Mirena Intracranial Hypertension Lawsuits to Proceed Without MDL

A panel of federal judges has rejected a request to establish new centralized proceedings for a number of Mirena IUD lawsuits that involve claims that the birth control implant caused women to suffer intracranial hypertension, involving a build up of fluid pressure in the skull that may negatively affect the brain. 

In May, a group of nine plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to centralize all Mirena intracranial hypertension lawsuits before one judge, as part of a new federal MDL, separate from the existing litigation involving women who have suffered Mirena IUD migration and perforation injuries.

Following oral arguments late last month, the panel issued an order (PDF) last week denying the request to transfer all the Mirena cases involving intracranial hypertension to the U.S. District Court for the Middle District of Tennessee, as proposed by the plaintiffs.

The MDL panel indicated that there are too few cases to justify centralized proceedings, and noted that all of the lawsuits have been filed by the same law firm. Therefore, the panel found that informal coordination of discovery and pretrial proceedings is appropriate, without the need to create a new Mirena MDL.

Mirena is a small T-shaped birth control device, 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.

There are currently about 600 Mirena lawsuits already centralized in the Southern District of New York, however that litigation is limited to claims where women suffered internal injuries after Mirena moved out of place, puncturing the uterus and migrating to other areas of the body, causing internal injuries, infections and leaving women unprotected against unwanted pregnancy.

Plaintiffs in the Mirena brain fluid cases allege that Bayer knew about the link between levonorgestrel and idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri (PTC), yet failed to provide any warnings about the risk of problems caused by pressure on the brain from the build-up of cerebrospinal fluid while on Mirena birth control.

Intracranial hypertension develops when cerebrospinal fluid levels become elevated. This causes increased pressure in the skull, acting like a tumor. Victims develop severe migraines, double vision, temporary blindness, and other vision loss symptoms. They often develop swelling of the optic disk, and ringing in the ears known as tinnitus.

The plaintiffs’ pointed out that intracranial hypertension from Mirena often presents as a swelling of the optic nerves, known as papilledema. In several other places around the world, including South Africa and Hong Kong, Mirena warning labels include information about the risk that papilledema is a possible side effect. However, the company has not given women in American or the U.S. medical community the same warning.

In June, Bayer filed a response in opposition to the creation of a new Mirena MDL, suggesting that plaintiffs were attempting to manufacture the litigation and arguing that the claims have no scientific basis.

“Some characteristics of this litigation suggest that it would benefit in certain respects from centralization,” the JPML admitted. “Several factors in this new wave of actions, however, weigh against centralization. Given the few involved counsel and limited number of actions, informal cooperation among the involved attorneys is both practicable and preferable to centralization.”

The judges made no ruling or opinion on the scientific merits of the case.

Mirena Lawsuits Over Migration, Perforation

The Mirena MDL established for all migration and perforation injuries is currently centralized before U.S. District Judge Cathy Seibel in the Southern District of New York.

Nearly 2,000 additional cases are pending out side of the federal court system, with about half of those cases pending in New Jersey state court, which is where the U.S. headquarters for Bayer are located. Those cases have also been centralized before one judge, as part of an MCL or multi-county litigation.

Bayer has continued to indicate that it intends to defend the migration injury cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs in that litigation maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

As part of the coordinated proceedings in New Jersey and the federal court system, small groups of cases are being prepared for early trial dates, known as known as “bellwether” lawsuits. The first Mirena trial dates are expected to begin in March 2016.

While the outcomes of these bellwether trials will not be binding in other cases, they are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. If Bayer continues to refuse to make any Mirena settlement offers following a series of bellwether trials in the MDL, the drug maker could face hundreds of individual trials throughout the United States.