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Grey Haze Over Lake of the Ozarks as Prolift Pelvic Mesh Death Case Begins

It is Camden Co courthousegrey and 13 degrees F. today in this small town of Camdenton, Missouri as the first day of the Budke v Ethicon defective product case gets underway.  The plaintiff in this case will not be here.

 

Joan Budke, 77, died from her injuries sustained from the Prolift mesh made by J&J’s Ethicon division, the plaintiffs contend.  Her husband  and three adult children are bringing this product liability/ death claim against J&J and a medical malpractice claim against her doctor.

Mesh News Desk will provide coverage in association with The Mesh Warrior Foundation for the Injured and the Sunday Mail, a newspaper in Scotland.

The case was filed by Donald Budke against Johnson & Johnson, Ethicon, Gynecare Worldwide (a division of Ethicon), Becky Simpson, M.D. d/b/a/ Lake Area Women’s Center and Becky Simpson, M.D. of Osage Beach Co. No. 10CM-CC00085, filed in the 26th Judicial Circuit Court, Camden Co. Missouri in July 2, 2014.

Since the plaintiff was first injured in Osage Beach, Camden County, Missouri, that was chosen as the venue for this trial.

The Prolift System was the largest polypropylene pelvic mesh made by Ethicon and was used to hold up sagging pelvic organs. Prolift is particularly difficult to remove because of the many arms used to attach to the body.

Day One Budke case

Attorney Adam Slater said sarcastically he hadn’t prepared his opening remarks to the jury. He planned to lay out a very similar case to the $11.1 million Linda Gross trial he had won two years earlier. She too had been implanted with the Prolift System and at the time of her trial had undergone 18 attempts to have the mesh removed. See coverage of the 31-day trial on Mesh News Desk here.

In his opening, Slater thanked the 16 jurors (9 women) for surviving jury selection the day earlier and by applying common sense to this case. “There is only one time for Donald Butke to seek justice,” Slater said gesturing to Donald Budke, an elderly man with a goatee who sat next to two young brunette women.

adam slater“You are the most qualified people in the world to be jurors, you are residents of this county, you have common sense, who know right and wrong, you know when someone is not telling you the truth, you know how to listen and decide the facts before you and that’s why you are the perfect person to be on this jury.” ~ Adam Slater.

Slater told the jurors we need to be able to trust what a company tells us in studying, testing and developing their products. Number one should be patient safety but the marketing department at J&J exerted a tremendous amount of influence over marketing and sales. “Unfortunately, doctors who went to work for that company let marketing take control and got swept up in sales and marketing.”

Using a traffic light analogy, Slater said there were warnings that the company “blew through” like running a red light. What were the yellow light warnings the company knew internally?

The Yellow Lights

Slater said internal company documents will show the Prolift mesh had small pores that caused the mesh to shrink and retract, and that a team of European doctors/ consultants to Ethicon warned the pores of the mesh pores needed to be larger. As early as February 23, 2007, a French consultant to Ethicon said “Polypropylene meshes might not be improvable in terms of shrinkage, we may need a completely new material.” ( M. Cosson)

Dr. Michel Cosson, TVM team

Dr. Michel Cosson, TVM team

Mesh erosions were not uncommon and doctor/consultants to Ethicon had predicted that multiple surgeries to remove mesh would be a “disaster.” Complications would be potentially life changing.

Before it was sold, Ethicon and the group of researchers in France studied a prototype. They set a primary end point to find out whether they should sell the Prolene Soft mesh or not. Prolene Soft had been refashioned from hernia mesh for new applications in a woman’s pelvic floor which the company predicted would yield huge returns. But the results and conclusions showed a failure rate at 12 months and a recurrence rate 26.6 percent. The study did not meet predefined criteria of less than 20 percent.  This was the final study report indicating the product did not meet the end point.

“Despite failure they sold it because failure doesn’t mean failure I guess” said Slater.

Gynecare, Prolift (J&J)

Gynecare, Prolift (J&J)

Prolift System

Holding a large box containing the Prolift System Pelvic Floor Repair Kit before the jury, Slater peeled back the protective coating, first to the trocars, stainless steel hooks that look like a pirate’s arm. He then uncovered the mesh itself which flopped over the sides of his hand, its arms hanging limp like tentacles.

