The Trial Lawyer Summer 2025 | Page 45

Despite this, many women say they were never warned— not by the drug label, not by their doctor, and certainly not by Pfizer. That lack of warning is now a major issue in the lawsuits. Plaintiffs argue that if they had known the risks, they could have chosen a different form of birth control. They could have been screened. They could have been safe.
HOW DEPO-PROVERA BECAME SO WIDELY USED First approved by the U. S. Food and Drug Administration( FDA) in 1992, the Depo-Provera shot is given once every three months and contains a high dose of a hormone called medroxyprogesterone acetate, a type of progestin. This hormone prevents pregnancy by:
• Preventing ovulation: The progestin blocks the release of an egg from the ovaries.
• Thickening cervical mucus: This makes it more difficult for sperm to reach the egg.
• Thinning uterine lining: This reduces the likelihood of a fertilized egg implanting.
At first, Depo-Provera was mostly used by women who couldn’ t take estrogen-based birth control. But over time, it became a popular choice for people who wanted something easy and long-lasting— no daily pills, no patches, no implants. The drug was also used in prisons and low-income clinics [ see sidebar ], raising serious ethical concerns.
Drugmakers promoted Depo-Provera as safe and convenient. But as its use grew, so did reports of serious side effects— including bone thinning, mood changes, and now, brain tumors like meningioma. Despite growing evidence of these risks, the FDA did not require stronger warnings. Meanwhile, in other countries, regulators acted faster. In 2019, the French National Agency for Medicines and Health Products Safety( ANSM) conducted a nationwide pharmaco-epidemiological study that confirmed a strong dose-response relationship between the use of certain progestogens, including depot medroxyprogesterone acetate( DMPA), and the development of meningiomas requiring surgery or radiotherapy. Following these findings, France decided to withdraw Depo-Provera from the market to mitigate the associated health risks.
European Union, United Kingdom, South Africa, and Canadian labels have included meningioma warnings for nearly a decade.
Here in the U. S., patients were left in the dark.
LAWSUITS AND WHAT THE MDL MEANS FOR VICTIMS As of May 5, 2025, there are 316 cases pending in the Depo-Provera MDL.
As more women came forward with meningioma diagnoses after using Depo-Provera, lawsuits started piling up. These aren’ t small claims. Women are saying they were never warned about the risk of developing serious, sometimes life-threatening brain tumors. Some had to undergo surgery. Others are living with permanent damage. And many are asking the same question: Why weren’ t they told?
The first lawsuits against Pfizer alleged that the company failed to adequately warn about the risks of prolonged Depo-Provera use and its link to meningioma. Plaintiffs claim that Pfizer knew or should have known about the dangers posed by medroxyprogesterone acetate but continued to market the drug without sufficient warnings.
Rubber Stamp, Then a Corner Office Pfizer Welcomes Back FDA’ s Cavazzoni
In February 2025, Pfizer announced the appointment of Dr. Patrizia Cavazzoni as Chief Medical Officer. The announcement has reignited long-standing concerns about the“ revolving door” between federal regulatory agencies and the pharmaceutical industry.
Dr. Cavazzoni, who served as Director of the U. S. Food and Drug Administration’ s( FDA) Center for Drug Evaluation and Research( CDER) until January 2025, had previously worked at Pfizer in high-level clinical research roles before joining the agency in 2018. Her return to Pfizer just weeks after leaving the FDA has raised alarm bells among public health watchdogs and political figures alike.
Critics argue that this pattern— moving from industry to regulator and back— undermines the public’ s trust in the FDA’ s ability to independently evaluate drugs like Depo-Provera. During Dr. Cavazzoni’ s tenure at the FDA, the agency maintained its stance on the safety and utility of Depo-Provera, even as litigation and new medical studies raised concerns about its long-term risks, including the potential for meningiomas linked to prolonged use.
“ This is the core rot in American regulation,” Dr. Vinay Prasad of University of California, San Francisco, recently blogged.
In an interview with Politico, Public Citizen’ s Dr. Robert Steinbrook called the announcement of Cavazzoni’ s new position at Pfizer a clear sign that“ the revolving door between the FDA and the industries it regulates is alive and well.” Diana Zuckerman of the National Center for Health Research added that when regulators return to the industries they once oversaw, it raises“ a lot of questions about how objective they are when they are supposed to be working for the public.”
Now that Dr. Cavazzoni holds a top position at Pfizer— a company that has profited from Depo-Provera— plaintiffs in the MDL and public health advocates are closely watching to see whether Pfizer will face increased scrutiny or continued regulatory leniency. The concern is not merely academic: it’ s about ensuring that drug safety decisions are made based on science and public welfare, not influenced by corporate ties. In the context of the Depo-Provera litigation, this revolving door dynamic adds another layer of complexity to the question of accountability and trust in the regulatory system.
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