Risk of Pseudeotumor Cerebri from Mirena IUD Should Be Included in Warnings: Lawsuit

According to allegations raised in a product liability lawsuit filed against Bayer Healthcare, warnings provided with the Mirena IUD fail to adequately warn women and the medical community about the risk of pseudotumor cerebri, a serious medical condition involving a build up of fluid pressure on the brain. 

In a complaint (PDF) filed in the U.S. District Court for the Southern District of New York on December 6, Jessica Watson indicates that without warnings, the Mirena IUD is unreasonably dangerous and defective.

Watson, 32, had a Mirena intrauterine device (IUD) implanted in February 2012, for long-term prevention of pregnancy. However, in September 2013, she was diagnosed with pseudotumor cerebri (PTC), which is also commonly known as as idiopathic intracranial hypertension (IIH).

Mirena IUD is a T-shaped plastic device that is implanted into the uterus, releasing the progestin levonorgestrel to prevent pregnancy.

While other forms of levonorgestrel birth control have been associated with a dangerous build up of fluid pressure in the skull, Mirena warnings failed to indicate that users should be on the look out for symptoms of pseudotumor cerebri, which may include migraines, double vision, floaters and blind spots.

Watson’s claim 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.

“Mirena’s label does not sufficiently warn about non-stroke neurological conditions such as pseudotumor cerebri, also known as idiopathic intracranial hypertension,” the lawsuit states. “Defendants did no clinical testing of Mirena and its known link to the development of IIH/PTC, despite over a decade of literature indicating further testing regarding levonorgestrel and IIH/PTC is needed.”

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.