This was what was used to treat Ms. Budke’s occasional incontinence. “She had a very mild first degree cystocele,” according to her doctor, Dr. Simpson, implying the massive amount of mesh was excessive to treat a condition that could have been resolved with far less mesh in the form of a suture treatment.

“The Prolift System looked snappy but when you put it in the human body it turned out to be a terrible idea because it didn’t work the way they were told it would.”

Jurors in the Budke case will not hear that in mid 2012, Ethicon quietly removed the Prolift and three other meshes from the market citing financial decisions. They will also not hear that the company launched Prolift without even notifying the Food and Drug Administration to the existence of the mesh, completely flying under the radar of the FDA.

Instructions for Use

What appeared in the patient Instructions for Use (IFU) were a world away from what the company was learning about the failures of its Prolene mesh.  While Ethicon told the end users- doctors – that Prolene Soft mesh was a revolutionary product, the medical director said the results were middle of the road; the French researchers said the TVM (transvginal mesh) study was a failure; what the company described as a “Transient minimum slight inflammatory reaction” was really a chronic sometimes severe inflammatory reaction; and despite the glossy brochure‘s promises of rare complications, mesh exposure was common and erosion was almost inevitable.

Experimental

The push to market for the Prolift in 2005 was so intense that consultant Dr. Vince Lucente bragged he had the word “experimental” removed from a practice bulletin to doctors presented in the American College of Obstetricians and Gynecologists. Dr. Anne Weber, a urognynecologist and leader in the field had said patients should be told there was limited data to support any other promise. Weber, a urogynecologist who led frequent studies for the National Institutes of Health, was furious when she found out “experimental” had been removed. In doing so, insurance companies could now fund mesh placement surgeries.

Lucente called his move a “total victory” and took credit to Ethicon’s Marketing Director, Price St. Hilaire, an email showed. In response, St. Hilaire wrote, “I am doing the happy dance I love you man !!!!!!!

Joan Budke

In April of 2008, Joan Budke, then 76 years old, was active with her family, her church, her husband and grandchildren. She had a first degree cystocele, or mild urinary leakage. She went to see her doctor, local gynecologist Dr. Becky Simpson, who suggested a mesh implant. Dr. Simpson was a consultant and preceptor (trainer) for Ethicon. She had been instructed on how to use the Prolift by another preceptor, Dr. Vincent Lucente. the surgery took place on April 28, 2008. A TVT-Secur, a sling to hold up the urethra also made by Ethicon, was implanted at the same time.

By July there was a mesh erosion and by January of 2009, Dr. Simpson performed surgery to remove some of the infected mesh. The opening of her ureters had closed from infection and her kidneys were swelling, said Slater. He showed the mesh removed from Ms. Budke on two occasions. It looked like a “V” folded in half and encapsulated with red tissue. “You can see the tissue on it is fibrotic bridging, the pores are completely closed off,” said Slater to the jury.  She developed a fistula or infected area between the bladder and vagina and the inflammation was destroying her vaginal wall. Eventually a massive infection led to deep vein thrombosis and a septic emboli that invaded her lung which was resistant to antibiotics. Living on a ventilator, doctors were unable to treat the fungus and bacterial infection in her respiratory system. Eventually Ms. Budke was removed from the ventilator and died August 5, 2009.

Showing a full screen image of the entire family with a smiling Joan Budke at the center, Mr. Budke held a tissue to his face. His eyes were red.

 

Christy Jones, from Linda Gross Trial, cameras are not allowed in this courtroom.

Christy Jones, from Linda Gross Trial 2013. Cameras are not allowed in this Missouri courtroom.

Christy Jones

Around 2: 20 pm, attorney Christy Jones, who has represented Ethicon in numerous trials, started out being defensive and angry. She told jurors she was going to start her opening about Joan Budke but, “I sat over there biting my tongue not to respond to some of the accusation that have been made against J&J and Ethicon.”  

Mesh has been used since the 1960s, she said. The French team of doctors took five years to study the Prolene Soft mesh used to make the Prolift. It had an 80 to 90 percent success rate when it was tested in 120,000 women. In randomized controlled trials of 500 women, there were five infections; in another there was one infection.

“There were zero lung infections. Zero!” she said is connecting the dots.

