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Mirena IUD Lawsuits In Discovery Phase in New Jersey

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In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Mirena lawsuits into one court in the Southern District of New York. About a month later, the Supreme Court of New Jersey also centralized state Mirena lawsuits into one court in Bergen County, creating a multi-county litigation (MCL). Superior Court Judge Brian R. Martinotti was assigned to oversee the proceedings.

Hundreds of lawsuits are now pending in New Jersey, filed by women who claim to have been injured after being implanted with the Mirena IUD. A revised confidentiality stipulation and protective order was issued on December 23, 2013, which will govern the production of documents by the plaintiffs and defendants.

Discovery processes continue to move forward in the New Year, with a projected end date of around May 2015, at the latest. If litigation fails to result in lawsuit settlements, the first bellwether trials are expected to begin in the second half of 2015.

Thousands of Reports of Mirena Injuries

The Mirena device received FDA approval in 2000, and has since been used by millions of women seeking an alternative to regular birth control pills. A small, T-shaped plastic device, the Mirena is inserted by a professional into the uterus, where it then slowly releases hormones to help prevent pregnancy.

Since its release, the FDA has received over 70,000 adverse event reports, with women claiming the device migrated from its original position to cause other injuries. Some of these problems left women with severe pain, suffering from infertility, or needing additional corrective surgeries. According to a report airing in August 2013 on ABC News, since 2008, a total of 4,755 women reported device dislocation, 3,774 complained about abdominal pain, and 1,322 reported the Mirena had perforated the uterus.

Mirena Migration Can Lead to Perforation

According to a Case Management Order released on September 25, 2013, the schedule for discovery in the New Jersey MCL includes a deadline of April 4, 2014, for both parties to select cases for the initial disposition pool. All generic discovery is to be completed by September 1, 2014, and all case-specific discovery by September 30, 2014. Expert reports will come due after that.

Manufacturer Bayer has maintained that it provided appropriate warnings about any potential side effects with the Mirena, including migration. Plaintiffs argue that the wording was vague and misleading, and that it spoke of migration occurring shortly after implantation. Some women have experienced migration months or years after first receiving the Mirena.

A 2011 study published in the Journal of the Society of Laparoendoscopic Surgeons, for example, called the device “The Wandering Mirena,” noting two cases of migration following insertion. Both patients underwent laparoscopic surgery to locate and remove the device.

Other Injuries Possible

Other injuries allegedly associated with the Mirena include organ damage, embedment, uterine tearing and scarring, infections, bleeding, infertility, miscarriage or premature birth, perforation of other organs, abscesses, pelvic inflammatory disease, and ectopic pregnancy.

In 2009, the FDA issued a warning to Bayer, noting they were overstating the efficacy of the Mirena in their marketing and advertisements, and presenting false or misleading statements to women. The agency requested that Bayer immediately stop distributing these materials and advertisements.