Bayer has announced a $1.6 billion dollar settlement covering 90% of pending Essure lawsuits in the United States. This development may signal the beginning of the end for Essure litigation.
Bayer's Essure Settlement Details
Settlement Size: $1.6 Billion Approximate Share Per Plaintiff: $456,000 Cases Included: 90% of cases in the state of California Joint Council Coordinated Proceedings (JCCP) and Federal District Court for the Eastern District of Pennsylvania (EDPA)
If plaintiffs agree to the settlement, they will be required to dismiss or refrain from filing their cases. Bayer will make no admission of wrongdoing or liability within the settlement. In fact, the official company position still asserts the safety and efficacy of Essure. As the door on this litigation closes, we thought it would be a good time to review exactly how Bayer and Essure got here.
Essure, Conceptus, Bayer and Facebook
Essure is an implantable contraceptive device developed by Conceptus. The device consists of metal coils designed to block the fallopian tubes. It was launched in 2002 as a "simple option for permanent birth control." Women were offered the device as an alternative to tubal ligation.
Essure supposedly has a number of advantages over surgical sterilization:
Device placement occurs in a doctor's office
No surgery is required
No general anesthesia is required
Essure is completely non-hormonal
Patients were promised rapid recovery from the procedure
Essure has a 99.8% success rate in preventing pregnancy
For women considering permanent sterilization, the lure of an office-based option proved effective. Conceptus provided the implant to thousands of women before its acquisition by Bayer in 2013. Bayer continued selling the device worldwide for another five years. As of 2020, more than 270,000 women world-wide have received Essure implants.
Unexpected Consequences: Bleeding, Pain and Pregnancy After Essure
Despite its commercial success, reports of serious Essure side effects began surfacing around 2009. Women reported the following problems to the FDA:
Prolonged bleeding after device placement
Incorrect device placement
Chronic pelvic pain
For many Essure users, these problems were life-altering. In fact, there are more than 70 reports of death associated with the device.
Eventually, Essure users created a Facebook group called Essure Problems. More than 20,000 women joined the group. The group encouraged one another to file adverse event reports with the FDA. The group also directly lobbied the FDA to protect consumers from what they deemed a dangerous device.
As women spoke out about their Essure complications, the magnitude of the problem became increasingly clear. Between November 2002 and December 2019, the FDA received 47,856 adverse event reports for Essure.
Essure Side Effects Created Legal Problems for Bayer
The Essure Facebook group boosted media coverage of device side effects. As a result, the FDA increased scrutiny of the device, eventually putting a black box warning on it. Several more enforcement actions preceded Bayer's decision to remove Essure from the U.S. market in 2018.
Amidst the media coverage and heavy FDA oversight, thousands of women linked their side effects to Essure. Many went on to file lawsuits against Bayer over the device. In September 2020, the company reported approximately 39,000 women had filed Essure lawsuits.
The settlement provides an opportunity for those harmed by Essure to obtain financial relief without going to court. It may also help Bayer bounce back from stock drops associated with their legal woes. The company has expressed a desire to end Essure litigation and focus on "its commitment to women's health."
Some Essure users blame the device for irreparable damage to their bodies. For these women, the $456,000 price tag on their suffering may come as a cold comfort.