Judge To Hear Depo-Provera Lawsuit Preemption Arguments on Monday

If Pfizer’s motion for summary judgment is rejected, the parties will continue with the preparation of five pilot cases to serve as early bellwether trials.

The U.S. District Judge presiding over all federal Depo-Provera lawsuits will hear oral arguments on Monday to determine if plaintiffs can pursue cases against Pfizer for failing to warn them about the risks of developing brain tumors from the popular birth control shot, or whether their claims are blocked by federal law.

Depo-Provera is a long-acting hormonal contraceptive administered quarterly, which has been injected into millions of women over the past three decades, since it was widely promoted as a safe, convenient alternative to daily birth control pills.

However, concerns about the side effects of the birth control shot have emerged after several recent studies linked Depo-Provera to increased brain tumor risks, noting that the progestin can promote the growth of intracranial meningioma.

As a result of the failure to disclose this risk to women or the medical community, Pfizer now faces more than 1,000 lawsuits, and Depo-Provera attorneys estimate another 9,000 or so claims are currently under investigation.

Given common facts and law shared in the complaint, all Depo-Provera lawsuits filed throughout the federal court system have been consolidated into a multidistrict litigation (MDL) in the Northern District of Florida, where U.S. District Judge M. Casey Rodgers is presiding over coordinated discovery and pretrial proceedings.

To help manage the litigation, Judge Rodgers has ordered the parties to prepare five pilot lawsuits for a series of early trial dates, which will give the parties an opportunity to see how juries are likely to respond to evidence and testimony expected to be repeated in thousands of claims.

However, before the first claims go before a jury, Pfizer has filed a motion for summary judgment, asking that the lawsuits be dismissed due to federal preemption laws, which state that a manufacturer cannot face failure to warn claims if they were not allowed to put those warnings on the label by federal regulators.

Court to Hear Arguments on Pfizer’s Preemption Motion

Pfizer claims that it attempted to add brain tumor warnings to the Depo-Provera label in 2023, and the U.S. Food and Drug Administration did not approve those warnings. The request came after a February 2023 epidemiological study involving 25 women 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.

Plaintiffs filed a response in opposition earlier this month, arguing that Depo-Provera was on the market for decades after science had established that the injections could promote brain tumor growth, and only sought to improve the labels after an investigation by foreign regulators. They accuse Pfizer of submitting the request in a way that concealed crucial information and peer-reviewed studies, making the label changes intentionally doomed to fail.

The parties submitted a joint update and proposed agenda (PDF) this week for a case management conference that will be held on Monday, after which Judge Rodgers will hear arguments from both sides on the preemption issue.

In a court order (PDF) issued on Wednesday, Judge Rodgers indicated that the Court will reserve 2.5 hours after the Case Management Conference for the oral arguments, with each side receiving 75 minutes to present its case.

Depo-Provera Lawsuit Pilot Trials

The agenda shows there are currently 1,164 Depo-Provera lawsuits consolidated in the federal MDL, as well as 101 similar cases filed in state courts across the country. Most of those are in New York (71 cases), California (19), and Delaware (6), with single cases pending in Illinois, Connecticut, New Mexico, Tennessee and Pennsylvania.

An additional claim was previously filed in Pennsylvania involving 100 different women on the same complaint. However, after a Philadelphia judge ordered the claims to be severed, that lawsuit was voluntarily dismissed, leaving only a single case still pending in the state.

If Judge Rodgers rejects Pfizer’s motion for summary judgment the parties are expected to move forward with preparation of five “pilot” lawsuits for bellwether trials.

While the outcomes of those trials will not be binding on other claims, they are expected to provide critical insight into how juries respond to key arguments and testimony, potentially paving the way for broader Depo-Provera settlement negotiations.

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