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Court Directs Parties to Select Potential Cases for Second Mirena IUD Disposition Pool

Mar 27, 2015

A judge in the Mirena intrauterine device (IUD) multidistrict litigation (MDL) recently issued an order directing both side to select five cases each for potential inclusion in the litigation's Second Disposition Pool. An additional five cases will be randomly selected from those filed. The case is In Re: Mirena IUD Products Liability Litigation, MDL No. 2434 in the United States District Court Southern District of New York.

For three years, national law firm Parker Waichman LLP has investigated claims of injuries associated with the use of Mirena. The Mirena has been alleged to migrate from its original position, in some cases becoming embedded in the uterine wall, and in others, perforating the uterine wall and becoming embedded in other organs. The Mirena is alleged to have caused serious injuries; some women have needed surgery to remove the device. When the Mirena migrates from the uterus, the woman can experience pain, bleeding and infection, and some women have become pregnant with the Mirena in place. A woman who develops pelvic inflammatory disease (PID) as a result of the Mirena can develop scar tissue that may make it difficult to become pregnant later.

The U.S. Food and Drug Administration (FDA) approved the Mirena IUD in 2000 to prevent pregnancy and treat heavy menstrual bleeding. The t-shaped contraceptive device, which must be inserted by a physician, works by releasing a daily dose of the hormone progestin levonorgestrel. According to label information, the device can be left in place for up to five years. Physicians say the woman should regularly check for the IUD's removal string to be sure it is still in place.

A number of the legal complaints filed against Bayer HealthCare Pharmaceuticals, maker of the Mirena, allege the IUD's design is defective and, further, that Bayer failed to warn about the risk of migration. Some plaintiffs claim that a Bayer marketing program significantly overstated Mirena's benefits while downplaying the device's risks. In 2009, the FDA sent Bayer a warning letter, taking issue with some of Bayer's claims about the device.

Parker Waichman has a played a leadership role in the Mirena litigation in the Southern District of New York. Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP, has been appointed co-lead counsel in the MDL. "We are pleased to see the litigation moving forward and are delighted that we are one day closer to ensuring justice for women who have alleged suffering serious, life-changing injuries as a result of the Mirena system," Mr. McCauley said. The firm, he added, is "committed to ensuring that the public remains informed of these events."

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