California Woman Files Mirena IUD Lawsuit

A 26-year-old Oakland, CA woman has filed a Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals Inc. Sandra O. Rangel had the product inserted on May 11, 2012 and was forced to have it surgically removed just over one year later.

Following the initial insertion of the device, her physician checked to ensure the strings on the Mirena were in place, and they were found to be present and properly positioned. However, she was forced to have it removed on June 18, 2013, after an attempt to remove the device by hysteroscopy on May 20, 2013 failed. According to the complaint, Rangel followed all instructions accompanying the Mirena and used it as directed.

“[The]Plaintiff suffered serious and life-threatening side effects and injuries including, but not limited to the following: pelvic pain, chills, fever, generalized pain and related sequelae requiring hospitalization, surgical intervention, extensive medical therapy, continuing treatment, and medical monitoring,” says the claim. “Further personal injuries suffered by the Plaintiff include, but are not limited to, pain and suffering, permanent bodily impairment, mental anguish and diminished enjoyment of life.”

Mirena IUD lawsuit

After going through surgical removal of the Mirena, the plaintiff filed suit against Bayer, under the following causes of action:

1. Negligent Misrepresentation
2. Manufacturing Defect
3. Fraudulent Misrepresentation
4. Failure to Warn
5. Design Defect
6. Breach of Express Warranty
7. Fraud by Concealment
8. Strict Liability
9. Negligence
10. Breach of Implied Warranty

About the Mirena intrauterine device

Mirena is an intrauterine (IUS) system designed to prevent pregnancy. The device is placed in a woman’s body within seven days of the first day of menstruation and can remain in the uterus for a period of up to five years. If a woman wants to continue using Mirena after five years, the old system must be removed and a new one will be inserted. The package labeling recommends the device for use in women who have given birth to at least one child.

The Mirena label does not provide a warning about spontaneous migration of the IUS, but only notes that migration may occur if the uterus is perforated during insertion. The product labeling also describes perforation as an uncommon event. However, the claim notes that numerous women have suffered migration and uterine perforation post-insertion.

Bayer admonished for overstating benefits;minimizing risks

According to the claim, the defendants have a history of exaggerating the effectiveness and understating the potential safety concerns of Mirena. In December 2009, Bayer was contacted by the Department of Health and Human Services’ Division of Drug Marketing, Advertising and Communications (DDMAC), regarding their “Mirena Simple Style Statements Program,” which as a live presentation targeting “busy moms.”

The Simple Style program was presented in a private setting and represented the Mirena IUD as a product that would increase the intimacy, romance and emotional satisfaction between sexual partners. The DDMAC determined these claims were unsubstantiated and highlighted the fact that the product’s package insert asserts that at least 5% of clinical trial patients reported a decreased libido after use.

Additionally, the Simple Style script also suggested that Mirena can help patients “look and feel great.” DDMAC also found these claims to be unsupported, noting that the product can actually cause women to experience a number of unpleasant side effects, such as weight gain, breast pain or tenderness and acne.

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