Jones explained the plaintiffs’ contention – that mesh particles had traveled through the body and somehow lodged in the lungs.  This threw a confusing curve to the jury because the plaintiff attorney had not clearly explained the connection to pelvic mesh and a lung infection.

By all accounts, Ms. Budke’s April 28, 2008 surgery was a success said Jones. She had no serious problems for eight months – no mesh exposure, no infection.  Over a period of time a CT scan showed an abscess in the area of the mesh. “When you have a foreign body like mesh in the body it can do what you heard this morning that is potentiate the infection, it can make it more difficult to treat the infection, not because it causes the infection,” said Jones.

Coincidence

Instead, by mere coincidence, Ms Budke experienced a massive antibiotic resistant autoimmune disease known as to Wegners granulamatosis.  “I’ll tell you up front that term does not appear in her medical records.   It doesn’t.” See:

http://www.mayoclinic.org/diseases-conditions/wegeners-granulomatosis/basics/definition/con-20028113

Complicating matters- Joan Budke was being treated by dozens of doctors, in three cities and five hospitals. There was not one single doctor coordinating her case, stressed Jones. Sometimes that makes for less than ideal communication. ‘Perhaps that the reason Wegners was never seen” she suggested.

Nor was it treated. The drug of choice for Wegners is a steroid.

“This is going to be a hard case” said Jones lowering her voice so it was barely audible.  “Mr. Budke has gone through a hard time and I don’t want anybody in this court including Mr. Budke or his daughters to think we don’t fully appreciate their loss and their grief, and their desire to know what happened. We understand that and I want you to know and I ask you to accept our word that any of our witnesses is meant in any way to minimize their loss and their grief.  I mean that sincerely.” #

25 Comments

  1. Hal says:

    Jane, please let us know what position the DOCTOR takes in this case. Does she do the right thing and blame J&J for lying to her about how great their product was… or does she actually turn against her own patient?

  2. jacqui scott says:

    my heart goes out to this family it could so easily have been me i had my prolift removed in august last year by dr raz if i had of left it a month longer i would not have been here to write this it had done extensive damage to me also bless this family no woman should have to suffer this way its criminal what they have done to us

    • Jane Akre says:

      So glad to Jacqui you had it removed by an expert. In my opinion watching these cases, it seems the worst outcomes from allowing anyone but experts take an attempt at treatment… partial removals can leave more infection, any surgery can cause further injury and just too many doctors do NOT understand mesh to treat it. Like Linda Gross,Ms Budke had many doctors, most of whom are not mesh experts.

      • jacqui scott says:

        You are right jane Dr Raz Wwarned me not to let anyone touch my meshes if they did not know what they were doing he also told me no partials it needed to be all or nothing he does not belive in partials he says they cause alot more problems as mesh is not ment to be cut i just thank god that i had him remove it all including the arms

  3. Emmie says:

    OMG “less than ideal communication” between doctors for Joan Budke? comment from J&J defense lawyer. Would you allow the mesh in your body if you needed this fix?

    I now have 13 different doctors all scratching their heads. My abdomen looks like I am 6 months pregnant. Most days I cannot bend and when I can bend I cannot get back up on my feet without help.

    The communication between research and manufacturers is where this problem started because it was all about the mighty $$ and not about the health of us patients. Doctors push patients from doctor to doctor because they do not know what to do with us.

    I have both Prolift and TVT in my body and regret the day I allowed my ego bloated doctor

    mentioned in this article convince me this was the “golden fix” for me. Ethicon…Johnson & Johnson and pro- mesh doctors need to understand the word FAILURE.

    J&J and money hungry doctors hurt women. My heart hurts for Joan and the Budke family. I am sure all she wanted is to feel well. If only I would have known what I learned from the Mesh Desk and other women, I would have stocked up on Depends and skipped the Prolift and TVT.

    Four of the three pelvic pain specialists now are telling me to go to Atlantic for an attempted second removal. I am afraid to go and afraid not to go. Four pelvic pain blocks in 2014 have failed and only added more pain to my life. I lost a great job and have been on SSD since 2011.

    To the Budke Family….I am so sorry for your loss. I am sure Joan is looking down on you with much love. I hope she is also looking down on us mesh victims. My days start with two choices..a pain pill that lets me live a zombie day or no pain pill and live the day in pain. I cannot carry or lift our first grandchild who is our 2014 Easter Blessing. My husband and I no longer try intercourse. Our relationship has changed and he would be better off with another women.

