National law firm, Parker Waichman LLP, has filed two lawsuits against Bayer Corporation, et al., on behalf of women who were allegedly injured by the Mirena intrauterine device (IUD).
The first lawsuit was filed on April 12th on behalf of an Ohio woman (Case No. MRS-L 924-12); the second lawsuit was filed on May 21st on behalf of an Oklahoma woman (Case No. MRS-L 1263-12). Both complaints were filed in the Superior Court of New Jersey, Morris County.
The complaints allege that both women underwent a hysteroscopy to remove the Mirena IUD when the device was not found in its expected location. The complaints allege that both women suffered severe and permanent physical injuries and substantial pain and suffering, that the women have amassed significant medical expenses that will continue to accumulate, and that the Mirena IUD led to their lost wages and impaired their ability to earn future wages.
The Mirena IUD was approved by the U.S. Food and Drug Administration (FDA) in 2000 as an intrauterine contraceptive. The T-shaped Mirena device releases a synthetic progestogen known as levonorgestrel into the uterus to prevent pregnancy, although Bayer admits that the exact mechanism remains unknown.
In 2009, the Mirena IUD was also approved to treat heavy menstrual bleeding in women who use IUDs. Mirena is recommended for women who have had at least one child, and is indicated for up to 5 years of use. The device is used in over 2 million women in the United States and more than 15 million women worldwide, according to the FDA.
The agency says that Mirena has been associated with serious complications such as ectopic pregnancy, intrauterine pregnancy, group A streptococcal sepsis, pelvic inflammatory disease, device embedment in the uterine wall, and uterine wall and cervix perforation. Side effects also include bleeding and spotting at irregular intervals, headaches, ovarian cysts, vaginitis, pain during menstruation, pelvic pain, and breast tenderness.
As we’ve mentioned, Canadian health regulators reminded healthcare providers there of Mirena’s risks of uterine perforation.
According to Parker Waichman, Bayer has history of misrepresenting of Mirena. Up until 2009, Bayer marketed Mirena to so-called “busy moms” via live presentations. The “Simple Style” program, conducted through the social networking site Mom Central, claimed that Mirena would increase intimacy and help users “look and feel great.”
In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) found these claims to be unsubstantiated, noting that the program failed to mention side effects such as weight gain, acne, and breast tenderness.
The FDA said the script for the program misbranded the drug in violation of the Federal Food, Drug, and Cosmetic Act, and the agency’s implementing regulations.