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The Death of a Pelvic Mesh Patient – Trial Enters Third Day

The Budke Family

The Budke Family

The Demise of Joan Budke

Ms. Budke, age 77, died in August 2009. The official cause of death was a pulmonary mass, with a secondary cause – pelvic mesh infection.

Her daughters, and husband Donald, are sitting in the Camden Co. courtroom. Joan and Donald lived in nearby Osage Beach, Missouri. Gynecologist and implanting physician, Dr. Becky Simpson is being sued by the family for medical malpractice.  And the family is suing Ethicon, a division of Johnson & Johnson over its pelvic mesh, the Prolift System, claiming it’s defective.

The third day of the  Budke v. Ethicon trial showed how the late woman suffered before she died from numerous infections.

The plaintiffs in this product liability/ medical malpractice trial blames the implantation of Prolift,  large polypropylene mesh used to treat incontinence, as the start of a series of infections that could not be controlled. Ms. Budke also had a transvaginal sling mesh, the TVT-Secur,  put in at the same time to treat incontinence.

Dr. Becky Simpson

Dr. Becky Simpson

This case puts Dr. Simpson between a rock and a hard place – Does she blame the company for not informing her about problems it knew existed with the Prolift?  Does she still defend her use of the Prolift? If so, did she make a mistake? 

So far in these trials, the plaintiffs have argued that mesh makers failed to inform doctors and they are not at fault.  This is one of the few cases that blames the physician too.

 

prolift box 200What Dr. Simpson Didn’t Know

As we’ve seen in this trial, a French team of doctors, the TVM group, had been working on innovating the Prolift for years, complete with its stainless steel implanting hooks and pre-cut mesh.

But Dr. Simpson had never been told that a June 27, 2006 final study report for the French TVM team found a failure rate of Prolift in excess of 20%.

Adam Slater

Adam Slater

Slater –“You weren’t given that information, that the study did not meet the predefined criteria of a failure rate of less than 20%.  Would that have been important for you to know?”

Simpson – “Yes.”

Slater – “Would you have been concerned if you were told we had failed our primary end point?”

Simpson – “I would have factored it in, yes.”

Simpson also didn’t realize the Prolift was recommended for stage 3 or 4 prolapse. Ms. Budke had stage one or two.

Dr. Simpson didn’t know that behind the scenes, the French doctors wanted to replace the Prolift polypropylene mesh with one that was slightly absorbable and had wider pores, the UltraPro. It allowed for easier integration with the body and less formation of scar plate and foreign body reaction which causes mesh to contract and encapsulate nerves.

Prolift, MedTech Marketing

Prolift, MedTech Marketing

Slater was friendly and light in his questioning of Simpson. He offered her a water.

Slater – “Fair to say you are not aware when you are being trained, the doctors who created the Prolift were all over the medical director because they wanted a new mesh and other changes to the Prolift as soon as possible, is that fair?”

Simpson – “That’s fair.”

Slater –“Would you want to know more about this if you knew?”

Simpson – “Absolutely.”

 

Dr. Simpson’s Trainer –  The $1.7 Million Dollar Preceptor vince lucente

Dr. Simpson was trained on implanting the Prolift in October 2006 by Dr. Vincent Lucente, a long-time preceptor or trainer for Ethicon.

In this day three of trial, Slater pointed out to the jury how Dr. Lucente collected $1,709,000 in compensation for his work for the company over a dozen years for training and recruiting other doctors to use the Prolift and other Ethicon products, a role known as a “preceptor.”

Dr. Simpson was not told that Dr. Lucente was favoring a new mesh made by Ethicon, the UltraPro,  that would eventually replace the Prolift Gynemesh PS, in the latest generation of Prolift, Prolift +M. Slater showed Dr. Simpson inside company documents quoting doctor’s reactions to the UltraPro, including Dr. Lucente was quoted as saying, “This one and throw the rest out, this feels like a piece of vaginal wall.”

