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Drug company Bayer Pharmaceuticals has been knee-deep in litigation over the past several years due to the reported side effects of birth control pills Yaz and Yasmin, which have been found in scientific studies to significantly raise the risk of blood clots more than older brands of birth control pills.

Now, the company faces a new source of legal action. Some women using the Mirena IUD as a birth control option have complained of serious complications, including Mirena IUD migration and perforation of organs like the uterus, bladder, and intestines.

As the number of Mirena lawsuits increased over the last year, Bayer sought centralization of New Jersey cases in August 2012, but that request was recently denied. Now Mirena lawyers have petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate each federal Mirena IUD lawsuit into one court, for ease of pre-trial proceedings.

Bayer Advertises Mirena as More Convenient

Approved by the FDA in 2000, the Mirena IUD is a small, T-shaped plastic device professionally inserted into the uterus, where it gradually releases small amounts of the progestin "levonorgestrel" to prevent pregnancy. Bayer originally marketed the device as being a more convenient, longer-lasting alternative to birth control pills, particularly for busy moms who didn’t want to bother with remembering to take a pill every night.

Post-marketing reports, however, have indicated that some women experience serious Mirena IUD side effects. As of June 2012, the FDA adverse event database had received 45,000 reports of problems related to the Mirena, including migration of the device from its original place of implantation, organ perforation, bleeding, infection, ovarian cysts, embedment of the device into the uterine wall, and ectopic pregnancy.

In December 2009, the FDA sent a warning letter to Bayer about their aggressive marketing, admonishing the company for overstating the benefits of the device while minimizing the risks. Statements indicating that the Mirena improved relationships and sex lives while helping women to "look and feel great" had no scientific basis, and Bayer was encouraged to stop making these types of misleading claims.

Mirena IUD Migration Leads to Hospitalization

A 2011 article published in the Journal of the Society of Laparoendoscopic Surgeons reported on two cases of Mirena IUD migration. In both women, the device had traveled to the abdominal area, and had to be surgically removed.

The Mirena is designed to last for about five years, but FDA reports indicate that many women are suffering from Mirena side effects long before that. Women filing a Mirena IUD lawsuit typically complain of migration and organ perforation. Most had to be hospitalized as a result, and the FDA has so far received reports of 42 deaths related to the device.

Each Federal Mirena IUD Lawsuit May Soon Be Centralized

Because of the rising number of women filing a Mirena IUD lawsuit, on January 16, 2013, plaintiffs petitioned the JPML to centralize all cases into one court in the Northern District of Ohio. Centralization would make pre-trial proceedings more efficient for all parties involved, the plaintiffs stated, and would reduce the risk of inconsistent rulings. According to the petition, Mirena lawyers are expecting hundreds of cases to be filed in the coming months.

Bayer requested centralization of New Jersey lawsuits as well, but the New Jersey Supreme Court recently denied that request for unknown reasons. Centralization of state cases will likely occur in other locations.




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