A total of 15 Mirena IUD lawsuits will be selected as eligible for potential inclusion in the Second Disposition Pool of the Mirena IUD multidistrict litigation (MDL), a recent court order says. Each side will select five cases for potential inclusion in the second trial. Additionally, five random cases will also be selected from a full list of filed lawsuits. Parker Waichman LLP, a national personal injury law firm, represents a number of women in the Mirena IUD litigation. The firm has also had an active leadership role; Matthew J. McCauley, Senior Litigation Counsel at the firm, has been appointed Co-Lead Counsel in the MDL.
Mirena IUD is a T-shaped device that is placed inside the uterus by a healthcare professional to prevent pregnancy. The IUD releases the hormone levonorgestrel and can be used for up to five years at a time. However, the user can suffer serious injuries if the device migrates from its original position. According to a press release issued by the U.S. Food and Drug Administration (FDA) in 2009, the most serious side effects associated with Mirena include:
- Perforation of the uterine wall
- Embedment of the device in the uterine wall
- Intrauterine pregnancy
- Ectopic pregnancy
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
Plaintiffs in the litigation allege, among other things, that Mirena is defective and caused injuries. Specifically, a number of cases allege that the device relocated from its original position and perforated the uterine wall, sometimes becoming embedded in other parts of the body.
The Department of Health and Human Services’ Division of Drug Marketing, Advertising and Communications (DDMAC) reprimanded Bayer HealthCare Pharmaceuticals Inc. in 2009 over the marketing of Mirena. DDMAC said the company’s “Simple Style” program did not fully disclose the risks of Mirena. Additionally, the agency said the program made unsubstantiated claims about the device, including the assertion that it will help women “look and feel great”.