21 Women Cite Uterine Perforation in Mirena Birth Control Lawsuit

Twenty one women have filed a Mirena birth control lawsuit against Bayer Healthcare Pharmaceuticals in California Superior Court. The products liability claim was brought on June 7, 2013 and alleges that the defendants manufactured a defective intrauterine device marketed as Mirena, which caused the plaintiffs to sustain life-threatening complications and injuries. The Mirena side effects suffered by the women included perforation of the uterus and organ damage that required surgical removal of the IUD.

The 21 plaintiffs in this suit are requesting economic, non-economic, statutory and punitive damages, and demand a trial by jury.

Horrific Mirena side effects blamed on spontaneous device migration

While the exact nature of the plaintiffs’ Mirena IUD complications aren’t detailed in the complaint, court documents state that each woman sustained injuries after the device migrated spontaneously, punctured the uterus then embedded in tiny fragments in the bowel, stomach and intestines, necessitating surgical removal. Allegations such as these aren’t the first to arise in court, as dozens of women who chose the Mirena as their primary method of birth control claim that Bayer misled the public about the IUD’s safety and efficacy.

The plaintiffs in this case contend that the product’s labeling fails to adequately warn consumers and health care providers of adverse Mirena side effects including:

• Risk of Mirena IUD migration post-insertion
• Risk of uterine perforation
• Perforation that leads to abscesses
• Infections
• Need for surgical removal
• Possible need for hysterectomy 

The defendants are being held liable for placing the Mirena in the stream of commerce with “wanton and reckless disregard for the public safety.” In the United States alone, an estimated two million women use the IUD, which has been linked to nightmarish injuries and complications stemming from spontaneous migration months or even years after the device is inserted. Some women who’ve filed a Mirena birth control lawsuit have suffered infertility after needing a full hysterectomy to address the internal damage caused by the IUD.

The following nine counts are leveled against Bayer in this complaint:

• Defective product design
• Negligent design defect
• Negligence
• Failure to warn
• Breach of Implied Warranty
• Breach of Express Warranty
• Negligent misrepresentation
• Fraudulent misrepresentation
• Fraud by concealment

Bayer remanded for misleading ad campaign

In 2009, Bayer was contacted by the Department of Health and Human Services Division of Drug Marketing, Advertising and Communications (DDMAC) regarding its “Mirena Simple Style” direct-to-consumer campaign that promoted Mirena as a means to enhance romance and intimacy between couples, while omitting information about possible risks. The marketing campaign centered around a carefully worded script targeted to busy moms, and was presented in private homes and restaurants.

The DDMAC noted that Bayer’s claims were unsubstantiated and that absent from these presentations was any mention of susceptibility to infections or miscarriage if a patient becomes pregnant while using the IUD.

Status of Mirena IUD litigation

With mounting reports of grim side effects ranging from chronic bouts of pelvic inflammatory disease to Mirena infertility, the product liability complaints involving Mirena are piling up in courtrooms. This past April, the JPML moved to centralize Mirena side effects lawsuits filed in federal courts under one judge in the Southern District of New York to help conserve judicial resources and expedite pre-trial proceedings. At last count, the Mirena IUD Products Liability Litigation, MDL No. 2434, had accumulated more than 50 cases, with more tag along actions being considered.