Va. Woman Files Mirena IUD Injury Lawsuit

A Virginia woman filed a Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals Inc. for personal injuries that she allegedly suffered after her Mirena IUD migrated.

The Mirena intrauterine device (IUD) was designed and sold by Bayer for insertion into the uterus as a means of birth control. Mirena has a T-shaped polyethylene frame with a steroid reservoir around the vertical stem. The reservoir is made of a mixture of levonorgestrel and silicone, containing a total of 52 mg of levonorgestrel.

Levonorgestrel is a progestin that is released by Mirena slowly, over time, directly into the uterus. Levonorgestrel is used to prevent fertilization by inhibition of ovulation and thinning of the uterine lining.

Plaintiff Katherine Gallaher was implanted with the Mirena IUD in November 2012 in Chesapeake, Va. According to her Mirena lawsuit, she was “diagnosed with migration of the IUD attached to the right adnexa,” which led to a painful surgical removal of the device on June 21,2013.

Gallaher’s Mirena IUD lawsuit alleges that had she received adequate warnings regarding the risks of the use of the Mirena IUD she would not have used it, but would instead have used other means for contraception.

While Bayer knew, or should have known, its product posed a serious risk of bodily harm to consumers, the Mirena IUD lawsuit alleges that the drug maker continued to manufacture and market Mirena for use by consumers and continued to fail to comply with federal requirements.

According to the Mirena IUD lawsuit, more than 2 million Mirena intrauterine devices have been placed in women in the United States since 2000.

More than 45,966 adverse events were reported to the U.S. Food and Drug Administration (FDA) associated with Mirena between Nov. 1, 1997 and June 30, 2012. Most of the adverse events reported are associated with uterine migration and perforation of the uterus.

The Mirena IUD lawsuit claims that 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. Because of this, the FDA warned Bayer for “overstating the efficacy of Mirena while understating the potential concerns of safety risks.”

Bayer also received a warning from the Department of Health and Human Services Division of Drug Marketing, Advertising and Communication (DDMAC) that its “Keep Life Simple” marketing slogan is misleading because it does not communicate risk.

The Mirena IUD lawsuit argued that Bayer “had a duty to exercise reasonable care in the design, manufacture, sale and distribution of their IUD product into the stream of commerce, including a duty to assure that their product did not pose a significantly increased risk of bodily harm and adverse events and a duty to comply with federal requirements.”

Because Bayer allegedly failed her when her Mirena IUD migrated, Gallaher is seeking compensatory damages for her injuries, health care costs, and medical monitoring. She is also asking for punitive and exemplary damages.

This Mirena IUD lawsuit is Katherine Gallaher v. Bayer Healthcare Pharmaceuticals Inc., Case No. 7:14-cv-03474-CS, in the U.S. District Court for the Eastern District of Virginia.

Join a Free Mirena Class Action Lawsuit Investigation

If you or a loved one had the Mirena IUD inserted after January 1, 2000 and had to have surgery – or will be required to have surgery – to remove the IUD because it migrated, you may be eligible to take legal action against the manufacturer. Joining a Mirena class action lawsuit or filing an individual Mirena IUD lawsuit may help you recover compensation for medical bills, pain and suffering and other damages. Obtain a free case evaluation now:

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