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As hundreds of Mirena IUD lawsuits continue to move forward in the federal court system, the U.S. District Judge presiding over the litigation has established the procedure for selecting a small group of cases for early trial dates, known as “bellwether” cases.
Mirena is a long-lasting form of birth control known as an intrauterine device, or IUD, which is manufactured by Bayer Healthcare. More than 1,100 women are now pursuing product liability lawsuits, alleging that they suffered a Mirena injury after the IUD perforated their uterus and migrated to other parts of the body.
In the federal court system, cases filed throughout the country have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Cathy Seibel in the Southern District of New York. Judge Seibel is presiding over coordinated discovery and pretrial proceedings to reduce duplicative discovery in hundreds of cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
As part of the coordinated pretrial proceedings, Judge Seibel has indicated that a small group of cases will be selected as early test cases, which will be scheduled for “bellwether” trials to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout other Mirena cases in the litigation. While the outcomes of these trials will not be binding in other cases, it may influence future Mirena injury settlement negotiations.
On April 9, U.S. District Judge Cathy Seibel issued an order (PDF), outlining the process for selecting a group of 24 cases that will be part of an “Initial Disposition Pool,” which will be later be reduced to a group of 12 cases that will be prepared for early trials.
Attorneys for the plaintiffs and the defendants have until June 3 to each submit a list of 12 cases, which may include any case in which a Plaintiff Fact Sheet and Defense Fact Sheet have been exchanged by the parties as of May 2. From these Initial Disposition Pool selections, the parties will then each strike six cases chosen by the other side on June 17. The first cases to be set for trial dates will later be selected from these remaining 12 lawsuits.
In complex pharmaceutical litigation, it is common for a small group of cases to be scheduled for early trial dates, which are expected to be representative of other lawsuits, offering similar factual allegations and arguments.
“The Court expects the parties to exercise good faith in selecting cases for potential inclusion in the Initial Disposition Pool, and to not select cases presenting unique or idiosyncratic facts that would render the results of these cases unenlightening,” wrote Judge Seibel in the order. “The Court cannot police this request and will not entertain applications regarding whether one side or another has abided by it. The Court merely sets for its expectation.”
Judge Siebel said the parties will discuss whether certain types of Mirena IUD cases should be excluded from the bellwether pool at a conference on May 14.
Mirena IUD Lawsuits
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.
According to a prior case management order issued by Judge Seibel, pretrial proceedings in the bellwether cases and challenges to expert witnesses are not expected to completed until at least July 15, 2015, meaning that the first trials will likely not begin before the second half of next year.
Judge Seibel has indicated that the parties should be prepared to discuss at the next conference whether a second wave of early-discovery cases should be selected. Following the completion of all pretrial proceedings and any bellwether trials scheduled in the MDL, 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.