January 12, 2017 — Lawyers for more than 100 women who were diagnosed with brain injuries after using Bayer’s Mirena IUD have filed another request to centralize the lawsuits into one court.
In August 2014, judges refused to centralize 9 lawsuits in a federal court in Tennessee because there were too few cases.
Lawyers filed another motion (PDF) to centralize the lawsuits on December 29, 2016. At least 116 cases are now pending in 17 district courts, and lawyers say there will be “many more” to come. This time, they are requesting a federal court in the Southern District of Mississippi.
The proposed Multi-District Litigation (MDL) would be separate from one involving uterine perforations in the Southern District of New York (MDL No. 2434), where over 1,700 lawsuits were recently dismissed.
The brain injury is Intracranial Hypertension (IH), a painful condition when too much fluid in the skull puts pressure on the brain and eyes. It can lead to papilledema, a condition that can cause blindness.
IH is also known as Pseudotumor Cerebri (PTC) because symptoms resemble a growing brain tumor — migraine headaches, neck pain, dizziness, nausea, ringing in the ears, and progressive vision loss.
Migraine headaches are very common side effects of Mirena. In clinical trials, 16% of women reported suffering from headaches. They are also the most common symptom of IH and PTC. Lawyers say IH and PTC are caused by levonorgestrel, the hormone that Mirena releases in the uterus to prevent pregnancy.
In a study published in 1995, 56 cases of intracranial hypertension were associated with another levonorgestrel-releasing IUD called Norplant. The researchers did not know if levonorgestrel was responsible, but they noted that headaches are one of the most commonly-reported side effects of levonorgestrel. “Removal of the implants may help relieve this symptom,” they recommended.
More recently, a study of FDA Adverse Event Reports found higher rates of IH and PTC associated with Mirena. Soon after the study was published in 2015, Bayer’s medical experts called it “erroneous and misleading.”