Legal Commentary

04/10/2018

FDA ISSUES NEW ORDER ON ESSURE


On April 9, 2018, the FDA stated Bayer may be subject to criminal and civil penalties should they not comply with its new order requiring new labeling for Bayer's controversial birth control device, Essure.

The FDA issued a press release today restricting the sale of the device to only health care providers that provide a "Patient-Doctor Discussion Checklist-Acceptance of Risk and Informed Decision Acknowledgment." This checklist is now mandatory and must be reviewed and signed by the physician implanting the device. According to the order, the FDA mandated that Bayer "immediately" implement the changes, noting that the "FDA plans to enforce these requirements" with applicable "criminal and civil penalties."

PWS attorneys Marcus Susen and Justin Parafinczuk met with FDA Commissioner Gottlieb in February to discuss the FDA's prior actions. Since the device's approval in 2002, the FDA has taken several steps to deal with this device. In February 2016, the agency ordered Bayer to conduct post-market studies and in November 2016 the FDA required Bayer to add a black boxed warning and a patient decision checklist.

Commisioner Gottlieb stated: "I've personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks." Gottlieb further tweeted: "#FDA took this first of its kind action to use certain post market authorities because we believe additional, meaningful safeguards are required to ensure women can make informed decisions about risk when considering Essure."

PWS attorneys Marcus Susen and Justin Parafinczuk, who filed the first lawsuit and are both on the Plaintiffs' Steering Committee in the Eastern District of PA. Marcus Susen is lead counsel for the steering committee and Justin Parafinczuk is the discovery chair.

If you have been injured by Essure, call our firm today at 954-462-6700.

View the original story: FDA Issues Order Against Essure

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