May 28, 2014 — Plaintiffs have filed a motion to create a centralized federal litigation for lawsuits involving Mirena, a popular contraceptive implant, and non-stroke neurological side effects, including pseudotumor cerebri (PTC) and/or idiopathic intracranial hypertension (IIH).
A motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer nine lawsuits into a new MDL in the U.S. District Court for the Middle District of Tennessee.
The litigation would be separate from MDL No. 2434, where over 500 Mirena lawsuits have been centralized in federal court in New York. Nearly 800 additional lawsuits are pending in state court in New Jersey. Those claims involve injuries caused by migration of Mirena and perforation of the uterus.
Plaintiffs allege that Bayer failed to adequately warn about the link between levonorgestrel, a hormone in Mirena, and PTC/IIH. They claim that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor. Symptoms include migraines, double-vision, vision loss, tinnitis (ringing in the ears), swollen optic nerves, and even blindness. In severe cases, women may have to undergo shunt surgery to drain cerebrospinal fluid from the skull.
The first lawsuit involving Mirena and PTC was filed by Shenika Houston. On March 28, a federal judge in Alabama allowed the lawsuit to move forward after deciding that the plaintiff sufficiently alleged claims of negligent design, strict liability, breach of express warranty, and fraud.
According to the complaint, patients who develop PTC might continue to use Mirena because the label does not include warnings about this potential risk. This could contribute to the development or progression of PTC or IIH.