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Plaintiffs Wraps Budke V. Ethicon with Family, Executives of J&J

ethicon logoA string of corporate executives with Ethicon, a division of Johnson & Johnson, highlighted this next to last day for the plaintiffs’ case in Budke v. Ethicon.  These were the individuals who allowed the Prolift pelvic mesh to be marketed in March 2005 with very little warning to implanting doctors or to the women who would receive the polypropylene mesh implants to treat prolapse.

This is the first death trial involving transvaginal mesh among the 70,000 or so defective product cases awaiting their day in court. The last and only case involving the Prolift mesh led to a jury award of $11.1 million to the plaintiffs in an New Jersey court with $7.76 in punitive damages almost two years ago.

Judge William Hass, Camden Co Mo.

Judge William Hass, Camden Co Mo.

Judge Hass of this Circuit Court in Camden Co. Missouri wants this trial to come to an end. He frequently acts more like he’s directing traffic.  Today, the jury got a shortened lunch break so an overwhelming amount of information could be presented as the plaintiffs wrap up their case.

Dr. Becky Simpson

Dr. Becky Simpson

Dr. Becky Simpson

This defective product case against Ethicon (Johnson & Johnson) and its Prolift mesh is just one component of this case. Dr. Becky Simpson, the implanting physician is facing medical malpractice charges. The family of the late Joan Budke blame her use of the Prolift for Joan’s death. So this morning the doctor was led through a series of questions about her surgical technique. She explained in great detail how she performed a Prolift surgery, which was designed to show her attention to detail and patient care.  “I’ve not had a lot of recurrence with Prolift,” she explained.

She said she no longer uses Prolift but didn’t say why. The jury has not been told Prolift, and three other Ethicon pelvic meshes, were quietly removed from the market in June 2012, allegedly for business reasons. It continues to be sold overseas.

The doctor is calm and deliberate but clearly not happy to be here.  Dr. Simpson lost Joan Budke as a patient in February 2009 after an excision of the center portion of the Prolift and a treatment for infection failed to deliver any relief and Budke transferred to St. Louis for further treatment. Even Dr. Simpson, a mesh defender, says you never try to remove the mesh arms of a Prolift which she called “no man’s land.”

Prolene Mesh

Prolene Mesh

In other words, the polypropylene mesh implant can potentiate an infection but can never be fully removed when complications like infection take hold, as it did in Budke’s case.

Dr. Vince Lucente was one of the highest paid preceptors or trainers for Ethicon when he trained Dr. Simpson in 2006. She thought he was telling her the truth, about the erosion rate, the infection rate, the complication rate, and she admired him.

Dr. Vince Lucente

Dr. Vince Lucente

Referring to Lucente, plaintiffs’ attorney Adam Slater asked Dr. Simpson, “If Vince Lucente didn’t tell you the full truth about the risks of the Prolift, would you still admire him?

“If didn’t know the truth, no, it would change my admiration,” said Dr. Simpson.

To counter her competence, plaintiffs’ attorney Adam Slater showed the 15 jurors the videotape

Dr. Richard Luciani, medical expert

Dr. Richard Luciani, medical expert

deposition of Dr.  Richard Luciani, an ob/gyn who has been in private practice in Millburn, New Jersey for 35 years. He was brought in as an medical expert in the medical malpractice portion of the  case.prolift box 200

Dr. Luciani testified Dr. Simpson didn’t exhibit the standard of care a professional. She should never have used the large, heavy duty Prolift for a stage one prolapsed bladder, a mild condition and relatively normal, he said, in a 73-year-old woman.

There is absolutely no indication to use anterior Prolift mesh for first degree cystocele (bladder prolapse) and one that was asymptomatic, that is one not causing any problems,” he said.  In his practice he does a native tissue repair and doesn’t use mesh.

When asked on cross examination by the defense, the doctor said he made a practice of testifying in medical malpractice cases, yes, but in 80% of the cases, he determines the physician did nothing wrong.

