August 13, 2014 — Law360 reports that the U.S. Judicial Panel on Multidistrict Litigation (JPML) has refused to centralize nine lawsuits involving neurological side effects of Mirena, ruling that there are too few cases.

Attorneys asked the JPML to centralize the litigation in May. They allege that levonorgestrel, a hormone in Mirena, can potentially increase levels of cerebrospinal fluid in the brain. This could increase pressure in the skull and lead to complications like idiopathic intracranial hypertension (IIH) or pseudotumor cerebri (PTC).

Meanwhile, attorneys have submitted a list of 12 cases, one of which will be selected for the first “bellwether” trial in 2016. All of the cases will go through preliminary discovery. Half will be eliminated next year; the rest will go through expert witness discovery. The court will select one case to go to trial.

The results of a “bellwether” trial provide critical information about how a jury will respond to testimony and evidence. If the jury awards compensation to the plaintiff, it can help attorneys negotiate a settlement or resolution in other cases with similar factual allegations.

Bayer HealthCare is currently facing more than 2,000 lawsuits involving Mirena, a popular intrauterine contraceptive device (IUD). About 800 cases are proceeding in state court in New Jersey. About 600 additional cases have been centralized in a federal Multi-District Litigation (MDL) in the U.S. District Court for the Southern District of New York, overseen by Judge Cathy Seibel.

Hundreds of lawsuits allege that Bayer failed to warn that Mirena can spontaneously migrate, perforate the uterus, and travel into the abdominal cavity where it must be removed surgically. Plaintiffs allege that the Prescribing Information for Mirena only warns about the risk of uterine perforation during the insertion procedure.


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