Patient Advocate Files Racketeering Charges Against FDA, Mesh Maker and Doctor Over Injuries
In the complaint, filed in the U.S. District Court for the Southern District of Florida, the petitioner says defendants have engaged in “a fraudulent scheme in violation of the Federal Racketeer Influenced and Corrupt Organizations Act (RICO)”.
Violations include mail fraud, perjury and a worldwide effort to influence doctors to use their products accomplished through professional medical societies such as AUGS (American Urogynecologic Society) and ICS (International Continence Society).
Also named are Ethicon, a wholly owned subsidiary of J&J, Gynecare Worldwide, Dr. Willy Davila of the Cleveland Clinic, the president of the Cleveland Clinic, and the U.S. Food and Drug Administration.
Dr. Davila performed numerous surgeries on the petitioner from 2002 through 2009 to remove a bladder sling, according to the complaint. At the time he was under contract with J&J, a fact unknown to her at the time, she says. He even attended her first Truth in Medicine conference in September 2009 as a speaker. Truth in Medicine is a nonprofit organization the petitioner founded after she became aware of injuries associated with pelvic mesh after her TVT implant (Ethicon) in December of 2001.
The complaint says since the mid 1990’s, Ethicon (J&J) has hid the risks of polypropylene mesh (Prolene is the Ethicon trade name) while heralding its benefits.
The complaint states:
“Further, David Krause, Branch Chief, General Plastic Surgery Devices at the FDA’s Center for Devices and Radiological Health (CDRH), interacted with Peter Cecchini, Fellow, Regulatory Affairs, Ethicon, Inc. disclosing Keeton’s activities at the FDA in 2010. Krause alerted Cecchini to the existence of damning information in a video, “The Benefits of Light Weight Mesh” funded by Ethicon, Inc. in collaboration with one of Ethicon’s experts, Dr. B. Todd Heniford at the Carolinas Medical Center in 2007. Krause was concerned that it was being shown to Dr. Jeffrey Shuren, Director of the CDRH in a meeting in November 2010.”
The complaint, filed February 4, asks for compensatory damages in the amount of $7 million and punitive damages of $21 million.
The Petitioner has requested her name be removed from Mesh News Desk, however the suit is filed in public court and so MND has abided by her request.
Keeton v. Ethicon, 1:15-cv-20442, U.S. District Court Southern District of Florida, RICO lawsuit, February 4, 2015