MDL 3140 Bellwether Trial (Pending)
Rule 702 hearings on general causation are scheduled for late May 2026. Bellwether trial selection and scheduling will follow. No verdict has been reached yet.
Depo-Provera (medroxyprogesterone acetate / MPA) is a contraceptive injection administered every three months. Over 2,000 lawsuits consolidated in MDL 3140 in the Northern District of Florida allege that Pfizer failed to warn about a significantly elevated risk of meningioma — a tumor in the tissue surrounding the brain and spinal cord. Women who received the shot for more than one year face up to a 5.6-fold increased risk, and the risk escalates with duration of use.
Upjohn Company submits a new drug application for Depo-Provera as a contraceptive. The FDA identifies cancer concerns after beagle dogs develop tumors and rejects the application.
The FDA approves Pfizer's supplemental label change adding meningioma to Depo-Provera's Warnings and Precautions — a full decade after Canada's 2015 warning. Rule 702 hearings on general causation are set for May 2026.
After a seven-year beagle study reveals malignant breast tumors in two of 36 test animals, the FDA again rejects Depo-Provera for contraceptive use in the United States.
A rare FDA Public Board of Inquiry convenes to evaluate Depo-Provera safety. The board recommends against approval, making it the third federal rejection.
Despite three prior rejections and opposition from women's health advocates, the FDA approves Depo-Provera as a contraceptive. Upjohn argues that international experience with over 30 million users supports safety.
Pfizer completes its acquisition of Pharmacia Corporation (which had merged with Upjohn in 1995), inheriting Depo-Provera and all associated regulatory responsibilities and liabilities.
The FDA requires its most serious warning — a black box — regarding significant bone mineral density loss with long-term use, recommending a 2-year usage limit.
Health Canada adds meningioma as an adverse reaction to the Canadian Depo-Provera label, noting reports of meningiomas following long-term progestin administration. American women receive no equivalent warning.
Roland et al. publish a landmark population-based study in The BMJ showing that women who received Depo-Provera long-term face a 5.6-fold increased risk of meningioma. The study triggers a wave of U.S. lawsuits.
The Judicial Panel on Multidistrict Litigation consolidates all federal Depo-Provera meningioma lawsuits into MDL 3140 under Judge M. Casey Rodgers in the Northern District of Florida.
Rule 702 hearings on general causation are scheduled for late May 2026. Bellwether trial selection and scheduling will follow. No verdict has been reached yet.
$12.2 million individual verdict in Mirena IUD litigation involving pseudotumor cerebri (elevated intracranial pressure). Bayer faced failure-to-warn claims similar to the Depo-Provera meningioma theory. The neurological injury parallel makes this a key benchmark.
$15 million verdict against Abbott Laboratories for failure to warn about Depakote birth defect risks. The pharmaceutical failure-to-warn theory and pregnancy/reproductive health context parallel the Depo-Provera litigation.
$9 billion verdict (later reduced to $36.8 million) against Takeda Pharmaceuticals for hiding bladder cancer risks of the diabetes drug Actos. Demonstrates potential for massive jury awards when pharmaceutical companies are found to have concealed known cancer risks.
$100 million global settlement by Merck resolving approximately 3,800 NuvaRing hormonal contraceptive injury claims. As a hormonal birth control failure-to-warn case with a similar plaintiff profile, NuvaRing provides a baseline comparator for per-plaintiff values in the Depo-Provera litigation.
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