A glossy brochure given to doctors said the Prolift mesh did not potentiate infection (increase the power, effect or likelihood), but medical literature at the time cited by Ethicon told a different story. A literature citation in the Ethicon brochure said, “The ideal synthetic mesh material for pelvic surgery, one that induced minimal foreign body reaction has yet to be developed,” wrote Dr. Cheryl Iglesia.

Dr. Simpson, a busy gynecologist, like most doctors, relied on the promises of a company and didn’t read all of the literature.

Slater in Linda Gross trial, Judge Hass will not allow cameras in this court.

Slater in Linda Gross trial

Slater – “If you knew all the things you now learned about the Prolift that you didn’t know April 2008, is it fair to say you would not have used a Prolift on Ms. Budke?”

Simpson – “If I had the same information…..if it was taught in that training class, no.”

 

Who Was Joan Budke?

Dr. Simpson looked sad when she described Joan Budke.  Budke was 76 at the time of her implant, she volunteered at the hospital, always had a smile. She was kind. Her daughter looks like her.  Dr. Simpson called her “a nice patient.”

Dr. Simpson put in an anterior Prolift System April 28, 2008 to treat a cytocele or prolapsed bladder that caused her to have urine leakage. At the same time, she also put in a TVT, transvaginal tape, a smaller piece of mesh under the bladder.  Raising the bladder and the urethra that empties the bladder at the same time just made sense.

Soon after the implants, Dr. Simpson found mesh had exposed in the vagina. The incision line cut in the vagina had never fully closed over. Dr. Simpson prescribed vaginal cream. Otherwise, Joan Budke felt good and called the doctor’s office to see if she could resume exercising.

Joan continued to have occasional spotting and by January 2009, she went back to Dr. Simpson – she just didn’t feel well.   She was voiding every 45 minutes at night. She wasn’t sleeping. She had a tender low mid-abdomen. Dr. Simpson ordered an ultrasound.

The ultrasound revealed a bright, white area – probably mesh the doctor documented. “Anatomically it was in the same location I knew I had placed the mesh and the density of the mesh doesn’t translate the sound waves the rest of the tissue does,” said Simpson on the stand.

The ultrasound did not show the cause of the post-menopausal spotting. Ms. Budke was treated for a bladder infection. Her ovaries were hard to find. The fear was she might have cancer.

January 20, 2009, still unable to urinate, Ms. Budke went to the emergency room. On January 21, she received a foley catheter to allow her to urinate and get some rest. A CT scan revealed a collection of air in the lower part of the uterus, an indication of an abscess or infection. Her bladder was very swollen and puffy and the opening to the ureters was very small. An inflammatory mass was impinging on the ureters, the tubes that run from the kidney to the bladder. A fellow surgeon was unable to put in a stent to open up the blockage.

Dr. Simpson’s diagnosis – vaginitis with secondary, probably infected subvaginal mesh.

Slater – “You thought the mesh had become infected?”

Simpson – “Correct.”

Dr. Simpson removed the mesh in the top part of the vaginal wall, essentially the center of the Prolift System, leaving behind its many arms anchored into the pelvis. Removal of the Prolift is one of the most difficult procedures. Most expert mesh removal doctors in the U.S. will not even try.

Necrotic or dead tissue was removed. A second trip to the hospital had her on IV antibiotics and pain medicine. She was discharged home but presented with a right flank kidney region pain. A Versijet was used to clean out the area, like a dental water pic, said Dr. Simpson. Because pressure on the kidneys for any time is dangerous, Ms. Budke was transferred to Missouri Baptist Hospital. She was released in February 2009. After that time, Ms. Budke sought treatment in three cities and five hospitals from dozens of other doctors.

Slater – “Shortly after that you stopped using the Prolift  correct?”

Simpson – “I don’t know the time frame. I went from Prolift to a different generation.”  (Note- Dr. Simpson said she started using the next generation of Prolift, Prolift M+ made with UltraPro, a larger pore partially absorbable mesh.)

Slater – “You didn’t use the Prolift anymore?”

David Ball an attorney for Ethicon objected.

Judge Hass sustained the objection. Dr. Simpson didn’t have to answer.

Joan Budke’s health went downhill and she eventually died August 5, 2009, sixteen months after her implant.

