ASHES

  

Advocating Safety in Healthcare E-Sisters

Medical Device Safety Act 2017

Introduced April 26, 2017

H.R.2164


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.

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.




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