January 13, 2015 — Bayer is facing about 1,400 lawsuits involving Mirena, an intrauterine device (IUD), in a consolidated mass-tort located in New Jersey.
The lawsuits are overseen by Judge Brian R. Martinotti in Bergen County Superior Court. Another 1,100 lawsuits are pending in a federal court in the Southern District of New York, Multi-District Litigation (MDL No. 2434) overseen by Judge Cathy Seibel.
Plaintiffs in all 2,400 cases accuse Bayer HealthCare and Janssen Pharmaceuticals of failing to update the label on Mirena to warn about the risk of spontaneous uterine perforations. Instead, the label only warns about perforations during the insertion procedure.
In some cases, Mirena embedded itself in the uterine wall or migrated into the abdomen. When women sought medical treatment for complications like pain or unintended pregnancy, doctors assumed Mirena had fallen out.
One recent lawsuit was filed by a 28 year-old woman from Cleveland. Only six months after Mirena was implanted in her body, it became embedded in the wall of her uterus and caused her to suffer from severe abdominal cramps.
Bayer is accused of misleading women about the risks and effectiveness of Mirena. In 2009, the FDA issued a warning letter for the “Busy Moms” marketing campaign, which suggested Mirena could help improve appearance and marital intimacy.
Another dozen lawsuits have been filed against Bayer by women who developed increased intracranial pressure due to elevated levels of cerebrospinal fluid — a complication known as secondary intracranial hypertension. However, last year federal judges refused to centralize the lawsuits in one federal court.
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