Patient Advocate Files Racketeering Charges Against FDA, Mesh Maker and Doctor Over Injuries

//Patient Advocate Files Racketeering Charges Against FDA, Mesh Maker and Doctor Over Injuries

Patient Advocate Files Racketeering Charges Against FDA, Mesh Maker and Doctor Over Injuries

j&j LOGOA patient advocate has filed a Pro Se complaint against Johnson & Johnson accusing it of organized corruption.

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. 

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 the petitioner’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.  

Learn More:

Keeton v. Ethicon, 1:15-cv-20442, U.S. District Court Southern District of Florida, RICO  lawsuit, February 4, 2015 


By |2018-06-19T10:52:56+00:00February 11th, 2015|Legal News|13 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. cari February 11, 2015 at 6:50 pm - Reply


    • Lori February 12, 2015 at 12:29 am - Reply

      your so right cari, it would be a whole different world, just wonder how many women work for these manufacturers, seems so wrong how they falsely advertise that they are here to help and heal women, at least Boston Scientific projects that image,

    • Linda Dodson February 12, 2015 at 3:24 pm - Reply

      Cari, That’s exactly what I said in my 27-page complaint letter to the FDA that I personally delivered to the FDA Director in AAtlanta, Ga. in February 2007. I said if this was placed in a man’s penis and they experienced all the complications that women experienced, then it would be taken off the market.

    • kitty February 20, 2015 at 9:53 am - Reply


      but it was stated in a vulgar and hurtful way to the male victims of hernia mesh. I know u didn’t mean to hurt anyone. It is true…we may have the same product..but our experience via the vagina is entirely different.

    • lisa February 23, 2015 at 2:40 pm - Reply

      I agree with you 100% The only ppl that are suffering are us and they/the companies don’t give a damn. Seems like they are taking their time waiting for us to die off.

  2. scott February 12, 2015 at 12:39 am - Reply

    Last week tonight with John Oliver, tells it all.

  3. kitty February 12, 2015 at 5:06 am - Reply

    I guess women shoulder so much of the life process. OUR vagina’s and uterus’ are taken for granted

  4. Terri White February 12, 2015 at 8:51 am - Reply

    Jane, this stuff I have been reading about company reps being in the OR during surgery is it truth or just talk? Sounds a little outrageous . What do you know ?

  5. keri February 16, 2015 at 10:01 pm - Reply

    Try to keep you complaints specificnand to the point. Dont want to hurt Any ones feelings , but a 27 page complaint to FDA will just be considered a rant and Never be read. 2-3 pages total is appropriate.

    • Jane Akre February 16, 2015 at 10:53 pm - Reply

      Keri- Linda Dodson is a hero in the mesh movement. Her words were so effective that the FDA contacted her for a sit down. If anyone knows how to communicate to the FDA in a language they understand, it is Linda Dodson, 27-pages and all! ~ ja

  6. All Meshed Up February 19, 2015 at 9:24 am - Reply

    I want to Thank “Cari” for the visuals of a mans penis being ripped and torn etc.. Please do not try to equate one Mesh Victims pain and suffering with anothers.

    8 years I have been dealing with the pain from my Mesh implants removals etc. My penis hasn’t ripped or torn but there have been many times that the pain was enough for me to consider suicide. I lost a testicle. I have lost my profession. I am on pain medications. I continue to have infections and just recently underwent my 6th and 7th surgery. SSI does not recognize Mesh damage as a disability even with documentation so I cannot get SSI. I have been and continue to live my life every day with the pain from a Mesh implant gone bad. So I do not want my Mesh problem made less because I am a man and have a Penis! The FDA does not give a damn one way or the other “Cari”! So please remember that when you start making comparisons or making stupid statements about a how if it been a “man’s penis being ripped apart” the FDA would take notice! The FDA does not give a damn either way.

    We as Hernia Mesh Victims have been dealing with the blindness of the FDA for more years than any of the Gynecological Mesh Victims have. Our complaints FILL the MAUDE data base. Bruce Rosenberg has met with and presented more documentation, including a DVD that Ethicon produced, than anyone has. And yet the FDA still does nothing. It is because there are so many cases concerning Gynecological Mesh that a Hernia Mesh victim cannot even get a Lawyer to talk to them about their Mesh gone bad. Gynecological Mesh lawsuits are advertised by different Lawyers every day on TV. You do not see these advertisements also offering legal services to Hernia Mesh Victims. The Doctor’s advertiseing on this site offer services to women with Gynecological mesh problems ONLY. Hernia Mesh Victims cannot find Doctor’s that remove Hernia Mesh very easily. The ones that do and are worth a crap are scheduled several months out and most are in their late 60’s or early 70’s! And if you have not figured it out by now, Hernia Mesh Victims include WOMEN! They don’t have a penis being ripped apart but their lives have been compleyely changed by Mesh, also

    Please, Dear Ladies, remember that we should ALL be in this fight together. We should all, as Mesh Victims and Survivors, fight to have Polypropylene Mesh taken off the market, the Manufacturers held resposible for their products damage and the FDA to recognize Mesh as a damgerous product and to change the laws regarding it. Men and women all over this Country and the World have been and continue to be Implanted with Mesh products, many without the knowledge of it dangers! We cannot stop this while we are small individual groups representing this mesh problem or this mesh product etc. So when you go on rants about “if it had been a man’s penis” blah blah, do not try to diminish my pain and suffering so as to promote your own. We all need to be in this together. Best Wishes…….

  7. Toni February 20, 2015 at 10:59 am - Reply

    Any news this week? Seems like nothing has come out this week. What is the status of the Perry case?

Leave A Comment