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A Louisiana woman indicates that after a Mirena IUD was implanted for long-term birth control, she developed severe headaches, blurred vision and other complications associated with a medical condition known as pseudotumor cerebri, according a product liability lawsuit filed this month against Bayer.
The complaint (PDF) was filed by Alicia Thames in the U.S. District Court for the Southern District of New York, indicating that the manufacturer failed to adequately warn consumers and the medical community about the risks associated with the birth control.
Mirena IUD is a form of long-acting birth control, which involves a T-shaped plastic device implanted into the uterus, which releases progestin levonorgestrel. While other forms of levonorgestrel birth control have been associated with a dangerous build up of fluid pressure in the skull, Mirena warnings failed to indicate that users should be on the look out for symptoms of pseudotumor cerebri (PTC), which may include migraines, double vision, floaters and blind spots.
Thames received a Mirena IUD in July 2014, and indicates that the implant procedure went without complication and was done in accordance to Bayer’s instructions. However, in July 2016, Thames sought treatment for severe headaches and other complications, which were ultimately diagnosed as pseudotumor cerebri, which is also sometimes referred to as idiopathic intracranial hypertension (IIH). As a result of the fluid build up around her brain, Thames has undergone a lumbar puncture, and been hospitalized on multiple occasions, the lawsuit indicates.
“Mirena’s label makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH,” the lawsuit states. “Defendants did no clinical testing of Mirena and its known link to the development of IIH/PTC, despite over a decade of literature indicating further testing regarding levonorgestrel and IIH/PTC is needed.”
Thame’s claim joins a growing number of Mirena lawsuits filed in courts nationwide, each raising similar allegations that women could have avoided serious and permanent injuries if Bayer had adequately warned them or the medical community about the risks of Mirena PTC and IIH.
Given similar questions of fact and law raised in lawsuits file by women 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.