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Bayer Healthcare has provided false and misleading information about the side effects of Mirena birth control, misrepresenting the implant as a low or no hormone contraceptive that carries few health risks, according to a product liability lawsuit filed by a woman who claims the levonorgestrel released by the IUD caused her to develop pseudotumor cerebri (PTC).
In a complaint (PDF) filed last week in the U.S. District Court for the Southern District of New York, Emmarie Anderson indicates that Bayer failed to provide adequate warnings about the risk of hormonal side effects that women may face from the intrauterine device.
The Mirena IUD is designed to be implanted in the uterus to prevent pregnancy for up to five years. The device also releases the hormone levonorgestrel (LNG), but no Mirena warnings indicated that women should be on the lookout for signs or symptoms of neurological problems that may result from a buildup of fluid pressure around the brain, known as pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH).
Anderson, 36, indicates that she developed PTC/IIH after a Mirena IUD was implanted in 2008. The condition typically results in the development of severe migrains, blurred vision, blind spots and other complications caused by pressure on the optic nerve.
According to allegations raised in the complaint, Bayer failed to adequately warn women or the medical community about these potential side effects, instead pointing to low serum levels of levonorgestrel delivered by the implant as signs that it is safe.
“It has been estimated that approximately 1-2 people per 100,000 in the United States have PTC or IIH, although reports suggest the prevalence of the disorder is increasing. In 1994, a study found that in females between the ages of 15 to 44, IIH occurred at a rate of approximately 3.3 per 100,000 per year,” the lawsuit notes. “Despite the rarity of PTC/IIH, women who use levonorgestrel-containing products, like the Mirena® IUS, more commonly develop the disorder.”
Anderson’s complaint joins a growing number of similar Mirena pseudotumor cerebri 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, if permanent damage is suffered to the optic nerve, it 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 500 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.