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Plaintiffs claim Depo-Provera causes brain-impacting

tumors

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FDA rejected Pfizer's ( PFE ) request to add tumor warning,

company says

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Pfizer ( PFE ) wants pilot cases dismissed

By Diana Novak Jones

CHICAGO, Aug 25 (Reuters) - Pfizer ( PFE ) 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 ( PFE ) asked the judge to enter judgment for the company in the

five cases.

If Rodgers sides with the company, Pfizer ( PFE ) 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 ( PFE ) had "substantial

scientific evidence" since the 1980s that Depo-Provera could

cause meningiomas but ignored it. "The law makes clear drug

manufacturers like Pfizer ( PFE ) are responsible for providing proper

warnings to patients and doctors," they said.

In a statement, a Pfizer ( PFE ) spokesperson said the FDA's

rejection "precluded Pfizer ( PFE ) 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 ( PFE ) 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 ( PFE ) 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 ( PFE ): Joseph G. Petrosinelli, Jessica Rydstrom and

Annie Showalter of Williams & Connolly