FiDA Failed Implant Device Alliance: The FDA 510(k) process is flawed. Patients treated as collateral damage.

Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.

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Patient Advocacy Events

6/16/2018 'The Bleeding Edge' documentary screening, Dallas, TX
10/31/2017-9/01/2020 Healthcare Safety Advisory Committee member/Texas Health and Human Services Commission (HHSC)
9/18/2017-11/14/2017 $247 Million verdict. Federal jury trial J&J DePuy Ultamet Hip MDL Fourth Bellwether NY plaintiffs, daily observer
9/25/2017 Rally in Washington, DC for the Medical Device Safety Act HR
7/27-29/2017 Leadership Women National Conference, Dallas, TX
6/21/2017 HealthwatchUSA presentation: An Update on PREVENTABLE Medical Device Harm: Indemnity & Injustice
5/18-5/20/2017 Cinderblocks4 Partnership With Patients conference and Walking Gallery, Grantsville, MD
5/6/2017 Bayer Essure (sterilization coils) Harmed Patients National Rally, Dallas, TX
4/27/2017 J&J Shareholders Meeting, New Brunswick, NJ
12/2016 Consumers Union Safe Patient Project Summit, NY
Settled. RESET to 12/5/2016 from 9/12/2016 & 5/2016 & 1/4/2016 Figuero v Boston Scientific, pelvic surgical mesh product liability Dallas, TX
12/1/2016 $1 Billion verdict: J&J DePuy Pinnacle Hip MDL Bellwether Dallas, TX federal jury trial
11/4/2016 HealthwatchUSA conference, Lexington, KY
Now postponed: RESET to 8/15/2016 from 6/3/2016 Mesh Awareness Movement rally 8am to 11am Edwards v. Ethicon Robert C. Byrd federal courthouse in Charleston, WV
6/3-4/2016 Advanced Patient Advocacy Workshop, National Center for Health Research, Washington, DC
5/19-21/2016 Cinderblocks3 Partnership With Patients conference and The Walking Gallery in Grantsville, MD
Date RESET:TBA 4/11/2016 (postponed) Rally in Charleston WV at federal courthouse. 86,000 surgical mesh MDL trials.
3/17/2016 $502M verdict Johnson & Johnson DePuy Pinnacle hip replacement trial in Dallas federal court
2/1/2016 to 2/4/2016 CU Safe Patient Project Summit in Washington, DC
11/13/2015 HealthWatchUSA conference in Lexington, KY @heathwatchusa #HWUSA15
10/21/2015 U.S. Congresswoman Eddie Bernice Johnson (TX-30), Dallas, TX
10/6-10/8/2015 PCORI Annual Meeting, Arlington, VA
9/21/2015-10/5/2015 Cavness v. JNJ Ethicon Prosima surgical mesh trial, Dallas, TX
6/4/2015-6/6/2015 #Cinderblocks2, The Walking Gallery, Grantsville, MD
5/4/2015 and 5/5/2015 Join EssureProblems Rally at the ACOG conference and Bayer headquarters for a rally, San Francisco and Berkeley, CA
1/19/2015 Author John T. James, PhD "The Truth About Big Medicine" Dallas, TX
11/11-13/2014 Consumers Union Safe Patient Project Summit in Yonkers, NY
11/7/2014 HealthWatchUSA conference in Lexington, KY
8/25-9/8/2014 $73M verdict, Salazar v Boston Scientific Obtryx surgical mesh - court observer
6/8-10/2014 Leadership America in Berkeley, CA
5/21/14 HealthWatchUSA webinar with guest presenter Dr. Tom Valuck
4/29/14 WFAA TV interview with Janet St. James regarding FDA announcement of reclassification of surgical mesh to "high-risk".
4/16/14 Mesh Warrior Foundation
3/24/14-4/3/14 Batiste v McNabb/J&J Ethicon jury trial, Dallas TX, plaintiff awarded $1.2M compensatory for defective MCM TVT-O surgical mesh
3/11/14-3/13/14 AAOS conference, New Orleans LA
11/5/13 Consumers Union Safe Patient Project at Columbia University School of Journalism NY,NY
11/1/13 Speaker at HealthWatchUSA, KY
10/17/13, TMIT webinar Unaccountable – The Latest from Dr. Marty Makary AND New Critical Issues for Patient Safety Leaders
9/27/13 Stanford Medicine X
9/18/13 AND 9/19/13 FDA Workshop/Webinar on Patient Preference and Medical Devices TMIT webinar Transforming Healthcare Leadership and Patient and Family Engagement
091113 CMS Deputy Chief Medical Director, Dr. Shari Ling/HealthwatchUSA
9/10/13 and 9/11/13 Mayo Social Media Residency in Dallas/Baylor
8/21/13 Health and the Built Environment webinar (ReportingonHealth)
7/29/13 PfP CMS Affinity Group webinar
7/9/13 The Science of Safety in Healthcare/Johns Hopkins/Coursera
6/13 & 14/13 PCORI Merit Reviewer
6/13/13 FDA 510(k) Public Meeting webinar - 5 minute presentation
06/10/13 CMS Partnership for Patients webinar Product Safety and Resource Management Group Meeting
4/15/13 screening of Regina Holliday's movie '73 Cents' in Austin TX
4/5/13 ProPublica #MedErrorsChat
3/18/13 Dallas #HCSM (Healthcare Social Media) Dallas meet-up prior to The Future of Information-Driven Healthcare webcast (Dell)
2/20-22/2013 Selling Sickness 2013, Washington, DC
1/29/13 University of Texas/Austin QUEST Lifelong Learning: Lana Keeton lecture "Think you are Protected? You're Not. What Doctors Don't Know & FDA is not Telling." Failed Vaginal Surgical Mesh Implants
11/12-14/2012 Consumers Union Safe Patient Summit
10/27-28/2012 PCORI Patient-Centered Outcomes Research Institute (applied/not included)
10/15-19/2012 Mayo Social Media Summit, Rochester MN (webinar-not awarded competitive scholarship)
9/21-23/ 2012 Partnership WITH Patients and HealthCamp, Kansas City MO --
6/4/12 The Walking Gallery (Regina Holliday) Washington, DC
4/26/12 Steven Baker - MN staff of Senator Al Franken
2/6/12 to 2/9/12 Capitol Hill to lobby with Consumers Union Safe Patient Project, visit PCORI
11/19/11 Leadership Texas Annual Meeting workshop - presenter on health and wellness advocacy - San Antonio
11/15/11 Senate HELP testimony: Steven Baker
10/24-26/11 CU Safe Patient Project Summit - Yonkers, NY
9/25-27/2011 Health 2.0 SF conference
9/22/11 FDA/CDRH Town Hall testimony, San Francisco CA
3/10/11 FDA/CDRH Town Hall testimony, Irving TX
1/13/2011 FDA MDUFA (invited but restricted from participation)
09/23-24/2010 FDA/CDRH Patient Representative Workshop
06/09/2010 Consumers Union Activist Summit DC
08/04/2009 Alliance for Justice: Medical Device Safety Act hearings

Wednesday, August 24, 2011

The FDA 510(k) process is flawed. Patients treated as collateral damage.

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