Get Help From Ennis & Ennis P.A. Today Contact Us

Essure Advocates Return to Washington Supporting the Medical Device Safety Act 2017

Holly Kelly Ennis May 4, 2017

Victims injured by the controversial medical device, Essure and other Class III medical devices, lobbied this week in Washington, D.C. in support of H.R. 2164, the Medical Device Safety Act 2017. This acts seeks to modify the Food, Drug and Cosmetic Act to clarify that nothing in this Act shall be construed to affect any action for damages or the liability of any person under the law of any State.  There are currently 157 Class III medical devices whose manufacturers claim a complete immunity from liability, even should their devices be deemed defective or dangerous. This alleged immunity from suit is based upon an incorrect interpretation of the Food, Drug and Cosmetics Act by the United States Supreme Court in a case, Riegel v. Medtronic. (2008).

The bill, H.R. 2164 was introduced by Congressman Brian Fitzpatrick (R-PA) and is co-sponsored by Rep. Louise Slaughter (D-NY) and Rep. Rosa DeLaura (D-CT). This bi-partisan legislation seeks to remove the barrier to patients who have been harmed by Class III devices, which are approved through the FDA's pre-market approval process.  Patients who are harmed by FDA-approved prescription drugs have the legal right to seek compensation if they were not adequately warned of the risks,  as do those injured by Class I or Class II devices. Ironically, manufacturers of the highest-risk devices, with the greatest potential for harm are shielded from liability even should their devices cause serious injury or death. H.R. 2164 merely allows states to determine how to best protect patients from unsafe medical devices, similar to how the law allows states to protect patients from unsafe prescription medications. 

Administrators from the Essure Problems Advocacy Group including Angie Firmalino,  Amanda Dykeman, Amanda Rusmisell and Tess Schulman relentlessly lobbied for two meeting packed days, gaining support for the Bill in the House and urging Senate offices to sponsor a similar companion bill for the Senate.  Also joining forces lobbying with the Admins, were Madris Tomes from Device Events, whose data gathered from the FDA has proved invaluable to the Essure cause, attorney Holly Ennis, who represents Essure victims and breast implant activist, Jamee Cook. (Breast implants are also Class III medical devices impacted by H.R. 2164.)

Overall, the meetings went well, however much greater awareness and advocacy is needed.  ALL  individuals harmed by Class III medical devices MUST call and email their respective house representative and ask him/her to co-sponser HR 2164, The Medical Device Safety Act. Citizens must then contact their Senators and ask them to sponsor a parallel bill in the Senate for HR 2164. We need this to be a bicameral action to move more quickly through the House and Senate. As there are over 150 Class III medical devices,  hundreds of thousands of people will be favorable impacted by the passage of this bill.

Persons with questions concerning H.R. 2164 and what you can do to help, should contact attorney Holly Ennis at or visit us online at and fill out an online form.