Under cross examination, attorney David Ball had to undo the damage done by the Slater questioning. Even though it is late in the afternoon, the jury appears awake and attentive.

Mr. Ball established that Dr. Simpson has performed about 100 Prolift surgeries and 100 TVT (transvaginal tape) surgeries to correct incontinence.She was a board certified gynecologist.

He suggested the surgeries kept the bladder where it was supposed to be for eight months, a rather confusing question considering the outcome. “As far as you were concerned it was a good result,” asked Mr. Ball.

Dr. Simpson answered yes.

Mr. Ball asked, “You don’t base medical decision on emails and internal company documents do you?”

No, said Dr. Simpson.

You don’t know if Mr. Slater cherry picked emails he presented to you do you? No, said Dr. Simpson.

You don’t know if he took them out of context do you? No, she said.

Mr. Ball asked in a leading manner, “And so you can’t as you are sitting here today, based on what he said, you can’t reach a final professional medical judgment whether it was accurate and in context and the whole story. You cannot reach a conclusion as to whether you would have done something differently or not, true?”

True, agreed Dr. Simpson.

 

Jump Through Hoops

Monday a number of lawyers will be absent from the courtroom. The must depose the doctor who signed off on the Budke death certificate to make it official.

It reportedly says the cause of her death was a pulmonary mass with a secondary pelvic mesh infection. Even though it is in writing and official, the defense wants it authenticated with testimony on videotape.  No doubt the plaintiffs will deliver just that.  #

 

26 Comments

  1. Tina g says:

    Dear God make them pay and please bless her family….

  2. Jan Urban says:

    Where is Mr. Ball going with his leading question as to keeping the bladder in place for 8 months and is a good result. Are they insane? Was this not to be a permanent solution for bladder prolapse? Whereby after 8 months all hell broke loose in Joan’s body. And the brochure with Doctor Iglesia stating that the ideal synthetic mesh material has not been developed. This clearly tells me that Ethicon is clearly negligent, they knew. And the Doctor did not read any of the literature? This new mesh Ultra Pro. Is it only used in the Prolift? They knew a lot about what reactions the body would have with mesh but went on to market these mesh kits. I glad that the jury is attentive.

    • Jane Akre says:

      UltraPro was used in the Prolift M+ but that too was taken off the market in June 2012. Perhaps it wasn’t ultimately the success the company had hoped. Remember the adage, the more mesh the more mess, those mesh kits put too much mesh permanently in a pelvic floor, in my opinion. Most if not all have been taken off the market, quietly removed by manufacturers who knew better.

  3. Dedra WILSON says:

    I did not know Mrs. Budke, but I weep for her, her husband and children everyday. One thing I do know is what is the cause of death on the death certificate will stand up in court!!! RIP Mrs. Budke!!! May God Be With Her Family!!!

  4. Bejah says:

    I just read about dear Joan last night. I had wondered why she was not at the trial, my GOD!

    I wonder now if Joan ever posted to Jane’s website or communicated with her and if any of that would help the plantiffs but as I write this I think Jane will speak of confidentiality and her inability to provide such information BUT what if there is something that would help?

    I was not only deeply saddened by this story but I have become terrified. Are there other victims who experienced the symptoms Joan did and died from them. What about the rest of us. I have the Prolift, emplanted in 2010 and I have been told by several experts who had a conference of sorts about my case that it is too dangerous to remove due to my particular complications. When I received this written notice I fell apart, sobbing, knowing this was a death sentance. Will the rest of us develop infections, experience sepsis and horrific deaths?

    And was Joan doing GODs work in living through this horror, focusing a light on this through Jane and others that may not have been quite as bright before? Joan is a martyr (sp?) for us all, for our common cause, and perhaps a saintly being I expect. It is not too late to light candles for her soul, pray for her and for her family. This will create a light around them that is protective and healing. I find that praying for others heals me, also and prayer need not be religious. It can be an expression of our humanity.

