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Bayer Healthcare faces a lawsuit over intracranial hypertension complications from a Mirena IUD, indicating that the popular birth control implant caused a dangerous build-up of fluid pressure around a Texas woman’s brain, leaving her with painful and permanent injuries.
The complaint (PDF) was filed by Rikki Satterfield in the U.S. District Court for the Southern District of New York on August 31, indicating that the birth control manufacturer failed to adequately warn about the risk of the intracranial hypertension, which is often referred to as a pseudotumor.
Satterfield, 38, was implanted with a Mirena IUD in April 2006 without complications. However, by the end of that year, she was diagnosed with pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH).
The condition involves a dangerous buildup of fluid around the brain, which appears consistent with a tumor. The intracranial pressure can impact the optic nerve, potentially resulting in permanent blindness in some cases.
According to allegations raised in the lawsuit, Satterfield maintains that she would have chosen a different form of contraception if she had been warned about the potential risk of Mirena IUD intracranial hypertension, and could have avoided permanent health problems she now faces.
“A reasonable alternative design existed which would have eliminated or reduced Plaintiff’s injuries. Other methods of contraception do not pose the risks that Mirena use presents, including the risk of developing IIH/PTC,” the lawsuit states. “Mirena was also defective due to inadequate warnings or instructions because the manufacturer knew or should have known that Mirena, along with its common side effect of rapid or sudden weight gain, created, among other things, a risk of developing IIH/PTC, and the Defendants failed to adequately warn of these risks.”
Satterfield’s case will be consolidated with hundreds of similar Mirena lawsuits being pursued by women who have experienced similar problems with intracranial hypertension complications 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.