Another woman who allegedly suffered injuries from using a Mirena IUD birth control device has filed a lawsuit against Bayer over allegedly not being properly warned of the risks.

An IUD is a small, “T-shaped” device inserted into the uterus by a healthcare professional as a method of birth control. Bayer Healthcare introduced the Mirena IUD in 2000.

Releasing small doses of hormones, the Mirena IUD was marketed as a stress-free form of birth control with a five-year life span. But not all users of Mirena found it to be a stress-free experience, including Florida plaintiff Erica H.

Erica, a healthy 34-year-old woman, had her Mirena IUD inserted in February 2012, according to her Mirena lawsuit. Following regular placement check-ups, Erica’s doctor found the Mirena to be missing from her uterus in October of the same year. An ultrasound found it to be overlying her sacrum, and she had to have it removed via laparoscopic surgery. Despite following all instructions, Erica had to endure pain and suffering, according to her Mirena IUD lawsuit.

Once inserted, the Mirena releases a synthetic hormone (levonorgestrel, a progestin) into a woman’s system. Regular side effects can include pelvic or abdominal pain and heavier bleeding for a few weeks after insertion. However, as Erica’s case points out, nowhere on Mirena’s label does it warn about spontaneous migration, and perforation is listed as an “uncommon” event.

More than 70,000 adverse events have been filed over the past 10 years with the U.S. Food and Drug Administration (FDA) involving Mirena issues, including migration and perforation of the uterus.

Additionally, Bayer’s marketing of the Mirena IUD included a consumer program called the “Mirena Simple Style Statements Program.” This program was a live presentation designed for “busy moms.”

The Simple Style program said using Mirena would “increase the level of intimacy, romance and emotional satisfaction between sexual partners.” These claims were also determined to be unsubstantiated.

Mirena has more than 2 million users in the United States, and currently close to 2,000 product liability lawsuits. Women filing the lawsuits allege their Mirena IUD migrated to other areas of their body after insertion, perforating the uterus, enabling unplanned or ectopic pregnancies, or causing other internal injuries.

Insufficient Warnings

Plaintiffs around the country claim Mirena’s label does not warn about spontaneous migration of the IUD, but only states that migration may occur if the uterus is perforated during insertion.

Moreover, perforation is described as an “uncommon” event on the packaging label. It states that spontaneous migration of the IUD is possible, but only if the uterus is perforated during insertion. This packaging label is alleged to be inadequate to properly warn consumers. Victims are alleging Bayer knew of the risks, concealed information and misrepresented the product.

With similar complaints to other plaintiffs around the country, Erica’s lawsuit accuses Bayer Healthcare of defective manufacturing, design defect, negligence, failure to warn, strict liability, breach of implied and express warranty, negligent misrepresentation, fraudulent misrepresentation fraud by concealment and violation of the Alabama Deceptive Trade Practices Act.

The Mirena IUD Lawsuit is Case No. 7:14-cv-08054-CS, in the U.S. District Court for the District of Minnesota.

National Litigation Centralized

More than 800 of the lawsuits outstanding against Bayer Healthcare are filed in the New Jersey state courts. They were consolidated there as part of a coordinated multicounty litigation (MCL) in hopes of lessening duplicative discovery, and to serve the convenience of all parties.

Additionally, a federal MDL with more than 500 cases is being handled in New York. In both groups, cases are being prepared for early trial dates. The hope is that the first New Jersey Mirena trials should begin the latter half of 2015.