Mirena IUD Problems from Pseudotumor Cerebri Caused Vision Loss, Sixth Nerve Palsy: Lawsuit

A Missouri woman indicates that she suffered severe vision problems, sixth nerve palsy and other injuries from pseudotumor cerebri caused by a Mirena IUD, indicating that side effects of the birth control implant resulted in a dangerous buildup of fluid around her brain that damaged to her optic nerve.

According to a product liability complaint (PDF) filed last week by Amanda Clark in the U.S. District Court for the Western District of Missouri, Bayer Healthcare failed to adequately warn women and the medical community about the risk that Mirena may result in pseudotumor cerebri (PTC), which is also commonly referred to as idiopathic intracranial hypertension (IIH).

The Mirena IUD is a small, T-shaped implant designed to prevent pregnancy for up to five years. Although the hormone levonorgestrel released by Mirena is known to increase the risk of PTC/IIH, Clark indicates that Bayer failed to disclose information about the potential Mirena IUD problems, and the importance of monitoring for signs of the fluid build up around the brain before it results in permanent nerve damage.

Clark indicates that she received the Mirena implant in December 2009, and began to experience blurred vision, double vision and a form of optic nerve damage known as sixth nerve palsy. She was diagnosed with PTC in March 2011, and indicates that the vision damage caused by the Mirena IUD is likely permanent.

“There is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure,” according to the lawsuit filed on February 8. “Because of this, treatment of PTC or IIH is focused on halting visual loss that has already occurred.”

The case joins a growing number of Mirena lawsuits over pseudotumor cerebri problems, each raising similar allegations that plaintiffs may have avoided severe and potentially life-long problems from permanent optic nerve damage if the drug maker had provided warnings about the importance of removing the device once symptoms first appeared.

Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, a petition was filed earlier this month to centralize and consolidate the Mirena IIH/PTC litigation before one judge for coordinated management as part of a federal MDL, or multidistrict litigation.

Although a prior request to centralize the cases was rejected several years ago, with more than 100 complaints filed by women with IIH/PTC, it is expected that the U.S. Judicial Panel on Multidistrict Litigation (JPML) will determine that centralization is now appropriate.

If a Mirena IIH/PTC MDL is established, Clark’s complaint will be transferred to the centralized proceedings. However, if Mirena settlements are not reached following bellwether trials and the MDL process, her case may be remanded back to federal court in Missouri for an individual trial date.