Based on common “factual allegations” among plaintiffs in dozens of Mirena IUD lawsuits, the U.S. Judicial Panel on Multidistrict Litigation in April consolidated claims against Bayer, Mirena’s manufacturer, before the U.S. District Court for the Southern District of New York in White Plains.
Those commonalities, the panel wrote, pertained to “the alleged risks of uterine perforation and migration associated with Mirena and the adequacy of the product’s warning label. Centralization … will eliminate duplicative discovery; prevent inconsistent rulings on pretrial matters; and conserve the resources of the parties, their counsel and the judiciary.”
The panel’s transfer order acknowledged the differences among the plaintiffs’ experiences, pointing out, nevertheless, “Almost all injury litigation involves questions of causation that are case- and plaintiff-specific. Such differences are not an impediment to centralization where common questions of fact predominate.”
The U.S. Food and Drug Administration approved Mirena (levonorgestrel intrauterine system) in 2000, broadening its use in 2009 to include the groundbreaking use of an IUD to treat “heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.”
The FDA described Mirena as “a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.”
The administration approved stronger safety labeling in May 2008 — and with good reason, based on the severity of Mirena side effects that plaintiffs and others experienced.
The agency reported that “the most serious adverse reactions” to Mirena have included “group A streptococcal sepsis; an infection called pelvic inflammatory disease; embedment of the device in the uterine wall; and perforation of the uterine wall or cervix.”
Bayer’s Frequently Asked Questions about Mirena explained that pelvic inflammatory disease, “if not treated quickly and appropriately,” can result in “serious problems, including infertility, ectopic pregnancy or constant pelvic pain. Serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed…”
The manufacturer also described sepsis as a “rare life-threatening infection,” additionally cautioning, “If your uterus is perforated, Mirena may no longer prevent pregnancy. It may move outside the uterus and can cause scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed.”
Current and former Mirena patients who have suffered any of these injuries may be entitled to compensation. An experienced pharmaceutical injury attorney can be an asset in this regard.
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