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According to allegations raised in a product liability lawsuit filed earlier this month against Bayer Healthcare, side effects of a Mirena IUD implant caused a dangerous buildup of fluid pressure around a Georgia woman’s brain, known as idiopathic intracranial hypertension (IIH) or pseudotumor cerebri (PTC), resulting in severe vision problems and nerve damage to the woman’s eye muscles.
The complaint (PDF) was filed by Maria Pitts in the U.S. District Court for the District of New Jersey on January 13, alleging that the manufacturer of the birth control implant failed to warn about the risk of IIH/PTC complications from Mirena.
Mirena IUD is a small, T-shaped implant designed to prevent pregnancy for up to five years. Although the hormone levonorgestrel released by Mirena is known to increase the risk of idiopathic intracranial hypertension (IIH) or pseudotumor cerebri (PTC), Pitts indicates that Bayer failed to adequately warn women or the medical community about the potential side effects after receiving the birth control implant, as well as the importance of monitoring for signs of the fluid build up around the brain.
Pitts had a Mirena IUD implanted in June 2012, and indicates that she later began to experience intense migraine headaches, blurred vision and double vision. In January 2015, she was diagnosed with papilledema and sixth nerve palsy, which were attributed to IIH/PTC from Mirena.
“Patients with PTC or IIH typically develop symptoms of severe migraines or migraine-like headaches with blurred vision, diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies,” the lawsuit states. “Visual problems and symptoms are a result of increased pressure on the optic nerve. Patients with PTC or IIH often develop papilledema, or optic disc swelling due to increased intracranial pressure.”
Although Pitts had her Mirena IUD removed in January 2015, the lawsuit indicates that she has been left with permanent damage to her optic nerve and vision problems caused by the fluid pressure in her skull.
The case joins a growing number of Mirena lawsuits over PTC/IIH injuries, each raising similar allegations that plaintiffs may have avoided severe and potentially life-long problems from permanent optic nerve damage if the drug maker had provided warnings about the importance of removing the device once symptoms first appeared.
Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, a petition was filed earlier this month to centralize and consolidate the Mirena IIH/PTC litigation before one judge for coordinated management as part of a federal MDL, or multidistrict litigation. Although a prior request to centralize the cases was rejected several years ago, with more than 100 complaints filed by women with IIH/PTC, it is expected that the U.S. Judicial Panel on Multidistrict Litigation (JPML) will determine that centralization is now appropriate.
If a Mirena IIH/PTC MDL is established, Pitts’ complaint will be transferred to the centralized proceedings. However, if Mirena settlements are not reached following bellwether trials and the MDL process, her case may be remanded back to the District of New Jersey for an individual trial date.