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50+ Mirena Uterine Perforation Cases Filed In U.S. Courts

Catalina Lucero filed a Mirena IUD migration lawsuit against Bayer Pharmaceuticals in the U.S. District Court of Minnesota on June 28, 2013. As the result of alleged injuries and complications stemming from Mirena uterine perforation, the plaintiff is seeking in excess of $75,000 in damages.

Mirena IUD migration lawsuit

According to the suit, the plaintiff had the Mirena IUD  inserted by her doctor on September 9, 2010. The procedure seemingly went well and the plaintiff was able to find the strings just after insertion. On a follow-up visit, the plaintiff’s physician confirmed that the device was in the uterus, where it was supposed to be.

However, the plaintiff began experiencing abdominal pain on December 28, 2010. There had been a Mirena uterine perforation and migration of the device outside the uterus, requiring surgical removal. Even though the plaintiff used the product as directed, she suffered complications that required medical therapy, surgery, hospitalization, continued treatment and medical monitoring. She is demanding compensation for pain and suffering, permanent bodily impairment, mental anguish and diminished enjoyment of life.

Causes of action in the Mirena uterine perforation case

Bayer Pharmaceuticals is being charged with defective manufacturing, defective design, negligence and failure to warn patients and doctors of the risks associated with the Mirena IUD. They are also being charged with strict liability, as it is their duty to put a product on the market that is reasonably safe. Other charges in the case include breach of implied and express warranties, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, and unjust enrichment for a total of 11 causes of action.

About the Mirena IUD

Mirena was FDA approved in 2000 and is currently used by more than 2 million women in the United States and over 15 million worldwide. Bayer’s trouble began in December 2009 when the Department of Health and Human Services accused their Simple Style Program – a direct-to-consumer campaign- of making false claims.

According to the Mirena uterine perforation lawsuit, in-home consultants were telling women that the use of Mirena would “increase the level of intimacy, romance and emotional satisfaction between sexual partners” – when, in reality, the data suggested a loss of libido in at least 5% of clinical trial participants. Other unsubstantiated claims investigated by the Division of Drug Marketing, Advertising, and Communications were that users would “look and feel great” after Mirena IUD implantation.

Also, the risks associated with the product were omitted in the presentation.  Currently, Mirena’s packaging does not warn patients of the risk of spontaneous device migration, although it states that the IUD may migrate in an “uncommon event… if the uterus is perforated during insertion.”

Mirena uterine perforation lawsuits mount

Owing to the escalating lawsuits alleging catastrophic Mirena IUD injuries, claims were organized as Mirena multidistrict litigation No. 2434 in the Southern District of New York in an attempt to centralize similar cases for efficient pretrial coordination. As of July 2013, there are more than 50 cases pending against Bayer involving Mirena uterine perforation, migration and other adverse side effects. New cases are still being added to the MDL.