Med Device Expert LLC

(c) 2005-2014 Lana C. Keeton. All rights reserved.

LANA C. Keeton _______  ____________________ CURRICULUM VITAE_______________

1602 Alton Road #423, Miami Beach, Florida 33139
(305) 671-9331 phone

(305)342-8002 & (786)566-7780 cell phones

(800)509- 9917 fax

lanakeeton@meddeviceexpertllc.com

MEDICAL DEVICE EXPERT

Extensive research on polypropylene and other foreign body polymers used to manufacture synthetic surgical mesh including:

*Mesh not inert
*Degradation and decomposition

*Physical and chemical properties and resulting complications in humans

*Foreign body polymers and autoimmune disease

 

Keeton has put more than 6,000 hours of research into the cause/effect of patient complications from synthetic and biologic surgical mesh and metal-on-metal hip implants focusing on physical and chemical properties of polymers and metals with consideration for the overall short and long- term impact of these foreign bodies surgically implanted in the human body.

Consulting contracts as a medical device expert with personal injury law firms designing discovery, with universal interrogatories for certain products and manufacturing processes, causes of action, deposition preparation, and consultation and research on legal and scientific issues and FDA regulatory compliance by medical device manufacturers

ENTREPRENEUR/ STEEL BROKER

Keeton sells painted and bare galvanized and galvalume coils of steel to original equipment manufacturers who roll-form steel coils into roofing and siding panels for metal buildings for over 30 years. Excellent knowledge of physical and chemical properties of steel and how they relate to the functioning of the finished product. Directly translates to physical and chemical properties and the manufacture of synthetic surgical mesh. Owner of Florida based Lana C. Keeton LLC since 2001.  

PRESIDENT AND FOUNDER  - TRUTH IN MEDICINE INCORPORATED

Truth in Medicine is a nonprofit patient advocacy organization Keeton founded in 2008 to educate the public about the potential risks and complications from the implantation of synthetic surgical mesh into the human body. The organization also educates and supports patients who have already been harmed by surgical implantation of synthetic mesh. 

 

Truth in Medicine has worked with key members of the U.S. Food and Drug Administration and specifically the Center for Devices and Radiological Health (CDRH) as a patient advocate since 2007. The organization was instrumental in the FDA issuing warnings on the serious risks and complications associated with the transvaginal placement of surgical mesh in October 2008 and a second much more serious Patient Health Notification issued by the agency in July 2011.

 

Truth in Medicine Focus at this time is to influence the CDRH to make better use of the FDA’s current regulatory authority for greater patient safety.

 

Organized two national mesh-injured patient conferences in Washington, D.C. including nationally recognized speakers, a doctor’s roundtable, brainstorming sessions, visits with members of Congress and a rally in front of the Capitol building.

February 2012

 

Invited by Consumers Union and Rep. Edward Markey (D-MA) to present to members of the press concerning the Sound Devices Act.

 

March 2012

 

Keeton presented at FDA’s public meeting on MDUFA III

Patient Consumer and Health Coalition of 20 different organizations, Truth in Medicine continues to work with the coalition, and has since 2008, to inform members of Congress about the inadequate use of patient safety provisions within the agency and to make changes to the antiquated 510(k) clearance process.

November 2011

Consulted with Public Citizen on its petition to have transvaginal mesh removed from the market.

Met with Union of Concerned Scientists – 2-day session to help prepare a White Paper on patient safety lapses within the FDA.

ON CAPITOL HILL:


Truth in Medicine and Keeton actively work with legislators on Capitol Hill on current legislation to strengthen medical device safety.  Particular focus is the current uninformed use of synthetic surgical mesh with a long term view to properly inform patients not only on synthetic surgical mesh, but on all permanently implanted medical devices.

