Pfizer says it couldn't have warned about tumor risk in Depo-Provera lawsuits

By Diana Novak Jones

CHICAGO, Aug 25 (Reuters) - Pfizer has urged a Florida federal judge to dismiss lawsuits claiming its birth control shot Depo-Provera can cause users to develop a type of brain tumor, saying regulators barred the company from including a warning about the tumors on the drug’s label.

The New York-based pharmaceutical company told U.S. District Judge M. Casey Rodgers in Pensacola in a Friday filing that claims the company failed to warn consumers and physicians about the risk of meningiomas associated with the drug were preempted by the U.S. Food and Drug Administration’s rejection of that warning before the litigation began. The tumors are often benign but can compress brain tissue and require surgery, the plantiffs said in the court filing.

Instead of following a more typical bellwether process to have both sides select cases to test the claims, the judge selected five so-called "pilot" cases to prepare for trial. Pfizer asked the judge to enter judgment for the company in the five cases.

If Rodgers sides with the company, Pfizer said it will move for a similar ruling in all of the remaining cases in the litigation, which was centralized in February and currently includes more than 500 cases, court records show.

In a statement, Chris Seeger, Bryan Aylstock and Ellen Relkin, lawyers for the plaintiffs, said Pfizer had "substantial scientific evidence" since the 1980s that Depo-Provera could cause meningiomas but ignored it. “The law makes clear drug manufacturers like Pfizer are responsible for providing proper warnings to patients and doctors," they said.

In a statement, a Pfizer spokesperson said the FDA’s rejection “precluded Pfizer from changing the Depo-Provera label and should preempt plaintiffs’ attempt to end-run FDA’s determination.”

Women who say they were diagnosed with an intracranial meningioma after receiving Depo-Provera injections began filing the lawsuits in 2024. Most of the women required surgery, and after surgery, many say they were left with neurological problems, including vision loss and seizure disorders.

In the Friday filing, Pfizer said that in late 2023, it had concluded that there was a potential causal association between an ingredient in the drug and the tumors. The company said it had asked the FDA for permission to add a warning about meningiomas on all of its medications with that ingredient.

The FDA had rejected Pfizer’s request, saying the data didn’t support the addition of the warning, according to the filing.

Federal law governs the labels on prescription drugs, and state law claims a company failed to warn consumers are preempted when it’s clear that the FDA would not have approved a change to the label, the company said.

The case is IN RE: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability, case number 3:25-md-03140 in the U.S. District Court for the Northern District of Florida.

For the plaintiffs: Christopher Paulos of Levin Papantonio; Bryan Aylstock of Aylstock Witkin Kreis & Overholtz; Ellen Relkin of Weitz & Luxenberg; and Christopher Seeger of Seeger Weiss

For Pfizer: Joseph G. Petrosinelli, Jessica Rydstrom and Annie Showalter of Williams & Connolly