Couple Sues Bayer for Wife’s Mirena IUD Complications

Couple Sues Bayer for Wife’s Mirena IUD Complications

By Jessica Tyner

A Delaware couple, Pepper Gale and Wade Gale, have filed a Mirena lawsuit after it was allegedly discovered that Pepper’s Mirena intrauterine device (IUD) was defective and the cause of much pain and suffering. In some cases, such as this one, the spouse of the victim can also file a lawsuit via loss of consortium. Their Mirena lawsuit was filed on September 19, 2013 against Bayer, the maker of the exceptionally popular IUD.

Unlike the copper IUD, which is still on the market but became the go-to contraception in the 1970s, Mirena is made of plastic and releases tiny amounts of hormones. These hormones cause many women to experience lighter cycles, no cycles at all and improved PMS symptoms — making Mirena an especially favored contraception for many women. However, the Mirena IUD also has a high chance of migrating and perforating tissue and organs well after insertion, which is considered the dangerous window for IUDs. The Mirena was first approved in 2000 and women around the world have used it. 

According to the Gales, Bayer has “a history of overstating the efficacy of Mirena while understating the potential safety concerns.” They say that “Mirena’s label did not warn about spontaneous migration of the IUD, but only states that migration may occur if the uterus is perforated during insertion.” 

Even worse, “Mirena’s label also describes perforation as an ‘uncommon’ event, despite the fact that there are numerous women who have suffered migration and perforation post-insertion, clearly demonstration this assertion to be false.” 

Pepper wasn’t given the option of deciding whether or not the benefits of Mirena outweighed the risk for her, since the warning label wasn’t inclusive. Bayer spent millions on advertising Mirena’s Simple Style Program, too, which promised that women could look and feel great. The portion “regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena,” the lawsuit says.

Pepper is now 32 years old and opted for Mirena in 2006. “Following the Mirena insertion, (she) self-checked the strings on Mirena, finding them to be present. In or about September 2011, (her) healthcare providers discovered the Mirena has migrated to her pelvis and caused injuries.” 

In September 2011, she had no choice but to undergo surgery to have the defective IUD removed. She “suffered serious and life-threatening side effects and injuries including, but not limited to: pelvic pain, chills, fever, generalized pain and related sequelae requiring hospitalization, surgical intervention, extensive medical therapy, continuing treatment, physical therapy and medical monitoring,” the Mirena lawsuit states.

Pepper also allegedly suffered “pain and suffering, permanent bodily impairment, mental anguish and diminished enjoyment of life” due to these Mirena IUD complications. According to the Gales, they “did not suspect, nor did she have reason to suspect, that wrongdoing had caused her injuries.”