May 28, 2014 — A group of plaintiffs has asked federal judges to create a new Multi-District Litigation (MDL) in federal court to centralize lawsuits involving Mirena and severe brain side effects including pseudotumor cerebri (PTC) and/or idiopathic intracranial hypertension (IIH).
The plaintiffs have requested the U.S. District Court for the Middle District of Tennessee to centralize nine lawsuits involving PTC/IIH.
The MDL would be separate from Mirena MDL No. 2434, which currently involved over 500 lawsuits in federal court in New York. An additional 800 lawsuits are proceeding in New Jersey state court. All of the claims allege that Bayer failed to warn that Mirena can spontaneously migrate and perforate the uterus.
The plaintiffs allege that levonogestrel, a hormone in Mirena, can potentially increase levels of cerebrospinal fluid in the brain. Over time, this gradually increases pressure on the brain, similar to the effects of a growing tumor. The symptoms of PTC/IIH may include severe migraine headaches, tinnitis (ringing in the ears), vision loss, swollen optic nerves, and even blindness. Treatment typically involves placement of a shunt to drain cerebrospinal fluid in the skull.
The first lawsuit involving Mirena and PTC was allowed to proceed in April, when a federal judge in Alabama ruled that Shenika Houston made sufficient allegations of negligent design, strict liability, breach of express warranty, and fraud. She alleges that the label on Mirena is deficient because it does not include warnings about PTC, which could delay diagnosis and contribute to the progression of the disease.