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After a Mirena IUD was implanted for long-term birth control, a Tennessee woman indicates she began to experience vision loss, increased eye pressure, headaches and other problems, which were caused by a buildup of fluid pressure around the brain associated with Mirena, known as pseudotumor cerebri (PTC).
Kayla Faulkner filed a product liability lawsuit (PDF) against Bayer Healthcare earlier this month in the U.S. District Court for the Southern District of New York, alleging that the manufacturer failed to adequately warn women and the medical community about the potential side effects of the Mirena IUD.
Faulkner is 32 years old, and indicates that a Mirena IUD was implanted in April 2008, to provide protection against pregnancy for up to five years. At that time, the levonorgestrel-releasing implant was placed in her body without complications. However, she then began experiencing intense headaches, blurry vision, eye pressure, loss of vision and tinnitus, which is a ringing in the ears.
In October 2012, Faulkner was diagnosed with pseudotumor cerebri, also known as idiopathic intracranial hypertension, which involves a dangerous buildup of fluid pressure in the skull, which can cause damage to the optic nerve. Although treatment can relieve the pressure, in many cases the damage to the optic nerve is permanent, resulting in continuing vision problems and complications.
According to the lawsuit, it was years before Faulkner and her physician linked the condition to the Mirena IUD, which was not removed until July 2015. If Bayer had properly warned Faulkner and her physician of the potential risks, she indicates that she could have chosen another form of birth control, and avoided the injury.
“A reasonable alternative design existed which would have eliminated or reduced Plaintiff’s injuries,” the lawsuit states. “Other methods of contraception do not pose the risks that Mirena use presents, including the risk of developing IIH/PTC.”
Faulkner’s case will be consolidated with hundreds of similar Mirena lawsuits being pursued by women who have experienced similar problems with pseudotumor cerebri. Given similar questions of fact and law raised in complaints filed throughout the federal court system, the cases are currently consolidated for pretrial proceedings as part of a federal multidistrict litigation (MDL), which is centralize before U.S. District Judge Paul A. Englemayer in the Southern District of New York.
As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will schedule a series of early “bellwether” trials to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the cases. However, if the manufacturer fails to reach Mirena settlement agreements or otherwise resolve the litigation in the MDL, each of the cases may ultimately be remanded back to various U.S. District Courts nationwide for separate trial dates in the future.