An Indiana appeals court has ruled that more than 30 women suing Bayer (ETR:BAYN) over its Essure permanent birth control device may proceed with their case.
The women claimed that after they had Essure implanted in their fallopian tubes, they suffered a number of health problems, including “menorrhagia, extreme fatigue, abdominal pain, back pain, joint pain, and various skin rashes.” Bayer pulled Essure off the U.S. market in 2018.
The pharmaceutical giant argued that the women made “only a cursory effort to describe the manufacturing defects” of Essure and that their allegations are conclusory, according to the court opinion. Bayer also said that the women described only potential defects and failed to tie any defect to the alleged injuries. Finally, Bayer said the women’s claims, based on Indiana law, were preempted by federal law.
The appeals court disagreed, saying that Bayer had sufficient notice of defect-related claims and that those claims were covered under Indiana law. The claim is not preempted because it is not based solely on a violation of federal law and because it is derived from Indiana tort law, the court concluded.
The controversy around Essure has grown in recent years under an increasingly vocal patient advocacy campaign. The FDA said in 2018 that estimates indicate that Essure has been used by more than 750,000 patients, and has been “associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”
An FDA panel met in November 2019 to discuss immunological responses to medical device implants made of metal, including artificial hips and Essure. An FDA research document on the topic may be found here. Links to FDA webcasts of both days’ proceedings may be found here. The FDA accepted comments on the topic until Dec. 16, 2019.