    Total victory….yeah right. Stop the $ Happy Dance and get real. Experimental…YES. Disaster…definite YES. Big $$$$ for companies and doctors who don’t care…YES.

    Thank God for the genuine doctors who know that mesh fixes nothing and should not be put in a woman’s body. Anyone questioning the procedure…don’t do it. If I had a million dollars, I give it up to feel back to my old/young self.

    Dear Joan….RIP

    Budke Family…..God Bless You. I am so sorry for your loss.

    • Jan Urban says:

      Emmie, I also have severe swelling of the abdomen, my legs and feet swell to extremes and now with discoloration, my compression stockings are not doing anything for the swelling, I can’t lie down to sleep, so I am up for 2 – 3 days for the pain is worse when I lie, stand or walk. Immune disorders galore… 60 pounds of weight I gained since implant, I never had a weight problem for I was so physically active. Will see the Doc next week for Legs. Did you all receive the email from Jane on the Pathological Findings of Transvaginal Polypropylene Slings Explanted For Late Complications: Mesh is Not Inert. It says so much that we mesh injured live with each day. The nerve growth findings within the mesh having living tissue and more. The study is spot on and as Jane said Look out Mesh Manufacturers. It talks about the mesh not being inert and when it degrades it elicits a continuous immune response. the innervated tissue within the mesh is exposed a source of pain compression stretching, inflammation, ischemia , etc . within the compartments of the mesh they are inhabited with living tissue, blood vessels and nerve branches. Interesting I am all over the place with this but it all makes sense and you need to read it several times. It is a must read. Jane do think this will be any part of evidence in cases that are coming up? Emmmie, If you are talking about Dr.s Milkos and Moore they seem to have a great deal of knowledge re mesh and have developed techniques for removal and understand it. Their web site is quite informative these days. Give them a call and Susie will set you up to talk with the Doctors. Try to settle down, breath deeply and relax a bit. Good things come to those who wait and somehow because of this latest study I have renewed hope, that help is on its way………….Let me know what you all thought of the study. Jan

  4. Emmie says:

    Sorry error ~~~~Atlanta, Georgia

    Like to hear from anyone who had mesh removal in Atlanta. Should I do it?

    Right now my left leg hurts so bad and I have spasms compared to childbirth.

    And as you can see from the time, I have problems sleeping. Time for another pain pill.

    • Daughter of a victim says:

      Emmie my mother had hers removed in Atlanta Dr. Miklos he was awesome. Not sure if I spelled his name correctly though.

  5. Mary pat says:

    Christy jones, I hope you read this site. Karma to you Christy….. Your words make every mesh victim’s blood boil. Its bad enough you don’t care about the injured. Really? You don’t even care about the deceased?l. You are shameful as a woman and as an attorney. You are evil to the core for all the world to see. Get mesh Christy. You deserve it!

  6. Terri says:

    Jane, I would love to know what type of fungal infection Mrs. Budke had, ironically I have been battling a fungal lung infection that is resistant to antibiotics and still can’t get rid of it completely.

    Mesh causes so much damage to our immune systems and it only takes one serious infection that we can’t fight off to end up like Mrs. Budke,

    My heart felt prayers to her family that they find peace and justice.

  7. jade says:

    OK, Slater! The “red light” strategy is a powerful one. Stick with it. Good luck and positive energy to you and your clients.

  8. jade says:

    As a victim, I can attest to the unrelenting PAIN and SUFFERING caused by pelvic mesh. One become desperate for relief, for rest, for sleep from its never-ending assaults on the body. The ONLY thing that caused Joan’s death was the MESH! Slater must keep the Jurors focused on the BIG picture! She was fine before the mesh was implanted – the implantation started her downhill spiral. What a tragedy. Keep the Jurors focused on the GENESIS!

  9. jade says:

    Adam Slater must focus on the BIG picture. The mesh implantation was the GENESIS of her death. Don’t let the Jurors be confused by the Defendants “smoke-blowing” implications regarding “other” possible causes. If not for the mesh implantation, Joan would most likely be well and alive today. PERIOD.

