Bayer AG does not admit any liability or wrongdoing for the medical problems tens of thousands of women suffered after using the company’s birth control device, but they are going to pay these women anyway. On Thursday, August 20, 2020, Bayer reached a settlement agreement in the amount of $1.6 billion, which will cover both resolved and outstanding claims.
A Brief History
The Essure contraceptive device consists of coils that are inserted into women’s fallopian tubes. The medical device was created by Conceptus Inc., which Bayer purchased in 2013 for $1.2 billion. Although the U.S. Food and Drug Administration (FDA) had approved the device 11 years prior, the agency grew concerned about Essure’s safety after they received a surge of complaints about the devices. In short, the devices were reportedly fracturing and migrating inside patients’ bodies, causing severe damage by puncturing the fallopian tubes and uterus.
The FDA convened a safety panel to evaluate the safety of Essure devices, resulting in the agency recommending that Bayer label the products with “black box” warnings—designed to draw attention to “serious or life-threatening risks”, according to the FDA’s guide of terms. In 2018, Bayer ceased all sales of Essure birth control devices.
For thousands upon thousands of women, however, the damage had already been done—and the lawsuits started streaming in. Litigation on claims was consolidated in California and in a Pennsylvania federal court. At the end of the day, 39,000 women had sued Bayer for its problematic contraceptives.
Finally, earlier this month, Bayer issued a statement that settlement talks with plaintiffs’ attorneys were progressing. The company mentioned putting aside $1.5 billion to resolve Essure and other litigation issues. Yesterday’s $1.6 billion dollar deal will address around 90 percent of the Essure claims.