Pfizer Seeks Dismissal of Depo-Provera Failure-To-Warn Lawsuits Over Meningioma Risks

MDL Judge will hear oral arguments for the birth control shot maker’s preemption motion on September 29, 2025.

As thousands of women continue to come forward to pursue Depo-Provera lawsuits against Pfizer, each raising similar allegations that they developed meningioma brain tumors after receiving the popular birth control shot, the drug maker has filed a motion arguing that it should be immune from liability in the failure-to-warn claims, based on federal preemption.

Depo-Provera is a long-acting hormonal contraceptive administered quarterly throughout the year, which contains the synthetic progestin medroxyprogesterone acetate. It has been widely used by millions of women over the past three decades, since it was promoted as a safe and convenient form of birth control, without the need to remember to take a daily pill.

However, lawsuits over Depo-Provera began to emerge last year, following publication of a study that revealed women receiving the birth control shot may face a 5.55 times higher risk of developing an intracranial meningioma, which is a dangerous brain tumor that can cause vision changes, headaches and neurological impairment, sometimes resulting in the need for brain surgery.

The complaints all raise similar allegations, indicating that drug makers, including Pfizer, Pharmacia, LLC and UpJohn Co, LLC, withheld critical safety information and warnings from women and the medical community about the potential for Depo-Provera brain tumor risks.

There are currently about 1,000 Depo-Provera failure-to-warn lawsuits already filed in the federal court system, with nearly 9,500 more claims under investigation by lawyers. However, the drug makers claim that the state-law based claims should be preempted by federal law, indicating that they asked federal regulators to let them add intracranial meningioma warnings to the drug label in 2023, but were rejected.

Given common questions of fact and law raised in complaints brought throughout the federal court system, a Depo-Provera MDL (multidistrict litigation) was established earlier this year in the Northern District of Florida, where U.S. District Judge M. Casey Rodgers has been appointed to preside over coordinated discovery and pretrial proceedings.

As part of the management of the litigation, Judge Rodgers has directed the parties to prepare a small group of pilot test cases for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. However, before the evidence is presented in open court, plaintiffs must overcome a series of anticipated pretrial motions seeking to have the litigation thrown out.

On August 22, Pfizer filed a motion for summary judgment (PDF), arguing that the state-law based failure-to-warn claims are preempted by federal law, which is a common argument raised in pharmaceutical litigation.

In support of its motion, Pfizer indicates that it presented a request to the U.S. Food and Drug Administration (FDA) in 2023, seeking to add information to the Depo-Provera warning label regarding intracranial meningioma risks.

That request followed a February 2023 epidemiological study involving 25 female patients, who developed intracranial meningiomas following Depo-Provera injections. In June of that year, a second study emerged with similar findings, and Pfizer indicates that its own scientists decided the evidence met the threshold for a label warning.

“(A)lthough a causal relationship between Depo-Provera use and meningioma had not been established, the team agreed there was enough evidence of a potential causal association (with long-term use) that a warning was justified.”

— Defense attorneys, in re: Depo-Provera Products Liability Litigation

The company’s attorneys claim that it also proposed an advisory to health care professionals, but the FDA rejected both requests. Because of that decision, Pfizer argues that the Depo-Provera failure to warn lawsuits should be dismissed, since it was legally not allowed to update the label without FDA permission.

Plaintiffs will file a response to the motion in the coming weeks, and Judge Rodgers has scheduled oral arguments for September 29, 2025, immediately after the next status conference in the litigation.

According to a case management order (PDF) issued last week, the parties will file a joint agenda letter by September 24, outlining topics they wish to review with the court regarding the status of the Depo-Provera lawsuits.

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