 

Donald and Joan Budke

Donald and Joan Budke

Joan Budke – a Legacy of Love

The most heartbreaking was testimony today was from daughter Susan and husband Donald. Susan broke down on the stand as the courtroom saw a number of pictures of Joan’s life after her mesh implant. No doctors could determine what was wrong with her.

All everyone knew is she had a continuous series of infections about eight months after the Prolift, which eventually led to her death.

Susan, who lives in Minnesota, says she talked to her mother every day. She broke down at the picture of Joan being transported to a nearby care facility in St. Louis one month before her death.  It only lasted ten days before she was back in the hospital.

In each picture Joan, an attractive brunette, was always smiling.

“She was a rock,” said her daughter. Susan narrated a picture of Joan and Donald sitting down to lunch at a nearby apartment he had rented. It only lasted ten days before she had to back into the hospital.  Susan said, “I wanted a picture of that.” After she was put on the ventilator, Joan didn’t wake up.

“I told her that I loved her and prayed with her.” Slater asked was there any response? “One time I was standing by her holding her and a single tear came out of her eye,” said Susan. “Nothing else, I took a tissue and wiped it off.”

The last photo was almost unrecognizable, a vague human form under a canopy of tubes and hanging IVs. Joan was on a respirator. She never spoke again after that.

“I miss my mom so much every day. I wish she was still with me,” Susan concluded.

Donald Budke was upbeat and spry. For a man of 91, he didn’t miss a beat with words such as ‘HIPPA’ and ‘interventional radiologist’. After describing his life as a WWII bomber pilot and life in Glendale, California, he talked about how he spied Joan in church.  The two were inseparable. Volunteering was her life, as was church and their family.

Yesterday would have been their 59th wedding anniversary.

Joan had been a careful patient with two knee replacements and rotator cuff surgery. She did everything the doctors told her to do and recovered each time.  Now to correct this incontinence, which was an embarrassing problem, she assured her family, it was a simple outpatient procedure. “I’m in and out,” he recalled her saying.

Adam Slater

Adam Slater

A failure to inform doctors and patients is part of the defective product claim. Slater asked, “Knowing your wife, what would she have done if she knew of major risks. “I think she’d find something else to take its place. I don’t think she would take the risk,” he said.

In the end when Joan was in the hospital “I lost my bride,” he cried his hand to his head. The jury was teary. The defense table lawyers had their heads down.

Plausible Deniablility

In the afternoon, Slater showed a series of videotapes of present and past employees – sort of a round-robin of faces that came and went within the company. Some appeared less than professional.  Medical Director Charlotte Owens was in charge of green lighting the Prolift, without which, it would never have been sold. She said she spent one week in deposition preparation and appeared to be rehearsed.

Owens was four years out of her medical residency in gynecology when she was made the Worldwide medical director for Gynecare, a division of J&J. Slater asked “Before Gynecare would you be considered an expert in mesh? No, Owens said.  “I was competent I was not a urogynecologist, so that was not my focus, no.” Instead, she relied on the expertise of others in the company.

A former regulatory affairs director, appeared to be in his early twenties, while Renee Selman, former World wide President for Women’s Health and Urology looked disheveled. Each had experienced relatively short stints with their high profile jobs with Ethicon and J&J before they were shuffled to another job or left the company.

The only employee who looked and appeared professional was Sheri McCoy, former vice chairman of J&J, who left the company after losing the CEO appointment to the current CEO, Alex Gorsky.  McCoy is now CEO of Avon.

What is not mentioned in this trial is that each time one of these employees was reassigned within the company, which happened often, Johnson & Johnson destroyed hundreds of thousands of pages of company documents that were on a litigation hold in these pelvic proceedings. See this background story here.

Presumably, many of the documents proved what the company knew and when it knew it about the dangers of its pelvic mesh products including the Prolift.

Dr. Piet Hinoul, Linda Gross trial

Dr. Piet Hinoul, Linda Gross trial

Piet Hinoul, VP of Medical Affairs at Ethicon will be on the stand tomorrow in Camden Co. before the plaintiffs wrap their case.

