In response to scores of lawsuits brought over Bayer Healthcare Pharmaceuticals, Inc.’s Mirena® intrauterine device (IUD), a mass tort is likely over allegations the device migrates after insertion, embedding in the uterus or puncturing organs.
The injuries, noted Lawyers USA Online, require surgical removal of the Mirena® and may also lead to other serious injuries and infections. Some 75 cases have been filed in New Jersey state court; 50 other cases have been filed in federal courts nationwide. Plaintiffs attorneys believe this number will continue to rise, especially given that about 2 million women use the Mirena® worldwide.
Bayer’s Mirena® IUD, a small, t-shaped plastic device attached to two strings, was approved by the U.S. Food and Drug Administration (FDA) in 2000. The hormonal IUD releases levonorgestrel when placed in the uterus to prevent pregnancy; Mirena® is both inserted and removed by a healthcare professional and may be left in the uterus for up to five years. According to the agency, the most serious side effects associated with the Mirena® IUD 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, Bayer was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for overstating the benefits—and neglecting to mention the risks—of Mirena® in the company’s “Simple Style” program.
“We’ve had several hundred intakes, and a large number of complaints overall,” said Matthew J. McCauley, of the national law firm, Parker Waichman LLP. “The way the label is written for Mirena, it states that after insertion of the device, the patient is to go back and have placement confirmed by her physician, then that’s it. With respect to the warnings, the current label says perforation is a risk during insertion” but not after insertion, said McCauley, according to Lawyers USA Online.
Parker Waichman has filed 50 of the 60 Mirena IUD lawsuits pending in the Superior Courts of New Jersey and recently submitted an application with the New Jersey Supreme Court that requests reconsideration for centralized management of multicounty litigation for Mirena® IUD lawsuits. According to the application, centralization of the Mirena® IUD cases is warranted due to the large number of parties that are widely dispersed and involve common questions of fact.
Mirena® lawsuits allege that the intrauterine device (IUD) is inherently defective, creates an unreasonable risk of injury to women, and that Bayer Healthcare Pharmaceuticals, Inc. failed to warn consumers about the risks associated with the Mirena® IUD.