- Pfizer faces lawsuits for not warning of Depo-Provera's brain tumor risk.
- A major study links long-term use to a 500% higher risk of meningioma surgery.
- Over 2,100 U.S. women are suing, citing permanent disabilities from the tumors.
- Pfizer only added a U.S. warning recently, lagging behind other nations.
- The company denies the claims and stands by the drug's safety.
Pharmaceutical giant Pfizer is headed to court, accused of failing to warn millions of women that a popular birth control injection could dramatically increase their risk of developing life-altering brain tumors. More than 2,100 women across the United States are now suing the company, claiming its contraceptive Depo-Provera left them with benign brain tumors that can cause blindness, seizures, and memory loss. With a pivotal trial set for December, the lawsuits allege Pfizer long knew of the risks but kept silent, prioritizing profits over patient safety while regulators lagged behind other nations.
The evidence fueling these cases has mounted in recent years. A landmark 2024 French study published in the British Medical Journal found that using Depo-Provera for 12 months or more was associated with a 5.6-fold increased risk of needing surgery for a meningioma. Another 2025 U.S. analysis confirmed a significantly elevated risk. These tumors grow in the lining of the brain and spine. While typically non-cancerous, they can compress critical nerves and brain structures, leading to permanent disability.
A warning long delayed
For decades, Depo-Provera has been a trusted contraceptive for millions, administered as an injection every three months. Centers for Disease Control and Prevention data estimates nearly one in four sexually active American women has used it at least once. It was only last month that Pfizer, under growing legal and scientific pressure, added a meningioma risk warning to the drug’s U.S. label. Attorney Virginia Buchanan, a court-appointed co-chair for the plaintiffs, told the Daily Mail this label "has been a long time coming" and is "long overdue."
This belated action stands in dramatic contrast to other countries. Regulators in Canada, the European Union, and South Africa have already mandated similar warnings. The lawsuits contend that Pfizer was aware of scientific literature suggesting a link between progestin hormones and meningioma growth for years, if not decades, but did not adequately investigate or warn the public. In a statement to NBC News, a Pfizer spokesperson said the company "stands behind the safety and efficacy of Depo-Provera," calling it "an important treatment option."
Life-changing consequences
The human cost is detailed in the lawsuits. Plaintiffs report a range of debilitating symptoms often discovered years after stopping the medication. "We have family members saying [the plaintiffs] are not who they used to be," Buchanan told the Daily Mail. She described clients suffering impaired hearing, vision, and smell, along with seizure disorders and cognitive changes. The tumors often require risky brain surgery, and sometimes they cannot be fully removed.
"It's a scary thing to think you have an inoperable brain tumor," Buchanan said. "Because even if it's benign, if it's compressing on critical nerves or something that controls an important bodily function, that's a very scary thing." She urges women diagnosed with a meningioma and a history of Depo-Provera use to contact an attorney to join the litigation, arguing that awareness can lead to faster diagnosis and treatment.
The legal battle now centers on the concept of pre-emption. Pfizer argues in court filings that it tried to add a warning earlier but was barred by the Food and Drug Administration, a common defense in drug litigation. The plaintiffs counter that Pfizer’s initial request to the FDA was overly broad and improperly grouped the high-dose injection with lower-dose products, leading to the agency's initial rejection. They argue the company cannot use regulatory process as a shield for its failure to warn.
As the December trial approaches, the case will test whether pharmaceutical companies can hide behind regulatory processes or must answer for what they knew, when they knew it, and whom they chose to protect.
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