Testimony advocating for patient safety within the FDA regulatory framework has been presented to the  Institute of Medicine, various members of Congress, key personnel within the FDA/ CDRH and at Truth in Medicine patient conferences. Keeton is actively working to have synthetic surgical mesh removed from the market by working within the current regulatory authority of the FDA/CDRH. She has expansive knowledge of FDA and CDRH regulatory authority relating to synthetic and biologic surgical meshes and medical devices as a whole.

INFLUENCED LEGISLATION:
Institute of Medicine – Review of FDA’s 510(k) regulatory authority, Truth in Medicine was the only patient advocacy group whose recommendations were included in the final IOM report to the FDA July 2011.


CURRENTLY WORKING:
Truth in Medicine is working with Advancing Patient Safety Coalition, a group of hospitals and patient advocacy groups – To enlighten and inform members of Congress concerning key patient safety issues currently not included in the proposed Unique Device Identifier on all medical devices.

 

AT THE FDA:

In person meetings: March 2, 2010 - November 3, 2010 - November 17, 2011 – February 2012 - Continuing efforts with key senior personnel at the CDRH to make patient labeling mandatory for all implantable medical devices to be provided in a separate non-sterile package along with the Instructions for Use (IFU).

PRO SE PLAINTIFF


Keeton’s lawsuit against Johnson & Johnson/Ethicon/Gynecare Worldwide for defective synthetic surgical mesh product liability was filed in December 2005. It led to her work as a legal consultant and research analyst designing discovery and providing unique comparative analysis of complications in humans as they relate to the design, manufacture and surgical implantation of the devices

MESH INJURED PATIENT


As a mesh-injured patient, Keeton understands the real personal trauma resulting from serious synthetic mesh complications. Her near-death experience from necrotizing fasciitis followed her own mesh implantation in 2001. Keeton has endured repeated mesh removal surgeries over the last decade.


FUTURE PUBLIC PRESENTATIONS

January 2013

Will present as a guest lecturer concerning Keeton’s work as a patient advocate and founder of Truth in Medicine at the University of Texas at Austin Osher Life Long Learning Institute UT Quest Program; Presentation titled: “The FDA’s Rules and Regulations. Reality: Why you are not protected as a patient.”

 

April 2013

Keeton is scheduled to be a featured speaker at the University of Miami’s, Florida BioEthics 21st Annual Conference on how patient advocates can impact decision- making at the FDA. This follows Truth in Medicine’s success in influencing the issuance of the 2008 and 2011 Public Health Notifications by the FDA on the serious dangers and complications concerning the use of transvaginal mesh used in pelvic organ prolapse and incontinence. 

RELATED EXPERIENCE

 

KK INTERNATIONAL BOXING PRODUCTIONS

Licensed Boxing Promoter in the State of Florida, 1999 – 2001 promoting boxers from Argentina; Company closed due to near death from mesh implantation

 

EVENT PLANNER AND FUNDRAISER

 

Raised monies for various nonprofit organizations.

PROFESSIONAL MEMBERSHIPS

 

Member: American Chemical Society

Member: Alpha Delta Pi Sorority

Florida Bioethics Network Conferences 2010 – 2011 (CME certificates)

Texas Christian University: attended on an educational scholarship 2 years

University of Texas at Austin: 1 ½ years; classified as a senior

High School: DAR Good Citizen of the year, National Honor Society, other honors, awarded scholarship to college, many other activities.

 

PERSONAL

*Extensive knowledge of FDA and CDRH regulatory authority relating to synthetic and biologic surgical meshes and medical devices as a whole

*Intellectually and Socially Passionate

*Excellent Speaking and Presentation skills

*High IQ and love of data result in Exceptional Analytical and Research skills

*Creation of numerous databases from research into surgical mesh complications which include thousands of detailed records on mesh injured patients

*Spanish - speak fluently and read/write with high proficiency

 

Native Texan, Daughter of a homemaker and cattle rancher who also owned a meat packing company. I grew up on a farm with a large extended family. Love the outdoors, travel, and my beautiful West Highland White Terriers

