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Day One of Ethicon Trial: Lawyers, Liars and Bridging Fibrosis

ethicon logoIt was a big news day in Charleston, West Virginia but not for the first day of a product liability trial that put healthcare giant Johnson & Johnson on the hot seat. Charleston held a public hearing about Freedom Industries, the coal cleaning operation and chemicals it inadvertently dumped into the Elk River. The satellite news trucks were parked outside to cover the hearing and apparently that’s where the reporters were too.

news truck near courthouse

news truck near courthouse

This was Day One of the transvaginal mesh case of Plaintiff Carolyn Lewis (CL) and her husband Kenenth.  CL was implanted with a polypropylene tape or sling made by Ethicon, a unit of J&J. The TVT (tension-free vaginal tape) was implanted in 2009 in Dallas by Dr. Muriel Boreham, of Texas Urogynecology Associates to treat stress urinary incontinence (SUI) that Lewis had been suffering with for more than a decade.

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

Judge Joseph Goodwin is overseeing 15,000 product liability cases filed against Ethicon alone and 50,000 pending against all six mesh manufacturers.  On this first day for one of the largest mesh makers, he promised the potential jurors the trial would last no more than nine days.

“It won’t take near the time of other places,” he promised the pool of 30 potential jurors assembled, referring to other jurisdictions that can take days to choose a jury.

Carolyn Lewis

Carolyn Lewis

Carolyn Lewis, 59, sat in the second row in a grey sweater. Her husband had his armed wrapped around her the entire day. At one point the attorney representing Ethicon, Christy Jones (Butler Snow) approached and leaned in introducing herself.

“I know this is an uncomfortable situation,” she said offering her to make it less so.

Thomas Cartmell of Wagstaff Cartmell, Kansas City, Missouri represents Lewis. He was flanked by Richard Freese (Freese and Goss) and Ben Anderson (Anderson Law).

As is standard, Judge Goodwin thanked the jurors assembled for their presence reminding them “jurors are the most important people in our system of justice.” The task this morning was to eliminate those who had any conflicts, so Judge Goodwin asked if any individuals had any association with Ethicon, the lawyers present, any lawyers, any doctors etc.

One by one they were called into a small circle of lawyers. A switch was pulled and white noise blasted in the courtroom so others could not hear the discussion.  By noon both sides had agreed to 10 jurors, five women and five men. Ultimately six will be needed to render a decision in this defective product case, the rest are alternates.

After lunch, Judge Goodwin finally told the ten what this case is about.

Defective product litigation involves defective manufacture, design and negligence by the defendant.  Negligence is defined as a failure to use ordinary care that a person of ordinary prudence would or would not have done. A proximate cause of injuries is something that a person using ordinary care would have foreseen.   The burden of proof is on the plaintiff. The proof is arrived at by the preponderance of evidence.

(Law firms using this information, do you really want mesh injured women to be the contributors?  Here   is the easy button to help keep this coverage going in the public interest~ thank you) http://tinyurl.com/mg922yo

Thomas Cartmell, Wagstaff Cartmell

Thomas Cartmell, Wagstaff Cartmell

Plaintiff Opening – Mesh Too Heavy, Pores Too Small

Thomas Cartmell had practiced his opening. He repeatedly referred to the mesh that would eventually be used to create TVT as causing “problems in the stomach” in hernia patients.

In 1974 Ethicon began selling its heavy weight, small pore mesh. Ethicon sees patients are having problems with pain and repeat surgeries to remove the mesh. Ethicon hires a world renowned experts to find out why mesh is causing problems in the stomach and how to design a new mesh. Ethicon learns the prolene (polypropylene) mesh is too heavy and the pores are too small. Ethicon learns it can design a new mesh with larger holes and a lighter weight and stops selling the old mesh.

That all changed, said Cartmell, when a Swedish inventor, Dr. Ulm Ulmsten, began cutting up the old mesh and putting into the pelvic area.

The Gynecare TVT polypropylene bladder suspension sling was invented offering a petroleum-based reinforcement to suspend a sagging urethra, the cause of the stress urinary incontinence. For his work, Dr. Ulmsten was paid millions.

Prolene Mesh

Prolene Mesh

The problem with the old mesh used in this new application was three fold, said Cartmell in defining defective.  A- it was outdated. The 1974 mesh designed for the stomach not a women’s pelvis was too heavy and the pores were not big enough.  B-the TVT mesh was machine cut causing the mesh to rope, fray and curl up when under any tension in woman’s pelvic area and C- the mesh degrades inside a woman’s body with the outer layer of a polypropylene falling off the mesh.

