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According to a lawsuit recently filed against Bayer Healthcare, a Texas woman indicates that she developed a pseudo-brain tumor from the Mirena IUD birth control implant, which resulted in blind spots, vision loss and other complications associated with a buildup of fluid pressure in the skull.
The complaint (PDF) was filed by Angela Kolebuck Utz in the U.S. District Court for the Southern District of New York on July 31, alleging that the popular intrauterine device caused the development of a medical condition known as idiopathic intracarnial hypertension (IIH), which is also commonly referred to as pseudo-tumor cerebri (PTC).
Utz, 45, was implanted with a Mirena IUD in February 2011. However, she was diagnosed with intracranial hypertension in August 2011. Because neither she nor her doctor were aware of the potential link between the Mirena and the risk of pseudo-brain tumors, she indicates that the implant was not removed until May 2014.
The condition involves a dangerous buildup of fluid around the brain, which appears consistent with a tumor. The intracranial pressure can impact the optic nerve, potentially resulting in permanent blindness in some cases.
According to the lawsuit, Utz indicates that she experienced blind spots in her vision, double vision, blurry vision, vision loss, and diminished peripheral vision. In addition, she also suffered severe headaches, blackouts, cognitive problems, tinnitus, dizziness, nausea and pain in the back, neck and shoulders, the complaint states.
To alleviate the problems, Utz has undergone multiple lumbar punctures and intracranial venous stenting. The lawsuit alleges that Bayer failed to adequately warn users or the medical community about this potential risk associated with the Mirena IUD.
“Defendants owed a duty to provide a reasonably safe product and to warn Plaintiff, patients, the FDA, prescribing physicians, the healthcare community, and other foreseeable users of the foreseeable risks associated with Mirena,” the lawsuit states. “The foreseeable risks associated with Defendants Mirena design outweigh its utility for the foreseeable uses for which it is prescribed to patients like the plaintiff.”
Utz’s case will be consolidated with hundreds of similar Mirena lawsuits being pursued by women who have experienced similar problems with pseudo-brain tumors from the long-term birth control implant.
Given similar questions of fact and law raised in complaints filed throughout the federal court system, the cases are currently consolidated for pretrial proceedings as part of a federal multidistrict litigation (MDL), which is centralize before U.S. District Judge Paul A. Englemayer in the Southern District of New York.
As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will schedule a series of early “bellwether” trials to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the cases. However, if the manufacturer fails to reach Mirena settlement agreements or otherwise resolve the litigation in the MDL, each of the cases may ultimately be remanded back to various U.S. District Courts nationwide for separate trial dates in the future.