Depo-Provera Lawsuits Say U.S. Label Lacks Tumor Warnings That Are Included Overseas
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Depo-Provera litigation over claims that it is linked to tumor development has begun to pick up, with multiple lawsuits now filed.
Two Depo-Provera lawsuits filed in California by women who used the contraceptive injection for years claim that the makers of the drug failed to warn of the risk of developing a meningioma.
Meningiomas are a type of tumor that forms near the brain and spinal cord, They are usually benign but can still have serious adverse health effects and, according to Cleveland Clinic, can require surgery.
The new lawsuits pose a critical question: Why do Depo-Provera labels warn of the risk of meningioma in other countries but not in the United States?
The lawsuits state that the Depo-Provera labels for the United Kingdom and European Union list meningioma under the “special warnings and precautions for use” section. The labels also advise patients to tell their doctor if they have a history of meningiomas before taking Depo-Provera.
Canadian labels have also listed meningiomas as a “post-market adverse drug reaction” since at least 2015.
However, the lawsuits allege that labels in the U.S. haven’t been revised, despite new research indicating an increased tumor risk for Depo-Provera users.
“Defendants have still made no change to the U.S. Depo-Provera label related to intracranial meningioma,” a lawsuit filed for plaintiff Kathleen Fazio on Oct. 28 stated. “[They] have failed to take any steps to otherwise warn the medical community and Depo-Provera users of these significant health risks.”
The growing litigation involving Depo-Provera stems from a study that was published in the British Medical Journal in March, which found long-term Depo-Provera users are at a significantly increased risk of developing a meningioma.
The research showed that long-term users are over five times more likely to develop the potentially dangerous tumors. According to the study, over 70 million women worldwide use Depo-Provera.
Plaintiffs Claim Meningiomas Stemming from Depo-Provera Had Serious Effects
An analysis of the two lawsuits filed in California highlights the types of claims plaintiffs plan to make as litigation tied to Depo-Provera continues to expand.
One plaintiff, Fazio, first began using Depo-Provera in 1999 when she was 31 and continuously received injections for nearly 20 years.
In 2017, she received an MRI after she became disoriented while driving. Leading up to that incident, she began having memory issues and headaches and would become disoriented or feel lethargic. The MRI uncovered that she had a meningioma, which would require surgery to remove.
But, even after the procedure, issues continued. She had blurred vision and double vision due to complications from the surgery, and her sense of taste and smell both deteriorated.
Fazio didn’t know about the association between Depo-Provera and meningiomas at the time, even asking her doctor if it was okay for her to continue receiving the drug in light of her new health condition. Her doctor approved, and she received more injections after the diagnosis.
Another plaintiff, Monique Jones, found herself in a similar situation. However, according to her lawsuit, her condition remains ongoing. A CT scan diagnosed her with a meningioma after she received around 90 Depo-Provera shots over nearly 25 years.
The placement of the tumor made it too risky to remove, forcing her to live with symptoms such as headaches, vertigo and blurred vision.
It was not until the BMJ study was published and publicized in March that Jones learned her condition could have stemmed from her years-long use of Depo-Provera. The study found that long-term use of the drug in particular could increase the risk of developing tumors.
Lawyers continue to accept new Depo-Provera cases as litigation grows.
Editor Lindsay Donaldson contributed to this article.