It could go to the jury by next week to determine if the Prolift was defectively designed and if Dr. Simpson was negligent in her care of Ms. Budke. #

24 Comments

  1. Aaron Leigh says:

    I am literally sickened with grief over this preventable death of Mrs. Budke. There were flashing red lights all along the way, that were enough to save this woman. She could have been saved.

  2. Aaron Leigh says:

    It is a tragedy of monumental loss. And this beautiful family is JUST ONE family being destroyed and robbed of their wife/friend/mother/grandmother. It’s simply unbelievable that this is allowed and even rewarded in the United States of America. What happened to us that this is the way we treat our own? WHAT HAPPENED TO US?

  3. Mary pat says:

    I have followed every mesh trial, thanks to Jane and her awesome reporting. This one renders me speechless. It is too tragic, too sad to even comment. Aaron I am grateful that you can express so articulately what the rest of us are feeling. Jane thank you for your efforts and for you stellar work. God help us all, especially Joan’s family.

  4. Emmie says:

    Jane….

    Thank you for reporting and keeping us informed. Without your reporting, we would be in the dark. You are awesome and I promise to send you some money as soon as I get my SSD check.

    Hope you can help me understand the below:

    #1. Why can’t the courts mention the Prolift and other mesh product that were taken off the market in 2012?

    #2. Why the the jurors cannot hear that 10,000’s of documents were destroyed by Ethicon / Johnson & Johnson?

    #3. How doctors pushing the mesh are not in jeopardy of punishments? My attorney said I cannot bring my injuries (Pudendal nerve damage) against my doctor in court? He rolled the dice and I lost. And now live my life in chronic pain. I could not do any steps today.

    If my home caught fire and I was alone, I would never make it out the house.

    I hope this trial ends soon and in favor of Budke Family.

    They deserve justice. My thoughts and prayers are with you.

    God bless you.

    • Jan Urban says:

      Hurry up???? As if Joan’s life didn’t matter.

      • Emmie says:

        Hurry up? You are misunderstanding my response.

        Joan’s family is reliving the horror while this case continues to remain open.

        I would not like to have my family endure the courtroom drama of the defense and I am sure Joan would not like what her family is enduring.

        I cannot see how the family will lose and I know the family would take Joan back over any amount of money awarded to them. No as mount of money will bring her back into tear lives.

        Joan was an amazing woman. I feel sorry for her and her family.

        • Jan Urban says:

          Emmie, my response “hurry up” was in response to the Judge wanting the case to end. Joan’s Family must of thought hard to make a decision to sue. I just feel all of Joan’s nightmare should be told and if it takes a little longer so be it.

    • Jane Akre says:

      Emmie- please take care of yourself first financially.. thank you though. You are referring to Motions in Limine- agreed to by both sides which limit testimony supposedly to get the case through the courts. The entire system presumes fairness on both sides – hence the problem – bad deeds get the presumption of innocence in my opinion. the system is slanted going in. You might want to consult with another attorney- this trial may open the door to more medical malpractice!

  5. Charles says:

    In lieu of complete removal of the mesh, which seems impossible in some cases, would it be possible to irrigate the entire pelvic cavity with a bacterial germicide and at least eliminate active infection and reduce systemic sepsis and spreading? I have good reason to ask

    • Jane Akre says:

      Good question Charles – in an ideal situation ( not ideal but in terms of removal) you remove the entire mesh if you can. The reason Prolift is defectively designed is because the arms cannot be safety removed – that is the crux of this case which Anne Weber testified to. I’m not sure they ever really determined if the arms carried infection or/and the TVT-Secur which she also had – a double whammy – because, like many doctors, they were not AWARE the extent to which mesh can cause/potentiate/ encourage/ seed/ carry/ host infection. Doctors- wake up to the realities this trial is showing us. Mesh is not insert! Mesh causes pain! I think we can walk away from this and agree with you Charles, the mesh should have been removed to the extent possible, which carries its own host of risks, and the infection addressed aggressively, sooner rather than later. this is my opinion as a non-doctor of course but someone who has now covered five of these trials!

