In early August, a California state court ruled against Bayer, allowing 11 Essure lawsuits to move forward. Bayer was trying to have the cases thrown out on three grounds. One of Bayer’s arguments was that it should not be held responsible for injuries caused by the device because the U.S. Food and Drug Administration (FDA) approved Essure warning labels and marketing. But the judge disagreed, and that ruling may do more than allow these Essure lawsuit to move forward.
It may clear the way for other Essure lawsuits as well as lawsuits against other device manufacturers who use the argument that federal regulation exempts them from liability.
Essure was approved by the FDA in 2002. The agency had received more than 5,000 adverse event reports linked to Essure by May 2015. In February, 2016, rather than pulling Essure from the market as many had hoped, the FDA announced that it will require Essure to carry a black box warning and a Patient Decision Checklist. The black box warning is the agency’s strongest warning. The Patient Decision Checklist is meant to warn women of the risks and help them make an informed choice.
The FDA is also requiring Bayer to conduct a postmarket surveillance study so the agency can get a better idea of the risks associated with Essure and compare its safety with that of laparoscopic tubal ligation. The FDA may, or may not, take further action on Essure based on the study results.
If you or someone you love has been harmed by Essure, please talk to an experienced defective drug attorney right away to learn more about your rights and potential compensation.