TVT was marketed by Ethicon in 1998, the same year that it had developed Vypro mesh with holes 600 times larger and 70 percent lighter than the TVT.  A lighter weight mesh with larger pores allows for more even tissue integration minimizing the bridging fibrosis, or scar tissue formation that causes mesh to harden, become rigid, entrap nerves, causes chronic inflammation and to shrink up to 50 percent.

Ethicon violated the first principal of patient safety, said Cartmell to the jurors, “We believe they put their own interests first.”

dr  muriel k borehamLewis never returned to Dr. Boreham after her TVT implant. She had chronic pain and suffered from dyspareunia (painful sex). She went to a number of doctors for other health situations including a ruptured disk in her back, but never again complained of her pelvic pain or dyspareunia.  She decided to live with it, said her lawyer until she and her husband saw a commercial on television soliciting clients for transvaginal mesh lawsuits.

“They had never been involved in a lawsuit. They learned they were not alone,” said Cartmell.

Months later she had Dr. Philippe Zimmern remove her TVT mesh but the arms were left behind and remain there today.  Her lawyer says Lewis is 85 percent better.

Defense Opening – TVT the Gold Standard

Christy Jones launched into a defense of the company she represents.  TVT was a “remarkable advantage” over its competitors, she told the jury. Before TVT was brought to the market, women suffering from SUI would have to undergo anesthesia and recovery in a hospital to receive a Burch suspension surgery or a vaginal sling made from one’s own tissue.

Prolene (polypropylene) mesh is used in sutures and in surgery on the heart, eyes and pelvic areas and has been used in the body for over 30 years, she said. TVT implantation is taught in schools all around the country. That’s why it is considered the “gold standard” said Jones.

“Look at studies that show how women’s sex function has improved after receiving the TVT,” she said.

Ms. Lewis actually told her implanting physician she was pleased with the outcome of her TVT surgery as late as January 2010, and two years later she filed this lawsuit, according to Jones.

Christy  Jones, Ethicon attorney

Christy Jones, Ethicon attorney

During this time she did not see any other medical doctor about any complications she filed in this lawsuit. She asked the TVT be taken out nine months after she filed this lawsuit, three years after she last saw Dr. Boreham. During this time she talked to not one doctor about complications of pelvic pain, urinary frequency and retention and painful sex. Over this period she saw over 30 doctors and not one record says she ever discussed the symptoms you will hear about today. I have no doubt Ms. Lewis believes she had pain because of the TVT but my job as a lawyer is to question the evidence and the fact of the matter is their doctors don’t show any of these complaints.”

Just a minority of doctors don’t like TVT, Jones admitted putting Dr. Zimmern in that category. She asked jurors to keep an open mind as they will hear a week of damaging evidence before defense gets to make its case.

“The product is not defective and it has nothing to do with Ms. Lewis’ problems. It’s a good product,” she concluded.

First Witness

Plaintiff presented the first witness, a videotaped deposition of Dr. Bernd Klosterhalfen, a surgeon and pathologist who has collected about 1,000 explanted hernia meshes and 500 explanted or removed meshes from women where it was used for pelvic organ repair.

Dr. Klosterhalfen collaborated with Ethicon to create the lighter weight large pore Vypro mesh, which he calls Class I and much more suitable for implantation than polypropylene (Class 2). The modern improved meshes have a pore size of 2 to 3 millimeters. The Marlex (polypropylene) mesh has a 1mm pore size and after implantation with the tension produced by the body, it shrinks even further.  Whether in an animal or human, bridging fibrosis or scar tissue, rigidity, and shrinkage up to 50 percent causing pain were all observed in his studies.

“Pore size and distribution of pore size is the most important for integration of mesh in the body.”

“The reason Ethicon launched the product was they were convinced large pore had advantages for the patient. Obviously they knew this.”

A lawyer on the videotape asked, “Do you mean the Vypro?”

Dr. Klosterhalfen answered “yes.”

