LANA C. KEETON TO FILE MOTION TO TAKE JUDICIAL NOTICE
IN-RE ETHICON PELVIC MESH REPAIR SYSTEM - MDL 02327 SOUTHERN DISTRICT OF WEST VIRGINIA
BEFORE THE HONORABLE JUDGE JOSEPH R, GOODWIN
Please support my work as I have supported thousands through my work at the FDA and in Congress
over the past decade. The work is not over!
Dear Meshie Friends,
The 4th Circuit Court of Appeals denied Ethicon/Johnson & Johnson in their petition for re-hearing of the Huskey v. Ethicon Case No. 15-2118. This is serious and affects all cases filed in the Transvaginal MDL’s in the Southern District of West Virginia before Judge Joseph Goodwin. I have personal knowledge and legal expertise to debunk their position, related to the FDA which I will now file in the Southern District of West Virginia before the Honorable Judge Joseph R. Goodwin
What I am filing supports Judge Goodwin's ongoing position NOT TO ALLOW any information on the clearance of transvaginal polypropylene mesh through the FDA. His rulings have been absolutely correct while Ethicon continually perverts the facts about the FDA's 510(k) Premarket Notification Clearance Process. Important point: 510(k) is Not Approval but simply clears Class II medical devices for sale into commerce without clinical trials or any proof of safety or efficacy (that it actually works). My Motion to Take Judicial Notice will include information I originally intended to file in an Amicus Curiae Brief with the 4th Circuit Court of Appeals.
The prolene suture is not the same as the heavyweight prolene mesh used in the TVT-O.
The FDA did not hold its Ob-Gyn Panel meeting September 8-9, 2011 because of lawsuits. Truth in Medicine and my meetings with the FDA presenting scientific evidence of the complications of Polypropylene mesh, in addition to the over 6,000 adverse events filed by mesh injured women, precipitated the meeting and the warnings issued July 13, 2011.
Ethicon completely misrepresents the FDA’s 510(k) PreMarket Notification clearance process. I testified before the Institute of Medicine multiple times in 2010 and am fully aware of the actual legal process.
An FDA employee involved in the clearance of many of Ethicon’s mesh products has also worked for, and been paid by, Ethicon for over 20 years. I have absolute proof of this.
Placing this before Judge Goodwin as a Motion to Take Judicial Notice will have a greater impact than if I only filed it as an Amicus Curiae Brief befoe the 4th Circuit Court of Appeals. It then becomes facts and evidence and precedence for all other cases, even Huskey v. Ethicon if by chance they succeed in getting the Supreme Court to hear an appeal on Huskey. This is very serious stuff for all patients injured by any Class II Medical Device as corporations will no longer be able to tell a jury their Class II Medical Devices are safe because they were CLEARED, NOT APPROVED, by the FDA.
WE MUST STOP THE IMPLANTATION OF MESH INTO HUMANS.
100,000 CASES IN ONE COURT IS RIDICULOUS. How is it possible in a free and open society in the United States of America there is ANY PRODUCT, ANYWHERE that injured 100,000 people and IT IS STILL ON THE MARKET?