    Next week I am making an appt. with a Pulmonologist to check my lungs and I will ask him to follow up periodically. I am not allowed to discuss the details of my own case as it is under consideration at present. My guess is that the defendants will not want mine in the court room but I am still uncertain how cases are selected and by whom.

    I advise everyone to try to keep their immune systems as strong as possible. I am guessing that we are just beginning to learn what this can do to the human body. The fact that so many physicians are still either unaware, afraid to become involved or bought and paid for by the defendants and their associates.

    Also take a lot of Vit. B12 to strengthen the brain and nervous system. You can not overdose and it is relatively inexpensive but buy good quality. If you ie before your case is settled or goes to trial it will lose value. BIG PHARMA is also getting into the vitiman business big time, buying up small companies, driving others out of business in an effort to control not only our food supply but our ability to keep ourselves healthy. If it has slick packaging and is heavily advertised best to buy your vitamins elsewhere. What is happening on a larger scale in this country is unimaginably EVIL. Eat natural foods. Avoid pre-packaged food and drink and fast food. It is all poison. Especially now this is important.

    Also do not ever cross your knees at the knee, but only at the ankle or not at all and try to keep your legs straight when sleeping or laying down on sofa to help prevent clotting. Leg massage (even with wintergreen alcohol) will help, expecially if you have been diagnosed post implant with peripheral neuropathy.

    Remember food is medicine so if blueberries seem expensive this week buy them anyway.

    Finally I have to say something about the defense counsel, Christy. She is not an innocent hired hand. If you keep counsel with evil you are also evil. Christy is, as many have suggested, as evil as those she represents regardless of her being in house or outside counsel. Anyone who must encounter these individuals should remember that they look into the face of evil (Whatever image that means for you) when they look into the eyes of these creatures.

    Bejah (Sorry about any spelling errors)

    • Bejah says:

      I thought of one other thing. Have we approaced LINK TV about this? If not someone should. Early in the year I felt better and thought to take up such efforts but now I am so weak and tired. Sometimes it is harder to breathe than it was and I have attributed this to the exhaustion. I feel like I must be dying. I can no longer see myself as able to reach out to the alternative media, the underground media which is probably the only option open to us as mainstream media is undoubtedly owned by BIG CORP America (Not all corporations are bad it should be said). I expect that the terrorist attacks may be used to deliberately galvanize the population in support of the government and military and Homeland Security, etc. and reduce support for what we fight against. We preserve our democracy by defending it, criticizing it through a free press which I am not sure we have now, voting (In the last election I think only 30% of registered voters excercized their right and duty to vote. I was not among them but I am going to start voting again if I live long enough. We can not just expect our nation to run on autopilot and go shopping. We have to take an active role in defending our Democracy and protecting our rights or we will continue to lose them, to see them erode. Please, those of you who can, take action, try to expose JNJ for what it is….not the all American family company it works so hard to tell us it is. Know what you are fighting against. Do the research, form support networks online or in the cities and towns where you live. Help each other an put up a good fight even knowing you may never win, we may never bring justice to bear. Look at the judges and how they support the defendants in the courts.

      I think I am also developing the pudental nerve problem now as I have these strange pains that feel linear and/or encircle my pelvis and come and go. I must find a new Neurologist…someone I can trust. Many physicians can not be trusted.

      In January 2014 I upgraded my health insurance to high option and paid an additional $50 a month for the premium. It was worth it. This January the increase shocked me. It was almost another $80 a month but I have to pay it so I have the best coverage. I will need to cancel cable TV and go to the poor womans grocery stores and who knows what else. I believe that this is happening at least in part because CORP America wants to control our medical care, our health, our choices. I will not let them control me. If I have to move out of this house I will. Please think about these things.

      Bless you all.

