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A Pennsylvania woman has filed a product liability lawsuit against Bayer Healthcare, alleging that side effects of a Mirena IUD left her with severe headaches, vision problems, ringing in the ears and other symptoms of pseudotumor cerebri, which is a medical condition involving a dangerous buildup of fluid pressure around the brain seen among women with the birth control implant.
The complaint (PDF) was filed by Andrea Novak last week in the U.S. District Court for the Southern District of New York, indicating that the manufacturer failed to adequately warn women and the medical community about the risks associated with the Mirena intrauterine device (IUD).
Nowak, 44, was implanted with the Mirena in March 2009, which is designed to provide long-term birth control for up to five years. While the IUD placement procedure went without complication, the lawsuit indicates that Nowak began to experience problems with headaches, dizziness, nausea, vision problems and a persistent ringing in her ears.
In October 2013, Nowak went to see a neurologist, and following a number of tests, including a diagnostic lumbar puncture, she was diagnosed with idiopathic intracranial hypertension (IIH). The condition is also commonly referred to as pseudotumor cerebri (PTC), involving fluid pressure on the brain and optic nerves, which may be caused by levonorgestrel released by the IUD.
Mirena is an increasingly popular form of birth control, especially among younger women, as it does not require adherence to use of a daily pill. The implant is a T-shaped plastic device, which is placed into the uterus, releasing the progestin levonorgestrel (LNG) to prevent pregnancy.
While other forms of levonorgestrel birth control have a known pseudotumor cerebri risk, Mirena warnings failed to indicate that users should be on the look out for symptoms like headaches, vision loss, and ringing of the ears.
“LNG is one of the most androgenic progestins on the market today, meaning that it acts more like testosterone in an individual’s body than most other progestins,” the lawsuit notes. “LNG’s broad and strong binding affinities for numerous hormone receptors increase the risk of hormonal side effects, including the risk of IIH/PTC.”
Nowak’s case 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.