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As Bayer works to resolve thousands of Essure lawsuits brought by women left with devastating injuries after receiving their controversial sterilization implant, the manufacturer has set aside $1.4 billion to fund settlements, according to a recent earnings report.
Ongoing litigation over Essure, Roundup and other products cut deep into Bayer’s second quarter profits. In addition to a recent announcement the company will be paying about $10 billion in Roundup settlements, Bayer indicated an additional $1.4 billion has been set aside for Essure settlement negotiations, according to a press release issued this week.
Essure was previously sold by Bayer as a permanent form of birth control, involving flexible coils inserted into the Fallopian tubes during a procedure designed to cause scar tissue to develop, which blocks the tubes and prevents insemination. However, the device was removed from the market amid thousands of reports involving painful and debilitating complications from Essure, including migration injuries, perforations, severe reactions and other problems.
Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 it was removing Essure from the US. market on December 31, 2018.
“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,” Bayer’s press release states. “Bayer therefore established appropriate provisions in the second quarter.”
In the second quarter filing, the company notes it lost $11.2 billion, closely paralleling the cost of the proposed Roundup settlement agreement and costs associated with potential Essure settlements.
Over the past year, Bayer has been hit with massive losses in the first three “bellwether” Roundup cases to go to trial in the U.S., which were viewed as a gauge for how juries may respond to similar evidence and testimony that would be repeated throughout thousands of additional cases.
In the Essure litigation, the company faces approaching trial dates and a continued onslaught of information that confirms the problems with Essure, including interim results from a post-marketing study that the FDA released last month, indicating that more than 20% of women implanted with the device faced hypersensitivity reactions, chronic abdominal pain, and abnormal bleeding, and many had much higher rates of additional gynecological procedures.
Bayer currently faces more than 18,000 product liability lawsuits filed by women nationwide, each involving similar allegations that the Essure birth control coils were unreasonably dangerous and defectively designed. With approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures in the United States, the size and scope of the litigation may continue to increase as Essure causes problems for women with the device in their body.