Generic Depo-Provera Manufacturers Call for Birth Control Shot MDL to Be Created in NY, Not California

Growing number of lawsuits against generic Depo-Provera manufacturers allege that women have not been adequately warned about the risk of meningioma brain tumors from the birth control shot.

Generic drug manufacturers indicate that they support creating a federal multidistrict litigation (MDL) for all Depo-Provera brain tumor lawsuits filed by women nationwide, but indicate that the claims should be consolidated before a judge in New York, near the headquarters of Pfizer and other pharmaceutical companies involved in the litigation.

Over the past few months, dozens of women have brought lawsuits against Depo-Provera generic manufacturers and Pfizer, each raising similar allegations that they were not adequately warned about the risk of meningioma brain tumors that may be caused by the popular birth control shot.

Given common questions of fact and law raised in the claims, a group of plaintiffs filed a motion last month seeking to create a Depo-Provera birth control shot MDL in the Northern District of California, which would include lawsuits filed against Pfizer, who sold the brand name version of the drug, as well as manufacturers of generic equivalents.

In responses filed last week, three generic drug manufacturers named in many of the lawsuits, Prasco, LLC, Greenstone LLC and Viatris Inc., told the U.S. Judicial Panel on Multidistrict Litigation (JPML) that they support centralization, but do not believe that California is an appropriate venue. Instead, they indicate the generic Depo-Provera lawsuits should be centralized in the Southern District of New York, arguing that court has the most direct connection to the rapidly growing litigation.

Depo-Provera is a popular hormonal birth control shot that has been used by 70 million women, containing medroxyprogesterone acetate, a synthetic form of the hormone progesterone. It was first introduced in 1992, and the brand-name version of the drug continues to be sold by Pfizer, with several authorized generic Depo-Provera equivalents also on the market.

The litigation over Depo-Provera emerged earlier this year, following the publication of a study that found Depo-Provera may cause brain tumors to develop, with women receiving the quarterly birth control shot facing a five times greater risk of developing a meningioma, which is a slow-growing tumor that can cause seizures, headaches, vision problems, hearing loss and other symptoms.

Depo-Provera MDL Application

According to the original request to establish an MDL, there are at least 22 Depo-Provera lawsuits currently pending in eight different U.S. District Courts, with six of those claims pending in the Northern District of California. Therefore, plaintiffs have proposed that venue to host the coordinated discovery and pretrial proceedings.

Plaintiffs noted each of the complaints raise nearly identical allegations, and it is widely expected that the size and scope of the litigation will increase dramatically in the coming weeks and months. Thus, plaintiffs argue that establishing an MDL will help prevent duplicative discovery into common issues in the lawsuits, avoid contradictory rulings and serve the convenience of all parties, witnesses and the court system.

Last week, a response was also filed by Pfizer supporting the creation of a Depo-Provera shot MDL, and additional filings have now been submitted by Prasco (PDF), Greenstone and Viatris (PDF), each indicating that the cases should not be sent to California.

“Forcing Prasco and its counsel to litigate this MDL in California… would add tangible and demonstrable inefficiencies and undue burdens not present in the alternate proposed Southern District of New York venue,” the Prasco response states. “Pfizer, the NDA holder for Depo-Provera, and according to plaintiffs the ’primary’ defendant, is headquartered in New York; the remaining defendants (including Prasco) are headquartered nearby or a short, direct plane flight away in the same time zone. Thus, the Southern District of New York is undeniably more convenient, accessible, and economical for defendants, defendants’ counsel, and plaintiffs’ counsel to reach.”

If the JPML agrees to consolidate the lawsuits into a Depo-Provera MDL, all current and future claims will be transferred to one judge for coordinated discovery, pretrial motions and potentially a series of early bellwether test cases.

However, if the parties fail to reach Depo-Provera brain tumor settlements or another resolution for the litigation after all pretrial proceedings are concluded, each individual lawsuit may later be remanded back to the U.S. District Court where it was initially filed for an individual trial in the future.

The U.S. JPML is scheduled to consider oral arguments on the motion at a hearing scheduled for January 30, 2025, at the Wilkie D. Ferguson, Jr. U.S. Courthouse in Miami, Florida.