Mirena IUD Migration and Perforation Injury Experts Excluded in MDL

The U.S. District Judge presiding over all Mirena IUD migration and perforation lawsuits has excluded the testimony of several key expert witnesses for the plaintiffs, potentially leaving about 1,200 women without the ability to establish causation in their cases and putting the future of the litigation in doubt.

Mirena IUD is a long-active form of birth control implanted into the uterus to prevent pregnancy for up to five years. However, in recent years, a growing number of product liability lawsuits have been filed by women nationwide who experienced painful and debilitating complications from Mirena, where the T-shaped IUD perforated the uterus or moved out of position, causing severe internal injuries and often resulting in the need for surgical removal.

Since April 2013, all Mirena cases filed throughout the federal court system involving migration and perforation injuries have been centralized before U.S. District Judge Cathy Seibel in the Southern District of New York, as part of an MDL, or multidistrict litigation.

As of February 16, at least 1,255 cases were pending before Judge Seibel for coordinated discovery and pretrial proceedings, with more than 2,000 other cases pending in New Jersey state court, where similar centralized proceedings have been established before one judge as part of an MCL, or Multi-County Litigation.

As part of the coordinated pretrial proceedings in the Mirena MDL, a small group of “bellwether” trials were being prepared for early trial dates, with the first cases expected to begin in April 2016 to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, Bayer Healthcare has challenged the admissibility of key expert testimony offered by plaintiffs in lawsuits over their popular form of birth control.

In an opinion and order (PDF) issued on March 8, Judge Seibel excluded the testimony of four plaintiff causation experts; Drs. Roger C. Young, John Jarrell, Susan Wray, and Richard Strassberg. The ruling also limited the testimony of Dr. Suzanne Parisian to regulatory issues, and Dr. April Zambelli-Weiner to epidemiological issues, and barred them from testifying on causation.

While some Bayer expert testimony was limited as well, the overall affect of the decision may leave plaintiffs with Mirena migration cases pending in the federal court system without the ability to establish that the birth control device caused their injuries. It is unclear what effect, if any, the ruling will have on cases pending in New Jersey state court.

Judge Seibel has asked both parties to submit letters to her on how the decision will affect a pending motion for summary judgment by Bayer, which seeks to dismiss case in the MDL. At a minimum, it appears that the ruling will result in a delay of bellwether trials pending any appeals, but it puts the entire future of the federal litigation over Mirena migration and perforation injury claims in question.

A small group of bellwether cases are also being prepared for trial in New Jersey state court, where the litigation is centralized before Superior Court Judge Brian R. Martinotti in Bergen County, New Jersey. According to a pretrial order issued on February 12, a number of pretrial deadlines have been established, with a Pretrial Conference set for June 22, 2016.

Mirena Pseudotumor Cerebri Lawsuits

In addition to claims over migration and perforation injuries, Bayer also faces a growing number of pseudotumor cerebri lawsuits filed by women nationwide who allege the Mirena implant caused them to suffer a serious buildup of fluid pressure on the brain, which can result in severe headaches, vision problems and blindness.

The expert ruling in the MDL will have no effect on these lawsuits, which are currently proceeding without any centralized case management in the federal court system.

Pseudotumor cerebri (PTC), which is sometimes reffered to as idiopathic intracranial hypertension (IIH), develops when cerebrospinal fluid levels become elevated, which causes increased pressure in the skull, acting like a tumor. Victims often develop swelling of the optic disk, and ringing in the ears known as tinnitus, together with other side effects.

As a result of Bayer’s alleged failure to adequately warn about the link between Mirena and pseudotumor cerebri, most doctors were unaware that the birth control implant may be a potential cause of intercranial hypertension, plaintiffs argue.

In several other places around the world, including South Africa and Hong Kong, Mirena warning labels include information about the risk that papilledema as a possible side effect of Mirena. However, Bayer has not given women in America or the U.S. medical community the same warning.

Amid a growing number of Mirena pseudotumor cerebri cases filed throughout the federal court system, a request was filed last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge. However, that request was rejected, so PTC/IIH claims filed by other women are proceeding without coordinated pretrial proceedings.