Bayer’s appeal rejected in Essure birth control device lawsuit

A pharmaceutical giant sued by dozens of women who claim they were injured by the company’s permanent contraceptive device did not convince the Indiana Court of Appeals on Tuesday to grant its motion for judgment on the pleadings.

Rene Leach and more than 30 women sued Bayer Corporation and other entities involved in manufacturing Essure, a permanent birth control device, after they claimed to experience injury after the device was implanted. Bayer stopped distributing the device in 2018.

The women alleged several potential defects and specific symptoms following the implantation of the device, including menorrhagia, extreme fatigue, abdominal pain, back pain, joint pain, and various skin rashes. The women also asserted Bayer violated federal manufacturing requirements and that they are users and consumers under the Indiana Product Liability Act.

Bayer and several other defendants sought judgment on the pleadings, asserting that aspects of the complaint were deficient and that the claims were pre-empted. Specifically, Bayer argued the women failed to adequately plead their claims of manufacturing defects, which it contended ran afoul of Indiana Trial Rule 8 because the women made “only a cursory effort to describe the manufacturing defects” and their allegations are conclusory. It also argued the women only described potential defects and failed to connect any defect to the alleged injuries.

The Marion Superior Court denied Bayer’s motion for judgment on the pleadings, which the Indiana Court of Appeals affirmed in the interlocutory appeal of Bayer Corporation, et al. v. Rene Leach, et al., 19A-CT-00625.

The appellate court found Bayer had sufficient notice of the defect-related claims under Indiana’s liberal notice-pleading standard. It likewise found the women’s claim of manufacturing defects is not expressly pre-empted because they are premised on the violation of federal requirements.

“Moreover, the claim is not impliedly preempted so long as it does not exist solely by virtue of the FDCA. That is, the claim survives if the Women are ‘relying on traditional state tort law,’” Judge L. Mark Bailey wrote for the appellate court.

“… Here, a jury could reasonably conclude that the alleged failure to comply with federal manufacturing standards rendered Essure in a defective condition unreasonably dangerous to any user or consumer. This type of claim is (1) not expressly preempted because it is premised on a violation of federal law and (2) not impliedly preempted because it is derived from traditional Indiana tort law. Thus, the state-law claim is viable,” the appellate court continued.

Finding the manufacturing-defect claim to be viable, the appellate court concluded Bayer did not demonstrate that the complaint was devoid of allegations upon which relief could be granted and that Bayer was therefore “not entitled to dismissal at this early stage of the proceeding.”