Mirena Ectopic Pregnancy Lawsuit Alleges IUD Migration

Plaintiffs Letitia and George Edwards are suing Bayer Pharmaceuticals for more than $75,000 in a Mirena ectopic pregnancy lawsuit filed in the Southern District Court of New York on June 17, 2013.

The Mirena IUD is an intrauterine contraceptive device that is inserted at the doctor’s office and may remain inside the woman for up to five years. The IUD releases small amounts of the progestin hormone levonorgestrel into the uterus to prevent pregnancy. This type of birth control is used by more than 15 million women worldwide, but some women have reported severe and even life-threatening injuries as a result of its use.

Allegations raised in Mirena ectopic pregnancy lawsuit

The 32-year-old plaintiff sought the Mirena IUD because it was marketed as an easy form of birth control that didn’t require much thought or care. She was unaware that the device could spontaneously migrate to other places in the body. On April 27, 2009, she had the Mirena implanted at her doctor’s office.

At her June 3 follow-up appointment, her gynecologist said the strings of the device were not visible, but it was presumed they were just cut too short during the implant. Later, at her April 30 annual checkup, the device was still not visualized during the routine pelvic exam. She was offered an ultrasound, but declined it because she experienced no adverse symptoms related to the Mirena IUD.

On October 12, 2011, Mrs. Edwards went in for a checkup prior to active duty deployment overseas. She ordered an ultrasound to locate the device before having to leave the country. It was then discovered that the IUD was not in the uterus, but had migrated to the left paracolic gutter – high within the abdomen, hanging off the colon. Surgical removal of Mirena was scheduled for November 9, 2011.

When she went in for surgery, medical staff informed Letitia Edwards that she was, in fact, pregnant. However, it was an ectopic pregnancy where the baby developed outside of the uterus. In her case, there was a rupture where the fetus had implanted, which is classified as a medical emergency. The removal of the pregnancy and Mirena IUD also required the removal of an ovary and fallopian tube in a procedure called a “salpingo-oophorectomy.”

As a result of complications stemming from Mirena IUD migration, the plaintiff suffered severe and permanent physical injuries and incurred significant medical expenses.

She and her husband are suing on 14 specific counts, including:

• Negligence
• Strict products liability – defective design
• Strict products liability – manufacturing defect
• Strict products liability – failure to warn
• Strict products liability – defect due to nonconformance with representations
• Strict products liability – defect due to failure to adequately test
• Breach of express warranty
• Breach of implied warranties
• Fraudulent misrepresentation
• Fraudulent concealment
• Negligent misrepresentation
• Fraud and deceit
• Violation of consumer protection laws
• Punitive damages
• Loss of consortium

Other cases of Mirena IUD migration

This is not the first case of Mirena IUD migration that has resulted in a lawsuit. More than 47,000 complaints have been filed with the FDA, according to news sources. Since 2008, there have been 4,775 reports of “device dislocation” and 1,322 reports of uterine perforation. Currently, the lawsuits are being consolidated into Mirena multidistrict litigation that was established in New York district court. A large, diverse steering committee that will include male and female attorneys is being assembled.