Depo-Provera, widely used as a female contraceptive injection for over three decades, has been linked to a significantly increased risk for development of meningiomas, a type of brain tumor. Numerous women who developed brain tumors after prolonged use of the drug are now pursuing legal action against Pfizer and other manufacturers. Based on FDA data, there could be a significant number of potential plaintiffs given the extensive use of Depo-Provera.

What is Depo-Provera?

Depo-Provera is Pfizer’s brand name for a contraceptive injection that contains progestin, a synthetic version of the hormone progestogen. Injected into the arm or buttocks every three months, Depo-Provera works by impacting ovulation and thickening the cervical mucus to prevent sperm from successfully getting to an egg.

What is the Depo-Provera lawsuit?

The ongoing lawsuits allege that manufacturers of Depo-Provera failed to warn women about the risk of developing intracranial meningiomas if the drug is used for more than a year.

Who are the defendants in the Depo-Provera lawsuit?

The defendants are the manufacturers of Depo-Provera and its authorized generics, which include:

  • Pfizer, Inc.
  • Viatris Inc.
  • Greenstone LLC
  • Prasco, LLC d/b/a Prasco Labs
  • Pharmacia & Upjohn Co, LLC
  • Pharmacia LLC

Depo-Provera has been available in the US since 1960 for noncontraceptive purposes. In October of 1992 it was approved by the US Food and Drug administration for contraceptive use. One reason Depo-Provera was not initially approved by the FDA was the evidence of the link between the drug and breast tumors and cervical cancer in animals revealed through clinical studies.

What injuries have been linked to Depo-Provera?

In March 2024, the British Medical Journal released a study that found women who were given medroxyprogesterone acetate, the active ingredient in Depo-Provera, had up to a 5.6 times greater risk for developing meningioma, a type of brain tumor. Meningiomas may typically be noncancerous and slow growing, but they often require surgery for removal. Their proximity to critical brain structures can make intervention risky, and in some cases, inoperable. A tumor that grows can lead to further acute and chronic complications by pressing on the brain or spinal cord, causing headaches, seizures, dizziness and vision problems.

What are recent key developments?

Broughton Partners Take: In light of the FDA’s rejection of Pfizer’s proposed warning label update, there are potential preemption problems. There are no other case developments until there is a ruling on the venue. The first bellwether trials are expected to begin midway through 2025.

January 2025: Hearing on Proposed MDL
At the end of the month, the Judicial Panel on Multi-District Litigation (JPML) held a hearing on the proposed MDL. The Depo-Provera litigation is expected to proceed as an MDL, but the panel is still deciding between New York and California for the MDL’s venue.

There are also potential preemption challenges. Pfizer claimed that it would update Depo-Provera’s drug label to include a warning about the risk of meningiomas. However, because the study Pfizer used as support included only seven individuals, the FDA denied the request, citing insufficient evidence.

October 2024: First Depo-Provera Pfizer Lawsuit Filed
At the beginning of October, the first lawsuit was filed against Pfizer as well as several other companies that sell the authorized generic form of the drug. The plaintiff, Kristina Schmidt, took about 64 injections of Depo-Provera or its generic equivalent between 2005 and 2021. In 2022, after suffering from severe headaches, dizziness, and vertigo, she was diagnosed with a brain tumor at the age of 37. This suit was filed in the U.S. District Court for the northern District of California.

April 2024: Pfizer Releases Statement Following Increased Brain Tumor Risk
Following the publication of a study in the British Medical Journal linking the prolonged use of Depo-Provera with an increased risk of developing brain tumors, Pfizer released a public statement: “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.”

As of October 2024, Pfizer had yet to make the promised changes to the warning label for products distributed in the United States. However, the company did update the Depo-Provera warning information for patients in Europe.

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