Created by Eidolon LLC

2018

2019 Congressional Push for The Medical Device Safety Act H.R.2669 (#MDSA)

 

The Medical Device Safety Act H.R.2669

https://www.congress.gov/bill/115th-congress/house-bill/2164

This was reintroduced in the House on May 10, 2019. This is a bipartisan bill that 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, artificial joint implants. This amendment will allow the patients who are injured, disabled, or killed by medical devices to seek litigation in state courts. It would eliminate the federal preemption protection of the manufacturers and empower patients who were wrongfully harmed to seek justice. 

 

Dr. Stephen Tower has been involved in a lobbying effort led by the non-profit ASHES-Advocating Safety in Healthcare, E-Sistershttps://www.ashesnonprofit.com/mdsa-push to get co-sponsors for the bill in the House and a companion bill to be introduced in the Senate. On May 16th, Christina, Dr. Tower’s Research Assistant, spoke with Senator Lisa Murkowski’s Legislative Health Aide, Anna Dietderich, to lobby for support of this bill. Senator Murkowski is a member of the Health, Education, Labor, and Pensions (HELP) Committee, and her support on this matter would be very beneficial. 

 

We ask that you reach out to Senator Murkowski’s legislative Health Aide, Anna Dietderich, as a constituent who is experiencing or has previously experienced problems with an artificial joint implant.  

Below you will find instructions on how to help:

  1. Call Senator Murkowski’s office at (202) 224-6665 and ask for Anna, the Legislative Health Aide. 

  2. Tell your story (no more than about 2-3 minutes).

  3. Request that Sen. Murkowski watch The Bleeding Edgeon Netflix.http://bleedingedgedoc.com/  This is a documentary regarding the problems with medical device regulations in this country, and it features Dr. Tower’s clinic, among other medical device issues. 

  4. Finally, please ask that she introduce the Medical Device Safety Act into the Senate this month. 

  5. Follow up regularly with the Health Aide. Reach out with news articles, updates on your health, updates on the FDA, updates on court actions, etc.

 

You can also help by signing the online petition for The Medical Device Safety Act 2019 H.R.2669:

 https://www.petition2congress.com/ctas/the-medical-device-safety-act-2019-h-r-2669

We also ask that you share the link for the petition on your social media accounts to help raise awareness and garner support for this matter. Once signed, this petition automatically gets emailed to President Trump, Senator Murkowski, Representative Young, and Senator Sullivan.  We have not yet been able to meet with the Health Aide for Representative Young and for Senator Sullivan. It would not hurt for you to reach out to their respective offices as well.

   

To contact Representative Young: 

  1. Call (202) 225-5765 and ask to speak with his Health Aide. 

  2. Tell your story (no more than about 2-3 minutes). 

  3. Request that Rep. Young watch The Bleeding Edgeon Netflix.http://bleedingedgedoc.comAsk that he support the Medical Device Safety Act in the House. 

  4. Follow up regularly with the Health Aide. Reach out with news articles, updates on your health, updates on the FDA, updates on court actions, etc.

 

 

To contact Senator Sullivan: 

  1. Call (202) 224-3004 and ask to speak with his Health Aide. 

  2. Tell your story (no more than about 2-3 minutes).

  3. Request that Sen. Sullivan watch The Bleeding Edgeon Netflix.http://bleedingedgedoc.com/

  4. Ask that he introduce the Medical Device Safety Act into the Senate this month.

  5. Follow up regularly with the Health Aide. Reach out with news articles, updates on your health, updates on the FDA, updates on court actions, etc.

 

If you send an email:

      •  For a Representative, please ask them to co-sponsor the Medical Device Safety Act (See sample below)

      •  For a Senator, please ask them to introduce the Medical Device Safety Act of 2017 into the Senate (See sample below)

 

Sample email For Members of the House (Don Young)

 

SUBJECT: Medical Device Safety Act

Honorable Congressman Young:

I am reaching out regarding the Medical Device Safety Act of 2017 (H.R. 2164). This bill is going to be reintroduced in the House in May. I would like to talk with you to see if the you would be interested in co-sponsoring this important bill. The current bill is identical to the Medical Device Safety Act of 2009 (H.R. 1346) that many members of the House co-sponsored in 2009.  

(Feel free to personalize the email with your story here)

As you may know, this bipartisan bill was introduced in the house in April 2017, by Congressman Brian Fitzpatrick. It is a bipartisan bill co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio, and the late Congresswoman Louise Slaughter. This 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, implantable pacemakers and breast implants. There are over 157 Class III medical devices on the market in the USA. Manufacturers of Class III medical devices currently enjoy federal preemption protection. This is due to the Riegel vs. Medtronic ruling in 2008, wherein the United States Supreme Court erroneously held that the preemption clause of the Medical Device Amendment essentially bars most state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval (PMA) from the Food and Drug Administration.

 

For a bit of background, I would suggest watching the documentary The Bleeding Edgeon Netflix. This documentary will give you a good understanding about how medical devices are approved through the FDA (510k and PMA process), a good background on how consumers are being impacted, and background on the Essure Problems Group. Also, the International Consortium of Investigative Journalists released their latest investigative reports in late November called the Implant Files. This had a huge impact on the FDA's decision to change the way they approved medical devices under the 510k products, as reported in this AP story.

 

After you read over this information, please do not hesitate to reach out with any questions you may have. I look forward to chatting with you about the possibility of the Congressman/Congresswoman co-sponsoring the Medical Device Safety Act. It’s time to take a bold stand for medical device post-market safety and accountability.

Thank you,
Your name  

 

                  

Sample email For Members of the Senate (Lisa Murkowski/Dan Sullivan)

SUBJECT: Medical Device Safety Act

Honorable Sen. Murkowski/Sullivan:


I am reaching out regarding the Medical Device Safety Act of 2017 (H.R. 2164). This bill is going to be reintroduced in the Senate in May. I would like to talk with you to see if the you would be interested in co-sponsoring this important bill. The current bill is identical to the Medical Device Safety Act of 2009 (H.R. 1346) that many members of the House co-sponsored in 2009.  

(Feel free to personalize the email with your story here)

As you may know, this bipartisan bill was introduced in the house in April 2017, by Congressman Brian Fitzpatrick. It is a bipartisan bill co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio, and the late Congresswoman Louise Slaughter. This 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, implantable pacemakers and breast implants. There are over 157 Class III medical devices on the market in the USA. Manufacturers of Class III medical devices currently enjoy federal preemption protection. This is due to the Riegel vs. Medtronic ruling in 2008, wherein the United States Supreme Court erroneously held that the preemption clause of the Medical Device Amendment essentially bars most state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval (PMA) from the Food and Drug Administration.

 

For a bit of background, I would suggest watching the documentary The Bleeding Edgeon Netflix. This documentary will give you a good understanding about how medical devices are approved through the FDA (510k and PMA process), a good background on how consumers are being impacted, and background on the Essure Problems Group. Also, the International Consortium of Investigative Journalists released their latest investigative reports in late November called the Implant Files. This had a huge impact on the FDA's decision to change the way they approved medical devices under the 510k products, as reported in this AP story.

 

After you read over this information, please do not hesitate to reach out with any questions you may have. I look forward to chatting with you about the possibility of the Congressman/Congresswoman co-sponsoring the Medical Device Safety Act. It’s time to take a bold stand for medical device post-market safety and accountability.
 

Thank you,
Your Name