Thousands of Mirena lawsuits have been filed against Bayer Healthcare by users of the intrauterine devices, seeking compensation for injuries. Injuries claimed int the lawsuits have included device migration, organ perforation, ectopic pregnancy, bleeding complications and pseudotumor cerebri.
Most frequently, users allege that the pharmaceutical company failed to warn them of the potential dangers of the device. They also claim that the company was aware of design flaws that led the device to malfunction yet continued to produce and distribute faulty medical devices.
Mirena lawsuits filed in federal and state courts were consolidated into three large groups:
- Federal multidistrict litigation (MDL 2434) Mirena organ perforation lawsuits included thousands of claims of internal organ perforation. Though 1,230 cases were dismissed, Bayer offered $12.2 million to settle remaining cases in September of 2018.
- Federal multidistrict litigation (MDL 2767) Mirena pseudotumor cerebri lawsuits included an estimated 1.000 cases of claims that the hormone, levonorgestrel, caused “false brain tumor” or pseudotumor cerebri. No settlements have been disclosed.
- New Jersey multicounty litigation (MCL 297) Mirena lawsuits claim injuries caused by the IUD due to a variety of complications. Though some cases were dismissed due to statute of limitations expiration, approximately 1,800 may have been pending settlement.
Mirena is an intrauterine device (IUD) manufactured by Bayer Healthcare, intended to prevent pregnancy for up to five years and can be used by both women who have had and who have not had children. It is also approved to treat heavy menstrual bleeding in women who wish to use an IUD for their birth control method.
Mirena was approved in 2000 by the U.S. Food and Drug Administration and is one of the most popular forms of reversible contraception worldwide. The Mirena IUD is a soft, plastic, T-shaped device that is inserted by a healthcare professional. It is over 99% effective at preventing pregnancy and works by releasing the hormone, levonorgestrel into the uterus over a period of up to 5 years.
This device, though a highly innovative form of birth control, has caused many life-threatening complications for users including device migration, uterine perforation, ectopic pregnancy, bleeding and pelvic inflammatory disease. According to the FDA, since 2004, there have been a reported 47,000 users suffering from adverse effects of using the device which has led to numerous Mirena lawsuits.
Approximately 8.5 percent of women in the United States use some form of reversible contraception and while Mirena has been effective for many women, it has also been linked to serious side effects and complications. Thousands of women and families have filed Mirena lawsuits against Bayer Healthcare for injuries including:
Mirena Cases and Settlements
Thousands of women have filed lawsuits against Bayer Healthcare for injuries caused by Mirena IUD. The lawsuits have accused the company of marketing a dangerous medical product and claim that complications caused by the device and drug it contains have resulted in serious injury.
Lawsuits have been filed in three major case groups including:
- Federal Mirena organ perforation lawsuits consolidated into multidistrict litigation (MDL 2434) in New York claim that IUD migration resulted in perforation of an internal organ such as the uterus or other abdominal organ. In 2016, 1,230 cases were dismissed however Bayer offered $12.2 million to settle remaining cases in September 2018.
- Federal Mirena pseudotumor cerebri lawsuits consolidated into multidistrict litigation (MDL 2767) in New York claim that the hormone, levonorgestrel caused the formation of pseudotumor cerebri or “false brain tumor”. An estimated 1,000 cases were consolidated in this case however no settlements have been announced.
- New Jersey Mirena migration and injury lawsuits claim a variety of injuries and were consolidated in multicounty litigation (MCL 297). Some cases in this group were dismissed as the statute of limitations had expired but up to 1,800 additional cases may have been pending with no announced settlements.
Hundreds of lawsuits have been filed and victims have received compensation for their injuries. Most frequently, users have alleged that the pharmaceutical company failed to warn them of the potential dangers of the device. They also claim that the company was aware of design flaws that led the device to malfunction yet continued to produce and distribute faulty medical devices.
Device Migration Case
Miriam Cruz filed her Mirena lawsuit when the device she had implanted in 2008 caused her severe pain years after implementation. Bayer claimed that the only way Mirena would migrate would be if the doctor made a mistake during placement. However, since Cruz did not suffer until several years after placement, it is evident that the device did in fact migrate. In her Mirena lawsuit, Cruz claimed that the company did not properly inform her of such risks and that the product was not properly represented when she chose to use it.
Spontaneous Migration Case
Desaree Nicole Lee Johnson suffered permanent injuries after using a Mirena IUD which perforated her uterus. She required two surgeries to remove the device after the first was unsuccessful due to device migration into her abdominal cavity. After undergoing surgery, she became pregnant but had a miscarriage and was told that she may be infertile. Her complaint alleged that Bayer knowingly sold an unsafe and defective product, which led to her injuries.
Migration through Fallopian Tubes
Melody Williams filed a Mirena lawsuit claiming that Bayer Pharmaceuticals was guilty of fraud, negligent misrepresentation, and failure to warn patients of dangerous side effects. Williams started experiencing severe abdominal pain and cramping within a year of her implantation. Her device was found to have migrated through her right fallopian tube and required surgery to have it removed.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.