      Bejah

  5. jade says:

    To Dr. Lucente:

    “He who stands on tiptoe, doesn’t stand firm. He who rushes ahead doesn’t go far.” – TAO TZU / TAO TE CHING

  6. Debbie says:

    It’s despicable that Ethicon is even making this poor family go through this as they know they are at fault we who have had the Mesh implant live on a daily basis the Horrors it has caused us with the pain and suffering.This poor woman lost her life due to MESH and her husband lost his wife and her children lost there mom and most likely grand children lost there grand mother.Ethicon you say you care for your clientele meaning us victims STOP and give your heads a shake I hope justice is served ENOUGH IS ENOUGH

    • Jane Akre says:

      Just tally the $$ – $500 per hour (at least)/ At a 40 hour week (it is more) That’s $20k a WEEK!!! that would pay for one removal surgery conservatively.

  7. Aaron Leigh says:

    Thank you Jane! Your coverage is EXCELLENT! This trial is that one tgat will change the tide, I BELIEVE!

    • Jane Akre says:

      Ethicon cannot take too many more of theses… J&J are you watching?

      • Jan Urban says:

        The Anxiety, Fear and Despair we as the mesh injured live with 24/7 can be overwhelming. Why has America’s healthcare system ignored this( Now) epidemic of the mesh injured with their denial that mesh is not the cause for our injuries. I’m so scared that proper treatment will come to late for the many side effects that are attacking my body. For heaven sakes we rid the world of Polio? Just Listen, really listen to what we are saying…….Quit being in denial. I think the people who had anything to do with these mesh devices should be forced to spend some time with a mesh injured person to see our pain 24/7. It’s time to throw in the towel Mesh Manufacturers and help those who are injured by your mesh medical devices..

  8. heart broken says:

    what annoys me is where are the media, we have the technology to make this a world issue, thousands and thousands of people are effected by this , nearly every country has this problem, you know why? because its about feminine hygiene and health Authorities are embarrassed , but this is as serious as any major infections like Ebola , bird flu. etc its hidden in the body causing unknown infections, disabilities , depression, we don’t have a choice about Ebola, but we can stop the mesh being implanted say NO to mesh implants wake up world, it wont stop until government’s health authorities get together and see the impact it has. there should be a register of mesh implants, collectively , Jane Akre and her team should be in the Queens honour list for all there hard work, and solicitors in England should be more active concerning taking the corporations to court , well done American Lawyers for pushing for the truth and helping mesh sufferers.

    • Jane Akre says:

      Just FYI- the judge in this case did not want cameras in the courtroom because they don’t have a media coordinator or some such thing. So that’s why I can’t take any pics which is annoying. You cannot even have your cell phone in the courthouse. Unless you are a lawyer. doesn’t quite seem right.

      • Linda Gaul says:

        Jane I am a mesh survivor. .of 2 yrs…didn’t know this trial was so close to me..I would like to be there to hear for myself and support the family and yourself..will it probably be going on til Friday? I had some of same prob..nearly died..Can u give me s of me info? Thank.u..bless u

  9. cybil says:

    Jane – How did Christy Jones know that the two women you mentioned who attended the trial were “mesh injured”? It is an open courtroom, correct? So, that means that anyone can attend a trial. How would one know IF a woman who came in had mesh surgery? Just asking cause all of our attorneys are telling us to lie-low, but IF one cannot be identified by attending, we can all rise up and attend trials we can get to – that would really put pressure on Jones as she would have nothing she could do about it! What say you?

    • Jane Akre says:

      I don’t know other than she saw us talking and hugging in the hallway. Maybe she assumed. yes its an open courtroom so she wouldn’t know if you showed up…..she might wonder though. I still think busloads would make a real impression.

  10. Debra says:

    Interesting if I could attend I would put something in writing over me hanging of my shoulders over my neck on a big peace of hard board saying I am a mesh victim and I have to suffer in silence because the manufacturer’s who make these Defected Mesh’s won’t listen to the TRUTH in a COURT OF LAW!!!

    • Jane Akre says:

      Please do…. the defense would not like it though. They would prefer you all stay in the background and not show up at these trials. I don’t know what they would do if you all started arriving by busload. !!

  11. A meshed-up nurse says:

    Thank you, Jane, for sticking with and reporting on the “mesh story” for so many years. It’s so much appreciated. I pray for the family. RIP Joan- may you be vindicated….

