A woman who used an injectable, long-acting contraceptive for five years is suing brand name and generic drugmakers in federal court in Pittsburgh, saying the companies failed to warn consumers about research linking the drug to brain tumors.
Patricia Bonilla, who lives in California, filed a two-count civil lawsuit demanding that makers of Depo-Provera set up a monitoring database for women who used the drug for birth control and to cover the cost of future cancer screening. The lawsuit, filed by Lynn A. Ellenberger from the North Shore firm of Fegan Scott LLC, seeks class action status to represent all women who used the contraceptive.
Brand and generic makers of Depo-Provera: Pfizer Inc., Pharmacia & Upjohn LLC, Pharmacia LLC, Viatris Inc., Greenstone LLC and Prasco LLC were named as defendants for failing to inform consumers about the risk of intracranial meningiomas with use of the contraceptive. Since it was filed Jan. 17, the lawsuit has been referred to Alternative Dispute Resolution, a court-ordered process that tries to reach a settlement without a trial, while 73 related lawsuits are pending in California, Nevada, Missouri and other states.
However, the Pittsburgh lawsuit is the first to demand medical monitoring for women who’ve used the contraceptive, Ms. Ellenberger said. The others claim personal injury from the drug.
The number of women filing the lawsuits could rise: Nearly a quarter of all sexually active women ages 18-49 have used Depo-Provera for contraception, according to a 2023 Centers for Disease Control and Prevention report.
“It’s very commonly used,” Ms. Ellenberger said. “The reason is the convenience and low cost.”
Cited in the Pittsburgh lawsuit was a 2023 study done by UPMC physicians and another by French researchers; both made the contraceptive-brain cancer connection.
Medical records for some 108,400 women were reviewed for the French study, published in 2024, which found a 53% greater risk of cancer in the women using the injectable contraceptive. Although the tumors were most often benign, they were usually located at the base of the skull, complicating surgical removal, which was associated with seizures and higher mortality rates than for women who didn’t use the drug.
In a statement, Pfizer said its drug was a safe contraceptive.
“Depo-Provera has been a Food & Drug Administration-approved medication for more than 30 years and has been a safe and effective treatment option for millions of patients during that time,” Pfizer said in the statement. “The company will vigorously defend these lawsuits.”
Pfizer was the only defendant to comment on the lawsuit.
Viatris was spun off from Upjohn in 2020 and acquired by Southpointe-based Mylan, which adopted the Viatris name.
Pfizer is a majority owner of Viatris with 57% of its stock, according to the lawsuit.
Depo-Provera, the brand name for medroxyprogesterone acetate, was first introduced in the U.S. in 1959 to manage menstruation, and it’s also used to treat some kinds of cancer. In 1992, the Food & Drug Administration approved the drug for use as a contraceptive.
The shot, which is given every three months, releases the synthetic hormone DMPA, which suppresses ovulation and thickens cervical mucus, helping keep sperm from fertilizing an egg.
A KFF analysis of the National Survey of Family Growth 2017-2019 found that younger, lower income and Black women most frequently used contraceptive injections. Use of the injection also decreased with educational attainment — smaller shares of women with bachelor’s degrees reported using the shot for contraception, according to the analysis.
The CDC has reported similar findings, with Depo-Provera use higher among women living in rural areas or without high school diplomas or GEDs.
The FDA issued a “black box warning” in 2004 for the contraceptive, the agency’s most serious caution, citing the potential for bone loss from prolonged use. However, the American College of Obstetricians and Gynecologists and World Health Organization disagreed with the warning.
“Plaintiffs and the class are reasonably concerned that they will develop intracranial meningiomas as a result of their Depo-Provera use,” according to the lawsuit. “They should not have to wait until they actually develop meningiomas; instead, they should benefit from a medical monitoring program that will allow early detection.”
Although Pfizer added the brain tumor warning to Depo-Provera sold in Europe in 2024, U.S. product labels have yet to be changed, the lawsuit said.
“Despite already including these changes in the European Union and the United Kingdom packaging, Pfizer has failed to do so in the United States,” according to the lawsuit. “To this day, Pfizer has not made any changes to the United States Depo-Provera label to mention meningiomas.”
First Published: January 31, 2025, 5:01 p.m.
Updated: February 1, 2025, 3:23 a.m.
