Depo-Provera Side Effects Hidden for Decades, Lawsuit Alleges

Scientists and manufacturers have known that progesterone-inhibiting hormones could stimulate the growth of intracranial meningioma brain tumors for decades, lawsuit indicates.

Despite being diagnosed with two brain tumors in 1997, Deborah Waldoch indicates in a recently filed lawsuit that it took her 30 years to discover that side effects of her Depo-Provera birth control shots may have caused the condition, since the drug manufacturers concealed information about the potential risk of intracranial meningioma.

Waldoch filed a complaint (PDF) against Pfizer Inc., Pharmacia & Upjohn Co. LLC, and Pharmacia LLC in the U.S. District Court for the Northern District of Florida on October 16, indicating that the companies knew that progesterone-inhibiting hormones may stimulate the growth of brain tumors, yet withheld information from consumers and the medical community.

Depo-Provera, often referred to as the “Depo shot,” is a long-acting hormonal contraceptive that is administered once every three months. As a result of the widespread belief that the shots are safe and effective, tens of millions of women have received the injections, often repeatedly, since the drug was first approved in 1992.

However, concerns have emerged over the past few years following studies linking Depo-Provera to brain tumor risks, specifically intracranial meningioma.

Waldoch’s claim, like more than 1,300 similar Depo Provera lawsuits, argues that the drug makers knew about the brain tumor risks, while failing to provide adequate warnings to the medical community and patients.

According to the complaint, Waldoch, of Minnesota, received Depo-Provera injections for years before developing severe and debilitating vision problems, chronic headaches and vision loss in her left eye.

As a result of imaging scans, doctors discovered Waldoch had an intracranial meningioma in 1997. It was located close to critical neurovascular structures in the brain, including the optic nerve, carotid artery and pituitary gland, and required surgical removal.

Follow-up scans revealed yet another brain tumor, which was not as close to areas of concern. Waldoch indicates she needs ongoing medical monitoring through regular MRI and CT scans, and remains at a high risk of developing additional and worsening neurological problems in the future.

Waldoch’s lawsuit notes that, at the time, neither she nor her doctors suspected the Depo-Provera injections were connected to the problem, which led to her continuing to receive the injections until 2009.

The complaint indicates that before Depo-Provera was ever approved, scientists linked progesterone-inhibiting agents, like those in the injections, to the growth of meningioma. However, it was only after recent studies and public attention that Waldoch and her doctors learned that Depo-Provera side effects could have caused the growth of her brain tumors.

“Through its affirmative misrepresentations and omissions, Defendants actively concealed from Plaintiff and Plaintiff’s physicians the true and significant risks associated with Depo-Provera use.”

– Deborah Waldoch v. Pfizer Inc. et al

Waldoch presents claims of strict liability – failure to warn, strict liability – design defect, negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraudulent misrepresentation, and breach of warranty. She seeks both compensatory and punitive damages.

Depo-Provera Lawsuits

The complaint will be consolidated with other Depo-Provera lawsuits in a multidistrict litigation (MDL) in the Northern District of Florida under U.S. District Judge M. Casey Rodgers, who is overseeing coordinated discovery and pretrial proceedings.

Judge Rodgers is leading the parties through the preparation of five pilot lawsuits to be used for a series of early trial dates. These bellwether trials will give the parties an opportunity to see how juries are likely to respond to evidence and testimony expected to be repeated in thousands of claims.

While the outcomes of these trials will not be binding on other claims, they will be closely watched to get an idea of the potential size of Depo-Provera payouts and help the parties reach a settlement agreement.

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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