Mirena Lawsuits in Federal MDL to be Prepared for Early Trials

The federal litigation over complications with Mirena IUD birth control continues to move forward, with the parties preparing to select a small group of cases that will be eligible for early trial dates that may begin in two years.

A growing number of Mirena lawsuits are being filed by women throughout the United States, who allege that they suffered painful and debilitating injuries when the implanted birth control perforated their uterus and migrated to other areas of the body, often resulting in infection and the need for surgical removal of the Mirena IUD.

In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated proceedings in the federal court system for the Mirena litigation, ordering that complaints filed in district courts nationwide will be transferred to U.S. District Judge Cathy Seibel for coordinated proceedings in the Southern District of New York.

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Mirena Lawsuits

Migrations and perforations caused by Mirena birth control have resulted in lawsuits nationwide.


According to the latest case list (PDF) released by the U.S. JPML, there are already 123 lawsuits that have been centralized before Judge Seibel in the Mirena MDL. However, as lawyers continue to review and file additional cases, it is expected that thousands of cases will ultimately be part of the coordinated proceedings.

In a Scheduling Order (PDF) issued on August 16, Judge Seibel outlined the discovery process for the litigation, including a time-table for the selection of a small group of cases that will go through case-specific discovery in preparation for early trial dates, known as “bellwether” trials.

Mirena Bellwether Trials May Begin Late 2015

In complex product liability litigation, where a large number of cases are filed by plaintiffs who allege that they suffered similar injuries from a single medical device or drug, it is common for a small group of cases to be prepared for early trial dates to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout other cases.

The prepartion and outcome of these test cases are designed to facilitate negotiations to settle Mirena lawsuits without hundreds of cases proceeding before juries throughout the United States.

According to the schedule issued by Judge Seibel, the parties are to move forward with written discovery and document production that pertains to all cases in the litigation, with all generic discovery completed within the next year.

In April 2014, the parties will select cases for an “Initial Disposition Pool”, which will then go through the case-specific discovery process, including designation of experts and depositions regarding the injuries suffered by those plaintiffs.

Judge Seibel has indicated that dispositive motions and challenges to the admissibility of expert witness testimony are due by May 15, 2015, with oppositions and reply dates to be determined at a future time.

While specific details have not been determined regarding the number of cases that will be selected or when the first trials will be scheduled, the first cases in the MDL could be ready for trial by late 2015.

Mirena Injuries

Mirena is a levonorgestrel-releasing intrauterine system, which is also often referred to as an IUD, or intrauterine device. The small T-shaped birth control is inserted into the woman’s uterus to prevent pregnancy for up to five years.

Introduced by Bayer in 2000, Mirena has been aggressively promoted as a hassle-free form of birth control. However, a growing number of women and their doctors have reported problems where the Mirena IUD migrated from its initial implant location, perforating the uterus and other organs, causing infections and abscesses, and leaving women unknowingly unprotected against the chance of pregnancy.

Similar allegations have been raised in most of the complaints, claiming that Bayer failed to adequately warn about the risk of spontaneous migration, which can occur months or even years after implant. While the Mirena warning label does indication that perforation of the uterus is a risk, the language provided by the drug maker suggests that it may only occur during implantation.

In addition to the federal litigation, Bayer also faces a number of Mirena IUD lawsuits in New Jersey state court, which have also been centralized before one judge for coordinated proceedings. There are currently nearly 200 cases pending before Judge Brian R. Martinotti in Bergen County, where the next case management conference will be held on September 25.


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