  12. Connie says:

    Thank you Jane : it’s so wonderful for you to still be rooting for us all after all this time. It’s so heart breaking to kniw what this poor woman & her family have been through . I truly do mean US ALL !! I’m just happy her family has had the courage to stay strong & believe in doing the right thing to HONOR her after death. I gave family members that cried and ask me to forgive them when they found out I wasn’t lying about something being terribly wrong with me . It’s so good to know that you felt your own mothers pain & you meant you will help others like her. To be a martyr like this lady is not what she bargained for . She bargained for the hope of a better quality of life & she got death as a result of it. No amount if money can compensate gir her loss of life & the agony & pain her family , friends & even doctors saw her go through . I’m hitting so bad in my bottom it’s 1:34 A. M. I can’t find sleep NOR a comfortable way to set . I live in a recliner or my love seat with my legs elevated all the time. I urinate on myself in public places Walmart checking out example because I couldn’t make it to the restroom in time. I could go on but this is about her not me . God bless her soul Im rambling from anger for her loss of life & I hope J&J pays dearly . I only wish I had the chance to tell my story but I don’t wont to die to get it told . Father in Heaven forgive them that have hurt so many . Have mercy on the souls that new what was happening to us yet for the sake of money $$$ they did nothing. There is a law if you see someone being harmed its hour moral duty to try and help them not stand back and watch the suffer . I wish I could add the defense of GOOD CITIZENSHIP to my lawsuit . HEART BROKEN IN ALABAMA

  13. cybil says:

    As to the busload/s of INJURED…I believe we should organize a trip/s to the next trials to show our solidarity. Possibly we could get a carrier to give us a break on the dollars if we offered them exposure/photos/news coverage. Is anyone connected with a carrier. When/where is the next trial taking place. MESH Sisters on Wheels. This would be a GREAT way to support Jane in her monumental sacrifices she has and is making for ALL of us! Let’s do it.

  14. jaque says:

    Hi justme,

    I am finding exactly the same reactions as you, dentists will either not even see me or if they do they will not do a thing to help, I have 3 tooth abcesses and a broken filling and I can get no help, I am sure its because I am a mesh sufferer, at present I am living off antibiotics which I am buying myself off the internet to keep me alive, my doctor is quite nasty behind my back too, apparently I have some weird views on health, this is because I have complained of the pain mesh gives me and the fact I cant sit or have sex, ect. I ask myself should these monsters actually be In healthCARE?

    • Jane Akre says:

      I’ve heard of others suffering dental problems after mesh implantation.. Others want to chime in here? Good observation….. yes there are many strange people in healthcare. Where are you located? There may be more expert practitioners in your area….~ ja

      • jaque says:

        Hi Jane,

        I am in the UK, its not the best place in the world for good dental surgeons even if you are a non mesh victim.

  15. Cyndi says:

    What do you do when your lawyer tells you that you have a case but the doctors deny that the mesh has caused the injuries? Since the mesh I have divorced, had additional surgeries, pain and depression. My life was greatly affected and no one seems to care that this all happened after the mesh. Within days of being implanted I had an infection, and eventually took layoff from my employer so that I would not be fired for missing work. I am now on disability and have constant pain. I have interstitial cystitis which was not diagnosed until 2012. I had my implant in 2009 and never was informed of this condition which is as close to an erosion of the bladder wall. After my lawyer received a summons for another plaintiff (that had my name) was involved in a separate case but was going to take my deposition and learned that they had canceled the deposition because I was not the person listed in the case. He then informed me that he could not pursue my claim since not one doctor that treated me said that it was the mesh. I informed him that I knew it was the mesh. He stated that I might get a summary judgement and costs would be my responsibility. After that he learned there was another plaintiff with my same name. Should I find another lawyer since this lawyer don’t wanna fight for me? I am tired of being treated like I did something wrong and when you go to the doctor they make you sign your life away for anything for pain. I have moved to a rural community which is 24 hrs away from my family so that I can get something for my pain. I cannot work because of the pain and pressure I feel in my abdomen. At this point I feel this is never going to get better and only get worse. What has to happen for the manufactures to see how many lives have been affected by their poor decisions!

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