Pfizer Ignored Depo-Provera Brain Tumor Risks for Decades, Plaintiffs Claim
As Pfizer works to escape the rapidly growing number of Depo-Provera lawsuits, plaintiffs claim the company ignored warnings for decades that its birth control shot could cause brain tumors.
These claims were made in a new motion filed on Friday, which opposes Pfizer’s attempts to dismiss the cases before they can advance further.
The company is facing hundreds of lawsuits claiming that its popular birth control shot is tied to the development of meningiomas, a typically benign tumor that forms in the lining of the brain and can cause serious health issues. These concerns became more prevalent following a French study published in 2024.
“For decades, as evidence amassed that Pfizer’s drug Depo-Provera caused brain tumors known as meningiomas, Pfizer refused to study or warn about that risk,” the new motion states. “It ignored biomechanistic and epidemiologic studies and doctors’ reports.”
Depo-Provera was first approved for use as a contraceptive in 1992. Lawyers representing people who have filed lawsuits claim that a neurosurgeon warned Pfizer that use of the drug could accelerate meningioma growth just five years after that approval.
Pfizer maintains that it cannot be blamed for failing to warn its customers of a tumor risk since the FDA rejected a label update that includes information on meningiomas.
Federal Preemption: The Key Issue for Depo-Provera Lawsuits
The issue at the heart of these cases is Pfizer’s claim that the Depo-Provera lawsuits should not be able to move forward due to federal preemption, where decisions made at the federal level overrule contradicting state laws.
Pfizer claims that, after new evidence emerged linking Depo-Provera use to meningiomas in 2023, the company drafted a label update for the drug that included information on a meningioma risk.
The FDA, however, went on to reject that label update at the end of 2024, saying that the available evidence was not substantial enough to warrant a change to the label. For that reason, Pfizer believes that the lawsuits should not be able to move forward since the FDA’s decision federally preempts the claims in these cases.
But plaintiffs’ representatives paint a different picture.
In the new motion, they claim that Pfizer drafted a label update that was so broad and applied to so many products that the agency would have had no choice but to reject it.
“FDA never rejected an adequate warning, because Pfizer never offered one,” the motion states. “Its flawed warning implicated a class of drugs, not just Depo-Provera, from low-dose oral tablets to high-dose injections. Science did not support this broad, undifferentiated warning.”
Additionally, the FDA offered Pfizer the option to resubmit its label application and talk through what would need to change for the label to be approved.
Judge to Weigh in on Future of Depo-Provera Lawsuits
The Depo-Provera lawsuits have been grouped together in multidistrict litigation (MDL), where many similar lawsuits are consolidated before one judge. This allows for a more streamlined legal process and efficient results.
At the start of this month, there were 806 active Depo cases in the MDL, with thousands more that could be filed.
The next major milestone for these lawsuits will be when the judge overseeing these cases decides whether or not to grant summary judgment to Pfizer based on the company’s federal preemption claims.
Summary judgment is where the judge rules in one side’s favor without holding a trial. If Pfizer were to be awarded summary judgment, it could be a potentially devastating development for defendants in these cases.
But if Pfizer’s motion fails, these lawsuits will continue to move through the MDL process and could potentially progress to bellwether trials.
These trials are common for MDLs and serve as test cases, with several lawsuits representing the larger litigation selected to go before a jury.
The outcome of those trials can help both sides better understand the strength of their cases and can influence settlement negotiations.
