On August 20, 2020, Bayer A.G. announced it would pay $1.6 billion to settle Essure claims from women who have been injured by the defective birth control device. The proposed settlement will resolve about 90% of the nearly 40,000 claims against Essure manufacturer, Bayer A.G. which halted Essure sales in 2018 but did not recall the device.
“Bayer’s proposed settlement to resolve Essure claims would provide expedited relief to thousands of women,” according to one attorney. “While we would have been ready for trial if needed against Bayer, to be able to get the assistance Essure’s victims need while avoiding putting their very personal lives on trial is reassuring for many. Women have suffered for years not only physically, but also emotionally and financially from the often enormous Essure-related medical bills they face. We look forward to working through the details of the settlement terms as quickly as possible to finalize the agreement.”
FDA Receives Thousands of Complaints About Essure
Before Essure was pulled from the market, more than 750,000 women received Essure implants. The U.S. Food and Drug Administration (FDA) received over 32,000 complaints and 10,000 adverse event reports related to Essure problems. Over 300 fetal deaths have been linked to Essure defects because of ectopic pregnancies in women who believed they could no longer become pregnant. The FDA even noted the skill level required to properly implant the coils in their proper position is beyond the level of most OBGYN doctors.
Due to the number of reported complaints, in February 2016 the FDA announced Essure will require a black box warning indicating extreme risks and possible serious injuries associated with its usage. The FDA directed Bayer to hold an extensive post-market study with 2,000 patients to further evaluate the safety of Essure.
Essure “Not a Recall” in Canada and the U.S.
Bayer voluntarily discontinued the sale of Essure in Canada claiming the decision was based on a decline in patient demand, not a product recall. Subsequently, in July 2018, Bayer issued a press release stating that it would halt sales of Essure in the U.S. on December 31, 2018. The press release stated the decision was based on a decline in U.S. sales over the past several years. Clearly Bayer realized the potential mounting liability created by Essure’s defective design outweighed the potential profits it expected to make from the defective product.
Originally hitting the market in 2002, Essure was designed and manufactured by a small U.S. based company called Conceptus Inc., that was later purchased by German conglomerate Bayer A.G. in 2013.
Case Works is assisting some of the leading firms in the Essure litigation with case development and processing. If your firm is looking for a partner law firm to assist with settlement discussions, we can help you get connected to the leading law firms in the industry.
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