August 11, 2016 — An Essure lawsuit has been filed in Illinois by a group of 98 women who accuse Bayer of failing to warn about severe side effects.
The lawsuit was filed on July 25 by a law firm in Florida representing over 200 Essure users. The case was filed against Bayer HealthCare in Madison County Circuit Court — Case No. 16-L-1046.
Until recently, Bayer has avoided lawsuits by claiming immunity under a federal law related to FDA-approved labeling. Women who are challenging that immunity have recently been making headway.
On August 2, California Superior Court Judge Winifred Smith allowed 11 lawsuits to move forward, according to MassDevice.
All of the women accuse Bayer of downplaying the risk of severe side effects. Essure is a metal coil that is designed to cause irritation and inflammation, which results in scar tissue blocking the fallopian tubes.
In February, the FDA ordered Bayer to add a “Black Box” warning label on Essure. In recent studies, Essure was associated with a 10-fold increased risk of needing follow-up surgery compared to “tube-tying” sterilization.
The FDA has received over 5,093 reports from women who were severely injured. Many of them required multiple surgeries or had a hysterectomy to remove Essure. The complications include chronic pain, bleeding, allergic reactions, implant migration, perforations, and more.
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