Mirena is an intrauterine device (IUD) prescribed as a contraceptive and as a treatment for heavy menstrual bleeding. Classified as a long-acting reversible contraceptive, the Mirena IUD slowly releases a synthetic progestin hormone, levonorgestrel, directly into the uterus. The cylinder of the device contains the hormone and is coated with a membrane that regulates the release of levonorgestrel. Mirena is inserted into the uterus where it may remain for up to five years before it should be replaced. Bayer Healthcare Pharmaceuticals, Inc. markets Mirena in the United States.
Mirena was first approved as a contraceptive by the FDA in 2000. In 2009, the United States Food and Drug Administration (FDA) also approved Mirena for the treatment of heavy menstrual bleeding in women using intrauterine contraception as their method of pregnancy prevention. Mirena was the first IUD approved by the FDA for the treatment of heavy menstrual bleeding. While the prescribing information for Mirena states that there are several possible ways the device prevents pregnancy, the mechanism by which the device actually works “has not been conclusively demonstrated.”
Since gaining FDA approval, the Mirena IUD has been associated with several potentially painful and serious side effects. According to a recent review of the FDA’s Adverse Event Reporting System, 32,528 adverse events were reported to the FDA for Mirena over the five-year period from 2006 to 2011. Serious adverse events associated with Mirena include perforation of the uterine wall or cervix and the embedment of the device in the myometrium (middle layer of the uterine wall). These serious adverse events can result in laparoscopic or other surgical treatment to locate and remove the device, and some cases require a hysterectomy.
Other potentially painful and serious Mirena side effects include pelvic inflammatory disease, ovarian cysts, ectopic pregnancy, intrauterine pregnancy, irregular bleeding, and amenorrhea.
Mirena IUD Litigation Update
Mirena lawsuits filed in federal court have been consolidated in a multidistrict litigation (MDL) in the Southern District of New York before the Honorable Cathy Seibel. The litigation, In Re: Mirena IUD Products Liability Litigation, MDL No. 2434, currently has more than 1,200 active cases filed against the manufacturers of Mirena.
Judge Seibel recently ordered plaintiff and defendants to each select five cases for possible inclusion in a second bellwether trial disposition pool. An additional five cases will be randomly selected from all filed cases for inclusion in this pool as well. The fifteen selected cases will undergo detailed discovery and trial preparation. Judge Seibel anticipates scheduling the first bellwether trials in 2016.
Mirena cases have also been filed in New Jersey state court, where Bayer Healthcare Pharmaceuticals maintains its headquarters. The New Jersey state court cases have been consolidated into a multicounty litigation (MCL) in Bergen County before the Honorable Brian Martinotti. There are currently over 1,800 cases docketed in the New Jersey MCL. In March 2015, Judge Martinotti issued an order setting a schedule for selecting a second group of bellwether cases to undergo more involved discovery and trial preparation. The first bellwether trials in New Jersey state court are scheduled to commence in March 2016.
If you or a loved one were injured by a Mirena IUD, you may be entitled to pursue a claim against the manufacturer for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.