Ethicon 7/21

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Mum of three leaks documents to Sling The Mesh campaign to show that pain suffered after her operation is being ignored - despite being part of a trial that promised to monitor her for three years

   Jul 20, 2015 | Wisbech Standard

   By Kath Sansom
   
   
   Women who have agreed to be guinea pigs for one of the first human trials into an operation for incontinence are not being listened to when they suffer extreme pain, it has emerged.
2. Patient Advocate Lana Keeton Sues J&J, FDA for Criminal Obstruction of Justice – Dead Women Matter!

   Jul 20, 2015 | Mesh Medical Device News Desk

   By Jane Akre
   
   
   ...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...

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Mum of three leaks documents to Sling The Mesh campaign to show that pain suffered after her operation is being ignored - despite being part of a trial that promised to monitor her for three years

   Jul 20, 2015 | Wisbech Standard

   By Kath Sansom

   Women who have agreed to be guinea pigs for one of the first human trials into an operation for incontinence are not being listened to when they suffer extreme pain, it has emerged.

   The news comes after a mum of three, who signed up for the trial, leaked documents to reporter Kath Sansom after seeing her Sling The Mesh campaign on Facebook, to show the research is not properly monitoring the 305 women involved.

   The woman told her surgeon that she was suffering chronic pain in November 2014.

   Eight months later, however, she has still not been treated. More worrying is that trial leaders insist there have been no complications so far.

   The woman said: “I am supposed to be part of a carefully monitored trial but nobody is taking notice.

   “Pain is so bad that at night I can’t lie on one side, I have constant stomach pains like period cramps, it sometimes takes my breath away, I have hip pain, sex is too painful. I was fit and active before, not anymore.

   “The sling only worked for eight weeks. When I went back to the surgeon I hoped he could offer something to fix this but I was told if it isn’t working we might as well leave it in.

   “He offered to put another sling in, inject me with botox to cure the incontinence or give me abdominal surgery. I signed up to the SIMS trials feeling I would be looked after, it is not the case at all. The pain has been ignored.”

   SIMS trials have been taking place in 11 hospitals across the country since July 2014 and are designed to compare mini slings with the TVTO mesh.

   The woman said she was sent a £15 love to shop voucher as a thank you for participating.

   By comparison surgeons are encouraged to find the 650 women needed for the trial with the lure of prizes such as a trip to Rio de Janeiro and laptops, which was exposed in an investigation led by Scottish journalist Marion Scott earlier this year.

   Mohammed Abdel Fattah, the surgeon leading the SIMS trials, based at Aberdeen University Hospital, said in 2011 that evidence did not support the use of mini slings.

   He now heads up the trials and on his CV says that he receives travel sponsorship from sling makers, Ethicon. A spokesman said he was currently on annual leave and not available for comment.

   The mum in the trial sent Kath a copy of the 19-page questionnaire sent five times over three years, to show that questions had been selectively worded to concentrate on a woman’s “urinary problem” and not give space to properly detail post operative pain or complications.

   “The questions all focus on if your urinary problem is affecting your life.

   “They are cleverly worded so you cannot answer saying you are in pain. This is wrong as it does not give space for women to detail terrible complications that can happen, so the reality of risks goes unrecorded” she said.

   A spokesman for the SIMS trials said: “The independent Data Monitoring Committee review safety data and, to date, have reported no concerns with data they have reviewed.

   “Mr Abdel-Fattah’s paper in European Urology was a review of the literature published on SIMS and Standard Midurethral Slings (SMUS) – the trials reporting on the use of the SIMS technique were considered sub-optimal and the authors concluded the paper by recommending the initiation of an adequately powered and properly designed Randomised Controlled Trial to compare the new adjustable SIMS with SMUS and this is exactly what is being done in the SIMS Trial.”

    

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2. Patient Advocate Lana Keeton Sues J&J, FDA for Criminal Obstruction of Justice – Dead Women Matter!

   Jul 20, 2015 | Mesh Medical Device News Desk

   By Jane Akre

   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
   LanaKeeton@MedDeviceExpertLLC.com

   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. #

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