Here’s some background on the allegations and facts surrounding the Mirena pseudotumor cerebri litigaiton. We are actively pursuing these claims for victims of the Mirena IUD device.
Mirena is an intrauterine system that is inserted by a healthcare practitioner during an office visit. Mirena® is a t-shaped polyethylene frame with a steroid reservoir that releases 20ug/day of levonorgestrel, a prescription medication used as a contraceptive. Mirena® contains 52 mg of levonorgestrel.
Mirena’s label makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.
Defendants’ Mirena® “Patient Information Booklet” also makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.
Pseudotumor cerebri or idiopathic intracranial hypertension is a condition that develops in the skull when a person’s cerebrospinal fluid becomes elevated, causing increased pressure. Fluid builds up in the skull and is not released and absorbed at the proper rate. PTC derives its name from the fact that the condition acts like a tumor but it is not actually a tumor.
Patients with PTC or IIH typically develop symptoms of severe migraines or migraine-like headaches with blurred vision, diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies. Visual problems and symptoms are a result of increased pressure on the optic nerve. Patients with PTC or IIH often develop papilledema, or optic disc swelling due to increased intracranial pressure
There is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure. Because of this, treatment of PTC or IIH is focused on halting visual loss that has already occurred
Mirena levonorgestrel, causes or contributes to the development of PTC/IIH, increases the risk of developing PTC/IIH, and/or worsens or exacerbates PTC/IIH. The makers of Mirena should have known this risk dating back to 1995. See John B. Alder & F.T. Fraunfelder, Letter to the Editor: Levonorgestrel Implants and Intracranial Hypertension, 332 New Eng. J. Med. 1720, 1720-21 (1995), available at http://www.nejm.org/doi/full/10.1056/NEJM199506223322519.
Other similar birth controls using levongestrel such as Norplant and Jadelle have long contained PTC and IH warnings in their labeling.
In December 2009, Defendant BAYER HEALTHCARE PHARMACEUTICALS, INC. was contacted by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (“DDMAC”) regarding a consumer-directed advertising program entitled “Mirena® Simple Style Statements Program,” a live presentation designed for “busy moms.” The Simply Style program was presented in a consumer’s home or other private setting by a representative from “Mom Central,” a social networking internet site, and Ms. Barb Dehn, a nurse practitioner, in partnership with Defendants
In all, the manufacturers of Mirena knew or should have known about the serious risks of leveongestrel before the device went on the market. In spite of this, they left their label completely void of any warning leaving doctors and patients in the dark. Further, they improperly marketed the device. In all, they behaved irresponsibly and need to be held accountable to victims of PTC/IH.