  10. Daughter of a victim says:

    I know Christy Jones is doing her job, but she is defending a bunch of lying crooks! I have watched my mother suffer for years because of J&J’s neglegents. Then they don’t want to take ownership of what they have done to all these women. Not just 1, 10 or 100 people, but thousands. Have they all been misdiagnosed? They were fine before the mesh and lives were ruined after. Coincidence? I think not! I don’t give a rats ass what Christy Jones says. Her clients are to blame and are the very ones who are responsible. I bet Miss Christy would change her tune if she was implanted with the mesh and it left her disabled or worse. My heart goes out to this family and all the others who have been Victimized by J&J’s blunt disregard to proper manufacturing.

  11. Still Suffering says:

    Christy Jones says Joan Budke died from Wegeners granulomatosis. I’m confused, the Mayo site link in this report about the disease states “The cause of Wegener’s granulomatosis is unknown. It appears to develop after an initial inflammation-causing event triggers an abnormal reaction from your immune system. The combination of these events can lead to inflamed, constricted blood vessels and harmful inflammatory tissue masses (granulomas). The triggering event may be an infection, but no specific infection has been identified as the cause.”

    Certainly the inflammation-causing event would be caused by the Prolift which the company knew could cause a “severe inflammatory reaction.” (from IFU in this report) thus leading to infection???

    It is shocking the Dr. Lucente would brag about having the word “experimental” about the mesh deleted from the ACOG practice bulletin so insurance companies would pay for mesh procedures. Is this behavior showing concern for the safety of patients or for a lucrative payoff? Why wouldn’t the attorneys for insurance companies investigate this?

    I admire this family courage to relive the events of Joan’s suffering and death from what surely must have been caused by the Prolift. May God sustain them through this stressful time.

    • Jan Urban says:

      I sit here at the computer and read how much Joan suffered as she reached out to so many Doctors for answers to what was happening to her body with no resolve. One would think with all the dangerous additives and toxins all around us in our daily lives someone could of diagnosis and figured out Joan’s descent into Hell and realize it was the mesh. My heartfelt sympathy goes out to the Family.. I am mostly alone, by myself 24/7 fearing the reaction that mesh has caused my body will overcome me and wondering if I can get the medical care needed. Like other mesh injured, there are so many places and reactions within our bodies you have to see so many Doctors (specialist) for each problem. Most of these specialists say they have never heard of mesh (Yea right) or we do not deal with mesh. I’m sick of this response. I finally got a surgery date for January 22, 2015 to begin removal of the TVT Exact sling. But because of the swelling in my legs and abdomen I need to first get clearance from Family Doctor and my Cardiologist and I am wondering if removing the mesh will help me in anyway? Should I bother at all? So many problems since the implant, maybe to many to be helped by this procedure. I’m just so sad and upset for Joan’s Family. Greedy, Greedy people of an Industry that knows better. Something is wrong when almost all the people that worked on this device are gone from the company. I guess those who have left the company do not have a conscious to step up and do the right thing. What motivates these people who created this death trap and those who continue using these devices and of course the people at the FDA in allowing this to continue to endanger and harm so many. I just can’t get my head around it. Too many years have past with nothing being done. It’ is just Tragic.

  12. kitty says:

    Dr Lucente and Dr Dennis Miller worked together on the a french connection.

  13. Bejah says:

    I wish to add my condolences to Joan’s family. Know that she is with the FATHER and she is at peace. You will see her again in Paradise. Bless her soul.

    Bejah

  14. Susan Melby says:

    Praying for your family. I know how much pain this has caused you and how much you miss your wife/mother/grandmother. Blessings to all of you for making these people accountable!

  15. Jackie Bray says:

    Hello,

    I am so sorry about your loss of mate, mother and grandmother. There is no replacement for such a precious life. I, too have had a long and painful journey with the mesh process and the surgery involved, plus therapy afterwards and then a second surgery to remove the mesh and use scar tissue to create a new sling(with a different doctor). There is no valid excuse for such sloppy work on the human body. I agree that there must be responsibility and accountability for procedures such as this. Bless you for being so brave and may you be blessed in supernatural ways for taking this journey. Feel free to contact me for more specific information, if needed.

  16. Jackie Bray says:

    I got an ERROR message. What does this mean?

    • Jane Akre says:

      Sorry… let me know if that continues…… You should not get an error message. please let me know and thank you. J. Akre

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