      • Charles says:

        I dont know what could be done about the arms May jus have to live with that and treat with abx. I was trying to address the vaginal wall tears and release of bacteria into pelvic cavity. I am a RN and have had to irrigate bladders like that before and it cleans and resterilizes the bladder and eliminates bladder and ureter infections. I dont see why it couldnt at least maybe give these precious ladies a few more years to live

        • Aaron Leigh says:

          Good idea Charles. In my own experience, I feel as if doctors will not do that because most of them still use the mesh and to admit the level of harm that requires a wash would mean they’d have to admit they were wrong. We know that it’s not often seen. Also, women are being told that 100% of the mesh has been removed, only to find out later they have another erosion, adhesion or fistula, caused by remaining mesh.

  6. LIsa says:

    Charles, I have the Prolift in. And after particial removal 2.5yrs ago have been infected ever since. I have taken my case to government health ministers here in Australia and all other levels below. And have been continuously ignored. The hospital refuses treatment and says its not their responsibility to keep me alive. The bacteria lives on the surface of the mesh. I have severe swelling where all anchors are and down both sinus tubes down buttocks to anchors under buttocks. 3 strong antibiotics 4x a day plus internal antibiotic cream only keeps the infection from spreading to surrounding areas. The prolift has cut into bowel causing bleeding. Hence severe anaemia. So my general practitioner gives iron & b12 shots regularly as hospital refuses to treat me. My heart is struggling and blood pressure is thru the roof. As for pain levels, I cannot stand or walk and pain on an average day is level 8 and above. I am only 42 this year. I had the prolift installed at 36. This mesh has cost me everything in life. My work,my shop,my home,my daughters well being and care,my cars, my marriage, everything gone within 6mths post op as I cannot sit for any period to work due to anchors under buttocks. I now get limited blood flow to hands or feet due to heart and anaemia. Had I known what this operation was,seen the product or the install I wouldn’t have had it. As I’m sure many wouldn’t have. It is sad to hear of Joan’s story and her family’s suffering. And understand as my daughter says to me often,she never knows when it will be the last time she speaks to me. No child should have to live like this so a company can make money. The stress its put on a young child is horrible. I’m sorry to write of my own story but just stating how the infection thrives. If I miss a couple of antibiotics 2 days in a row,the infection is out of control and next week is hell. Living in bed for 4yrs is not a life from 38. Unable to walk and using a mobility scooter to go out. Cannot drive as I fall asleep at wheel from pain relief. It’s been 5yrs of not driving more than 10 mins away. My surgeon has lied to me for 7yrs now. On top of refusing treatment for infection and wont allow removal. which includes a colostomy bag.And is still putting mesh into women and telling them nothing. My only hope is to somehow raise the money in time to stay alive and get to Dr V to remove the prolift. Tv channel here interviewed me but chopped my story up and aired it saying I was selling a kidney!!?? WTF??! which meant all fundraising pages had to be taken down to cyber bullying. Is there a cover up or what going on !??

  7. Connie says:

    Oh me all these stories are so horrible ! Aaron after your email I went on to my regular Dr. I tried to get in at UAB to the urogynocology unit. They can’t see me until Dec. 4 th inked they get a cancelation . My Dr. Found nothing he could see externally to be causing the burning & horrible pain . He prescribed me ultram pain meds & a gel with lidocaine in it fir numbing my bottom . The swelling is horrible , the pain med hasn’t kicked in yet & I’ve had two pills. Can anyone tell me anything I could do to possibly help this. I am urinating so often I can’t keep up with it. I had a trace of blood in my urine but negative for yeast inf. he said it was pertaining to severe nerve damage & my skin tears very easily from so many surgeries. I called crying when I got home & bagged the Dr. office at UAB to try & work me in . I just don’t think I can take it two more wks. I’m very strong minded but this is getting to be more than I can physically or mentally stand . Any help from anyone I’m willing to try . I’m getting so tired & weak I have to stay setting on my hips for over 4 years now . It’s absolutely to painful to set in a regular chair for long . Thank you, through YOUR following this case is paving the way for people like me to get help. The right arm on my mesh was removed two years a go. The surgeon said he couldn’t the rest of it . I was so scared where is it ? Where could it have gone or how could it just fall out of me. I get so little infirmation from the doctors . Thank you dearly !!!

