Mirena Vision Problems, Body Pains Linked to Brain Pseudotumor: Lawsuit

After developing vision problems, headaches and pains throughout her body, a North Carolina woman has filed a lawsuit against the makers of the Mirena IUD birth control implant, alleging that inadequate warnings were provided about the risk of developing a brain pseudotumor, which results in pressure on the optic nerve.

The complaint (PDF) was filed by Rachelle Lilley in the U.S. District Court for the Southern District of New York on May 18, indicating that Bayer Healthcare sold a defective and unreasonably dangerous birth control device, failing to disclose that it may cause a buildup of fluid pressure in the brain.

Lilly indicates that she was implanted with a Mirena intrauterine device in March 2011, which is designed to provide long-term birth control for up to five years. However, she began suffering from vision problems, ringing in the ears, as well as headaches and pains in her neck, shoulders and back, as well as extreme cramping, vomiting and fever.

From August 2012 to December 2012, Lilley had to undergo three lumbar punctures to evaluate and alleviate intracranial pressure, eventually leading to a diagnosis of pseudotumor cerebri (PTC), which is also commonly referred to as a brain pseudotumor or idiopathic intracranial hypertension (IIH).

In January 2013, Lilley had a right Ventricul-atrial shunt implanted to alleviate the brain pressure caused by side effects of the Mirena IUD. She had the device removed in February 2016.

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, Lilley indicates that Bayer withheld information about the risk from users of Mirena.

“Defendants failed to adequately and properly test the Mirena both before and after placing it on the market,” the lawsuit states. “A prudent seller in the exercise of ordinary care would and should have discovered and foreseen the dangerous and defective condition of Mirena and its potential to cause severe conditions, including PTC/IIH, when placing the product on the market.”

Lilley’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, 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 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.