Number of Mirena IUD Pseudotumor Cerebri Lawsuits Convince JPML To Order Centralization

After previously denying a similar request to centralize all Mirena IUD pseudotumor cerebri lawsuits, finding that there were not enough cases to justify coordinated pretrial proceedings, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has now acknowledged that the size and scope of the cases now warrant formal consolidation.

There are currently at least 113 product liability lawsuits pending in 17 different U.S. District Courts, each involving similar allegations that women developed a dangerous buildup of fluid pressure around their brain due to the side effects of Mirena IUD birth control.

In addition, as Mirena injury lawyers continue to review and file cases over the coming months and years, it is ultimately expected that hundreds, if not thousands, of cases will be added to the litigation in the coming months and years.

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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), which is also sometimes referred to as idiopathic intracranial hemorrhage (IIH), 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.

In January, a group of plaintiffs filed a request with the U.S. JPML, seeking to centralize and consolidate all Mirena PTC/IIH lawsuits before one judge to avoid duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges presiding over the cases and to serve the convenience of witnesses that will testify in many cases, as well as the judicial system. Bayer opposed centralization of the cases.

In complex litigation, where a large number of plaintiffs allege similar injuries were caused by the same medication or medical device, it is common for coordinated pretrial proceedings to be established, known as an MDL or multidistrict litigation.

The JPML rejected a previous effort to consolidate the cases in August 2014, indicating at the time that there were only nine lawsuits and that informal coordination was preferable. They also determined that individual factors in every case were likely to be dominant issues.

After considering oral arguments for a second time during a hearing at the end of last month, the JPML issued a transfer order (PDF) on April 6, finding that the caseload had grown large enough that centralization before one judge for pretrial proceedings was justified.

“While we previously expressed concern that individualized causation issues might predominate in this litigation, the records in the many actions filed since then demonstrate that discovery and pretrial motions concerning the issue of general causation have been, or will be, at the center of all actions – that is, whether the hormonal component in Mirena is capable of causing intracranial hypertension,” the panel noted. “Thus, we believe that the existence of individualized causation issues will not negate the efficiencies gained by centralization.”

The cases will be consolidated in the U.S. District Court for Southern New York before District Judge Paul A. Engelmayer for coordinated pretrial proceedings.

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