Mirena

Mirena is a T-shaped intrauterine device (IUD) and used for long-term contraception. It’s a hormonal device that thickens mucus in the cervix and prevents sperm from reaching the egg. Its manufacturer, Bayer Pharmaceuticals, received U.S. Food and Drug Administration (FDA) approval in 2000 and is the only hormonal IUD to be approved by the agency. After insertion, it can prevent pregnancy for up to five years. It’s designed to be removed by a string at a simple doctor’s office visit.

Since 2000, there are reportedly more than 45,000 adverse events alleged to be connected with the Mirena IUD. The number of Mirena-related lawsuits in the United States is now approaching 2,000, and the number of women using the device in the United States is estimated to be 2 million. The device costs about $700.

Mirena lawsuit allegations

Complaints common to Mirena lawsuits are that the manufacturer failed to warn women that the device could embed itself in the uterus, perforate it and migrate into the pelvic area. Other adverse consequences alleged are infections, damage to organs, adhesions and hemorrhages. It’s also claimed that Mirena significantly increases the chances of ectopic pregnancy if a woman becomes pregnant while using it. Other allegations involve miscarriage and infertility as adverse effects. General common complaints are that the manufacturer intentionally sold a dangerous product, concealed the risks of complications and engaged in deceptive advertising.

Mirena and the FDA

In December of 2009, the FDA issued a warning letter to the manufacturer of Mirena regarding claims it made as to the efficacy of the IUD. The letter pivoted on marketing at Mirena parties that the manufacturer was sponsoring through a moms social networking website. These parties were held at homes or restaurants. A nurse practitioner was present who made scripted claims along with a social network member that Mirena would enhance users’ looks, demeanor, and intimacy with their partner. A review of this script triggered the FDA warning letter relating that the marketing overstated the efficacy of Mirena, presented unsubstantiated claims, minimized risks of Mirena and included false and misleading representations regarding the device. The FDA letter then detailed known risks of Mirena including pelvic inflammatory disease, ovarian cysts, increased bleeding, and amenorrhea. Apparently the manufacturer had stopped holding these parties before issuance of the warning letter.

Status of Mirena litigation

As of early 2014, over 1,000 Mirena cases are pending in New York and New Jersey. Some are federal multidistrict litigation in White Plaines, NY and others have been filed in Bergen County, NJ Superior Court. The state court cases in New Jersey are also consolidated under the same concept of multidistrict litigation. This is all to expedite and facilitate pre-trial proceedings. All cases remain in the evidence gathering stage. No Mirena cases have been settled, and none has gone to trial. The first 12 Mirena lawsuits that will go to trial in federal court have been selected. The first case is expected to go to trial in March of 2016. Once verdicts are reached in a few of these cases, they’ll be useful to the litigants in assessing their likelihood of success in other Mirena cases.