C.

The Depo-Provera litigation is In re: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, Case No. 3:25-md-03140, in the U.S. District Court for the Northern District of Florida.

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