Failure To Warn Of PTC/IIH Risks from Mirena IUD Result in Lawsuit Against Bayer

According to allegations raised in a lawsuit filed against Bayer Healthcare, the drug maker failed to adequately warn about the potential side effects of the Mirena IUD, including the risk that women who receive the birth control implant may develop a medical condition known as pseudotumor cerebri (PTC), which is also sometimes referred to as idiopathic intracranial hypertension (IIH).

The complaint (PDF) was filed by Jessica Gardner in the U.S. District Court for the District of New Jersey on February 19, indicating that the failure to warn about the PTC/IIH risks associated with Mirena left her with severe vision problems and permanent optic nerve damage.

Pseudotumor cerebri (PTC) is a dangerous medical emergency caused by a buildup of fluid pressure in the skull. This can cause severe headaches, vision problems and result in permanent damage to the optic nerve, even after the fluid pressure has been relieved.

Gardner indicates that she received the Mirena IUD in April 2013, which involves a T-shaped implant placed in the uterus to prevent pregnancy for up to five years. The device releases the progestin levonorgestrel, which is also used in other birth control products, and has previously been linked to a risk of PTC/IIH.

The lawsuit indicates that after Gardner had the Mirena IUD placed in her body, she began to suffer intense headaches, blurred vision, double vision and dizziness. She was diagnosed with papilledema in February 2014, which doctors later determined was caused by PTC/IIH from the Mirena implant.

“Mirena’s label makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH,’ the lawsuit states. “Defendants also provide a ‘Patient Information Booklet’ to physicians to be given to patients at the time of Mirena insertion. Defendants’ Mirena ‘Patient Information Booklet’ also makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.”

The case joins a growing number of Mirena PTC/IIH lawsuits filed in recent years, 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 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 PTC/IIH, it is expected that the U.S. Judicial Panel on Multidistrict Litigation (JPML) will determine that centralization is now appropriate.

If a Mirena MDL is established for the PTC/IIH cases, Gardner’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.