Mirena IUD Vision Loss Lawsuit Filed Over Pseudotumor Cerebri Complications

According to allegations raised in a lawsuit filed by a 32 year old woman diagnosed with pseudotumor cerebri from a Mirena IUD, complications associated with the buildup of fluid pressure around her brain caused her to suffer vision loss, severe headaches and other severe health problems, some of which are likely to be permanent.

The complaint (PDF) was filed by Amber Hanson in the U.S. District Court for the District of New Jersey on March 30, indicating that Bayer Healthcare failed to adequately warn consumers or the medical community about the risks associated with their popular birth control implant.

Hanson indicates that she received a Mirena IUD in November 2011, which involves a T-shaped implant designed to provide protection against pregnancy for up to five years. However, Hanson indicates that after Mirena was implanted, she began to experience severe headaches, pain in her neck and shoulders, blurred vision, double vision, vision loss, memory loss, dizziness, tinnitus (ringing in the ears) and nausea.

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In October 2013, Hanson was diagnosed with pseudotumor cerebri (PTC), which is a serious medical condition that is also known as idiopathic intracranial hemorrhage (IIH), involving a buildup of fluid in the skull. As a result of the complications, Hanson underwent a lumbar puncture to relieve the pressure around her brain and optic nerves.

The IUD releases the progestin levonorgestrel, which has been linked to the development of fluid buildup around the brain in other birth control products. However, Bayer failed to provide adequate warnings about the risk for women implanted with a Mirena IUD, or information about the importance of seeking medical treatment if women develop symptoms of pseudotumor cerebri after the device is implanted, according to the lawsuit.

As a result of pseudotumor cerebri complications, women may be left with permanent damage to the optic nerve even after the fluid pressure is addressed, resulting in continuing vision loss long after the device is removed.

“It has been estimated that approximately 1-2 people per 100,000 in the United States have PTC or IIH, although reports suggest the prevalence of the disorder is increasing. In 1994, a study found that in females between the ages of 15 to 44, IIH occurred at a rate of approximately 3.3 per 100,000 per year,” the lawsuit states. “Despite the rarity of PTC/IIH, women who use levonorgestrel-containing products, like the Mirena® IUS, more commonly develop the disorder.”

The case joins a growing number of Mirena 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 in January 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 Mirena pseudotumor cerebri cases, Hanson’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.

The U.S. JPML heard oral arguments on the motion to centralize the Mirena pseudotumor cerebri lawsuits during a hearing on March 30, in Phoenix, Arizona. A decision is pending.


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