Mirena lawsuits have been filed against Bayer Pharmaceuticals, the manufacturer of the intrauterine contraceptive device. Mirena, used by women to prevent pregnancy, is inserted directly into the uterus. It has been associated with uterine perforation and other serious side effects.
According to AdverseEvents.com, the top three adverse events related to the use of Mirena were device expulsion, device dislocation and vaginal hemorrhage, with more than six percent of patients requiring hospitalization or surgery.
Mirena birth control side effects can include:
• Uterine perforations
• Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
• Intrauterine pregnancy (a pregnancy with Mirena in place)
• Group A streptococcal sepsis
• Pelvic inflammatory disease (PID)
• Embedment of the device in the uterine wall
• Perforation of the uterine wall or cervix
• Infertility, abscesses, erosion of adjacent areas such as the vagina
Here we provide an update on the Mirena lawsuits.
Mirena Multi-district Litigation (MDL)
• Lawsuits have been filed in the state of New Jersey, and Bayer petitioned the state’s Supreme Court to have the cases consolidated. That request was denied in January 2013.
• In June 2013, over 60 Mirena lawsuits filed in New Jersey were consolidated in In Re: Mirena Litigation (Case No. 297, Superior Court of New Jersey, Bergen County), because they had common causes for suit. According to the court documents, the plaintiffs allege that their Mirena hormonal implants have caused them several serious adverse events, including uterine perforation, device migration and pelvic pain. A case management conference was scheduled for July 1.
• Many federal Mirena lawsuits have also been filed in New York. These complaints claim Mirena can perforate the uterus and migrate within the body.
• These lawsuits were also consolidated in MDL in the Southern District of New York (In Re: Mirena IUD Products Liability Litigation, MDL Docket No. 2434, JPMDL). US Judge Cathy Seibel is the judge assigned to these cases.
• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for trying all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.
Mirena Product History
• Mirena was approved by the FDA in 2000 as a contraceptive device, and in 2009, it was approved for the treatment of heavy menstrual bleeding for women who prefer an IUD as their method of birth control.
• The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic “hormone” to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combined oral contraceptives.
• FDA issued a warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. Up until the FDA’s reprimand for deceptive marketing of Mirena, Bayer held live presentations as part of its “Simple Style” program that targeted “busy moms,” and claimed that the IUD would help increase libido and “look and feel great.” Instead, and included in the FDA warning letter, “at least 5 percent of Mirena IUD users reported decreased libido in clinical trials.”
• As of June 30, 2012, The US Food & Drug Administration (FDA) received 45,697 reports of a serious Mirena birth control side effect.