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. 2669) will allow consumers harmed by

Class III Medical Devices to seek justice in a court of law.

It is simple to help...

Click on this  link

It will automatically email ALL of your reps asking for their support of

The Medical Device Safety Act!

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!!! 

The Medical Device Safety Act 2019

Introduced May 10, 2019

H.R.2669

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 2019 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 2019 would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

116th CONGRESS

1st Session

H. R. 2669

To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

IN THE HOUSE OF REPRESENTATIVES

May 10, 2019

Ms. DeLauro (for herself, Ms. Schakowsky, and Mr. Fitzpatrick) introduced the following bill; which was referred to the Committee on Energy and Commerce

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.

Class III Medical Devices on the market today

Agent Absorbable Hemostatic Collagen Based

Agent Absorbable Hemostatic Non-Collagen Based

Agent Occluding Vascular Permanent

Aortic Valve Prosthesis Percutaneously Delivered

Artificial Heart

Atrial Defibrillator

Band Tubal Occlusion

Barrier Adhesion Cardiovascular

Biologic Material Dental

Bone Grafting Material Dental With Biologic Component

Bone Heterograft

Clip Tubal Occlusion (Filshie Clips)

Coronary Drug-Eluting Stent

Cultured Human Cell Skin Dressing

Defibrillator Automatic Implantable Cardioverter With Cardiac Resynchronization (Crt-D)

Defibrillator Implantable Dual-Chamber

Device Dermal Replacement

Device Impotence Mechanical/Hydraulic

Device Incontinence Mechanical/Hydraulic

Device Intrauterine Contraceptive And Introducer

Device Occlusion Tubal Contraceptive Laparoscopic (Essure)

Dorsal Root Ganglion Stimulator For Pain Relief

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Drug-Eluting Sinus Stent

Electrode Stabilized Epidural Spinal

Filler Recombinant Human Bone Morphogenetic Protein Collagen Scaffold With Metal Prosthesis Osteoinduction

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Glue Surgical Arteries

Heart-Valve Mechanical

Heart-Valve Non-Allograft Tissue

Hybrid Cochlear Implant

Implant Anti-Gastroesophageal Reflux

Implant Auditory Brainstem

Implant Cochlear

Implant Collagen For Non-Aesthetic Use

Implant Dermal For Aesthetic Use

Implant Dermal For Aesthetic Use In The Hands

Implant Hearing Active Middle Ear Partially Implanted

Implant Hearing Active Middle Ear Totally Implanted

Implant Intragastric For Morbid Obesity

Implantable Cardioverter Defibrillator (Non-Crt)

Implantable Pacemaker Pulse-Generator

Implantable Pulse Generator Pacemaker (Non-Crt)

Implanted Brain Stimulator For Epilepsy

Implanted Cerebellar Stimulator

Implanted Diaphragmatic/Phrenic Nerve Stimulator

Implanted Fecal Incontinence Device

Insert Tubal Occlusion

Interarticular Disc Prosthesis (Interpositional Implant)

Intracranial Aneurysm Flow Diverter

Intraocular Lens

Intraocular Pressure Lowering Implant

Joint Temporomandibular Implant

Leadless Pacemaker

Lens Intraocular Phakic

Lens Intraocular Toric Optics

Lens Iris Reconstruction

Lens Intraocular Accommodative

Ligaments And Tendons Synthetic

Materials Repair Or Replacement Pacemaker

Mesh Surgical Non-Synthetic Urogynecologic For Pelvic Organ Prolapse Transvaginally Placed

Mesh Surgical Synthetic Urogynecologic For Pelvic Organ Prolapse Transvaginally Placed

