The Medical Device Safety Act H.R. 2164

The Medical Device Safety Act 2017 H.R. 2164 #MDSA17

The Medical Device Safety Act of 2017 was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.

We are asking for your support of The Medical Device Safety Act 2017, H.R.2164, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are tens of thousands of consumers who have been harmed by, disabled by, or lost a loved one to a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA17

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Public Comments (2,009)
Jan 7th, 2018
Hilda L. from Odon, IN writes:
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I am only 36 years old and have had essure for almost 4 years. I've went in to doctors over pain in my stomach many of times and never once thought about it being essure. I get migraines right before my period that lasts for a few days and while having intercourse with my husband I can't even enjoy it due to the pain I have. Why is is if we are American than it's ok to have this procedure done? I wish I did research before inserting them but it's to late now!
Jan 3rd, 2018
Someone from Oklahoma City, OK signed.
Dec 30th, 2017
Hallie m. from Wooster, OH writes:
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Essure problems: joint pain, body aches bloating (look 9 months pregnant), bleeding, during sex, weight gain, hair loss. just a few of mine.
Dec 30th, 2017
Hallie m. from Wooster, OH writes:
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Essure problems: joint pain, body aches bloating (look 9 months pregnant), bleeding, during sex, weight gain, hair loss. just a few of mine.
Dec 30th, 2017
Hallie m. from Wooster, OH writes:
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Essure problems: joint pain, body aches bloating (look 9 months pregnant), bleeding, during sex, weight gain, hair loss. just a few of mine.
Dec 29th, 2017
Sheila S. from Nixa, MO signed.
Dec 29th, 2017
Bonnie D. from Blue Springs, MO writes:
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Breast implants are nothing but bags of toxic waste perpetrated on unsuspecting women wishing to conform to societies expectation of beauty. All the while, our bodies are slowly being poisoned to fill the pockets of those who implant them. If most of use were told the contents and the potential of the enormity of symptoms many of us would fight before finding out - usually on our own - that the implants are to blame - we would have NEVER had the surgery to begin with,
Dec 28th, 2017
Angela F. from Cartersville, GA writes:
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The essure implant is being put in women like myself who are told it is safe and effective to then face horrible, painful and life-altering side effects. These companies do not need protection, the real people being harmed daily need the protection!
Dec 25th, 2017
Cheresa H. from Colorado Springs, CO writes:
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Breast implants are harmful and are poisioning women across the globe. The implant companies must be held liable. To protect them is to tell them that harming human beings for profit is acceptable.
Dec 23rd, 2017
Samantha D. from Memphis, TN signed.

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