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MDL Coordinates Federal Mirena Lawsuits in New York

On April 8, 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federal Mirena lawsuits consolidated into the Southern District of New York for pre-trial proceedings.

Plaintiffs, represented by their Mirena lawyer, petitioned the JPML for consolidation on January 16, 2013, arguing that it would increase efficiency for all parties involved. The petition suggested the Northern District of Ohio as a location for the MDL, however.

According to court documents, nearly 50 plaintiffs have filed Mirena lawsuits in various courts around the country, seeking damages for serious side effects resulting from device migration, uterine perforation and other complications.

Women complain of Mirena side effects

The FDA approved the Mirena intra-uterine device (IUD) in 2000 as a birth control option for women. A small, plastic, T-shaped device, the Mirena gradually releases hormones into a woman’s system to prevent pregnancy. Manufacturer Bayer originally marketed it as a more convenient option to the birth control pill, since women didn’t have to think about taking a pill every day.

The FDA sent Bayer a warning in December 2009, however, for over-promoting the Mirena as helping women to “look and feel great,” when there was no scientific evidence behind these types of claims. To date, the FDA has received over 45,000 complaints about adverse Mirena side effects, including bleeding, abscesses, migration of the device, perforation of the uterus, infections, and more, many requiring additional corrective surgery.

Plaintiffs typically claim that Bayer was negligent in creating adequate warnings about the health risks, particularly those associated with perforation and migration, and that the company should have performed additional safety studies before releasing the IUD.

Bayer opposes centralization of federal Mirena lawsuits

Bayer tried to consolidate all New Jersey state Mirena lawsuits into one court in August 2012, but the New Jersey Supreme Court denied the request. After the Mirena lawyer representing plaintiffs filed the petition for federal consolidation, however, Bayer balked, releasing a statement saying they did not support federal centralization.

In their response to the petition, Bayer noted that they had already been involved in federal Mirena lawsuits for two years, and that an MDL would require them to start over. They also stated that there were factual differences in the actions, especially with respect to what caused the alleged injuries, and that the cases were not similar enough to qualify for coordination.

JMPL establishes MDL in New York district court

The JPML agreed with the plaintiffs, however, that centralization was appropriate for Mirena lawsuits. “While we agree that these actions present a number of individualized factual issues,” the panel wrote in their transfer order, “the existence of such issues does not negate the common ones, including, in particular, those concerning the alleged risk of perforation and migration posed by the product and the adequacy of the product’s warning label with respect to those risks.”

The panel noted that putting all legal actions in front of one judge will help reduce the risk of duplicative discovery demands, increase convenience for all parties, and prevent inconsistent rulings on pre-trial matters.

In deciding on the location for the MDL, the panel stated that the Southern District of New York was most appropriate since Bayer Healthcare LLC is headquartered in the state, and other corporate affiliates are nearby in New Jersey, Connecticut, and Pennsylvania. They assigned Judge Cathy Seibel to oversee the proceedings, noting her experience with three related actions.