Almost a year after Bayer stopped selling Essure, the company has reported that 99% of the unused birth control devices have been returned due to its outreach to patients and health care professionals. Bayer maintains that the reason it took Essure off the market in the U.S. was the 70% drop in sales the company experienced after the FDA required it to conduct a post-market surveillance study and add a black box warning to its product. The post-market study recently finished the enrollment of patients in December 2019.
Essure is a permanently implanted birth control device manufactured by Bayer AG. The original developer, Conceptus, was acquired by Bayer in 2013 for $1.1B, over 11 years after the FDA had approved the implant.
By 2015, a rising number of reported complaints about Essure prompted the FDA to convene a safety panel to assess the risks. Since then, about 32,000 women have filed lawsuits related to their use of the device, and 27,000 of these are pending in California’s Alameda Superior Court. The lawsuits relate to a range of issues caused by the implant including abdominal, pelvic, or back pain, perforation of the uterus or fallopian tube, unintended pregnancy, and headache.
On January 15th, at a hearing on over 40 Essure motions, Bayer’s lawyers argued to Superior Court Judge Winifred Smith that all 27,000 cases should be dismissed because Bayer never violated any requirements or regulations imposed by the FDA. Counsel for Bayer emphasized that the state claims were preempted by federal law and that continuing with the lawsuits would impede the ability of the FDA to enforce its own regulations. Additionally, counsel argued that a number of states’ laws do not require parties to notify the FDA of any adverse events. Plaintiffs’ counsel stated that the key issue was that Bayer didn’t report any of the Essure-related injuries of which they were aware to the FDA, and contended that the California laws run parallel to and do not conflict with the FDA requirements.
Judge Smith reserved her right to rule on the argument and the first trial is scheduled for Feb 18.
This past Tuesday, January 14th, a New Jersey appeals court dismissed a woman’s lawsuit citing the fact that Essure had been approved by the FDA by the time her health issues caused by the device appeared.