The first Mirena IUD complications bellwether trials in the multidistrict litigation against Bayer Healthcare have been scheduled for early 2016.

U.S. District Judge Cathy Seibel, who is presiding over 600 Mirena IUD lawsuits centralized in a multidistrict litigation in the Southern District of New York, has scheduled 12 cases to go to trial beginning in March 2016, a figure that will be narrowed to six cases by March 2015.

These cases were chosen by representatives for both the plaintiffs and the defendants.

Bellwether trials are intended to serve as a litmus test to see how juries may rule on similar evidence and testimony. Bellwether cases help reduce duplicative discovery, avoid conflicting rulings from different federal judges and mitigate the inconvenience of the various parties, witnesses and the courts.

If, after the conclusion of the Mirena IUD bellwether trial, Bayer does not settle the cases, the judge presiding over the multidistrict litigation can send the cases back to the courts where they were originally filed for individual trial dates.

The Mirena IUD is an intrauterine device inserted by a healthcare provider during an office visit. It is made of polyethylene and contains a steroid reservoir that releases levonorgestrel, a prescription medication used as a contraceptive.

The Mirena has been approved for use in the United States since December 2000 and currently is the method of contraception used by more than 2 million women in the United States and more than 15 million women worldwide, according to Mirena lawsuits. But warnings about the Mirena IUD side effects are at issue in more than 1,000 lawsuits across the country.

Bayer AG, which manufactures the Mirena IUD, is accused of failing to adequately warn users that the device could pierce the uterus and migrate to other parts of the body.

Complications reported from the Mirena IUD include pelvic inflammatory disease, perforation of the uterus or cervix, ectopic pregnancy, intrauterine pregnancy and pelvic pain, and intracranial hypertension.

Should a woman’s body reject the IUD, it can dislodge and puncture or embed in the uterus, resulting in scarring and infertility.

Plaintiffs also accuse Bayer of failing to change its packaging despite numerous reports of “embedment of and perforation through the uterine lining and/or migration of the IUD through the uterine lining after the period of insertion.”

The U.S. Food and Drug Administration (FDA) approved the Mirena IUD in December 2000 as a long-term contraceptive device. In 2009, the FDA issued Bayer a Notice of Violation letter warning that marketing material used to promote the Mirena IUD “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena,” in violation of the federal Food, Drug, and Cosmetic Act.

Bayer has continued to manufacture, advertise, and sell the birth control device, which is used by more than 15 million women worldwide for birth control.

Side effects reported by women using the Mirena IUD include weight gain, acne, breast pain or tenderness, perforation, migration, ectopic or intrauterine pregnancy, cancer, adhesions, cysts, fetal injury, premature menopause and even death.