Mirena Lawsuit Claims Label Carries No Mention of Pseudotumor Cerebri Risks

In a product liability lawsuit filed earlier this month, a Wisconsin woman alleges that she was never adequately warned that the side effects of a Mirena IUD birth control device may include a risk of pseudotumor cerebri, a serious medical condition involving a buildup of fluid pressure on the brain, which caused her to suffer severe headaches and vision problems. 

Catherine Jensen filed the complaint (PDF) in the U.S. District Court for the Southern District of New York on January 4, naming Bayer Healthcare as the defendants.

In the lawsuit, the 28 year old Jensen indicates that she had a Mirena IUD implanted in January 2015, which is designed to provide long-term birth control for up to five years.

Less than a year later, in November 2015, Jensen had to go to the Mayo Clinic due to severe headaches, vision problems, ringing in her ears, extreme pain, cramping and fever. She was diagnosed with idiopathic intracranial hypertension (IIH), which is also known as pseudotumor cerebri (PTC).

The Mirena IUD 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 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.

Jensen’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.

“Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema, and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risk of developing IIH/PTC with Mirena,” the lawsuit states. “Mirena was under the exclusive control of Defendants and was unaccompanied by appropriate warnings regarding all of the risks associated with its use.”

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.