Motion Seeks New MDL for Mirena IUS Lawsuits Over Brain Problems

As hundreds of lawsuits continue to move forward in the federal court system involving injuries associated with the Mirena intrauterine system (IUS) where the implanted birth control migrated out of position and perforated the uterus, a request has been filed to establish a new centralized proceeding for cases filed by women who allege that side effects of Mirena IUS birth control caused them to suffer neurological problems.

There are currently more than 500 Mirena IUS lawsuits consolidated in the federal court system as part of an MDL, or Multidistrict Litigation, which have been centralized before U.S. District Judge Cathy Seibel in the Southern District of New York. However, all of those complaints involve injuries caused by migration of a Mirena IUS and perforation or embedment in the cervix or uterine wall.

On May 27, a group of nine plaintiffs filed a motion (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for the creation of a separate MDL in the Middle District of Tennessee for lawsuits brought by women who have suffered non-stroke neurological conditions, such as pseudotumor cerebri (PTC), which is also known as idiopathic intracranial hypertension (IIH).

According to the motion, lawyers representing the plaintiffs indicate that they are prepared to file complaints on behalf of at least 65 other women who have experienced similar brain problems after receiving Mirena IUS birth control.

PTC 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.

Mirena IUS is a small T-shaped birth control, which is implanted into the uterus to provide protection against pregnancy for up to five years. The polyethylene frame contains a steroid reservoir that release levonorgestrel, which is a second generation progestin used in many forms of birth control.

Plaintiffs in these Mirena brain injury lawsuits allege that Bayer knew about the link between levonorgestrel and PTC/IIH, yet failed to provide any warnings about the risk of brain problems caused by pressure on the brain from the build-up of cerebrospinal fluid.

“Because Mirena’s IUS label is devoid of any warnings of PTC or IIH, once a patient’s healthcare provider rules out transient cerebral ischemia or stroke as a cause of symptoms of migraine and/or asymmetrical visual loss, the healthcare provide will not typically know or advise a patient with PTC to remove Mirena IUS, which causes or contributes to the development and/or progression of PTC/IIH,” according to the motion seeking transfer of the claims to one judge.

Separate MDL from Mirena Migration Lawsuits

Plaintiffs seek a separate and distinct MDL, which they indicate should be assigned to a different judge given the lack of common questions or law and fact involved in the PTC/IIH lawsuits and the migration lawsuits.

In addition to the complaints pending before Judge Seibel, more than 785 Mirena lawsuits have been filed in New Jersey state court, which is where the drug’s manufacturer has their U.S. headquarters. The New Jersey cases have also been consolidated before one judge, with complaints filed throughout the state being handled by Superior Court Judge Brian R. Martinotti in Bergen County as part of a Multi-County Litigation (MCL).

In both the federal Mirena migration MDL and in New Jersey state court, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. These bellwether Mirena trials are not expected to begin until the second half of 2015, but 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.

Bayer has previously maintained 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.

Following a series of bellwether trials, if Bayer continues to refuse to make any Mirena settlement offers, the drug maker could face hundreds of individual trials spread throughout the country.

The U.S. JPML is unlikely to hear oral arguments on the motion to establish a second MDL for Mirena PTC/IIH lawsuits until a hearing set for July 31 in Kansas City, Kansas.