Maria Gmitro & Julie Lykins Advocate in DC
Donation protected
The Medical Device Safety Act DC Trip 2019
Maria Gmitro and Julie Lykins both spoke at the recent FDA hearing on the safety of breast implants in March of 2019. They are joining the Medical Device Problems group as breast implant device representatives. Maria and Julie will be working along with a coalition of several prominent patient advocates injured by diverse medical devices, including some who were featured in the award winning documentary The Bleeding Edge. They will be traveling to Washington DC May 14th-18th of 2019 to meet with members of Congress to discuss their support of The Medical Device Safety Act .
The Medical Device Safety Act would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting Class III devices. The bill is being reintroduced this May 2019 Congressman Brian Fitzpatrick, Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio, Congressman Bobby Rush and Congressman Lloyd Doggett have all committed to sponsoring the bill.
Contributions will be used to cover travel, lodging, meals & incidentals for Maria & Julie as they join the efforts of other patient safety advocates. Your support in this endeavor will help advance the cause of all those who have been injured by a medical device. Donations of any size are greatly appreciated, as we understand the significant financial burden placed on the families of those who have been injured by a medical device.
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, Essure, and implanted cerebral simulators to name just a few. Once a Class III device has received PMA, it’s manufacturer is then essentially granted preemption protection, or to put it simply, it is difficult, if not impossible, to hold the manufacturer liable for injury or death in court.
Maria Gmitro and Julie Lykins both spoke at the recent FDA hearing on the safety of breast implants in March of 2019. They are joining the Medical Device Problems group as breast implant device representatives. Maria and Julie will be working along with a coalition of several prominent patient advocates injured by diverse medical devices, including some who were featured in the award winning documentary The Bleeding Edge. They will be traveling to Washington DC May 14th-18th of 2019 to meet with members of Congress to discuss their support of The Medical Device Safety Act .
The Medical Device Safety Act would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting Class III devices. The bill is being reintroduced this May 2019 Congressman Brian Fitzpatrick, Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio, Congressman Bobby Rush and Congressman Lloyd Doggett have all committed to sponsoring the bill.
Contributions will be used to cover travel, lodging, meals & incidentals for Maria & Julie as they join the efforts of other patient safety advocates. Your support in this endeavor will help advance the cause of all those who have been injured by a medical device. Donations of any size are greatly appreciated, as we understand the significant financial burden placed on the families of those who have been injured by a medical device.
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, Essure, and implanted cerebral simulators to name just a few. Once a Class III device has received PMA, it’s manufacturer is then essentially granted preemption protection, or to put it simply, it is difficult, if not impossible, to hold the manufacturer liable for injury or death in court.
Organizer
Maria Gmitro
Organizer
Mt. Pleasant, SC
