Bayer’s Essure agreement includes a settlement to cover about 90 percent of the lawsuits filed by 39,000 women in the U.S. As well, a fund has been set up to negotiate outstanding claims against Bayer.
Santa Clara, CAAlmost two years after Bayer stopped selling Essure in the U.S., and four years after the FDA told Bayer its birth control device needed a black box warning regarding potential serious side effects, the pharma giant will pay $1.6 billion to settle Essure lawsuits brought by nearly 39,000 women in the U.S. who suffered serious health complications as a result of Essure fallopian tube implants.
Bayer Denies Wrongdoing
Women implanted with Essure have reported for many years serious side effects, from allergic reactions and chronic pelvic pain to the need for a hysterectomy, and even death. The black box warning caused Essure sales to drop, but Bayer said it was pulling its permanent birth control device due to lack of consumer interest. According to AboutLawsuits.com, plaintiffs who accept this settlement agreement will have to drop their pending claims, and as part of the deal, Bayer will not admit to wrongdoing or liability in the settlement deals. In a written statement, Bayer said it "continues to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 270,000 women over the past two decades."
"Bayer sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure," the company said in a statement. Fidelma Fitzpatrick of Motley Rice LLC,, the lead lawyer for the plaintiffs, said that while the money is a welcome result for her clients, “it’s also an incredibly important case to stress the need for full disclosure and transparency when people’s health is at stake.”
Essure and the FDA
From November 4, 2002-- the date that the FDA approved Essure— through December 31, 2019, the agency received 47,856 Essure medical device reports. But the FDA didn’t study and undertake an “extensive evaluation” of more than 17,000 reports until 2017 and 2018—when many of those reports involved having Essure surgically removed. According to the FDA, most of those reports “came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer.”
In August 2020 the FDA posted the first spreadsheet of reported adverse events from Bayer, which included 53 deaths, 1376 serious injury reports, and 24 malfunction reports. Because of litigation, Bayer asked the FDA to change its reporting requirements, hence the spreadsheet that will collate adverse events and filed to the agency monthly. The FDA said that “Reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts, sometimes by the same individual. Among the specific event descriptions reported are pain, pregnancy, foreign body/device fragment in patient, and perforation.” The FDA will continue to evaluate and monitor Essure reports, even though it has been pulled from U.S. shelves.
Essure Litigation
Litigation started around 2014. Complaints ranged from hair and tooth loss, bleeding, chronic pelvic pain, miscarriages and death for those implanted with the device and their babies. The device has also been known to migrate, which can lead to perforation of the fallopian tube or the uterine wall. It is also suspected of nickel allergy. Some women had a hysterectomy or other procedures, such as removal of a fallopian tube, to remove coils.
The first Essure lawsuit was filed in 2014, which challenged the application of federal preemption to Essure lawsuits. It alleged that the doctrine should no longer apply to Essure. A federal lawsuit was filed in September 2015, just a few days before the FDA advisory panel convened to review Essure complaints. In her lawsuit Tanya De La Paz alleged doctors told her that she needed a total hysterectomy. In 2013, she had the device removed along with her right fallopian tube, on advice from Bayer. The lawsuit further claims that Bayer concealed evidence of adverse reactions to the birth control device.
"Bayer's proposed settlement to resolve Essure claims would provide expedited relief to thousands of women," said Fitzpatrick in a statement to the Wall Street Journal. "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." According to Law.com, the settlement includes all the cases in venues with high volumes of cases such as the coordinated litigation in California Joint Council Coordinated Proceedings and in the U.S. District Court for the Eastern District of Pennsylvania.
Approximately 750,000 women worldwide have been implanted with Essure, and about 70 percent of those procedures occured in the United States.
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