Pfizer Indicates Depo-Provera Meningioma Lawsuits Should Be Preempted by Federal Law

According to the birth control shot manufacturer, federal officials rejected a 2024 attempt to add brain tumor label warnings to Depo-Provera.

As a growing number of women continue to file lawsuits against the makers of Depo-Provera, alleging that side effects of the birth control shot caused meningioma brain tumors to develop, Pfizer and other generic manufacturers are calling for a U.S. District Judge to dismiss the litigation, arguing that the failure to warn claims should be pre-empted by federal law.

The U.S. Food and Drug Administration (FDA) first approved Pfizer’s Depo-Provera shot in 1992. The long-acting hormonal contraceptive, which requires a quarterly injection of the synthetic progestin medroxyprogesterone acetate to prevent pregnancy, has been used by tens of millions of women since its approval, with some estimates suggesting 25% of U.S. women aged 18 through 49 have received at least one injection.

However, litigation began against Pfizer and generic manufacturers of the drug following a study published in 2024 that linked Depo-Provera to increased brain tumor risks by a factor of five. Known as intracranial meningioma, these kinds of tumors can cause potentially life-threatening complications, frequently requiring brain surgery and life-long medical monitoring.

Currently, nearly 2,100 women or their families have filed Depo-Provera meningioma lawsuits. Each complaint raises similar allegations, indicating that the drug makers placed a desire for profits before the health and safety of women, by failing to adequately disclose Depo-Provera’s actual risks.

Late last year, the FDA approved an updated Depo-Provera brain tumor warning, adding new language to the drug’s label to alert users to the risk of intracranial meningioma. The update called for patients to be monitored for brain tumors and recommended the birth control medication be discontinued at the signs of meningioma development or growth.

Now, Pfizer is claiming that, because the FDA did not require the warning earlier, the drug makers should not be held liable for failing to update the label sooner.

Given common questions of fact and law raised in lawsuit brought throughout the federal court system, all claims have been centralized into a Depo-Provera meningioma lawsuit MDL, or multidistrict litigation, which is pending in the Northern District of Florida before U.S. District Judge M. Casey Rodgers, who is overseeing coordinated discovery and pretrial proceedings.

To help the parties gauge the relative strengths and weaknesses of their claims, and promote potential Depo-Provera meningioma settlements, Judge Rodgers previously instructed the parties to prepare a group of five “pilot” cases for early trial dates, which will give them a chance to see how juries respond to evidence and testimony likely to be repeated.

However, the Judge must make a decision first as to whether the lawsuits can move forward after a challenge by Pfizer, which says that the FDA refused to allow earlier label warnings plaintiffs say the drug should have carried, and that the company is therefore protected from liability by federal preemption laws.

On January 23, Judge Rodgers approved a schedule (PDF) for the parties to submit additional briefings outlining their position on the impact the recent FDA warning update has on previous motions filed. Pfizer’s supplemental brief (PDF) was submitted on January 30, and plaintiffs’ response brief is due by February 20, 2026, with any reply by the drug makers needed by February 27.

In its brief, the manufacturer argues that the FDA initially rejected the company’s request to add a meningioma warning to Depo-Provera’s label in February 2024. According to Pfizer, it was the second time the FDA had refused such a request. The company indicates this is evidence that it could not have supplied warning labels any earlier than the 2025 label update.

Judge Rodgers has not announced when a decision on the preemption claims will be released.

To stay up to date on this litigation, sign up to receive Depo-Provera lawsuit updates sent directly to your inbox.