Mirena Bellwether Trial Deadlines in MDL Pushed Back 60 Days

The U.S. District Judge presiding over the coordinated litigation for all Mirena IUD lawsuits pending in the federal court system has pushed back deadlines regarding the preparation of a small group of cases for early trial dates.

Mirena is a long-lasting form of birth control known as an intrauterine device, or IUD, which is manufactured by Bayer Healthcare. More than 1,000 women are now pursuing product liability lawsuits, alleging that side effects of Mirena caused them to suffer injuries when the T-shaped plastic device perforated their uterus and migrated to other parts of the body.

In the federal court system, cases filed throughout the country have been centralized before U.S. District Judge Cathy Seibel in the Southern District of New York as part of an MDL, or Multidistrict Litigation, for coordinated handling during pretrial proceedings and a series of early trial dates.

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As generic discovery into issues that apply to all cases is ongoing in the Mirena litigation, the parties were expected to begin next month with the selection of a small group of cases that will be prepared for early trial dates. Known as “bellwether” lawsuits, these the preparation and outcome of these trials are designed to help the parties gauge the relative strengths and weaknesses of their cases, and may lead to Mirena settlement agreements in a large number of cases.

On February 26, Judge Seibel issued a case management order (PDF), which extends many deadlines relating to this initial disposition pool. While the parties were originally expected to select cases for this bellwether pool by April 4, 2014 and complete all case-specific discovery by September 30, 2014, these deadlines have been pushed back 60 days.

The first Mirena trial dates still have not been scheduled, but the pretrial proceedings and challenges to expert witnesses are now not expected to be completed until at least July 15, 2015.

Mirena IUD Litigation

Bayer introduced Mirena in 2000, aggressively promoting the IUD 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.

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.

Bayer has attempted 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 the completion of all pretrial proceedings and series of bellwether trials, if the parties do not reach an agreement to settle or otherwise resolve a large portion of the Mirena litigation, Judge Seibel may begin remanding hundreds of cases back to U.S. District Courts throughout the country for individual trial dates.


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