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Lawyers involved in the federal Mirena pseudotumor cerebri lawsuits are set to meet this week with the U.S. District Judge recently appointed to presided over the consolidated litigation.
In late April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all cases brought by women diagnosed with pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH) from a Mirena IUD birth control implant, centralizing the claims before U.S. District Judge Paul A. Englemayer in the Southern District of New York.
More than 100 complaints filed throughout the federal court system have been transferred to Judge Englemayer over the past month, since they each raise similar questions of fact and law, alleging that Bayer failed to adequately warn women and the medical community that side effects of Mirena may cause a dangerous buildup of fluid pressure around the brain, which typically results in severe headaches, vision problems and the need for emergency medical treatment.
According to the first order (PDF) issued by Judge Englemayer, an initial conference is scheduled for Tuesday, June 13 at the Thurgood Marshall Courthouse in New York City.
On June 5, parties involved in the litigation filed a joint proposed agenda (PDF), indicating that they intend to discuss a proposed structure for plaintiffs’ leadership, including the appointment of lead and liaison counsel, which will take actions on behalf of all plaintiffs during the coordinated discovery and pretrial proceedings.
During the initial conference, the lawyers also indicate that they will discuss a number of proposed orders covering document production, document preservation, direct filing orders, master pleadings and other issues, as well as a schedule for future conferences.
Over the coming weeks, as Mirena psuedotumore cerebri lawyers continue to review and file claims for women nationwide, it is expected that the size and scope of the litigation will continue to grow, with over 1,000 cases likely to be added to the MDL.
As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will establish a bellwether program, where a small group of cases will be 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.
Mirena is a small, T-shaped birth control device sold by Bayer, which is implanted into the uterus to provide protection against pregnancy for up to five years. Known as an intrauterine device (IUD) or intrauterine system (IUS), the polyethylene frame for Mirena contains a steroid reservoir that release levonorgestrel, which is a second generation progestin used in many forms of birth control.
While other forms of birth control that involve levonorgestrel have been associated with a risk of pseudotumor cerebri (PTC), the Mirena warnings have failed to alert women and physicians about the importance of monitoring for signs or symptoms of the buildup of fluid pressure around the brain, which may cause severe headaches, vision problems and potentially result in blindness if permanent damage is suffered to the optic nerve.
If no Mirena PTC settlements are reached following the MDL proceedings, each individual case may eventually be remanded back to the U.S. District Court where it was originally filed for a separate trial date.