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A Florida woman indicates that she suffered pseudotumor cerebri side effects caused by her Mirena IUD, after the birth control implant caused a dangerous buildup of fluid pressure around her brain, according a failure to warn lawsuit recently filed against Bayer Healthcare.
The complaint (PDF) was filed by Lakeyshia Tate in the U.S. District Court for the Southern District of New York on July 31, indicating that she has been left with permanent injuries due to the defective and unreasonably dangerous Mirena IUD.
Tate is 34 years old, and indicates that she had a Mirena IUD implanted in August 2006, which is designed to provide long-term birth control through a T-shaped plastic device placed in the uterus. However, just a few months later, in January 2007, Tate indicates that she was diagnosed with pseudotumor cerebri (PTC), which is also known as intracranial hypertension.
The condition involves elevated levels of cerebrospinal fluid around the brain that increases pressure, typically producing severe headaches, visual disturbances and potentially resulting in permanent vision loss due to damage to the optic nerve.
Due to false and misleading statements made by Bayer to consumers and the medical community, which indicated that Mirena was a low or no hormone product, without hormonal side effects, Tate indicates that neither she nor her doctors were aware that the Mirena IUD may be the cause of her pseudotumor cerebri problems. Due to the manufacturer’s failure to warn, Tate indicates that she could not reasonably have discovered that the cause of her injury, until she recently learned that many other women had suffered similar pseudotumor cerebri side effects from Mirena.
“Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risk of developing IIH/PTC with Mirena,” according to the complaint. “Likewise, Defendants knew or should have known that Mirena, a levonorgestrel-releasing IUD, should be removed immediately to avoid exacerbation of injuries, once a patient is diagnosed with papilledema, IIH/PTC, or once a patient develops symptoms consistent with these conditions, and Defendants have made no effort to warn patients, physicians, the healthcare community, or the public of this fact.”
Tate’s claim joins a growing number of Mirena IUD lawsuits filed in courts nationwide, each raising similar allegations that women may have avoided serious injuries if adequate information had been provided. Although fluid pressure on the brain can often be relieved by removal of the Mirena IUD, once damage has been suffered to the optic nerve, women may be left with permanent vision problems and other complications.
In late April 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all cases brought by women diagnosed with PTC/IIH from the Mirena birth control implant, centralizing the claims before U.S. District Judge Paul A. Englemayer in the Southern District of New York.
As Mirena lawyers continue to review and file claims for women nationwide, it is expected that the size and scope of the litigation will continue to grow over the coming weeks and months.
As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will establish a bellwether program, where a small group of cases will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.