June 10, 2016
The Honorable __________________
Washington, DC 20515
H.R.5403 Ariel Grace’s Law https://www.govtrack.us/congress/bills/114/hr5403
On June 8, 2016, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced an important new bi-partisan bill. This bill seeks to remove the preemption protection granted to Class III medical devices which receive initial premarket approval by the FDA. Accordingly, manufacturers of medical devices, which later may be shown to be defective and dangerous, will not be automatically shielded from liability. Often the threat of civil litigation is the necessary force to ensure that manufacturers provide medical devices that are both effective and more importantly, safe. A similar bill had over 100 cosponsors several years ago, and we hope to drive similar bipartisan support.
The bill is aptly named, Ariel Grace’s Law, after Ariel Grace Burrell, whose stillborn birth was caused by a Class III medical device. Kristiana Burrell has given her blessing to have the bill named after her daughter and the bill was introduced on the one year anniversary of the birth/death.
This bill is applicable to all Class III medical devices. It is an amendment to an already existing statute and merely amends the statute to allow access to courts for those injured by defective medical devices and is 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.
As your constituent, I strongly urge your support of this bill. 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 dangerous and/or defective and causes injury to device users. It was never the intent of the Federal Food, Drug and Cosmetics Act to provide blanket immunity for medical device manufacturers for defective devices placed into the stream of commerce. Quite simply, there is no plausible reason nor rationale for the failure to support this amendment, which serves to protect your constituents. Accordingly, I strongly urge you to join forces with Representatives Fitzpatrick and Slaughter and make this bill into law as soon as possible.