Depo-Provera: Why Was the U.S. Last To Know the Risks?

In 2024, a study from The BMJ made national headlines after it linked Depo-Provera to an increased risk of brain tumors called meningiomas. Researchers found that patients who received injections for at least one year could be 5.6x more likely to develop a meningioma in their lifetimes.

Quickly after the study was published, thousands of Americans with meningiomas began filing lawsuits against Pfizer for not disclosing Depo-Provera’s safety concerns. By December 2025, the Depo shot’s warning label was officially updated in the U.S. to warn doctors and patients about meningioma risks.

But attorneys and lawsuit participants have lately been asking the same question: why weren’t Americans warned about this risk sooner? And why does Pfizer claim it only recently learned about this risk, when other countries have already required meningioma warnings for years?

Pfizer “discovers” link between Depo and meningiomas

Pfizer first tried to update the American warning label to include meningioma risks in February 2024, shortly before The BMJ’s study was published. According to the company’s filing with the U.S. Food and Drug Administration, Pfizer discovered a “potential causal association” between Depo-Provera and meningiomas in late 2023, while the study was still in development.

But then, the FDA denied Pfizer’s application nine months later, stating it could not approve the company’s updated label in its “present form.” Ever since, Pfizer has claimed it can’t be held liable for not disclosing Depo-Provera’s meningioma risks because the FDA blocked it from updating the U.S. warning label, even though a new label was later approved in 2025.

However, according to attorneys involved in the lawsuit, this claim doesn’t hold up for a couple reasons:

  1. Pfizer’s first application to update the warning label included ALL forms of Depo-Provera, including low-dose pills. Currently, researchers have only linked the injectable form of Depo-Provera to an increased risk of meningiomas. When Pfizer re-applied (and succeeded) to update Depo’s warning label in 2025, the new filing only listed the Depo-Provera shot, leaving out the pill entirely.
  1. Because of Depo-Provera regulations in Canada and Europe, many attorneys suggest Pfizer must have known about Depo-Provera being linked to meningiomas much sooner than 2023.

Let’s dig into that second point a little deeper, because that’s where the crux of the entire lawsuit exists.

Depo-Provera warnings in other countries

The Canadian version of Depo-Provera was updated to notify doctors about meningiomas back in 2006—19 years before the product label was eventually changed in the United States. Though meningiomas were not added to the Warnings and Precautions section of the product label until 2024, they were marked as a potential “Post-Market Adverse Drug Reaction” due to several reported cases.

This fact alone almost singlehandedly dismantles Pfizer’s argument that it only learned about Depo-Provera potentially causing meningiomas in 2023. As the manufacturer of Depo-Provera, it would be nearly impossible for Pfizer to NOT be aware of these reported meningioma cases, even if they came from outside the United States.

The European Union has also taken action to update the product label, officially adding a meningioma warning for Depo-Provera in 27 different countries. This warning was added in September 2024, but various governmental agencies across Europe had been investigating potential risks since 2022.

So what does this all mean for Pfizer?

Since Canada and other countries have known about Depo-Provera’s potential meningioma risks for longer than even Pfizer claims to have been aware of, many lawyers believe there may be something fishy going on with Pfizer’s defense. The company appears to have been caught in a web of its own making, and the lawsuit will only continue to grow as Pfizer dances around taking accountability.

As of July 2026, nearly 6,000 patients with meningiomas have filed claims against Pfizer for not disclosing Depo-Provera’s potential risks. A settlement covering roughly 80-90% of claims has also been recently announced, but the amount has not yet been disclosed.

File a Depo-Provera claim

If you or an immediate family member were diagnosed with a meningioma or another brain tumor after using Depo-Provera, you may be entitled to significant compensation from the lawsuit.

Ready for a free case review? Take our online Depo-Provera eligibility evaluation to see if you may be eligible to file a claim.