TRUTH IN MEDICINE INCORPORATED www.truthinmedicine.us.com

MED DEVICE EXPERT LLC www.meddeviceexpertllc.com

PERSONAL WEBSITE: www.lanakeeton.com

PERSONAL BLOG: www.theladyisachamp.blogspot.com

 

MESH ACTIVISM TIMELINE

 

December 21, 2005

Filed Pro Se Product Liability lawsuit vs. Johnson & Johnson/Ethicon/Gynecare Worldwide for defective Gynecare TVT Prolene polypropylene Bladder Suspension System

 

May 2006

Lana Keeton vs. Gynecare Worldwide removed to United States District Court for the Southern District of Florida; in Federal Court through October 2007

 

Spring 2007

Multiple successful motions to compel discovery from defendants – Have tremendous insight into manufacture, processing, distribution and marketing of all Johnson & Johnson/Ethicon/Gynecare synthetic surgical mesh products including Mersilene, Prolene, Gynemesh, UltraPro, etc.

 

April 2007

Hired Peter Schmitt, Textile Development Associates, a textile engineer as expert witness.

 

July 23, 2007

Court ordered Summary Judgment in favor of Ethicon/J&J based on procedural error. Failed to name my treating physicians, who were experts, as non-retained experts. Judge ruled unable to prove medical causation.

 

September 16, 2007

created Medical Mesh, a yahoo members only health group for mesh injured patients – over 8,000 posts moderated over 4 year period

 

September 27, 2007

Provided my expert witness reports to Henry Garrard III, at Blasingame, Burch, Garrard & Ashley, demonstrating lack of substantial equivalence in the 510(k) clearance of the Gynecare TVT and scientific defects in synthetic surgical mesh for his use in the Mentor Obtape litigation he later won

 

June 2008

Truth in Medicine, a patient advocacy organization, organized in the State of California

 

June 16, 2008

First FDA Center for Devices and Radiologic Health (CDRH) Synthetic Mesh Conference Call

Dr. Daniel Schultz, Center Director CDRH

Dr. Murray Malin, Medical Officer Office of Compliance

Ann Ferriter, Network Leader

Betty Collins, Division Director- Office of Compliance

Tom Knott, Branch Chief Office of Compliance

Wayne Miller, CSO Office of Compliance

Harriet Albershiem, Public Health Advisor Office of Communication, Education and Radiologic Programs

Lori Bernato, Senior Regulatory Officer- Office of Compliance

 Scott McNamee, Materials Engineer- Office of Compliance

Les Weinstein, Ombudsman CDRH

Roxolana Horbowyj, Medical Officer Office of Device Evaluation

Vicky Wolfhard, Executive Secretary CDRH

 

July 2008 

Provided 300 pages of discovery re: failures of  Gynecare TVT System to Murray Malin at the FDA.  At the same time, the CDRH was clearing for sale the Gynecare Prolift mesh kit which had been on the market since 2005 without any clearance or authorization from the FDA

 

July 3, 2008

Conference call with Jim Shull and Dr. Murray Malin, FDA Medical Officer, Office of Compliance

 

July 21, 2008

Conference call with Jim Shull and Dr. Murray Malin, FDA Medical Officer, Office of Compliance

 

August 11, 2008

Conference Call with Dr. Murray Malin, FDA Medical Officer, Office of Compliance and Dr. Kimber Richter, Deputy Director of Compliance

 

July 2008

Met and consulted with Nancy Hersh and Amy Eskin, Hersh & Hersh at their offices in San Francisco, CA advising them on the inherent defects of synthetic surgical mesh

 

September 2008

CDRH conference call

 

September 2008

WPLG Channel 10 Miami ABC affiliate television interview

 

October 21, 2008

First FDA Public Health Notification warning of serious risks and complications of Transvaginal Mesh. 9 manufacturers

 

October 2008

Adam Slater, Mazie, Katz, Slater contacted me re: legal consulting; Results: Mazie Katz’s website meshcomplications.com created the very next day; Mazie, Katz was able to capitalize on my work; placed multiple internet ads alongside my internet postings immediately thereafter

