Bayer Failed To Warn Women of Pseudotumor Cerebri from Mirena IUD, Lawsuit Claims

The side effects of a Mirena IUD caused a Pennsylvania woman to develop severe migraine headaches, blurred vision and a host of other health problems associated with the buildup of fluid pressure around her brain, according to allegations raised in a lawsuit recently filed against Bayer Healthcare. 

The complaint (PDF) was brought by Kelli Salazar in the U.S. District Court for the District of New Jersey on March 21, indicating that the manufacturer of the long-term birth control implant failed to adequately warn women about the risk that they may develop a serious medical condition known as pseudotumor cerebri (PTC), or idiopathic intracranial hypertension (IIH).

Mirena is an intrauterine device (IUD), involving a T-shaped implant placed into the uterus to provide protection against pregnancy for up to five years.

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, or information about the importance of seeking medical treatment if women develop symptoms of pseudotumor cerebri, according to the lawsuit.

Salazar indicates that after the Mirena IUD was implanted in August 2012, she began to suffer intense migraine headaches, pain in her neck, shoulders and back, dizziness, nausea and vomiting, blurred vision and double vision. However, the device remained in place until October 2016, and Salazar indicates that she was not diagnosed with pseudotumor cerebri until the following month.

“[B]ecause Mirena’s label is devoid of any warnings of PTC or IIH, once a patient’s healthcare provider rules out transient cerebral ischemia or stroke as a cause of symptoms of migraine and/or asymmetrical visual loss, the healthcare provider will not typically know or advise a patient with PTC to remove Mirena, which causes or contributes to the development and/or progression of PTC/IIH,” according to allegations raised in the complaint.

As a result of pseudotumor cerebri from a Mirena IUD, women may suffer permanent damage to the optic nerve, resulting in continuing vision loss long after the device is removed.

Even though Bayer knew or should have known about the PTC/IIH risk with Mirena, Salazar indicates that the manufacturer failed to warn about the signs, symptoms, incidents or severity of the risk.

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 PTC/IIH cases, Salazar’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 has scheduled oral arguments on the motion to centralize the Mirena pseudotumor cerebri lawsuits during an upcoming hearing set for March 30, in Phoenix, Arizona.