Pfizer Faces Lawsuits Over Depo-Provera: Wrongful Death, Failure to Warn, Design Flaws

Pfizer is facing a class action lawsuit from more than 1,300 women who claim the manufacturer failed to warn about the increased likelihood of intracranial meningioma for women who have used the quarterly injectable birth control method Depo-Provera for at least one year. A 2024 study found a 5.55x increased likelihood of meningioma for women who used medroxyprogesterone acetate, the primary hormone that is in Depo-Provera.

Pfizer argues this is a “clear preemption case” and alleges the FDA barred Pfizer from placing a warning on the box. The class action attorneys said Pfizer’s warning label was denied by the FDA because the request was “too broad.” 24.5% of all sexually experienced women in the United States have used Depo-Provera, including 41% of all black women.

The drug was rejected by the FDA multiple times in the 1970s and 1980s due to concerns of tumors and bone density loss. It was approved in 1992 and received a black box warning in 2004, citing higher risks of bone mineral density loss. The black box warning states, “ It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.”

Brain tumors that are more likely to develop after use of Depo-Provera are often benign, but can still cause significant damage, serious side effects, and possibly death. The tumor can push into brain structures and cause vision loss, seizures, and neurological issues. The solution for this type of tumor typically involves craniotomies, which are considered an invasive surgery.

A wrongful death suit has also been filed against Pfizer for the drug, specifically related to a meningioma tumor that the plaintiff’s lawyers argue ultimately led to her death at the age of 47 years old. The deceased woman received Depo-Provera injections from her healthcare providers from 2006 until her death in October, 2024.

The black box warning says the injectable medication should not be used longer than two years unless other birth control methods are considered inadequate. An autopsy was conducted on the woman’s body, and it was determined that she died of “Posterior Cranial Fossa Hemorrhage, due to: Meningioma of the Left Side of the Posterior Cranial Fossa.”

The lawsuit brief said the woman’s tumor was not discovered until the autopsy was performed following her death. The complaint says, “At no point prior to her death could Anita have discovered, or reasonably discovered, the causal connection between her use of Depo-Provera and the tumor. Indeed, Anita did not know she had a meningioma during her lifetime.”

The plaintiff alleges that UpJohn, which was later acquired by Pfizer, was well aware of the increased risk of meningioma from research studies conducted long before the drug was approved by the FDA.

“In the nine years before Depo-Provera was approved for contraception, and in the thirty-three years since—more than forty years in total—Defendants have seemingly failed to investigate the effect of their high-dose progestin Depo-Provera on the development of meningiomas,” the lawsuit complaint states.

The complaint alleges that Pfizer knew of the dangers and risks of this product as a result of multiple studies over the course of decades, including a study published nearly a decade before the initial approval of Depo-Provera in the United States. The United Kingdom and the European Union both updated their warning labels last year to include a warning about increased meningioma risk.

“Defendants willfully, wantonly, and intentionally conspired, and acted in concert, to withhold information from Anita, Anita’s healthcare providers, and the general public, concerning the known hazards associated with the use of, and exposure to, Depo-Provera, particularly over extended periods of time,” the lawsuit complaint states.

The wrongful death suit has been consolidated with the class action suit in Northern Florida and other similar claims. On Monday, Judge Casey Rodgers heard preemption arguments from the defendants and the explanation for why the pharmaceutical manufacturers were unable to warn the public of meningioma dangers. The transcript from this hearing is currently sealed, and no information has been released regarding the arguments that were made on Monday, September 29, 2025.

The Guardian reported comments from Virginia Buchanan, court-appointed co-chair of the plaintiffs’ executive committee, who said “Pfizer is attempting to avoid accountability by invoking a preemption defence, yet there are serious questions about whether it ever provided the FDA with the full picture. Preemption was never meant to serve as a shield for drug companies that fail to warn patients adequately. Pfizer has consistently failed to take reasonable steps to alert patients and their physicians to this very real danger.”

Pfizer is being investigated regarding a potential breach of fiduciary duties by the Pfizer board of directors in the marketing of Depo-Provera. Pfizer paid over $2 million in a Canadian class action settlement alleging that Depo-Provera caused bone mineral density loss and bone fractures.

The wrongful death lawsuit complaint alleges multiple counts of wrongful death, including failure to warn, negligence, and a design defect in the product itself. The complaint references the toxicological statement, “the dose makes the poison,” while stating that Depo-Provera contains a “higher dose of progesterone than was necessary for effective contraception, such that it posed an unreasonable risk of intracranial meningiomas.”

Pfizer issued a statement in early 2024 stating, “We are aware of this potential risk associated with long-term use of progestogens and, in collaboration with regulatory agencies, are in the process of updating product labels and patient information leaflets with appropriate wording.”

Despite this acknowledgement, there has been no update to the Depo-Provera label in the United States.