LANA C. KEETON, PLAINTIFF PRO SE, FILES NEW SUIT UNDER RICO ACT V. JOHNSON & JOHNSON, ETHICON, INC, GYNECARE WORLDWIDE, ETHICON SARL in SWITZERLAND, the FDA/CDRH, DR. G. WILLY DAVILA, CLEVELAND CLINIC, ARNSTEIN & LEHR LLP ET.AL.
CASE #1:15-CV-20442-JLK in the UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF FLORIDA
FEBRUARY 4, 2015
PURSUANT TO THE FEDERAL RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS
ACT (RICO), 18 U.S.C. §1961, MAIL OR WIRE FRAUD, 18 U.S.C. §§ 1341 and
1343 and an OBSTRUCTION OF JUSTICE18 U.S.C. § 1503,
BY OMISSION and/or FRAUD BY CONCEALMENT
DIVERSITY JURISDICTION 28:1332ri
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Med Device Expert LLC
Legal Consultant . Research Analysis . Strategist
Synthetic Surgical Mesh
Lana C. Keeton filed a product liability lawsuit Pro Se against Gynecare Worldwide, Ethicon Inc and Johnson & Johnson in late 2005 for the defective Gynecare TVT implanted in her in December 2001. April 2006 Ethicon placed a litigation hold for its Gynecare TVT product based on Ms. Keeton's suit.
Today that is the litigation hold date applied to thousands of cases filed in Ethicon MDL 02327 in the Southern District of West Virginia. Extensive research for the suit gave her the knowledge to help other mesh injured patients.
She is the President and Founder of Truth in Medicine Incorporated, a nonprofit patient advocacy organization she 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 was instrumental in the FDA trans-vaginal mesh warnings of 2008 and 2011.
Keeton’s background as a steel broker/entrepreneur, selling steel coils to manufacturers of metal buildings for over 30 years, influenced her research into polymers from a commercial perspective. Her clear understanding of the physical and chemical properties of steel contributed significantly to her original hypothesis on the inherent defects in the manufacturing process of polymers, polypropylene in particular, and its direct cause of autoimmune disease as a complication of surgical mesh implantation
Keeton presented this to the FDA on August 22, 2014. The FDA/CDRH audience was quite impressive, including bio-medical engineers, a polymer engineer, toxicologists, a microbiologist and medical doctors.
Keeton asked the FDA not to allow any clinical trials on mesh for pelvic organ prolapse repair until each company properly characterizes the polymer materials they use to manufacture their synthetic surgical meshes.
Synthetic Surgical Mesh does not belong in the human body. The fact that patients do not die from its implantation is a testament to the human body's ability to deal with foreign body polymers. 50 years of use as sutures is not license to implant it willy nilly in the body.
Lana Keeton has spent thousands of hours researching synthetic surgical mesh, has tremendous insight into the cause of mesh complications she developed while working as a patient advocate, has a highly technical background in the steel business, was instrumental in getting the FDA to issue warnings on the serious risks and complications of transvaginal mesh (twice) who personally treated with at least 20 doctors and underwent 19 surgeries/procedures to deal with the complications of mesh.
Ms. Keeton has a very unique educated perspective on the fallacies and causes of serious complications of the dangerous medical device, synthetic surgical mesh.
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