 Mesh News Desk appreciates donations to cover this coverage. Additional detailed verbatim coverage can be arranged via janeakre@meshnewsdesk.com.  Thank you!

http://tinyurl.com/mg922yo

 

27 Comments

  1. Kristine says:

    How dare that attorney assume that she isn’t in pain. I’ve been to several doctors and yes they will dismiss the pain because they don’t know what to actually diagnose you with. Mesh damage can present itself in many different ways. Pelvic pain . Butt pain. Hip pain. Abdominal pain. Muscle cramps so severe you cannot walk. Bad back pain . Urethra burning. Stabbing jerking pain in the groin. Rectal and pelvic burning. Trouble sitting for long. I can’t sleep because of pain. I suffer from all of the above. No joke. I see a pain specialist and a neurologist and a physical therapist. Sometimes doctors do not chart your complaints. Keep track of each appointment and what you discuss with the doctor and date is important. Don’t dismiss her complaints.

    • Catrina says:

      If only I had been warned…I can relate with every word you said. One thing I am thankful for is the Advertisements on TV with related symptoms…My daughter begged me to file. “That is you mom! Everything you have been going through”. It took my mother months later urging me to call the number.

      It is embarrassing and has given me a great deal of SHAME & PAIN. When a pain management doctor dismissed me, because he didn’t have time to wait for a urine sample. I went to see a urologist. She said “No way that product should have been used, It can’t be removed”. After a urodynamic test, I was diagnosed with a neurogenic bladder and given caths. THAT IS WHEN it all came together, as I continued to fall apart.

  2. Jaramillo says:

    Thank you Jane. What would we do … You are the only person that keeps us informed of what happens in the hearings. I don’t understand why it is not in the media??

    • Jane Akre says:

      I can’t explain it either…. I’m clueless about that…I’m afraid it doesn’t speak well for our attitudes toward women… but that’s just speculation.

      • MarieAnn says:

        Mesh is the true War on women. Where are the NOW women? To heck with free birth control for women, how about justice for our lives being ruined. Our intimate lives are a thing of the past due to this medical disaster.

      • jade says:

        Hi, Jane – Just watched your sample documentary “Enmeshed”. Your thoughtful selection of victims shows that crime knows no boundaries – it does not differentiate. It attacks women from all walks of life! None of us could have, at the time, known the vast conspiracy taking place at the manufacturers level for the sheer greed of advancing their bottom line. This was truly intent to commit fraud and experimentation on unsuspecting women who had no idea that they were the sacraficial lambs in this truly CRIMINAL and murderous act. Thank you, again, for yet another excellent job of getting to the core of this vast coverup.

  3. Heatha Anderson says:

    The Manufactures ought to go to jail.

    I have this rubbish mesh in me for 10 years now.

    How can they actually have no medical ethics to ruin our lives.

    I will never marry or have a partner because of damage and pain.

  4. Mary pat says:

    Jane – thank you for your faithful reporting. Words could never express ghe gratitude I feel for your commitment to bring the truth to light. God Bless you in your work and in every part of your life!

  5. Shirley Dodson says:

    Its a darn right shame that they dismiss pain and the damage the defective devices have on women’s lives in all aspects mine has been removed for over a year now and the thought of sex kills me I cannot have a normal life anymore and yet because of cases like this other woman suffer the consequences. I have suffered with vaginal bleeding, pain in the vaginal and legs and groin area due to my internal organs rotting for nearly a decade. And gynecare pushed these products on doctors with them having no clue the side effects we have endured. Even the FDA process of surpassing these products was not notified but yet doctors really have no clue as to how the mesh has affected our everyday lives of being able to do normal activities makes me wonder why they have tested them themselves. A womans body should not be used to gain a profit in our pharmaceutical industries God forbid what they will try to put through the system next for a profit. All I can say is imagine your vaginal area feeling like raw inside everyday and there is no comfort especially if there is side affects to certain medicines for pain. I hope they find Justice for all us women who have suffered in pain and agony not to mention the stress of being able to do normal everyday activities.

  6. John says:

    The reason for the lack of media coverage in my opinion has to be the advertising dollars handed to them by big pharma, i.e. J&J 57M per day! they won’t bite the hand that feeds!

