A recent court order indicates that 15 cases will be selected as eligible for potential inclusion in the Second Disposition Pool of the Mirena IUD multidistrict litigation (MDL). According to the order, the plaintiffs’ and the defendants’ parties will select five cases each and another five will be selected at random from a full list of filed lawsuits. Plaintiffs in the litigation allege that the contraceptive device caused serious injuries and that Bayer HealthCare Pharmaceuticals Inc. failed to warn about the risks. In particular, a number of lawsuits allege that the device migrated from its original position and perforated through the uterine wall. In some cases, the IUD has allegedly embedded itself in other parts of the body.
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 may be used for up to five years at a time. However, the user may 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)
In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising and Communications (DDMAC) contacted Bayer over the marketing of Mirena. According to DDMAC, the company’s “Simple Style” program made unsubstantiated claims about the device, including the assertion that it will help women “look and feel great”. The company was also criticized for failing to mention the risks.