Director, Center for Devices and Radiological Health
Jeffrey Shuren is the Director for the Center for Devices
and Radiological Health. He oversees the Center’s operations and strategic
direction. Dr. Shuren, along with several other FDA officials, ordered the
initial computer monitoring and was a later proponent of its expansion.
Associate Director for Management and Executive Officer,
Center for Devices and Radiological Health
Ruth McKee is the Associate Director for Management and
Executive Officer for the Center for Devices and Radiological Health. McKee
reports directly to Dr. Shuren, who tasked her to lead the charge to determine
what steps the FDA needed to take after it learned of the potential leak. McKee
also ordered the monitoring and determined the initial monitoring search terms
given to the Office of Information Management.
Deputy Director for Radiological Health for In Vitro
Diagnostics, Center for Devices and Radiological Health
Mary Pastel is the Deputy Director for Radiological Health
for In Vitro Diagnostics with the Center for Devices and Radiological Health.
Ruth McKee instructed Pastel to review encrypted flash drives containing
surveillance of information on scientists’ computers.
Chief Information Officer
Lori Davis was the Chief Information Officer for the FDA.
Prior to being named the Chief Information Officer in January 2009, she served
as the Deputy Chief Information Officer. She worked with Ruth McKee to set up
computer monitoring of Dr. Robert Smith, and was asked to search through
e-mails of FDA employees to determine the source of the information leak.
Chief Information Security Officer
Joe Albaugh was the Chief Information Security Officer for
the FDA until March 2011. Lori Davis approached Albaugh to set up the computer
monitoring for Dr. Robert Smith.
Medical Officer, Center for Devices and Radiological Health
Robert Smith was a Medical Officer for the Center for
Devices and Radiological Health. He was the first employee at the FDA to
experience computer monitoring. Based on information gathered from Dr. Smith’s
computer, officials at the FDA later expanded this monitoring to include
additional FDA scientists. His contract was not renewed after his contacts with
Congress, the Office of Special Counsel, and his personal attorney were
captured through the FDA’s monitoring program.
Ombudsman, Center for Devices and Radiological Health
Les Weinstein was the Ombudsman in the Office of the Center
Director for the Center for Devices and Radiological Health. Weinstein asked
the U.S. Department of Health and Human Services Office of Inspector General to
investigate the disclosure of confidential information to the press.
Chickasaw Nation Industries Information Technology, LLC
Contract Forensic Engineer, Incident Response Team
Christopher Newsom is a Forensic Engineer with Chickasaw Nation
Industries Information Technology. Newsom conducted the computer monitoring of
FDA employees. After the FDA first set up this monitoring for Dr. Robert Smith,
Newsom prepared an interim report to summarize the status of the monitoring.
Contract Investigator, Incident Response Team
Joseph Hoofnagle is a Contract Investigator with Chickasaw
Nation Industries Information Technology. Hoofnagle installed Spector 360
software on the monitored employees’ computers. He worked with Newsom to conduct
computer monitoring of FDA employees, and assisted Newsom in writing an interim
report to summarize the status of the monitoring.
"J&J Unit Can't Shake $15M Pelvic Mesh Verdict In NJ > By Bill Wichert Law360, Hackensack, N.J. (March 5, 2018, 9:24 PM EST) -- A New Jersey state judge on Monday refused to disturb a $15 million verdict against Johnson & Johnson unit Ethicon in a lawsuit alleging that a pelvic mesh product left a woman in debilitating pain, citing evidence that the business did not warn about certain risks associated with the device. Superior Court Judge Rachelle Lea Harz denied the company’s motion for judgment notwithstanding the verdict or a new trial, upholding a jury’s Dec. 14 decision that plaintiff Elizabeth Hrymoc’s injuries were caused by the defective design"
From: Lana Keeton
[mailto:email@example.com] Sent: Sunday, January 2, 2011 10:02 PM To: firstname.lastname@example.org Cc: Denise Jacobs; Marian Goldberg; Janet Holt;
email@example.com; firstname.lastname@example.org; Kelly Villoch;
Jaye117577@aol.com; Barbara Smith; email@example.com;
Luvbug958281950@aol.com; Lorraine Evans Subject: 2011 - Our Year of Victory!!!
Happy New Year Everyone!
It's been 3
months since the conference in D.C. and I am finally able to get started on
putting together the committees we discussed there. The first step is Dianne
Kelley's offer to help with the website, which hopefully will be implemented
this month. Truth in Medicine is making terrific headway but no one knows about
it because it is never publicized on the web/website. So Megan Gilbea will be
doing our website development, including better function of the pages, connection
to the search engines, and a lot of other stuff to spiff it up. Our lovely
Lorraine is a terrific webmaster but her time is consumed with her own
websites, TVT Mum and House of Francheska, and the terrific research she does
on mesh. (And her own health issues with mesh.)
