Mass. Woman Sues Bayer for Mirena IUD Injuries

Mass. Woman Sues Bayer for Mirena IUD Injuries

By Amanda Antell

Massachusetts plaintiff Kimberly A Sharples is suing Bayer Pharmaceuticals for the injuries she allegedly sustained from Mirena IUD. The device allegedly perforated and migrated from her uterus, forcing her to undergo surgery on Oct. 19, 2010.

The Mirena IUD was initially implanted into the plaintiff by her physician in October 2008. There were no complications during the procedure, and the plaintiff had reacted normally to the device, according to her lawsuit. The device was used without problem for about two years until Oct. 19, 2010, when the IUD had to be surgically removed. Upon a previous medical inspection, it was discovered that the device had perforated and migrated from her uterus, causing a variety of medical concerns and complications.

The Mirena lawsuit states that at no point in time was the plaintiff warned of this possible occurrence, nor was her physician aware that this was such a possibility. Additionally, Bayer made no effort to notify her of any possible side effects, nor were there any indications on the product’s warning label.

So for being directly responsible for designing, manufacturing, selling, marketing, and distributing a dangerous product, Sharples is suing Bayer Pharmaceuticals. The charges include: negligence, false advertising, misrepresenting a product, and concealing information.

Overview of Mirena IUD Complications

The Mirena IUD is an intrauterine device that is meant to be a long-term birth control option for women. It is meant to last up to five years, and is manufactured by Bayer Pharmaceuticals. It was first approved by the FDA in December 2000, and has since become one of the most popular contraceptive options in the United States, with over two millions prescriptions. It is currently the only intrauterine device sold in the United States, while several other brands are available in Europe. Despite the product’s popularity, there have been recent medical and legal concerns over an apparent design flaw.

The Mirena IUD is a small t-shaped device in which the endpoints are composed of a hormone called levongestrel, which is directly released into the uterus to prevent pregnancy. Due to some complications associated with levongestrel, the defendant company recommends that women who have already had one child to use the Mirena IUD. Levongestroal has been associated with cramps, miscarriages, and ectopic pregnancies in the most extreme cases. In this case, the plaintiff suffered a fairly common mishap associated with the Mirena IUD: device perforation and migration.

According to FDA injury reports, it is becoming more and more common that the device perforates that uterus of the patient, migrates out of the uterus, and then implants itself onto a different part of the lower or upper abdomen of the patient. Between Nov. 1, 1997 and June 30, 2012, there have been more than 45,966 injury reports indicated device migration and perforation. The device’s label describes this occurrence as uncommon, despite this staggering statistic.

Repeatedly, Bayer has been criticized by the FDA for exaggerating the benefits of the Mirena IUD, and for not adequately describing its side effects.

Mirena IUD Litigation Movement

Sharples is an example of a woman who claims she was not adequately warned of this possibility, and has joined her lawsuit with a multidistrict litigation (MDL) movement against Bayer Pharmaceuticals. Plaintiffs in this case allege similar injures as her, and seek similar damages.