Pfizer Inc. (NYSE: PFE) faces mounting legal challenges over claims that its contraceptive injection Depo-Provera (DMPA) is linked to brain tumors, with a key court hearing set for late September that could determine whether affected women can pursue their cases in court.
The multidistrict litigation (MDL), consolidated in Florida, was launched on behalf of women who developed intracranial meningiomas after using Depo-Provera.
Plaintiffs argue the company failed to provide adequate warnings about potential risks, while Pfizer maintains federal law preempts state-level failure-to-warn claims.
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The dispute centers on Pfizer’s pre-emption defense, a strategy frequently used in drug litigation. Pfizer contends the FDA previously rejected its request to add tumor warnings to Depo-Provera’s label, shielding it from liability.
Plaintiffs counter that Pfizer submitted an overly broad proposal by grouping Depo-Provera with lower-dose hormonal contraceptives, leading the FDA to decline the labeling change.
A hearing scheduled for September 29 at the U.S. Courthouse in Pensacola, Florida, will allow both sides to present arguments on this defense. Judge M. Casey Rodgers has urged law firms to file claims promptly.
The litigation comes after multiple scientific studies identified elevated risks of meningiomas among Depo-Provera users. A March 2024 British Medical Journal study found women using the injection for more than a year faced a 5.6-fold higher risk.
Follow-up research in 2024 and 2025 confirmed elevated risks ranging from 2.4 to 3.5 times compared to women using other contraceptives or none.
Beyond product liability claims, at least one law firm is exploring potential shareholder litigation against Pfizer’s board, alleging breaches of fiduciary duties related to the marketing of Depo-Provera.
Pfizer has added tumor-related warnings to Depo-Provera packaging in Canada, the U.K., and Europe, but U.S. labeling remains at issue. The outcome of the Florida hearing could determine whether thousands of claims proceed to trial.
Price Action: PFE stock was trading higher by 0.30% to $23.67 at last check Friday.
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