Mirena® IUD Lawsuit Update: Number of Cases Continue to Grow in the MDL
The number of Mirena® lawsuits continues to grow with 105 lawsuits currently on file in federal court in the Multidistrict Litigation In re: Mirena® IUD Products Liability Litigation (MDL 2434). The Multidistrict Litigation is pending in the United States District Court for the Southern District of New York before The Honorable Judge Cathy Seibel. On August 14, 2013, a court hearing was held by Judge Seibel to keep the litigation on track and moving forward.
Mirena® is an intrauterine device (IUD) manufactured by Bayer Pharmaceuticals and approved by the Food and Drug Administration (FDA) in 2000. 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.
Since Mirena® was approved by the FDA in 2000, FDA records indicate that the number of Adverse Event Reports indicate that the agency received over 50,000 complaints from women and health care providers reporting side effects and injuries suffered by women while using Mirena®. In particular, 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.
In 2010, the FDA issued a Warning Letter objecting to Bayer’s 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 provided in part: “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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