• by Thom Forbes  @tforbes, August 21, 2020

Bayer AG has agreed to pay roughly $1.6 billion to settle about 90% of the nearly 39,000 total filed and unfiled claims in the United States against its Essure birth-control device. It is not admitting any wrongdoing or liability and “settling claimants will be required to dismiss their cases or not file,” according to the release announcing the agreements with plaintiffs’ law firms.

The Leverkusen, Germany-based company also says it is in “resolution discussions with counsel for the remaining plaintiffs.”

“Bayer halted sales of the implant in 2018 after the FDA placed additional restrictions on the device, which consists of 2-inch-long metal coils placed within each fallopian tube, designed to generate scar tissue and block off the ovaries to prevent pregnancy,” Conor Hale writes  for Fierce Biotech.

“Many women have claimed in lawsuits that Essure’s coils can pierce the walls of the tubes or can come loose entirely, causing pain and other serious side effects. Removal of the implant may require a hysterectomy in some cases,” Hale continues.

“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 stated yesterday.

“Fidelma Fitzpatrick, 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,’” Sara Randazzo writes  for The Wall Street Journal.

“Essure was first approved by the FDA in late 2012. Between 2012 and 2018, the agency received 32,773 adverse events or other issues related to Essure through the agency’s Manufacturer and User Facility Device Experience database,” Medtruthreports.

“New research on Essure suggests its breakdown releases potentially toxic metals. 

“A recent analysis from Bayer found that women implanted with Essure reported experiencing heavier periods and more pelvic or abdominal pain than patients who were sterilized by tubal ligation,” Medtruth adds.

“Bayer bought Essure’s creator, Conceptus Inc., for $1.1 billion in 2013, saying at the time it was looking to bolster its flagging birth-control division. The device first received FDA approval in 2002.

“The U.S. litigation started around 2014, with plaintiffs alleging Essure caused complications ranging from allergic reactions and chronic pelvic pain to the need for a hysterectomy, and even death,” Randazzo adds.

The FDA maintains a timeline and summary of its most significant activities related to Essure. On August 11 it “posted the first spreadsheet of reportable adverse events from Bayer” that contains 1453 reportable events consisting of 53 death reports, 1376 serious injury reports and 24 malfunction reports.

“Reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts, sometimes by the same individual,” according to the FDA.

“A Bayer AG official warned the company of increased government scrutiny of injuries from its Essure contraceptive implant years before it was pulled from the market, according to recently unsealed court documents,” Bloomberg’s Jef Feeley  and Edvard Pettersson report.

“Four months after Bayer bought [Essure], a senior manager of product surveillance, Michael Reddick, said in an email the company would see ‘a large increase in the number of (side-effect reports) filed’ that ‘will certainly be noticed’ by the U.S. Food and Drug Administration,” they continue.

“Complaints did increase, and in 2016, the FDA required a stricter warning label about Essure safety risks. Sales fell, and Bayer stopped selling the implant two years later. David Kessler, a former FDA commissioner and expert witness paid by women suing the company, said Bayer and Conceptus failed to properly report complaints and that regulators may have demanded stricter labeling as early as 2006 if they’d been aware of all the problems patients claimed,” Feeley and Pettersson add.

In June, Bayer agreed to pay up to $10.9 billion to settle nearly 100,000 lawsuits in the U.S. that claim its glyphosate-based Roundup weed killer causes cancer.