 

February 2009

CDRH conference call

 

May 2009

Truth in Medicine re-organized in the State of Florida

 

May 2009

“Suffering in Silence” series, Jane Akre, Injury Board

 

August 2009

Ken Goodman PhD collaboration to create Informed Consent Website, initially for synthetic surgical mesh and then to follow with other implanted medical devices; ongoing collaboration at the FDA/CDRH, Speaking at Truth in Medicine Annual Conferences; a tremendous asset to Truth in Medicine

 

September 25-26, 2009

First Annual Conference Truth in Medicine, “Surviving the Complications of Synthetic Surgical Mesh”, Ft Lauderdale, FL

Friday - Ken W. Goodman, PhD, Director, Bioethics Program and Co-Director, Ethics Programs, University of Miami, Nancy Muller, Executive Director NAFC, Diana Zuckerman, President, NRC

Saturday - Doctors Roundtable: Dr. Dee Fenner, Dr. Cheryl Iglesias, Dr. G. Willy Davila, Cleveland Clinic Weston, Florida

 

December 2009

won medical malpractice lawsuit against Dr. Bernard Cantor; Mt Sinai Medical Center settled before trial.

 

February 25, 2010

WSVN Channel 7 Fox Affiliate Lana Keeton interview on pitfalls of synthetic surgical mesh for hernia repair, bladder suspension and pelvic organ prolapse

 

March 1, 2010

Testified as patient advocate at 1st Institute of Medicine (IOM) workshop on the 510(k)

 

March 2, 2010

Presentation at FDA, Silver Springs, MD to senior personnel on the FDA’s Surgical Mesh Investigative Team:

      Truth in Medicine Formal Requests to FDA/CDRH:

1.       Issue a Public Health Notification warning of the serious risks and complications of Synthetic Mesh used for Hernia Repair

2.       Informed Consent packaged in non-sterile packaging with package insert

3.       Re-review of surgical mesh based on GAO’s recommendations

4.       Future Synthetic Surgical Mesh not be cleared through 510(k) process

5.       Require Post Market Studies of Meshes already on the market

6.       Warnings clearly demonstrating serious risks and complications, including death

7.        Black box warning on all synthetic surgical meshes

8.       Special Guidance Document on synthetic surgical mesh

      How do we help protect patients?

1.        Better Patient Education - Informed Consent - How the FDA/CDRH will play a vital role in this process.

2.       Synthetic Surgical Mesh is an example of the inadequacies of the 510(k) approval process. How will we use the example of synthetic surgical mesh to facilitate the FDA’s current review of the 510(k) process ?

3.       Physical and Chemical Properties of Synthetic Surgical Mesh; Processing of the Mesh;      Maintaining the Integrity of the Mesh; Biocompatibility of Mesh; Performance in Vivo

4.       Going Forward: Questions without Answers. What to address first? Which should not be addressed at all? Which ones have already been answered? 

 

March 10, 2010

Truth in Medicine Hospitality Suite, American Hernia Society, Orlando, FL – filmed patient and doctor interviews

 

June 14, 2010

Testified at 2nd IOM  workshop on the 510(k); Organized group of mesh injured patients who also testified at IOM workshop; Meeting with Congresswoman Ileana Ros-Lehtinen on Surgical Mesh at her office in D.C. to discuss ongoing efforts of Truth in Medicine

 

July 2010

Hired as legal consultant/research analyst by Mark Mueller, Mueller Law, Austin, TX; Provided extensive legal, scientific and FDA regulatory authority information to Mueller from my research which started in 2005; Showed Mueller how to organize their client intake so it related to the FDA’s 510(k) clearance of the products implanted in their clients

 

August 2010

Hired as legal consultant/research analyst by Henry Garrard III, Blasingame, Burch, Garrard & Ashley, Athens, GA; Provided extensive legal, scientific and FDA regulatory authority information to Garrard, introduced him to multiple doctor experts, investigated misconduct of medical device companies, significant research on Sofradim Production, Covidien and Tyco led to their successful inclusion as Defendants in the Bard Avaulta litigation in West Virginia; Extensive analysis of why mesh is not inert; showed correlation between multiple studies and their conflicting conclusions

 

August 2010

Attended 3rd and final IOM workshop on 510(k) Clearance Process in Washington, D.C.

