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Bayer Opposes Motion of Mirena Plaintiffs Seeking New MDL

Mirena IIH lawsuits Bayer is opposing a request by plaintiffs in nine Mirena IIH lawsuits to establish a new federal multidistrict litigation (MDL), which would centralize all IIH complaints in the U.S. District Court for the Middle District of Tennessee.

The plaintiffs, who filed the motion with the U.S. Judicial Panel on Multidistrict Litigation (U.S. JPML) on May 27th, allege that levonorgestrel, an active ingredient in the Mirena intrauterine device, caused them to suffer idiopathic intracranial hypertension (IIH), which is also commonly known as pseudotumor cerebri (PTC). IIH develops when cerebrospinal fluid levels become elevated, causing increased pressure in the skull.

Victims can develop severe migraines, double vision, temporary blindness, swelling of the optic disk, and ringing in the ears known as tinnitus.

There are currently 800 Mirena injury lawsuits in the federal court system, which are consolidated as part of an existing multidistrict litigation (MDL) centralized in the Southern District of New York. However, that proceeding is limited to cases involving allegations that the Mirena IUS perforated the uterus and migrated out of position. Therefore, according to the nine plaintiffs, a second MDL is needed which would be limited to cases involving plaintiffs who allegedly suffered neurological conditions such as IIH.

Mirena IIH lawsuits

Mirena IUD is a small T-shaped birth control device implanted in the uterus. It holds a reservoir that time-releases the active ingredient levonorgestrel, a progestin which provides birth control by changing the physical and chemical environment of the female reproductive tract, making it hostile for sperm. The device is intended to last for five years before needing replacement.

In a response filed June 17, Bayer maintains that there are not enough Mirena IIH lawsuits pending in the federal court system to justify a new consolidated proceeding. According to Bayer, only ten cases have been filed to date alleging that Bayer failed to warn that side effects of Mirena may cause neurological problems associated with the buildup of fluid around the brain resulting in pressure on the skull.

The Bayer opposition brief states that, “… so few IIH cases have been filed … because there is not a single study published anywhere in the medical literature suggesting that Mirena is even associated with IIH, let alone causes IIH. Instead, Plaintiffs’ entire theory of causation is that Norplant— an entirely different form of hormonal contraception that was on the market 20 years ago — might have caused IIH. Plaintiffs reason that because Mirena contains the same active ingredient as Norplant, it too may somehow cause IIH.”

However, 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 birth control.

Same active ingredient, same dangers, plaintiffs argue 

The plaintiffs’ argument for a causal relationship between Norplant and its widely documented connection to IIH is based on the fact that the Mirena IUD uses the same drug, levonorgestrel, as its active ingredient. Their question is why wouldn’t there be a similar risk of IIH? The plaintiffs allege that Bayer knew about the link between IIH and levonorgestrel, yet withheld information about the risk from consumers and the medical community.

Bayer claims plaintiffs are “manufacturing an MDL”

By filing a handful of IIH lawsuits in different federal district courts, Bayer says the plaintiffs are attempting to “manufacture an MDL”. The validation of the cases should be “predicated on a recognized scientific theory rather than the guesswork underlying plaintiffs’ causation theory”. Bayer says only then should the courts take up the idea of a second MDL.

If the U.S. Judicial Panel on Multidistrict Litigation determines that consolidation of the cases is appropriate, Bayer proposes that the cases be added to the existing 800 federal Mirena lawsuits pending before U.S. District Judge Cathy Seibel in the Southern District of New York (Mirena MDL). The drug maker indicates that given overlapping issues and discovery, Judge Seibel is in the best position to efficiently manage the cases.

The U.S. JPML is scheduled to hear oral arguments on the motion July 31, at a hearing session that will be held in Kansas City, Kansas.

  1. Hopkins Medicine, Idiopathic Intracranial Hypertension (IIH)
  2., Warnings Based on Experience with the NORPLANT (levonorgestrel implants) SYSTEM