Bayer Faces Essure Lawsuits From 18,000 Women Nationwide

Bayer currently faces more than 18,000 Essure lawsuits filed by women nationwide, each involving similar allegations that the controversial birth control device left them with severe and devastating injuries.

At the end of December, Bayer ceased sale and production of all Essure birth control implants in the United States, amid continuing questions about the safety and health risks associated with the device that has been placed in women worldwide for permanent sterilization.

While the company has claimed that the halt in Essure sales was due to financial and business decisions, allegations raised in lawsuits filed nationwide allege that Bayer knew or should have known that the Essure device posed an unreasonable risk for women, yet failed to provide adequate warnings for consumers or the medical community.

In a third quarter investor report, Bayer indicated that it faced about 18,000 product liability lawsuits over Essure as of October 30, 2018. The claims involve women who suffered injuries such as hysterectomies, perforation, pain, bleeding, weight gain, allergic reactions to nickel, depression and unwanted pregnancies. In addition, the company warned investors that additional lawsuits were likely.

Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States. Amid mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.

Following the decision, the FDA confirmed that Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased.

FDA officials have reported that the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.

In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

The manufacturer has reportedly spent about $413 million defending the litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.