  7. jade says:

    Was this case chosen by the Defendant? To me this is a classic scenario the Defendants are trying to put forth – only when women saw the “commercial” re: TVM did they want “in” on the MDL??? This case in that sense does NOT represent the majority of women who, from very shortly after implantation, began sufffering the horrific complications of mesh. Let’s look at those women who were “perfectly healthy” and functional right up to their surgury and then were literally physically destroyed by pain shortly after. Like Dr. Moore said – “no pain before, extreme pain after – ureka – it doesn’t take a genius to figure out what caused it!” (paraphrased)

  8. Patricia Shaffer says:

    Thank you so much Jane for the coverage. I get so mad tho when I hear what the defense is claiming. I for one am grateful for all the hard work the plaintiff lawyers have done for women. Of course they make money and they should. However, we sure would have no hope without them. As for the tv ads, if our doctors had given us the truth or even information all of us would have known that the mess was doing crazy things to us. I suffered for years thinking I was just getting old. Never thought for a minute it was caused by mesh. That’s because the implanting doctor just said this new mess is so easy to use and I will never even know I have it in me. So I believed him and forgot about it. But spent a lot of money through the years on MRI’s, CAT scans and all kinds of medical care that was not necessary. Thank you tv ads for the truth!!!!!!!!!

  9. karen johnson says:

    I agree with Jade. Who chose this case to represent thousands of women that have documented medical records detailing the pain and agony from the mesh bladder slings? I am sure this lady had pain from the mesh. She unknowingly went to other doctors for various symptoms we endure from the TVT mesh. She trusted her surgeon who implanted the defective device. This seems to be a weak case to start these hearings off with. My pain was so localized in my bladder and pelvic region the weeks after recovering from the implant surgery in 2011. I had 5 revisions and finally I went to a surgeon in Cincinnati and had the sling removed. He used my own tissue to support my urethra and bladder. I still have the arms in my pelvic and now experiencing spinal problems. Nerve ending problems. My point is I believe a stronger case exists then the one used in this hearing. I sure hope the plaintiffs did not chose this case to open up the hearings with. That makes me skeptical of the justice system which is one more thing to worry about. I pray justice is served and that the FDA comes down hard on the mesh companies and that we are compensated for being guinea pigs. We have a lot of bodily tissue that a good surgeon can create support for our bladders using our own tissue.

  10. http://www.dailyrecord.co.uk/news/scottish-news/health-secretary-alex-neils-medical-3127388 J&J is having secret talks to negotiate with entities that will bargain with them. Harmed women are excluded from these discussions. Where is the justice in that?

  11. top judge Efiert in West VA charged J & J with “spoliation” . They erased hard drives and destroyed documents and then claimed They don’t know how it happened. I think that angered Judge Goodwin and therefore a Legal Charge of “spoliation” would apply to J & J.Punishment would be to “strike down all their motions and “default” to settlement of Bellweather cases. I will never buy a Johnson and Johnson product ever again. I always thought of them as “baby powder and other loving products. As we know that is NOT the case. I wish you all well. Going into my 6th year. There was an FDA warning on the wall. I saw it when I went back to OB office. First time I knew something was terribly WRONG, I was in Atlanta holding my grandchildren and walking up stairs 4 days. The pain hit me like a stab in the gut . I had to take wheelchair to get on my plane home. I will pray for you all as we walk thru this nightmare all these companies put us thru for the “almighty dollar”.God bless you all.

    • Also, forgot to say that I read on the West Virginia Courthouse site in regard to “spoliation” charge: “I will Bulldoze these cases forward”” (I think Judge Goodwin and others are great/WISE and Judge Goodwin will keep his word on this. The West Virginia Courthouse in Charleston has a HUGE amount of civil, criminal cases and now the Mesh cases to deal with. They appear to be doing a great job with such an enormous case load.This Courthouse is on line and is open to General Public .the number of cases they have to deal with is staggering. God bless them.

  12. Anna says:

    I am very excited to see this trial because it does look like it’s one that was chosen by Johnson and Johnson.

    I am one of the lucky ones — I had fantastic doctors who took the mesh out of me 7 months after they put it in – my surgery to put the mesh in was in March of 2005 and the surgery to remove it was in October of 2005. My doctors were actually witnesses in one of the earlier trials and are two of the top urogynecologists in the country. I have recovered well and it’s probably because they got it out quickly. When he went back in to remove it, he told us that my insides looked like raw hamburger meat and he had never seen adhesions like this develop so quickly. I have occasional pain now but overall have had good results.

    The other plaintiffs have been so extreme compared to my situation so I am looking forward to see what happens with this one. There are so many different levels of complications from this stuff and it will be good to see how the jury reacts to someone whose situation is less severe than some of the others.

