Mirena Lawsuits Continue to Mount, Approaching 2,000 Cases

A growing number of women throughout the United States are pursuing product liability lawsuits against Bayer after experiencing complications with Mirena IUD birth control implant, with the drug maker now facing nearly 2,000 claims involving perforations, migrations and other injuries.

Mirena is a small T-shaped form of birth control, known as an intrauterine device or IUD, which is implanted in the uterus by doctors to provide long-term protection against pregnancy for up to five years.

While it has been marketed as a “hassle free” form of birth control, avoiding the need for women to remember taking a daily pill, many women have reported suffering severe and debilitating injuries after the IUD perforated the uterus and migrated to other areas of the body, often resulting in infections, organ perforations and other injuries.

Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD problems, including at least 5,000 cases involving women who indicated that Mirena migrated out of place since 2008, and 1,322 reports where the Mirena IUD punctured the uterus.

According to a stockholders report filed by Bayer this week, at least 1,810 complaints had been served on the drug maker as of April 8, and additional Mirena lawsuits are anticipated.

Mirena IUD Birth Control Litigation

In the federal court system, the Mirena litigation has been consolidated for pretrial proceedings before U.S. District Judge Cathy Seibel in the Southern District of New York, where nearly 500 cases filed in U.S. District Courts throughout the country have been centralized as part of an MDL, or Multidistrict Litigation.

Centralized proceedings have also been established in New Jersey state court, where more than 700 cases are consolidated before Superior Court Judge Brian R. Martinotti in Bergen County as part of a Multi-County Litigation (MCL). The remaining cases are spread throughout various throughout various state courts.

In both the federal Mirena MDL and in New Jersey state court, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. These bellwether Mirena trials are not expected to begin until the second half of 2015, but are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Bayer has previously maintained that it intends to defend the cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

Following a series of bellwether trials, if Bayer continues to refuse to make any Mirena settlement offers, the drug maker could face hundreds of individual trials spread throughout the country.