Bayer AG is in talks to resolve thousands of lawsuits that claim its Essure contraception device failed to prevent pregnancy or injured women, company officials said.
The company has reserved 1.25 billion euros (US$1.47 billion) to settle the Essure cases and to cover settlements in other company litigation, Bayer officials said in a press release Monday about second-quarter earnings.
“Discussions on potential settlements in connection with Essure, a medical device offering permanent birth control with a nonsurgical procedure, recently intensified and have made good progress in recent weeks,” officials said in the release.
“Bayer therefore established appropriate provisions in the second quarter. The Pharmaceuticals Division recorded special charges of 1.245 billion euros for litigations, primarily for Essure,” they added.
Chief Executive Officer Werner Baumann said on a call with analysts that, “to be clear, there is no settlement that has been signed and no payments have been paid in connection with this provision. We will have more to say on this subject if and when we reach a formal resolution.”
Fidelma Fitzpatrick, a plaintiffs’ lawyer leading a consolidation of Essure cases in state court in California, didn’t immediately return a call for comment on the company’s announcement of settlement talks.
Bayer acquired Essure when it bought medical-device maker Conceptus Inc. for US$1.1 billion in 2013. Both companies have been accused by women of failing to report thousands of complaints about injuries caused by the product to protect sales.
Thousands of women launched a campaign on social media to have regulators take the device off the market because it allegedly caused unintended pregnancies, autoimmune problems and organ damage. Many were forced to have the device surgically removed.
Bayer pulled Essure off the market in 2018, calling it a “business decision.” That move came after the U.S. Food and Drug Administration made the company toughen safety warnings about the contraceptive device and sales fell.
The first trial of Essure claims was set to start in state court in Oakland, California, earlier this year but was delayed by the coronavirus pandemic that closed businesses and courts.
The case is Essure Products Cases, JCCP No. 4887, Superior Court for Alameda County, California (Oakland).