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Mirena® IUD Lawsuit Update: Number of Cases Filed Continues to Grow in MDL 2434

According to a recent report, lawsuits are continuing to be filed against Bayer Corporation, the maker of the Mirena® intrauterine device, alleging that women haven’t been adequately warned of the potentially serious health risks associated with the device.

The number of Mirena® lawsuits continues to grow with 528 lawsuits currently on file in federal court in the Multidistrict Litigation In re: Mirena® IUD Products Liability Litigation (MDL 2434), according to the most recent report issued by the Judicial Panel on Multidistrict Litigation (JPML). The Mirena® MDL is pending in the United States District Court for the Southern District of New York before The Honorable Judge Cathy Seibel.

Mirena® is an intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. The device is a t-shaped IUD which is inserted into a woman’s uterus and serves as a pregnancy prevention method – for up to five years. The device releases the hormone levonorgestrel – a third generation progestin – into the uterus to prevent the release of eggs from a woman’s ovaries. Generally, plaintiffs allege that the Mirena® IUD migrates from its original position in a woman’s body and causes serious injuries, such as uterine perforation, ectopic pregnancies, infertility, embedment of the device in the uterine wall or other organs, migration of the IUD, serious infections, and surgical removal of the device. Plaintiffs also allege that the product manufacturer failed to adequately warn women of the serious risks associated with the Mirena® IUD.

The FDA approved Mirena® in the United States in 2000.  According to FDA reports, there have been more than 45,000 adverse events reported, including device expulsion, device dislocation, and vaginal hemorrhage. In 2010, the FDA issued a Warning Letter to Bayer objecting its marketing campaign and informing Bayer that the company was downplaying the health risks of the Mirena® IUD, while overstating the benefits of the Mirena® IUD. In particular, the FDA said the “program overstates the efficacy of Mirena®, presents unsubstantiated claims, minimizes the risks of using Mirena®, and includes false or misleading presentations regarding Mirena®.” The FDA also directed Bayer to change the “side effects” portion of the Mirena® IUD product label in order to warn women of additional side effects associated with the Mirena® IUD. The new warning label now includes language indicating that use can be associated with serious health problems, such as congenital anomalies, embedment, perforation, expulsion, ovarian cysts and breast cancer.



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