Pseudotumor Cerebri Caused Permanent Vision Impairment from Mirena IUD, Lawsuit Alleges

Bayer continues to face a growing number of product liability lawsuits over pseudotumor cerebri complications from the Mirena IUD, the latest of which involves a woman who indicates she has been left with permanent vision problems due to the dangerous build up of fluid pressure around her brain allegedly caused by the birth control implant. 

The complaint (PDF) was filed by Tiffany Sawyer in the U.S. District Court for the District of Colorado on March 7, indicating that Bayer failed to warn users and the medical community about the potential side effects associated with the birth control implant, as well as the importance of monitoring for early symptoms of the condition before it results in permanent damage to the optic nerve.

Pseudotumor cerebri (PTC), which is also known as idiopathic intracranial hemorrhage (IIH), is a complication that has been linked to other levonorgestrel based birth control products. Although the Mirena IUD releases the progestin, Bayer failed to provide adequate warnings with their implant, according to allegations raised in the lawsuit.

Sawyer indicates that she had a Mirena IUD implanted in July 2012, which is designed to provide long-term protection against pregnancy. However, she indicates that she began to experience headaches and vision impairment, which were later diagnosed as PTC/IIH in June 2015. However, by then she indicates the fluid build up had already caused permanent damage to her vision.

“Despite a wide body of information available to Defendants regarding the connection between levonorgestrel and PTC/IIH, Mirena’s label is devoid of any warning regarding PTC or IIH,” according to the complaint. “[B]ecause Mirena’s label is devoid of any warnings of PTC or IIH, once a patient’s healthcare provider rules out transcient cerebral ischemia or stroke as a cause of symptoms of migrain and/or asymmetrical visual loss, the healthcare provider will not typically know or advise a patient with PTC to remove Mirena, which cause or contributes to the development and/or progression of PTC/IIH.”

The case joins a growing number of Mirena vision impairment lawsuits filed by women who developed pseudotumor cerebri 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.