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As a growing number of Mirena IUD lawsuits continue to move forward nationwide, a small group of cases pending in New Jersey state court are being prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
Bayer Healthcare currently faces about 2,000 product liability lawsuits filed by women who experienced problems with Mirena IUD birth control, alleging that the small, T-shaped implant perforated the uterus, migrated to other areas of the body or caused other internal injuries.
More than 800 of the cases are currently pending in New Jersey state courts, which is where Bayer’s U.S. headquarters are based. The Mirena litigation in New Jersey has been centralized before Superior Court Judge Brian R. Martinotti in Bergen County, as part of a coordinated Multicounty Litigation, or MCL.
According to an order (PDF) issued by Judge Martinotti last month, the parties were each directed to submit a list of eight cases by June 3, which will be included in an Initial Disposition Pool. It is expected that these 16 cases will go through case-specific discovery in preparation for the first state court Mirena trials in New Jersey, which will be scheduled at a future date.
Judge Martinotti indicates that cases selected for this Initial Disposition Pool may not be voluntarily dismissed by plaintiffs without prejudice, unless good cause shown for why they should be permitted to refile again at a future date. However, if any of the selected plaintiffs do decide to drop their case rather than moving forward, Bayer will be permitted to select a new case. If any of the selected cases are resolved through a Mirena settlement paid by the drug maker, plaintiffs will be permitted to select a replacement case of their choosing.
The first Mirena trials are not expected to begin until at least the second half of 2015.
Mirena IUD Problems
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.
In addition to the New Jersey state court litigation, Bayer also faces more than 500 cases that have been centralized in the federal court system before U.S. District Judge Cathy Seibel in the Southern District of New York, as part of a Multidistrict Litigation (MDL).
A small group of cases are also being prepared for early trial dates in the federal Mirena MDL, where a group of 24 cases have been selected as part of an “Initial Disposition Pool,” which will later be reduced to a group of 12 cases that will be prepared for the first trials.
If Bayer fails to settle Mirena lawsuits or otherwise resolve the litigation following these bellwether trials, the drug maker could face hundreds of individual trials in courts throughout the country.