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A 40 year old woman indicates that she had to have a Mirena IUD birth control implant removed about two years after it was inserted, after suffering blurred vision, severe headaches, back pains and other symptoms of a medical condition known as pseudotumor cerebri (PTC), or idiopathic intracranial hypertension (IIH).
The complaint (PDF) was filed by Olushola Walker in the U.S. District Court for the Southern District of New York on March 1, indicating that Bayer Healthcare failed to warn about the risk that Mirena may cause the dangerous buildup of fluid in the skull, which acts similar to a brain tumor.
Walker indicates that a Mirena intrauterine device (IUD) was implanted without complications in July 2009, involving the placement the T-shaped device in the uterus to prevent pregnancy for up to five years. However, after suffering severe headaches, blurred vision, ringing in the ears, back pain and other problems, Walker was eventually hospitalized in October 2011.
After a CT scan filed to identify any evidence of an acute intracranial abnormality, Walker underwent a diagnostic lumbar puncture a month later to evaluated increased intracranial pressure. About a week later, she was diagnosed with PTC/IIH during a follow up exam
According to allegations raised in the complaint, the problems were caused by the Mirena IUD, which releases the progestin levonorgestrel, which has been linked to a risk of PTC/IIH in other birth control produces. However, the Mirena warnings failed to adequately warn women and doctors about the need to monitor for symptoms after the IUD is implanted, or about the importance of promptly removing the device to avoid permanent damage to the optic nerve.
“Mirena is a defective and unreasonably dangerous product, because its labeling fails to adequately warn consumers and prescribers of, among other things, the increased risk of developing IIH/PTC,” Walker’s lawsuit states. “Mirena was under the exclusive control of Defendants and was unaccompanied by appropriate warnings regarding all of the risks associated with its use.”
Walker’s complaint joins a growing number of similar Mirena IUD lawsuits filed nationwide by women who suffered intracranial hypertension or pseudotumor cerebri, often resulting in vision loss and other injuries associated with damage to the optic nerve caused by the fluid pressure around the brain.
Given similar questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings in April 2017, centralizing all cases involving pseudotumor cerebri or intracranial hypertension complications from Mirena IUDs before one judge in the Southern District of New York.
There are currently more than 200 complaints pending before U.S. District Judge Paul A. Englemayer as part of an MDL, or multidistrict litigation. However, as Mirena injury lawyers continue to review and file claims for women nationwide, it is expected that the size and scope of the litigation will continue to grow over the coming weeks and months.