January 13, 2015 — About 1,400 lawsuits involving spontaneous uterine perforations caused by Mirena have been consolidated in Bergen County Superior Court, New Jersey, overseen by Judge Brian R. Martinotti.
Women involved in the litigation allege that Bayer failed to warn that Mirena can spontaneously puncture the uterus and migrate into the abdomen. When this serious complication occurs, women can become pregnant and they may need abdominal surgery to remove Mirena.
Another 1,100 lawsuits are pending in a federal Multi-District Litigation (MDL No. 2434) in the U.S. District Court for the Southern District of New York, overseen by Judge Cathy Seibel.
In total, about 2,500 lawsuits has been filed. The number of lawsuits has grown rapidly since the MDL was established in June 2013. The first “bellwether” trials are scheduled to begin next year.
Bayer is accused of engaging in a misleading marketing campaign to promote Mirena. For example, the “Busy Moms” campaign suggested that women who used Mirena would enjoy more spontaneous intimacy and better appearance. The FDA issued a warning letter to Bayer in 2009 regarding these issues.
Bayer is also facing about a dozen lawsuits involving neurological side effects of Mirena, including Secondary Intracranial Hypertension (high pressure inside the skull). However, unlike claims involving uterine perforations, Mirena brain injury lawsuits have not been consolidated.