    • Debbie says:

      Hi Connie I don’t know if this will help but I had the same problem with the burning and urinating as I could not keep up with it either have you had blood work done recently as I found out that I got type two diabetes out of no where I read up about it and found it could of happened due to an auto Amun decease by having the revision surgery done.Hope the best for you!!

    • LIsa says:

      Connie, is your burning, the burning from the pain under buttocks and down your legs? I use heat mats,heat pads for all burning areas plus use a TENS machine to help where it burns and searing nerve pain down legs. Heat helps swelling round groin etc. internally I take endone for internal pain. Tramadol for the searing pain and OxyContin for the leg nerve pain. I refuse the anti depressant nerve pain. No way! Warm baths with Epsom salts and Himalayan salts work well to relieve nerve pain and swelling at end or beginning of day. You get to the stage anything is better than that pain. And medication doesn’t do much after a few years. They do not expect me to live much longer due to how heart is struggling.And lawyers have said its then up to my young daughter to fight for any right to a payout. Take care and sending big hugs.

  8. stopmeshimplants says:

    I finally figured out why I am having such a difficult time reading and following this trial. This is my biggest fear. I believe someday I will lose my life due to this mesh. Some of my mesh was removed. They could not get all of it out! I worry that someday my family will be sitting in a hospital watching me take my last breath. I can so relate to these family members as they share the experiences of their wife and mother. I wonder how many of us share this deep dark fear. I am sending the biggest hug to Joan’s family for the courage Joan had living this mesh nightmare. I hope and pray there will be some justice and that this family wins this case. These trials need to end and the manufacturers need to stop marketing and selling these mesh products today! How many more people will have to suffer and die?

    • Connie says:

      Hey sweetly I just read your comment . I do have the same fears you have . For those of us that weren’t solicited & truly do have serious problems . If you don’t mind do you share in having the same problems I do with the burning , throbbing pain. Mine is in vaginal , rectal & growin area. It travels down my legs to my feet like a back injury with nerve damage . My number is 256-510-0244 if you text me. I have spoken to Jane & talked to Aaron through text & EMail. Aaron is trying go get me a lust of some ladies that may could help be . I’ve had four operations & secere berve danage . Thanks , Connie

      • Debbie says:

        Hi Connie I had the revision surgery done 2014 I had the burning and throbing in the same places as you are experiencing the burning has gone away for now as my blood surgars where so high and have been brought down due to medications.As goes for the throbing it’s in the same places going through my groin area buttocks down through my lower back and down my legs my legs more so on the left side the aching feels like it’s really deep within the bone its self.The pain is just getting worse my husband sent an email to UCLA where I had the surgery telling them what is happening to me and asked for there view as he is getting concerned they replied saying to get a CT scan done to make sure there is nothing going on in the Pelvis it seems to be one thing after another happening to me.

  9. kitty says:

    The reporting is very good Jane The details of Joan’s demise is gruesome. I am very Frightened

  10. Diane Elliott says:

    I found that a capfull of Organic apple cider vinegar in 16 oz of water a few times a day helps neutralize the P H levels in the bladder and reduces the bladder infections. I use BRAGGS APPLE CIDER VINEGAR! I was having frequent urinary trac symptoms, since using the vinegar I am doing better. I hope this is helpful. Also don’t over do the vinegar, more is not better.

  11. Diane Elliott says:

    More about apple cider vinegar drink, you only need to sip on it throughout the day, is not necessary to drink a lot. Hope this works for you.

  12. cindy says:

    J&J ruined my life in 2007. Many surgeries later…. Still in pain. You ruined my marriage, my life and you have killed someone. Take responsibility jerks!!!!

  13. Michael says:

    My wife, just out of surgery again today, continues to battle post Prolift issues, after removal so much nerve damage had been done they had to use a medtronic interstim device so she could know when she had to go to the bathroom, this is the second revision of this device. Now I may not be the college wrestler I was 30 years ago, but I damn sure would like 15 minutes in a room with these morons from Ethicon.

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