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A product liability lawsuit filed against Bayer Healthcare alleges that a Florida woman developed severe headaches, blurry vision and other health problems after Mirena complications caused a dangerous buildup of fluid pressure in her skull.
Elizabeth Paige filed the complaint (PDF) in the U.S. District Court for the Southern District of New York on June 1, indicating that a Mirena IUD caused her to develop a medical condition known as pseudotumor cerebri (PTC), which is also known as idiopathic intracranial hypertension (IIH).
Paige, 31, indicates that she had a a Mirena IUD implanted in May 2009, for long-term birth control. However, in May 2011 she began suffering vision problems, headaches, neck pain and other complications. Following a diagnostic lumbar puncture, Paige was diagnosed with PTC/IIH, and had the Mirena IUD removed in August 2011.
“Defendants failed to provide adequate initial warnings and post-marketing warnings or instructions after the manufacturer and/or supplier knew or should have known of the extreme risks associated with Mirena, and continues to promote Mirena in the absence of those adequate warnings,” according to the lawsuit. “Despite Defendants’ knowledge of an increasing number of adverse events reporting IIH/PTC or its symptoms, including papilledema, diplopia (double vision), severe migraine-like headaches, and blindness, Defendants did nothing to alert the healthcare community or patients or otherwise warn of these risks.”
Mirena is a T-shaped plastic device, which is also known as an intrauterine device (IUD) or intrauterine system (IUS). The polyethylene frame for Mirena contains a steroid reservoir that releases the second generation progestin levonorgestrel, which has been linked to the development of brain pseudotumors in other birth control products. However, women indicate that Bayer withheld information about the risk from users of Mirena.
Paige’s complaint joins a growing number of similar Mirena pseudotumor lawsuits filed nationwide by women who suffered symptoms associated with increased fluid pressure on the brain and optic nerve. While treatment can relieve the pressure, permanent damage to the optic nerve can result in permanent vision problems, headaches and other complications.
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 months.