Essure Problems Group Returns to Washington
Several key Essure Problems Group administrators, medical device specialist Madris Tomes and attorney Holly Ennis return to Washington D.C. today to garner support for Ariel Grace’s Law. This proposed bill seeks to remove the preemption defense utilized by medical device manufacturers, whose devices cause injury to patients. The bill is an amendment to an existing statute governing medical devices and merely amends such statute to allow access to the civil courts for those injured by defective medical devices. State law causes of action against manufactures for defective products have long been considered a powerful vehicle to incentivize manufacturers to prevent and correct dangers associated with their products. It not only compensates innocent consumers injured by defective products, but also encourages manufacturers to engage in appropriate behavior or suffer consequences if they fail to act in a swift and responsible manner.
The bill is aptly named Ariel Grace’s law, after Ariel Grace Burrell, whose stillborn birth was caused when Essure, a Class III medical device, prematurely ruptured her amniotic sac, causing her premature labor. The Essure Group will be joined by representatives of other groups injured by Class III medical devices in a joint effort to garner support for the bill, which applies to all Class III medical devices. The bi-partisan bill, which is co-sponsored by Representatives Mike Fitzpatrick and Louise Slaughter, will apply to over 400 Class III medical devices, which are currently marketed in the U.S. While previous lobbying efforts have been focused in the House of Representatives, this week’s efforts will be geared toward key Senators. The timing is crucial as the controversial 21 Century Cures Act is currently being debated in the Senate.
The Essure Group will also be meeting with key FDA executives to discuss various issues of concern regarding the Essure device. The most important issues for discussion include:
When will the black box warning and Patient Decision Checklist be implemented?
What is the proposed final wording of the black box warning and patient checklist?
Where will the black box warning be required? Only on the packaging or also in product brochures, advertising and Internet sites?
What procedures are in place to ensure physician compliance with the Patient Decision Checklist
Discussions regarding the recent FDA report on clinical trial misconduct.
Discussions regarding the upcoming post market clinical trial Bayer is required to perform.
Ongoing alleged misconduct in current Essure clinical trials.
The Essure Group will also focus on getting the Senate Committee on Energy and Commerce to hold hearings regarding unsafe medical devices and the FDA’s inability to oversee both the pre-market and post-market approval and safety of these devices. According to Representatives Mike Fitzpatrick and Louise Slaughter, the time for action is now. “With the 21st. Century Cures Act still pending in Congress, and the Senate continuing its work on a medical innovation package, the time is now for Congress to take action. Therefore, we respectfully request that the committee on Energy and commerce hold hearing on the impact unsafe medical devices have had on patient outcomes, as well investigate way to improve the FDA’s ability to monitor and rapidly act when presented with evidence of potentially deadly medical devices.”
For more information regarding Ariel Grace’s Law or Essure related injuries, contact Holly Ennis or visit us online at www.Ennislaw.com.