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Bayer Healthcare made false and misleading statements about the potential side effects of the Mirena IUD, according to a product liability lawsuit filed by a woman who indicates she suffered severe vision problems, headaches and other health issues caused by a pseudotumor that developed in her skull due to the hormones released by the birth control implant.
The complaint (PDF) was filed by Tabitha Lee in the U.S. District Court for the Southern District of New York on September 19, indicating that the Mirena warning label was misleading, inadequate and false, since it failed to disclose the risk that levonorgestrel released by the IUD birth control may cause the dangerous buildup of fluid pressure on the brain and optic nerve.
Lee is a 38 year old woman from North Carolina, who received a Mirena intrauterine device (IUD) in August 2007, which is a T-shaped device designed to prevent pregnancy for up to five years. The device was removed in August 2012, but Lee indicates that she was diagnosed with a condition known as pseudotumor cerebri (PTC) in October 2014, which left her with severe headaches, blurred vision, dizziness, tinnitus (ringing of the ears), and depression.
The Mirena pseudotumor problems have been linked to the progestin released by the IUD, which may cause some women to experience elevated levels of cerebrospinal fluid around the brain. While treatment may resolve the fluid pressure in the skull, the condition may result in permanent damage to the optic nerve.
Lee’s lawsuit points out that Bayer failed to add warnings to Mirena or alert the medical community to these potential pseudotumor risks, maintaining that she would have chosen a different birth control option had she been fully informed of the potential side effects.
“Defendants knew or should have known that physicians and other healthcare providers began commonly prescribing this product as a safe and effective contraceptive device despite its lack of efficacy and potential for serious permanent side effects, including IIH/PTC,” the lawsuit states. “There are contraceptives on the market with safer alternative designs in that they provide equal or greater efficacy and far less risk.”
Lee’s claim joins a growing number of Mirena pseudotumor lawsuits filed in courts nationwide, each raising similar allegations that women may have avoided serious injuries if adequate information had been provided that symptoms like headaches, vision problems and other complications associated with the fluid pressure may be the result of the birth control implant.
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 pseudotumor 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.