Metal Cemented Constrained Femorotibial Knee Prosthesis

Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

Microsphere Trace

Microspheres Radionuclide

Mitral Valve Repair Devices

Monitor Intracranial Pressure Implanted

Neuromodulator For Obesity

Occluder Patent Ductus Arteriosus

Pacemaker Battery

Pacemaker Bladder

Pacemaker/Icd/Crt Non-Implanted Components

Permanent Defibrillator Electrodes

Permanent Pacemaker Electrode

Prosthesis Ankle Cemented Non-Constrained

Prosthesis Ankle Uncemented Non-Constrained

Prosthesis Breast Inflatable Internal Saline

Prosthesis Breast Non Inflatable Internal Silicone Gel-Filled

Prosthesis Elbow Hemi- Humeral Metal

Prosthesis Finger Constrained Metal Cemented

Prosthesis Finger Constrained Metal Uncemented

Prosthesis Finger Constrained Metal/Polymer

Prosthesis Hip Constrained Metal

Prosthesis Hip Hemi- Acetabular Cemented Metal

Prosthesis Hip Pelvifemoral Resurfacing Metal/Polymer

Prosthesis Hip Pelvifemoral Resurfacing Metal/Polymer Uncemented

Prosthesis Hip Semi-Constrained (Metal Cemented Acetabular Component)

Prosthesis Hip Semi-Constrained (Metal Uncemented Acetabular Component)

Prosthesis Hip Semi-Constrained Ceramic-On-Metal Articulation

Prosthesis Hip Semi-Constrained Metal/Ceramic/Ceramic Cemented

Prosthesis Hip Semi-Constrained Metal/Ceramic/Ceramic/Metal Cemented Or Uncemented

Prosthesis Hip Semi-Constrained Metal/Metal Resurfacing

Prosthesis Intervertebral Disc

Prosthesis Knee Femorotibial Unicompartmental Semi-Constrained Metal/Polymer Mobile Bearing

Prosthesis Knee Hemi- Femoral

Prosthesis Knee Hinged (Metal-Metal)

Prosthesis Knee Patello/Femorotibial Constrained Cemented Polymer/Metal/Metal

Prosthesis Knee Patello/Femorotibial Unconstrained Uncemented Porous Coated Polymer/Metal/Polymer

Prosthesis Knee Patello/Femorotibial Semi-Constrained Metal/Polymer Mobile Bearing

Prosthesis Ligament Ptfe

Prosthesis Penile Inflatable

Prosthesis Shoulder Constrained Metal/Metal Or Metal/Polymer Cemented

Prosthesis Spinous Process Spacer/Plate

Prosthesis Testicle

Prosthesis Testicular

Prosthesis Urethral Sphincter

Prosthesis Vas Deferens

Prosthesis Wrist Constrained Metal

Pulse Generator Pacemaker Implantable With Cardiac Resynchronization (Crt-P)

Pulse Generator Permanent Implantable

Pulse-Generator Single Chamber Sensor Driven Implantable

Pump Infusion Implanted Programmable

Replacement Heart-Valve

Replacer Ureteral

Replacer Urethral

Ring Endocapsular

Sealant Dural

Sealant Polymerizing

Shunt Portosystemic Endoprosthesis

Spinal Pedicle Screw Fixation Appliance System

Stent Carotid

Stent Coronary

Stent Iliac

Stent Renal

Stent Superficial Femoral Artery

Stent Superficial Femoral Artery Drug-Eluting

Stent Urethral External Sphincter Permanent

Stimulator Autonomic Nerve Implanted (Depression)

Stimulator Autonomic Nerve Implanted For Epilepsy

Stimulator Carotid Sinus Nerve

Stimulator Electrical Implantable For Incontinence

Stimulator Electrical Implanted For Essential Tremor

Stimulator Electrical Implanted For Parkinsonian Symptoms

Stimulator Electrical Implanted For Parkinsonian Tremor

Stimulator Hypoglossal Nerve Implanted Apnea

Stimulator Intracerebral/Subcortical Implanted

Stimulator Neuromuscular Implanted

Stimulator Spinal-Cord Implanted For Bladder Evacuation

Stimulator Spinal-Cord Totally Implanted For Pain Relief

Suture Absorbable Ophthalmic

Suture Cardiovascular

Suture Dental

Suture Nonabsorbable Ophthalmic

System Endovascular Graft Aortic Aneurysm Treatment

System Endovascular Graft Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

System Hemodynamic Implantable

Telescope Implantable Miniature

Tissue Adhesive For Internal Use

Transcatheter Septal Occluder (Atrial)

Transcatheter Septal Occluder (Ventricular)

Valve Tubal Occlusion

Valve Ureterovesical

Ventricular (Assist) Bypass