Essure Birth Control Lawsuits
The FDA received thousands of complaints about Essure and ruled in September of 2015 that the packaging for Essure must include a “black box” warning that includes the known risks of the device and a Patient Decision Checklist to determine whether or not it is indeed the patient’s best option for pregnancy prevention. The FDA also recommended further research, including a follow up on the original clinical trial participants.
The FDA designated Essure as a Class III device, which means it was subjected to the most stringent testing prior to being approved. Because of this, Class III devices are shielded from product liability in most cases. A number of lawsuits have been filed to puncture that liability shield. In March of 2016, a Federal judge dismissed ten of the twelve claims out of a set of five such lawsuits, but allowed the remaining two claims to proceed—that Bayer used misleading advertising and failed to notify patients about the potential risks. The judge also merged the five cases into a single case. The case has not yet been resolved, but could potentially open Bayer to liability in further lawsuits.