 

October 1, 2010 

“Mesh Out” Rally on the National Mall in front of the Capitol Building

 

October 2, 2010

Second Annual Conference Truth in Medicine in Washington, D.C. “Alternatives to Synthetic Surgical Mesh”

Dr. Kevin Petersen, Summerlin Surgical Asso, Las Vegas, NV

Ken Goodman, PhD, Professor & Director Bioethics Program, University of Miami, Miami, FL

Paul Brown, Governmental Relations, NRC, Washington, D.C.

Shannon Brownlee, Author “Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer”, Washington, D.C.

 

November 3, 2010 Meeting

Presentation at FDA, Silver Springs, MD to the following senior personnel on the FDA’s Surgical Mesh Investigative Team:

Diane Mitchell: CDRH Assistant Director for Science, Office of the Center Director

Geetha Jayan: Network Leader, Office of the Center Director

James Saviola: Network Leader, Office of the Center Director

Bakul Patel: Policy Advisor, Office of the Center Director

Patricia Dillon: Staff Fellow, Office of the Center Director

Nilsa Loyo-Berrios: Branch Chief, Office of Surveillance and Biometrics

Nasrin Mirsaidi: MDR Specialist, Office of Surveillance and Biometrics

Cara Krulewitch: Lead Epidemiologist, Office of Surveillance and Biometrics

Nancy Pressly: Acting Associate Division Director, Office of Surveillance and Biometrics

Douglas Wood: Acting Division Director, Office of Surveillance and Biometrics

Thomas Knott: Branch Chief, Office of Compliance

Charles Anamelechi: Commissioners Fellow, Office of Compliance

Murray Malin: Medical Officer, Office of Compliance

Dora Vega: Medical Officer, Office of Compliance

Xin Xie: Commissioners Fellow, Office of Compliance

Wayne Miller: Consumer Safety Officer, Office of Compliance

Paula Silberberg: Public Health Advisor, Office of Communications Education and Radiation Programs

David Krause: Branch Chief, Office of Device Evaluation

Colin Pollard: Branch Chief, Office of Device Evaluation

Julia Corrado: Medical Officer, Office of Device Evaluation

Jill Brown: Medical Officer, Office of Device Evaluation

Martin McDermott: Biomedical Engineer, Office of Science and Engineering Laboratories

 

March 10, 2011

Testified at CDRH Town Hall Meeting, Irving, TX; organized group of mesh injured women who also testified

Town Hall Discussion With the Director of CDRH and Other Senior Center Management http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm239730.htm

 

April 13, 2011

Attended Special Committee on Aging Congressional Hearing on Medical Devices in Washington, D.C.; Organized group of other mesh injured patients to also attend; Invited by Senator Kohl’s office to put statement on Medical Device Patient Safety in the record

 

May 17, 2011

Truth in Medicine hosted Capitol Hill Briefing with Dr. Shlomo Raz as Keynote speaker. Other testimony by Lana Keeton, President and Founder, Truth in Medicine, Diana Zuckerman, NRC and Janet Holt, Regulatory Affairs Director, Truth in Medicine.

 

May 17, 2011

Truth in Medicine introduced Dr. Shlomo Raz to CDRH Director Dr. Jeff Shuren and other key senior personnel (see list below) involved in Surgical Mesh Investigative Team at the FDA in Silver Springs, MD. Made request direct to Dr. Shuren to please have ObGyn Advisory Panel meeting; Request was granted and meeting was held Sept 8/9, 2011. Presentation by Dr. Raz was a big precipitator of the July 13, 2011 Transvaginal Mesh Warnings because of questions presented to the CDRH personnel by Dr. Raz: 

                1.  Dr. Raz is seeing systemic effects of mesh and provided illustrations.

                2.  Mesh is not inert, despite representations by industry to the contrary.

                3.  A “minimally invasive” procedure is causing permanent disability.

                4.  Interstim implant patients receive a card after surgery documenting the medical

                     device implanted in them. Mesh implant patients should be provided the same.

