Raising The Bar

A Missouri federal judge remanded an Essure injury case to St. Louis Circuit Court on Dec. 2—ruling against defendant Bayer Corp.’s motion to dismiss based on federal question jurisdiction and diversity jurisdiction. Judge Henry E. Autrey of the U.S. District Court for the Eastern District of Missouri ruled in favor of 32 women, who filed suit in March in St. Louis against Bayer—the manufacturer of Essure—for serious and permanent injuries as a result of being implanted with the alleged dangerous and defective medical device. The suit was filed by St. Louis attorney and National Trial Lawyers member Eric Holland and Louisiana-based law firms Unglesby + Williams and Baggett, McCall, Burgess, Watson & Gaughan.
In his ruling, Judge Autrey asserts, “The Court finds that the federal issues raised in plaintiffs’ complaint are not substantial, and accepting federal jurisdiction would disrupt the federal-state balance contemplated by Congress.”

Essure, which is currently still on the market, is advertised and sold as a permanent birth control device that consists of two metal coils, which is implanted into a woman's fallopian tubes. Essure has been issued to approximately 750,000 women globally, according to Bayer.

Earlier this year, the FDA ordered Bayer to strengthen its Essure warning label by adding a “black box warning” to the label so that patients may have a better understanding of the risks and potential health problems associated with the device. The new warning label, which was approved in November, better addresses the risks of device migration, organ perforation, allergic reactions, persistent pain, and the fact that surgery will be required if the device is to be removed for any reason. Additionally, the FDA is now requiring Bayer to include a “patient-decision checklist,” which must be received and signed by each patient prior to undergoing the Essure procedure. The checklist summarizes key information regarding the use, safety, and effectiveness of the device, and also addresses the risks and health problems that are now associated with the device.