    NOT to discount her pain but when I compare the explanations of her experience and my experience with the other plaintiffs who have gone through a dozen or more surgeries, I count myself lucky. I endured less than a year of agony and am satisfied with the outcome now that the mesh is out of my body. I had nerve blocks in my vaginal wall, pelvic floor physical therapy, lost an ovary because the adhesions were so enmeshed and had horrible pain right up to the time they took that crap out of me.

    I can’t imagine those of you who have had to endure this for so much longer. My prayers truly go out to you but none of us should have had to deal with that whole ordeal.

    Jane, thank you so much for your tireless dedication to this and to the women who have suffered because of this mess.

  13. Donna says:

    The Blaze, Glenn Beck, is not afraid to tell the truth.

    Anyone know how to contact him? I cannot find an email address.

    I agree the media should reporting on the mesh trials.

    Thank you Jane for your continued support and coverage of trials.

    Is there anything we can do to support you as you support us? If it wasn’t for your updates, us victims would be in the dark on what is happening with the mesh.

    I am in pain almost every day and lost my job. My pain free days are limited, however would like to do whatever I can to help support you. I look forward to any ideas you can give me.

  14. D J Bailey says:

    This is a bunch of bull crap !! My life has been ruined because of this mesh, I had the crap put in me in 2010 and what was said to be an out patient procedure become to several days in the hospital and I have never been so sick and in so much pain and I went back to my OB and several other doctors because I knew something was wrong and I felt like I was going to die and after being put on pain medications and anti nausea meds I still could not function so after a few months I was told by a urologist that she would recommend to remove the mesh and once she did the surgery she told my husband she could only remove part of the bladder sling and now I have had more surgeries than I care to count because of this crap So !!!! who the hell does this lawyer think she is to say the product safe, I would love for her to walk in my shoes just for one day and then tell me this product is safe !!!! I am so pissed

  15. MarieAnn says:

    Maybe Bill O’Reilly, he claims to be looking out for the folks? What about Geraldo? The 700 Club, surely isn’t in bed with advertising dollar amounts??? I can’t believe some powerful woman in America does not know of anyone with mesh complications? I interact daily with people and almost everyone I know, knows someone who has been harmed by this unsafe device. I thought the liberal media loved Women’s Issues…

  16. Lori says:

    My main surgery was hysterectomy but since I had incontinence problems that I had asked about the surgeon says he can fix that while doing my hysterectomy. Lucky me! (Not). I was out of hospital two days

    And my body was rejecting this foreign object but I didn’t know. Dr. Figured I had an infection and I was back into hospital with multiple antibiotics – I didn’t even recall I had mesh or anything about that. It has been HELL EVER SINCE. My doctors all had no explanation. My husband saw mesh commercials and then he remembered that I had mesh from the surgery. I had lost my job due to hospitalization and continued illness. Prior to this mesh I had gone through so much to get my health back. I have lost so much because of mesh plant. Now I just need it out.

    PS. An opthologist (now retired) has removed mesh from eye surgery because the

    Mesh had bad effects in eyeball repair. It was NOT successful for eye surgery either, not

    What defendant attorney claims in this case.

  17. Bejah Notrettu says:

    You ask why there is no media coverage for this issue and why there never has been? It is simple. BIG CORPORATE AMERICA owns the media. As for Mr. Beck, whose truth do you think someone like Mr. Beck is going to tell? I promise it is not yours. There are millions of us. Are we writing to our congresspeople and senators in droves? Not that that is any guarantee of some movement in the coverage and attention concerns related to this issue. Also the fact that there was a news truck there on the first day of the trial but for some other issue is interesting…was that just coincidence? The question is what are we going to to about these matters now? After this trial and Ethicon wiggles its way out of responsibility and we all go home, what then? More of the same and so it goes. Ethicon goes on running its game and we disappear into the sunset or the ground. The more I see of even the justice system in this country the more I am sickened. It is all rigged. Pehaps it is true that we do not have a chance and never really did. And do you think it is some smart kick ass plantiff they put on the stand? No it is a quiet, simple, gentle older woman who does not understand this evil and sophisticated world…just the kind of person Ethicon wanted…someone who did not aggressively persue medical care…and probably does not have the funding to do so. It is a game to Ethicon that they control. They care about making money. They do not care about you. They never did. They are a Narcissistic organization, without empathy, or compassion or a sense of responsibility. They are not like you, they do not have the humanity you do yet you continue to expect or hope for humanity in their actions. It will never happen. We are lab rats to them. So what are we going to do about it?

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