                5.  Should mesh be considered a drug?

                6.  The MAUDE database is not user friendly for filing adverse event reports. 

                7.  If Synthetic Mesh were a drug with at least 10 associated deaths, it would most likely already be         off the market. 

Office of the Center Director: 

Dr. Jeff Shuren, Director, Dr. Diane Mitchell, Rachel Turow, Geetha Jayan

Office of Device Evaluation:

Jill Brown, Becky Robinson, Joyce Whang, Dr. Julia Corrado, Colin Pollard, Herbert Lerner

Office of Surveillance and Biometrics: Cara Krulewitch, PhD, Nasrin Mirsaidi, Megan Gatski, Ozlem Topaloglu, Samantha Jacobs, Colin Anderson-Smits

Office of Compliance: Charles Anamelechi, Jason Brookbank

Office of Communication, Education, and Radiation Programs:  Paula Silberberg, Kemba Ford

 

July 13, 2011

FDA issues second Public Health Notification (PHN) on serious risks and complications of Transvaginal placement of synthetic surgical mesh.

 

July 14, 2011

Participated in FDA Conference Call re: July 13, 2011 PHN on serious complications of Transvaginal Mesh

 

August 2011

IOM report issued; Truth in Medicine recommendations included; TIM recommendations were only patient advocate recommendations included in report

 

September 8/9, 2011

Testimony at ObGyn Advisory Panel Meeting on Synthetic Surgical Mesh

 

September 16, 2011

Testimony at FDA Institute of Medicine (IOM) Public Meeting – Recommendations Proposed in Institute of Medicine Report: Medical Devices and The Public’s Health, the FDA 510 (k) Clearance Process at 35 years

 

November 14, 2011

Meeting with Nick Carome, M.D. at Public Citizen. Public Citizen filed a legal petition August 25, 2011 to have all mesh for Pelvic Organ Prolapse recalled immediately and completely and meetings with government officials in D.C.

 

Nov 15/16, 2011  

2 day meeting of the Union of Concerned Scientists at George Washington University convening a group of experts to look at the FDA right now titled “FDA at a Crossroads”. Margaret Hamburg, Commissioner of the FDA, keynote speaker. Day 2 was a closed session where we broke up into small groups and the "insights generated during these small-group discussions will be summarized in a white paper offering formal recommendations to government decision-makers". See link below. 

 

 November 17, 2011

Meeting with the FDA/CDRH Surgical Mesh Investigative Team to present substantial new scientific research I have done showing mesh is not inert and the resulting autoimmune complications.

 

Nov 18/19, 2011

Invited Guest by Joleen Chambers, Founder, Failed Implanted Medical Devices, Dallas, TX  75201 http://fida-advocate.blogspot.com/ Leadership Conference "It’s All About You – Health and Wellness for Texas Leaders" presented by The Foundation for Women’s Resources www.womensresources.org in San Antonio, TX

 

February 2, 2012

Partnership with Consumer’s Union on Capitol Hill meeting with Congressmen and Senators and their staffers

 

March 28, 2012

Invited to participate on Stakeholder Perspectives Panel and make presentation at FDA Public Meeting on Medical Device User Fee Act (MDUFA III); Meeting at Hubert H. Humphrey Building in Washington, DC

 

April 20, 2012                                     

 Mass Torts Made Perfect Invited Patient Advocate fGuest Panelist - Transvaginal Mesh Panel with attorneys Robert Price, Henry Garrard III and Amy Eskin

 

Mesh Activism Timeline will be updated with additional 2012 activism. There is much more!