Patient Advocate Lana Keeton Sues J&J, FDA for Criminal Obstruction of Justice – Dead Women Matter!
Lana Keeton has probably done more to bring awareness of the pelvic mesh mess than any single individual.
She has spoken to the Food and Drug Administration (FDA), held rallies in Washington, D.C., testified to the expert panel convened to discuss transvaginal mesh in September 2011. Having worked within the system for so long, with a very slow if not nonexistent response from the FDA, Keeton has filed a federal, criminal lawsuit naming Johnson & Johnson, the FDA and its Center for Devices and Radiological Health (CDRH) and the CDRH regulators who ignored his responsibility to act in the public interest. Below is her news release. This week a series of interviews will follow.
FOR IMMEDIATE RELEASE
July 20, 2015
PATIENT ADVOCATE LANA KEETON SUES J&J AND FDA FOR CRIMINAL OBSTRUCTION OF JUSTICE UNDER FEDERAL RICO STATUTES
DEAD WOMEN MATTER
Patient advocate and medical device expert, Lana Keeton has filed a civil RICO lawsuit in Miami federal court alleging criminal conspiracy by doctors, pelvic mesh maker Johnson & Johnson, the U.S. Food and Drug Administration (FDA) as well as regulators within the Center for Devices and Radiological Health (CDRH) which oversees the approval of medical devices in the U.S.
The most recent 86-page filing by Keeton includes the reports of death of at least a dozen women after their Gynecare TVT bladder sling. The deaths were reported to the FDA before January 2007.
“The FDA failed to take any enforcement action against J&J despite a clear pattern of harm from the Gynecare TVT bladder sling evidenced by the deaths associated with the defective pelvic mesh kits filed with the agency by Johnson & Johnson itself, but rather the FDA continued to clear pelvic mesh kits knowing the fatal consequences.” Keeton calls that a violation of their mission of protecting the public health. Working with industry doctors, J&J and its subsidiaries, the Cleveland Clinic and employees of the FDA conspired to obstruct justice and commit fraud, a violation of the Federal Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. §1961.
“Defendants have committed mail fraud, wire fraud, perjury and a massive cover up to influence doctors and surgeons worldwide through professional societies, the International Urogynecological Association (IUGA), the International Continence Society (ICS), the American Urogynecological Society (AUGS) to implant millions of women over the last 20 years with a petroleum waste byproduct, the Ethcion/Johnson and Johnson trademark Prolene polypropylene synthetic surgical mesh for surgical treatment of incontinence and pelvic organ prolapse.” states the Original Complaint filed on February 4, 2015.
Unlike a defective product lawsuit, a RICO filing alleges “a pattern of predicate act” crimes which are punishable by at least one year imprisonment.
The FDA is not immune from prosecution when it harms another federal agency. Keeton says in her case, the cover up by the FDA Defendants in her case defrauded the U. S. Bankruptcy Court and Medicare. Her lawsuit hinges on the damage done to her business and property.
In her filing, Keeton chronicles the deaths of a dozen women beginning in 1999. All of the women suffered and died after being implanted with an implant made by Ethicon. Some died from bacterial infections, some from bleed outs after or during a mesh implant.
“Dead women matter. Their deaths were reported to the FDA but the agency failed to act even though it knew the mesh products were misbranded and adulterated and should have been recalled. It’s their job to protect the public health. How many chances do corporations get before the FDA/CDRH uses its enforcement authority? The dead women did not get a second chance” ~ Lana Keeton
The pattern and practice of the FDA/CDRH allowed the deaths to continue when the reports came into the agency and it failed to enforce its own regulations. She names David Krause, PhD, a senior member of the FDA who conspired along with Johnson & Johnson employee Peter Cecchini to cover up knowledge of the dangers of mesh even when in 2010 he obtained a 2007 videotape hosted by a consultant/doctor to Ethicon showing the Prolene mesh, also used for hernia patients, was too heavy for the pelvis, shrank and hardened like a stone inside the body.
“For years I’ve been bringing evidence to the FDA about polypropylene mesh and its dangers to patients. Instead, the FDA communicates secretly with industry and conspires to protect industry, not Keeton, not the public, and certainly not the women who died from the Johnson & Johnson Gynecare TVT bladder sling.” she says. #