Lawsuit Alleges Depo-Provera Caused Brain Surgery, After Meningioma Diagnosis

While Pfizer has warned women in Canada and the EU about the risks of Depo-Provera brain tumors since 2015, the company has not given women in the U.S. the same courtesy, lawsuit notes.

A California woman says she and many others would have never received injections of the Depo-Provera birth control shot if the manufacturers had been open and honest about the risks of developing brain tumors that can be life-threatening and require invasive brain surgery.

The complaint (PDF) was filed by Monica J. Steele and her husband, M. Eugene Steele, in the U.S. District Court for the Northern District of Florida on November 7, naming Pfizer Inc., Pharmacia LLC and Pharmacia & Upjohn Company LLC as defendants. 

Steele indicates the companies failed to provide adequate warnings to the medical community and recipients of Depo-Provera shots, which would have alerted them to be on the lookout for the development of a form of brain tumor known as intracranial meningioma.

Depo-Provera (depot medroxyprogesterone acetate) is a long-acting form of birth control that has been available since 1992, involving a shot administered four times a year, which has been used by tens of millions of women over the last three decades.

However, data has emerged in recent years linking Depo-Provera to brain tumor risks, specifically intracranial meningioma, leading to more than 1,200 Depo Provera lawsuits similar to Steele’s, which argue that the drug makers knew about the brain tumor risks, yet chose profits over patient safety.

According to Steele’s claim, she began receiving Depo-Provera injections in 1997 and continued to receive the shots through 1998. However, she began to develop severe headaches, confusion and difficulty speaking, the lawsuit indicates.

It was not until February 2018 that a CT scan discovered Steele had developed a brain tumor, which the lawsuit blames on Depo-Provera side effects. That same month she underwent a left stereostatic craniotomy, which is a highly delicate and invasive form of brain surgery that involved carefully cutting the meningioma out of her brain.

While the surgery was deemed successful, Steele must still undergo medical monitoring and additional treatment for the rest of her life, the lawsuit alleges. She indicates it took years to link her injuries to Depo-Provera injections due to the manufacturers intentionally keeping that information away from U.S. patients.

The complaint notes that Pfizer and generic manufacturers provided brain tumor warnings on Canadian and European Union Depo-Provera labels as early as 2015, while intentionally leaving American women in the dark. Both Canadian and EU warnings specifically mention meningioma as a risk, and warns doctors to be careful when prescribing the drug to women with known or suspected tumor risks.

“Defendants failed to disclose a known defect and, instead, affirmatively misrepresented that Depo-Provera was safe for its intended use.”

– Monica J. Steele, et al v. Pfizer Inc. et al

The lawsuit presents claims of failure to warn, design defect, negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraudulent misrepresentation and breach of warranty. The Steeles seek both compensatory and punitive damages.

Depo-Provera Side Effects Lawsuits

Steele’s claim will be consolidated with other federal Depo-Provera side effects lawsuits in the Northern District of Florida under U.S. District Judge M. Casey Rodgers, who is overseeing pretrial proceedings. 

The parties have been instructed to prepare a group of five “pilot” cases to serve as bellwether trials, which will provide an opportunity to see how juries are likely to respond to evidence and testimony expected to be repeated in more than 1,200 claims.

While the outcomes of these early trials will not be binding on other cases, they are expected to provide valuable insight into the potential size of Depo-Provera settlements and help guide negotiations toward a broader resolution.

If no settlement is reached, Judge Rodgers would likely remand the lawsuits back to their originating district courts for individual trial dates.

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