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A Tennessee woman has filed a product liability lawsuit against Bayer, alleging that side effects of a Mirena IUD birth control implant left her with severe headaches, blurred vision and other complications resulting from a buildup of fluid pressure inside her skull.
The complaint (PDF) was filed by Nichole Thomas in the U.S. District Court for the Southern District of New York on September 4, indicating that Bayer Healthcare failed to provide women and doctors with adequate warnings about the risk that Mirena IUDs may cause the development of a medical condition known as pseudotumor cerebri (PTC).
Also known as intracranial hemorrhage (IH), the condition involves the development of cerebrospinal fluid around the brain, which may result in headaches and damage to the optic nerve, as well as other problems.
Thomas indicates that she developed these problems after a Mirena IUD was implanted for long-term birth control in August 2016. Following the procedure, she began suffering headaches and blurred vision, ultimately leading to a diagnostic lumbar puncture in June 2017, which led to her diagnosis of PTC/IH.
“Mirena’s label does not sufficiently warn about non-stroke neurological conditions such as pseudotumor cerebri (PTC), also known as intracranial hypertension (IH),” the lawsuit states. “Mirena’s label makes no mention of PTC/IH, despite a known link between levonorgestrel and PTC/IH.”
Thomas’s case will be consolidated with hundreds of similar Mirena IUD birth control lawsuits pending throughout the federal court system, each involving similar allegations that women suffered similar problems from the long-term birth control implant.
Given similar questions of fact and law raised in complaints filed throughout the federal court system, the cases are currently centralized for pretrial proceedings as part of a federal multidistrict litigation (MDL), which is pending 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.