Mirena® IUD MDL has been filed in New York.
Mirena® IUD Multidistrict Litigation Filed in the Southern District of New York.
Mirena® IUD multidistrict litigation has recently been filed against Bayer Healthcare Pharmaceuticals, Inc., (“Bayer”) the manufacturer of the device, in the Southern District of New York. Many plaintiffs in these cases experience numerous complications, leading to serious injuries and sometimes even death. Additional cases are also being filed nationwide. Specifically, 75 cases had been filed In New Jersey state court, as well as 50 more being filed in federal courts across the country. These numbers are expected to increase, as over 15 million women currently use the Mirena® IUD across the globe. In general, these lawsuits allege that the IUD is flawed in its design, leading to an unreasonable risk of injury to its users. Further, plaintiffs claim that Bayer failed to properly warn consumers of the risks associated with the Mirena® IUD.
The Mirena® IUD, originally released in 2000, is a small piece of plastic shaped like a “T” with a small filament attached thereto that contains Levonorgestrel, a time-released hormone used to prevent pregnancy. When placed in the uterus by a healthcare professional, the device is intended to remain there for upwards of five years. However, many women have experienced the IUD migrate within the uterus, sometimes causing it to perforate, or even worse, become embedded within the uterine wall. Removal of an embedded device requires a surgical procedure to correct, leading to pain and potential future complications.
According to the U.S. Food and Drug Administration (“FDA”), the most serious side effects can include;
- Perforation of the uterine wall: a potential complication leading to injury of the viscera such as the bowels and uterus. In addition, uterine perforation and its associated complications can lead to severe bleeding and infection, also known as sepsis.
- Embedment of the device in the uterine wall: the device can embed itself in the wall of the uterus and cause injury to other organs as a result.
- Ectopic Pregnancy: also known as a tubal pregnancy, this occurs when a fetus embeds itself in the fallopian tube.
- Group A streptococcal sepsis: this is a dangerous bacterium that can lead to complications ranging from minor sickness to even death.
- Pelvic inflammatory disease (PID): a common infection of a woman’s reproductive organs that if left untreated, can cause damage to the fallopian tubes, ectopic pregnancy, infertility, and chronic pain and complications.
In 2009, Bayer reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications for exaggerating the benefits of the product and downplaying the risks. Specifically, Bayer had marketed the Mirena® IUD as a way in which busy moms simplify their life styles. Specifically, Bayer held “Mirena Parties,” creating a direct marketing program that used a series of “house parties” to introduce women to the product. Scripted phrases such a “look and feel great” and you’ll be “more likely to be more intimate” were emphasized. It was on this basis that the FDA warned the manufacturer against implying that use of the product would lead to a more satisfied life. Unfortunately, what was downplayed at these “parties” were the potential for serious side effects. As a result, the FDA sited Bayer over the scripted statement that the IUD “has no daily, weekly, or monthly routines to comply with,” which the agency asserted was false.
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