ASHES
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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.
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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