The FDA announced last month that it will require Bayer to add a Black Box Warning to the Essure product information. Essure is Bayer’s permanent birth control implant. A Black Box Warning is the strongest warning the FDA requires and is used to highlight when there is reasonable evidence that a drug or device causes a serious risk of injury. The FDA will also require women to sign a multi-page patient checklist and informed consent form outlining the risks associated with the Essure device prior the Essure implant procedure. Additionally, the FDA has directed Bayer to conduct a post-market surveillance study to evaluate the risks of Essure in a real-world setting. These actions came after FDA received thousands of injury complaints from women using Essure.
Because of the possibility of federal preemption issues, unfortunately many lawyers have been hesitant to file Essure lawsuits. The recent regulatory action, however, will likely result in these being increased interest in the litigation with a renewed focus on ways to defeat preemption. While the United States Supreme Court has been very clear that nothing in the Medical Device Act prevents a state from providing a traditional damages remedy for violations of common-law duties when those duties parallel federal law, the courts have been mixed as to the types of claims that are parallel and survive preemption.
If you need more information on the Essure litigation, contact Frank Woodson, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
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