Jane will be developing membership (and funds from membership) once the
website is properly set up. Marian (Mrs. Rockefeller) will be working on fund
raising and/or other projects she finds the time to develop. She did a fabulous
job with the silent auction at the Conference! Denise will hopefully
be working on a "Be Your Own Patient Advocate" journal for
meshies, helping patients through the maze of recovering from mesh. It will
include "Alternatives to Synthetics", the topic of our Second
Conference. She is also working on a research project. Jaye will be increasing
our presence on the internet through Facebook and Marsha is our member at large
working on patient relations and other initiatives.
will be our Informed Consent project with Dr. Ken Goodman at the University of
Miami, our Patient Coalition work with Dr. Diana Zuckerman of the National
Research Center for Women and Families and working by myself
with the FDA and Congress in other capacities. Hopefully our wonderful Jim will
be able to re-join us again in the near future. I am lost without him and his
support which was so instrumental in getting the FDA Public Health Notification
issued in October 2008. He is my rock and I sorely miss our past collaboration
on stopping the use of mesh. He WILL be back!
Kelly and Barbara, they are indispensable to Truth in Medicine. They have given
me support for years now and are always there with feedback and input when I
need it. They keep me grounded in this insane world of mesh.
Mesh will be closing down. It is holding Truth in Medicine back, as there are
not enough hours in anyone's day to do all the jobs I have created for myself.
There will be a forum/blog on Truth in Medicine as part of the website
everyone for your patience with me! I sincerely appreciate it. Probably the
hardest thing I have to deal with is the constant pain (headaches, neckaches,
backaches) from the two car accidents I had at the end of 2009. I am better but
still working at about 50% because I simply have such a hard
time sitting at the computer for extended periods of time, which is
absolutely necessary to do the job I would like to do.
So 2011 is
the Year of the End of Mesh!!! God has given me a purpose and I claim the
Victory HE has given us!!! God will defeat the enemy, the evil, that is mesh!
WE ARE VICTORS!!! Praise the Lord!!!
blessings to all,
Founder and President
Truth in Medicine Incorporated 901 Pennsylvania Avenue, Suite 3-423
Miami Beach, FL 33139
JUDGE GOODWIN HAS DONE HIS VERY BEST. SIX (6) YEARS INTO THE BEHEMOTH THAT IS TRANSVAGINAL #MESH THERE ARE OVER 23,000 CASES ON THE ACTIVE DOCKET. CONSIDERING THE MONSTROSITY #MESH HAS BECOME, IT IS AMAZING HOW HE HAS KEPT CONTROL OF IT ALL.
PLAINTIFF S ARE KIDDING THEMSELVES IF THEY BELIEVE JUDGE GOODWIN IS GOING TO RULE AGAINST PLAINTIFFS ATTORNEYS. SEE BELOW. THE WHOLE MULTI $ BILLION $ DOLLAR $ ENTERPRISE WOULD COME APART AT THE SEAMS.
THE ONLY WAY FOR PLAINTIFFS TO GAIN CONTROL OF THEIR 7TH AMENDMENT RIGHTS TO A FAIR TRIAL IS TO GO TO CONGRESS, AGAIN AND AGAIN AND AGAIN. “Amendment VII In suits at
common law, where the value in controversy shall exceed twenty dollars, the
right of trial by jury shall be preserved, and no fact tried by a jury, shall
be otherwise reexamined in any court of the United States, than according to
the rules of the common law.”
FIGHT WITH ME IN CONGRESS FOR YOUR 7TH AMENDMENT RIGHTS!
York (December 4, 2017, 9:09 PM EST) -- A West Virginia federal judge on Monday
tossed a suit against "The Law Firm" by a pelvic mesh
class member who said she was pushed into a settlement and the money became
property of her bankruptcy estate, saying a different court already settled the
question of whose property it was. U.S. District Judge Joseph Goodwin granted
the law firm's dismissal bid in the suit brought by Danna Morrison,
who said the firm committed legal malpractice by pushing her to settle for $300,000.
She also alleged...
To god be the Glory! Patients/Plaintiffs Join the Battle Against #MESH! The War is Not Over!
TheLadyisaChamp.Blogspot.com and Lana C. Keeton (c) all rights reserved 2007 - 2020
Lana C. Keeton, Legal Consultant, Medical Device Expert, Expert Witness, Patient Advocate - When I kneel unto God, I can stand before anyone! - *Please note: Nothing on this blog is to be construed as legal and/or medical advice. Postings are personal opinion of the authors.