Mirena Lawsuit Guide

What is Mirena and how does it work?

Mirena is a hormonal intrauterine device (IUD) which is implanted in the uterus to prevent pregnancy. According to the manufacturer Bayer Pharmaceutical, the flexible T-shaped device is a 99% effective birth control method. It acts by slowly releasing a small quantity of levonorgestrel, a synthetic equivalent of the naturally-occurring female reproductive hormone progesterone. This progestin acts by thickening the mucus in the cervix, effectively inhibiting sperm from moving in the uterus and fertilizing the eggs, for up to five years.

Mirena is the first levonorgestrel-based IUD which was first introduced in Europe in 1993, but the Food and Drug Administration (FDA) approved it for the U.S. market in 2000. With over 2 million American women currently using it every day, Mirena earns the pharmaceutical company over $800 million in yearly revenues.

Why is Mirena a dangerous device?

Since Mirena was first released to the market, the FDA received well over 47,000 adverse event reports regarding serious side effects. Some women reported suffering from disastrous complications shortly after being implanted with the device, ranging from pain and discomfort to more severe damage such as organ perforation. If the T-shaped device is not properly placed, it may detach from its position and perforate the wall of the uterus or the fallopian tubes. In the more severe instances, it may even migrate to other parts of the body, causing even more gruesome internal injuries. If a woman inadvertently ends up pregnant while wearing Mirena, the constant release of levonorgestrel may lead to spontaneous abortion, ectopic pregnancy and preterm labor.

In 2009 the FDA sent a warning letter to Bayer claiming the pharmaceutical company violated the federal Food, Drug and Cosmetics Act after falsely advertising Mirena as a device that would increase intimacy and romance. The manufacturer also claimed that the device would make women “look and feel great” despite many plaintiffs later alleged it was associated with acne, bloating and weight gain. Thousands of patients accused Bayer of releasing a defective device to the market after suffering from its serious complications. Many of these lawsuits have been centralized in the first Multidistrict Litigation (MDL) No. 2434 in the Southern District of New York.

Mirena unexpected side effects: Pseudotumor Cerebri (PTC)

Back in the 1990s, many researchers found a worrisome link between certain birth control methods and a dangerous condition known as Pseudotumor Cerebri (PTC). Also known as intracranial hypertension (ICH), PTC’s symptoms mimic those of a brain tumor as a build-up of excess cerebrospinal fluid starts accumulating inside the skull. While not fatal, this excess fluid increases the pressure inside the head causing pain and sometimes permanent damage such as vision loss and blindness. A first study published in the New England Journal of Medicine found that contraceptives such as Mirena could increase the risk of PTC by inhibiting the body’s ability to absorb the excess spinal fluid properly. Findings of these early studies about this risk have been confirmed later by a more modern study published in 2015 which used data coming from the  FDA’s Adverse Events Reporting System (FAERS database).

Mirena Organ Perforation Lawsuits and the New York MDL No. 2434

In April 2013, to speed up the proceedings, the Judicial Panel on Multidistrict Litigation (JPML) started consolidating the many Mirena lawsuits pursued by victims and their attorneys across the country. Eventually, the MDL No. 2434 was formed in the Southern District of New York, overseen by Honorable Judge Cathy Seibel. The over 1,800 plaintiffs accused Bayer of failure to warn about the many health risks associated with the use of Mirena, and tried to hold the company liable for all damage sustained under the product liability law. According to the attorneys who fought in court, the original Mirena’s label did not contain warnings for secondary perforation or spontaneous migration.

In 2016, however, the MDL 2434 was later dismissed, since all the expert witnesses brought by Mirena lawyers were not deemed qualified enough to give testimony. More than 1,300 cases still pending at the time were then reassigned and centralized in the Multicounty Litigation (MCL) Case No. 297 in New Jersey under Judge Rachelle L. Harz. A total of 2,046 cases in the MCL are currently in the discovery phase as of August 2017.

Mirena Pseudotumor Cerebri MDL No. 2767

Although most of the existing litigations filed so far focus on device migration and other injuries caused by organ perforation, a new group of Mirena Pseudotumor Cerebri lawsuits recently emerged. More than 100 plaintiffs claim to have suffered from this condition shortly after being implanted with the contraceptive device. On February 2017, the attorneys who act on their behalf filed a motion to centralize the cases currently pending in many state courts, in a new MDL No. 2767.

If you or a loved one suffered an injury including intracranial hypertension (ICH), PTC, organ perforation or device migration, call us now. We will help you file a litigation and seek proper financial compensation in court.