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

Essure Sisters Lobby for Changes to Medical Device Laws

Holly Ennis Sept. 16, 2016

This week, key administrators from the Essure Problems Group, attorney Holly Ennis and medical device specialist, Madris Tomes,  joined forces with members of the Breast Implant Victims Advocacy Group to lobby for legislation that benefits all victims of  Class III medical devices.  The women met with many key Senate and House offices to urge support for Ariel Grace's Law and the Medical Device Guardian Act. Ariel Grace's Law  was introduced on June 8, 2016 by Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY).  These representatives realized that a poorly reasoned Supreme Court decision (Riegel v. Medtronic) needs to be legislatively remedied, as it prevents Americans harmed by unsafe, high-risk medical devices from seeking compensation from the companies who manufactured the harmful devices.  

The legislation is vital, both to compensate injured victims and to create the necessary incentive for companies to ensure their products are safe, and to conduct better clinical trials, both before and after the products are on the market. The bill is named after Ariel Grace Burrell, whose stillborn birth was caused by Essure, a Class III medical device and states as follows:

This Act May Be Cited as The Ariel Grace’s Law

(a) Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:

(b) NO EFFECT ON LIABILITY UNDER STATE LAW- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.

(c) EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall

(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and

(2) Apply to any civil action pending or filed on or after the date of the Act.

This bill is applicable to ALL Class III medical devices. There are approximately 400 Class III medical devices which have been approved since the classifications were created. It is unconscionable and unjust that manufacturers who have a medical device approved by the FDA pursuant to a premarket approval process can be forever shielded from liability and immune from suit, even when the device later proves to be defective and/or dangerous.  The Group strongly urged the Senators and Congressmen to:

            * Vote this bill into law as soon as possible.

            * Send a letter to the Health Committees urging a hearing on this issue.

            * Incorporate this bill into MDUFA or the 21st Century Cures Act.  

Interestingly, this bill contains the exact same language as a previous bill proposed by Senator Ted Kennedy in 2009 called the The Medical Device Safety Act of 2009. Senator Kennedy proposed this bill immediately following the Supreme Court's erroneous decision in Riegel v. Medtronic as a legislative correction to the Court's misinterpretation of the Medical Device Act of 1976.  It is clear that Congress never intended for manufacturers to be immune from suit for injuries caused by defective medical devices.  It was envisioned that state tort liability and FDA regulation each provides a distinct and integral layer of protection.  The bill had nearly 130 co-sponsors so there is no reason why the same bill should not be enacted today. 

Ariel Grace's Law benefits consumers by allowing injured patients to seek compensation for injuries caused by dangerous and defective medical devices. It creates incentives for companies to ensure their products are safe and to continue to monitor devices already placed in the marketplace. It also restores the same policy for drugs and medical devices as drug companies do not share the same immunity.

How You Can Help!

Congress needs to be told that their constituents want Ariel Grace's Law passed. They need to hear from each and every one of you urging support for the bill. You can mail or email your Senators and Congressmen the attached letter and request that he or she supports the bill.  Do it today, as tomorrow you or a loved one could be injured by a Class III medical device and left without recourse. For more information regarding Ariel Grace's Law, contact attorney Holly Ennis or visit us online at