The Medical Device Safety Act DC Trip 2019

In May, the board members of ASHES nonprofit, along with several other patient advocates, will be returning to DC. We are setting up meetings to meet with members of Congress or their staffers to discuss their support of The Medical Device Safety Act.

The Medical Device Safety Act would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting Class III devices.

The bill is being reintroduced this May 2019
Congressman Brian Fitzpatrick, Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio, Congressman Bobby Rush and Congressman Lloyd Doggett have all committed to sponsoring the bill.

Initially introduced in 2017:
IN THE HOUSE OF REPRESENTATIVES
Mr. FITZPATRICK (for himself, Ms. DELAURO, and Ms. SLAUGHTER) introduced the following bill; which was referred to the Committee on April 26, 2017
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Medical Device Safety Act’’.
SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS 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:
‘‘(c) 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 law of any State.’’.
(b) EFFECTIVE DATE; APPLICABILITY.—The amendment made by subsection (a) shall—
(1) take effect as if included in the enactment 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 enactment of this Act.

We could use your help covering travel costs and expenses! Any little bit helps! Thank you.

Also, we need constituents to reach out to their representatives asking for them to support this bill. Here is a template and directions to make this easy for you to do! https://www.ashesnonprofit.com/mdsa-push 

There are currently 157 Class III medical devices  on the market protected by preemption. Preemption is the rule of law that if the federal government through Congress has enacted legislation on a subject matter it shall be controlling over state laws. Riegel v. Medtronic, Inc., (2008), was a United States Supreme Court case in which the Court held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received premarket approval (PMA) from the Food and Drug Administration. Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III medical devices are supposed to have the strictest guidelines because they pose the greatest risk. Class III medical devices must follow Class I and II guidelines but must also get premarket approval by the FDA, and a scientific review of the medical device must be made prior to marketing. Class III medical devices normally support or sustain human lives. These devices include implanted pacemakers, heart valves, Essure,  and implanted cerebral simulators to name just a few. Once a Class III device has received PMA, it’s manufacturer is then essentially granted preemption protection, or to put it simply, it is difficult, if not impossible,  to hold the manufacturer liable for injury or death in court.




Want to join me in making a difference? I'm raising money to benefit ASHES Advocating Safety In Healthcare E-Sisters Inc., and any donation will help make an impact. Thanks in advance for your contribution to this cause that means so much to me.

More information about ASHES Advocating Safety In Healthcare E-Sisters Inc.: Our nonprofit organization blossomed from the hearts of a group of women who were advocating awareness about the dangers of a permanent birth control device called Essure. After spending a few years running a support group and being advocates for women who experienced complications from this dangerous procedure, we realized there was a need for proper and complete education and information regarding ALL types of medical devices and drugs. From that need, ASHES was born.