Update: Mirena Lawsuits Centralized in New York
April 26, 2017 – More than 100 federal Mirena lawsuits have been consolidated as part of a multidistrict litigation (MDL No. 2767) in the District of New York. The complaints allege that the levonorgestrel released by Mirena increases the risk of idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri (PTC) and benign intracranial hypertension (BIH).
Mirena is an intra-uterine device (IUD), which is a type of birth control that is implanted directly into a woman’s uterus. It was approved by the FDA in 2000 to prevent pregnancy, and in 2009 to treat heavy menstrual bleeding. Mirena slowly releases the hormone levonorgestrel, which prevents pregnancy by inhibiting ovulation, thickening cervical mucous, and thinning the lining of the uterus.
What’s the problem?
Since 2000, the U.S. Food and Drug Administration (FDA) has received over 70,000 complaints about the Mirena IUD, including nearly 5,000 complaints involving “device dislocation.” Since 2008, 7 Action News investigators have obtained reports of the following adverse events:
- 4,775 reports of device dislocation (embedment, erosion, or migration outside the uterus)
- 3,774 complaints of abdominal pain
- 1,322 reports of uterine perforation
Mirena and Spontaneous Uterine Perforations
Bayer HealthCare is facing hundreds of Mirena lawsuits from women who were injured by spontaneous uterine perforations. This injury occurs when the T-shaped Mirena IUD erodes into the uterine wall and punctures the uterus. It may become embedded in the uterine wall or migrate outside the uterus into the abdominal cavity. When a uterine perforation occurs, Mirena must be removed with surgery.
Mirena Lawsuits Centralized in State and Federal Litigations
Plaintiffs in Mirena lawsuits accuse Bayer of ignoring evidence showing that Mirena can spontaneously perforate the uterus months or even years after it is implanted in a woman. In fact, Bayer only warns about the small risk of uterine perforation during implantation of the Mirena IUD. According to court documents, Bayer is being held liable for:
“…its promotion of the subject product in an overly aggressive, deceitful, and fraudulent manner, despite evidence as to the product’s defective and dangerous characteristics due to its propensity to cause serious injury and/or death.”
In April 2013, federal judges centralized Mirena lawsuits in a Multi-District Litigation (MDL), which is similar to a class action, in the U.S. District Court for the Southern District of New York (In re: Mirena IUD Products Liability Litigation, MDL No. 2434). At least 60 additional lawsuits are pending in a centralized litigation in New Jersey before Superior Judge Brian R. Martinotti.
FDA Warning Letter for Mirena
In 2009, the FDA sent two warning letters to Bayer. The first was sent in response to “misleading” online advertisements for Mirena that “fail to communicate any risk information.” The second warning letter was sent in response to a series of promotional videos in which a nurse claimed Mirena could help women achieve greater intimacy and a more spontaneous romantic life. According to the FDA:
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act.”
Mirena Risks & Complications
- Erosion into uterine wall
- Uterine perforation
- Migration outside uterus
- Intestinal perforation or obstruction
- Ectopic pregnancy (outside the uterus)
- Abdominal pain
- Pelvic Inflammatory Disease (PID)
- Organ damage
- Additional surgery
Mirena Lawsuit Update
August 15, 2015 – More than 1,000 federal Mirena lawsuits dating back to April 2013 have been consolidated into a multidistrict litigation (MDL) before Judge Cathy Seibel in the Southern District of New York. Judge Seibel has chosen 5 cases for a second round of bellwether trials to be heard as part of the MDL. A final schedule of trial dates will be announced later this month.
Do I have a Mirena Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Mirena lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one was injured by Mirena, you should contact our law firm immediately. You may be entitled to compensation by joining a lawsuit and we can help.