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Ariel Grace Depicts Painful Injustice of Preemption

Holly Kelly Ennis May 15, 2017

Today, the world celebrates Mother’s Day.  Children and adults alike pay tribute to the mothers who raised them and their children whom they adore.  However, for one group of women, implanted with Essure, the day is a painful reminder of the child they lost, who will never get to celebrate mother’s day or any other day.  These women, who made the responsible choice regarding birth control, ended up not only getting pregnant, but once the pregnancy news was welcomed, suffered the painful loss of miscarriage or worse, a stillborn baby.  Of these women, no story is more painful and more emblematic of the injustice of preemption than Ariel Grace Burrell.

After a failed Essure procedure, Kristiana Burrell unknowingly became pregnant, despite being on additional birth control.  After going into premature labor due to the Essure coil rupturing Kristiana’s amniotic sac, beautiful Ariel Grace was born sleeping at only 27 weeks old.  Devastated, the family mourned the lost of their premature daughter and filed suit against both the physician who implanted the device and Bayer, the manufacturer of the defective device.  The case was recently dismissed against Bayer based upon the legal theory of preemption. Unfortunately, the ill-informed judge failed to follow the longstanding correct law regarding remanding the case back to state court and the nuances of preemption where certain claims are clearly allowed to go forward. However, such is the state of the judiciary, where too often judges, siding with corporate America, take the easy route, finding it far easier to simply invoke the ‘blanket’ of preemption.

A close study of the evolution of the Essure birth control device leads one from disbelief to outrage. How this device has flourished in the marketplace despite the serious and widespread injuries inflicted on its users is both heartbreaking and anger provoking. The entire process by which Essure has been implanted in hundreds of thousands of women is egregiously flawed and needs to be changed. The approval of Essure was wrong from its inception. Judges making erroneously rulings regarding the application of preemption only adds to gross insult to an already egregious situation.  Legislation is urgently needed to remedy the wrongs inflicted by Bayer, the FDA and the judiciary.

Representative Brian Fitzpatrick (R-PA) has recently introduced such needed legislation in Congress.  The Medical Device Safety Act 2017 is crucial to all consumers injured by Class III medical devices and is likely to gain significant bi-partisan support. It has already been co-sponsored by Representative Louise Slaughter (D-NY) and Representative Rosa DeLauro (D-CT). The proposed legislation would essentially abolish medical device manufacturers’ preemption defense in product liability cases. The Medial Device Safety Act, H.R. 2164 seeks to amend the Federal Food Drug and Cosmetic Act with respect to liability under state and local requirements pertaining to Class III medical devices and would apply to 157 such devices. The bill states as follows:

                        This Act may be cited as the “Medical Devices Safety Act”.

            Sec. 2.  LIABILITY UNDER STATE AND LOCAL REQUIRMENTS                             RESPECTING DEVICES.

 (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 [17].

 This bill is historic in that it will allow patients who have been injured by defective medical devices approved pursuant to the 360k Premarket Approval Process to pursue their rights in court and to hold manufacturers of defective devices liable and accountable. Civil litigation is both necessary to compensate patients who have been injured by defective devices and to keep manufacturers in check to ensure that the products they put into commerce are safe. The bill has already been endorsed by the National Center for Health Research and Consumers Union, a division of Consumer Reports.  Everyone is strongly urged to contact their Congressmen and ask for support of this bill as well as requesting their Senators to sponsor a similar bill in the Senate. 

Persons with questions regarding the Medical Device Safety Act, Essure or Preemption, contact Holly Ennis at