Lawsuit Claims Depo-Provera Linked to Brain Tumors for Thousands of Women

PENSACOLA, Florida — Pfizer faces a significant legal challenge as over 1,300 women have filed a class-action lawsuit alleging that the contraceptive injection Depo-Provera caused them to develop brain tumors. The hearing will take place in a federal court on Monday, where Pfizer will argue against liability concerning a potential brain tumor risk associated with the drug.

The lawsuit claims that Pfizer failed to adequately warn patients and healthcare providers about the increased risk of developing intracranial meningiomas after using Depo-Provera for more than a year. Meningiomas are typically benign tumors that can lead to severe health issues and necessitate surgical removal.

In a recent assessment, studies showed that women who used Depo-Provera for an extended period have a significantly higher risk of meningioma. One notable study published in the British Medical Journal in March 2024 reported a five to six-fold increase in risk for long-term users.

The hearing on Monday will be crucial, as it will address oral arguments related to whether the case can proceed based on Pfizer’s defense of federal preemption. Pfizer contends that the U.S. Food and Drug Administration (FDA) rejected its request to include a meningioma warning on the drug’s label, arguing that this protects the company from liability under state laws.

“This is a clear pre-emption case because FDA expressly barred Pfizer from adding a warning about meningioma risk,” stated the company in its court filings.

However, plaintiffs’ attorneys argue that Pfizer’s request to the FDA was too broad, including other lower-dose hormonal contraceptives, which ultimately led to the regulator’s decision to deny the warning.

Virginia Buchanan, a partner at Levin Papantonio and co-chair of the plaintiffs’ executive committee, expressed concerns about Pfizer’s transparency with the FDA. “There are serious questions about whether it ever provided the FDA with the full picture,” she said.

As lawsuits against Pfizer continue to grow, the number could potentially rise to between 5,000 and 10,000 claims. In addition to the federal MDL, multiple state courts are also seeing active litigation, driven by concerns about the safety of Depo-Provera and its long-term effects.

Depo-Provera, an injectable contraceptive, has been in use since the 1960s and is prescribed to millions of women worldwide for the prevention of pregnancy. However, persistent concerns about its safety, particularly regarding meningiomas, have intensified as more women come forward with their experiences of serious health complications following its use.

Pfizer maintains that Depo-Provera has been effective and safe for women seeking to manage their reproductive health, emphasizing its extensive history of use globally.