Pseudotumor Cerebri Lawsuit Filed Over Mirena IUD Birth Control

According to allegations raised in a recent product liability lawsuit filed against Bayer, side effects of Mirena IUD birth control caused a Texas woman to suffer a serious build up of fluids on her brain, known as pseudotumor cerebri or idiopathic intracranial hypertesion. 

The complaint (PDF) was filed by Kimberly Black in the U.S. District Court for the District of New Jersey early last month, indicating that Bayer failed to adequately warn about the risks associated with the Mirena intrauterine device (IUD), which is implanted in the uterus to provide long-term protection against pregnancy for up to five years.

Black, 30, indicates that she had Mirena birth control implanted in January 2014, and a few months later she began experiencing “severe headaches, blurred vision, diminished night and peripheral vision, weight gain, tinnitus, nausea, and neck and shoulder pain,” according to the lawsuit.

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As a result of the pseudotumor cerebri problems from Mirena, Black has required multiple lumbar punctures, had a brain stent implanted, and required removal of the IUD to alleviate the condition. The lawsuit says she has suffered permanent injuries, past and future medical expenses, lost wages, pain and suffering, and is likely to have health problems in the future.

Mirena is an increasingly popular form of birth control, allowing women to avoid pregnancy without needing to remember to take a daily pill. However, a number of women have reported experiencing a number of different complications from Mirena, including reports that the IUD perforated the uterus or moved out of position, causing severe internal injuries.

The case joins a growing number of other Mirena lawsuits pending in courts throughout the U.S., which allege that Bayer failed to adequately warn about certain risks associated with their popular birth control. While most of the complaints involve migration problems with Mirena, several other women have claimed they developed pseudotumor cerebri (PTC) or idopathic intracranial hypertension (IIH from levonorgestrel used in Mirena.

Plaintiffs allege that Bayer knew or should have known about the link between Mirena and pseudotumor cerebri (PTC)/idiopathic intracranial hypertension (IIH), and should have provided stronger warnings about the risk of problems caused by pressure on the brain from the build-up of cerebrospinal fluid while on Mirena birth control.

Intracranial hypertension develops when cerebrospinal fluid levels become elevated. This causes increased pressure in the skull, acting like a tumor. Victims develop severe migraines, double vision, temporary blindness, and other vision loss symptoms. They often develop swelling of the optic disk, and ringing in the ears known as tinnitus.

The pseudotumors from Mirena often presents as a swelling of the optic nerves, known as papilledema.

In several other places around the world, including South Africa and Hong Kong, Mirena warning labels include information about the risk that papilledema is a possible side effect. However, Bayer has not given women in America or the U.S. medical community the same warning.

Mirena Migration Lawsuits

The Mirena pseudotumor cerebri lawsuits come as Bayer continues to face about 4,000 product liability claims over Mirena migration and perforation injuries, where the T-shaped implant spontaneously punctured the uterus or moved out of position.

Since April 2013, those cases pending throughout the federal court system have been centralized for pretrial proceedings before U.S. District Judge Cathy Seibel in the Southern District of New York as part of an MDL, or multidistrict litigation.

Bayer has continued to indicate that it intends to defend the migration injury cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs in that litigation maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

Plaintiffs filed a request last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish a separate MDL for Mirena psuedotumor lawsuits. However, that request was rejected, so each case is proceeding with informal coordination of discovery among the parties.

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