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Mon Mar 11, 2019, 01:39 PM

Please consider supporting this cause, MDSA17 HR2164

#MDSA17 HR2164


Advocating Safety in Healthcare, E-Sisters

Medical Device Safety Act 2017

Introduced April 26, 2017


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 and implanted cerebral simulators to name just a few. Once a Class III device has received PMA, it’s manufacturer is then granted preemption protection, or to put it simply, the manufacturer cannot be held liable for injury or death in court.

We come to you asking for your support of The Medical Device Safety Act 2017 as consumers who have been harmed by some of these devices. Even decades after PMA approval, if a Class III device has been proven ineffective or proven to cause harm, individuals still cannot hold a manufacturer liable for injury. We deserve the same rights as all consumers and patients.

The Medical Device Safety Act 2017 would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.


Mr. FITZPATRICK (for himself, Ms. DELAURO, and Ms. SLAUGHTER) introduced the following bill; which was referred to the Committee on April 26, 2017


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,


This Act may be cited as the ‘‘Medical Device Safety Act’’.


(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.

*Snip. List of unregulated medical devices. Snip.*

We need your help to get support for this bill from Members of Congress and get it passed. The more Members of Congress get calls and emails about something, the more they listen!

In short, the Medical Device Safety Act (H.R. 2164) will allow consumers harmed by Class III Medical Devices to seek justice in a court of law.

It is simple to help...

This link will automatically email ALL of your reps asking for their support of The Medical Device Safety Act for FREE!

EVERYONE PLEASE go to this link and fill out a request to send this letter to your reps! It is quick, simple and free!!!! You can CHOOSE to pay $3 to have a hand written letter delivered if you wish, but not necessary!!!


List of medical devices at the link.

Thank you for considering supporting this cause.

#Esisters at #Essureproblems.

On Facebook at https://www.facebook.com/groups/Essureproblems/?ref=share

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Reply Please consider supporting this cause, MDSA17 HR2164 (Original post)
littlemissmartypants Mar 2019 OP
littlemissmartypants Mar 2019 #1

Response to littlemissmartypants (Original post)

Mon Mar 11, 2019, 01:43 PM

1. Hidden FDA reports detail harm caused by scores of medical devices


By Christina Jewett, Kaiser Health News
Mar. 7

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

More at the link.

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