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Lewis v Ethicon: Day Four ~ When did Ethicon Know TVT Had Problems?

So District WV federal court

So District WV federal court

Its difficult to know what’s missing if you are a juror watching this trial.

Ten jurors sit in the Charleston, WV courtroom to listen to the first of 15,000 cases filed against Ethicon, a subsidiary of Johnson & Johnson over its polypropylene transvaginal mesh. In this case, Plaintiff Carolyn Lewis had a TVT (tension-free tape) implanted in 2009 to stop a problem of urine leakage, or SUI (stress urinary incontinence),  usually not a painful condition, just annoying and embarrassing.

The permanent plastic medical device  still pains Lewis to this day. Some of the mesh was eventually removed but the arms of the TVT remain behind, a sort of ticking time bomb if you believe plaintiff witnesses’ who say that the polypropylene (PP) takes on destructive life of its own inside the body. Today Lewis says she feels about 85 percent better.

TVT from Meshed Up UK

TVT from Meshed Up UK

What was Lewis promised by her doctor before agreeing to the procedure? Was she told there could be complications, astronomical medical costs and a series of surgeries? Was she told she might suffer dyspareunia (painful sex) and have a return of incontinence as well as pelvic and chronic nerve pain.

Dr. Muriel Boreham

Dr. Muriel Boreham

We will not know the answer to that question because one of the elements of a defective product case, as this is, is a failure to warn. Judge Joseph Goodwin had ruled pretrial that the failure to warn element is off the table. Why?  Because the implanting physician, Dr. Muriel Boreham of Dallas, hadn’t read the product instructions (IFU or Instructions for Use)  since 2002.

Never mind that the instructions that inform a doctor who then in turn informs her patient, haven’t changed much since then.  Ethicon never contained in its IFU information that it had received hundreds if not thousands of patient complaints concerning chronic pelvic pain, mesh erosion, infection, nerve entrapment, an inability to have pain free sex, repeat surgeries and mesh removal.

Without a failure to warn case, Lewis v. Ethicon has become a highly technical defective product case with battling videotaped depositions of scientists. The level of energy from a screen replacing a live person on the stand is generally low and there were three back-to-back videotaped depositions presented to the jury throughout the morning and part of the afternoon. Some jurors paid attention, some didn’t while Judge Goodwin seemed to be resting his eyes for awhile. More on the videotapes in a moment.

Dr. Uwe Klinge from Linda Gross trial Feb 2013

Dr. Uwe Klinge from Linda Gross trial Feb 2013

The German Doctor and Scenes of a Mesh Gone Wrong

Things picked up a bit late in the afternoon with the arrival of Dr.Uwe Klinge. His deposition has been entered into evidence in this case here. 

The German medical doctor works at Aauchen University where the technical aspects of hundreds of mesh explants are studied in a laboratory. The top university for biomaterials in Germany, no one else has studied and published more than he and Dr. Klosterhalfen (See yesterday’s report here).

Using histopathology  to analyze tissue at the microscopic level that the eye can’t see, they have established criteria to define the good and bad responses to mesh implanted in the human body for both hernia repair, pelvic organ prolapse and SUI.  Dr. Klinge told the jurors that he had viewed at least 20,000 of these slides where he saw small pore mesh amass scar tissue and inflammation around it. Nerves became entrapped as the body tried to rid itself of this foreign invader and a a result, patients are left in pain.

Dr. Klinge told jurors that polypropylene (PP) plastic is commonly used in our everyday lives, for plastic bags for example. This was not something they had heard before, nor have they heard PP is used in making plastic blinds or indoor-outdoor carpets. A few jurors took notes.

Dr. Klinge began analyzing PP mesh  (the  same mesh used in TVT) in 1994. Beginning in the early 90’s, what he described as “intense discussions” began within the medical community whether to continue using mesh or to just use sutures, the traditional repair.

Dr. Uwe Klinge

Dr. Uwe Klinge

“We felt it was necessary to learn more about mesh because we saw some complications. We said we have to learn more about this material in the hopes of reducing the amount of material and to make it safe.”

At this time, most of the PP mesh used was in hernia repair but by 1998 the same mesh would be crafted into the TVT mesh for SUI repair.

Ethicon,  a division of Johnson & Johnson, had a research facility in Germany and together with local scientists/consultants, including Dr. Klinge, they developed the Vypro and UltraPro, one-third the weight with 3mm pores (macropores) three times larger than the PP mesh (brand name Prolene) that improved patient outcomes.

Questioned by attorney Ben Anderson: “When did Ethicon stop selling Prolene for hernia mesh?”

Dr K: “I remember in 2001, the old Prolene was replaced with the new version.”

Anderson: “Is there a light weight small pore mesh for SUI?”

Dr. K: “No.”

Anderson: “Do you know why Ethicon continues to sell …”Objection, said David Thomas for Ethicon.

Judge Goodwin had ruled earlier on limiting the testimony from Dr. Klinge. See here.

Anderson tried to ask, how many of your explanted meshes are hernia versus pelvic floor mesh? Again an objection from Thomas which resulted in an attorney sidebar with the judge. Those in the courtroom looked around- what was happening?

As part of his expert report for the case, Dr. Klinge presented stained slides of Ms. Lewis explant samples magnified 40 times. They showed areas like white land masses surrounded by pink which were actually scar tissue masses surrounding the plastic mesh fibers. Tissues had activated a foreign body defense mechanism  in reaction to the Prolene mesh. Scars (bridging fibrosis) shrink and lead to chronic pain in patients. Nerves entrapped in scar tissue cause pain and are often the reason mesh has to be removed.

A second slide was an example of deformed mesh that had folded, something Dr. Klinge had seen in explants. “The complications from folding increase the risk of pain and erosion into adjacent organs,” he told the jurors.

The judge cautioned jurors that correlation might not mean causation.

Anderson asked, ” Do you have an opinion with a reasonable degree of medical certainty whether the images we’ve seen today are related to the pain in Ms. Lewis?  “Objection” again said Thomas.  “I’ll allow it,” said the judge.

Dr. Klinge started to answer blaming “overengineered mesh” but again his answer was interrupted with an “objection.”

On cross exam, David Thomas established that Dr. Klinge did not himself prepare the Ms. Lewis slides, that he’s not a pathologist, hadn’t performed surgery since 2006 and that he’s never done SUI surgery.  “A ‘real pathologist’ prepared this report?”  Yes, said the doctor.

“You did hernia surgery knowing the risks,” said Thomas referring to the fact that Dr. Klinge had in the past used PP for hernia repair. “You used Prolene believing the benefits exceeded the risks?”

“Yes, but I’ve changed over time significantly,” Dr. Klinge uttered.

Thomas then pointed out that in a 2010 book, Dr. Klinge said the “gold standard” for SUI repair is the sub-urethral sling using tension-free TVT tape, to point out his inconsistencies.  Underneath the portion of the book he had highlighted was an unhighlighted portion in the same book that said there are fewer injuries with macroporous (large pore) mesh.

Dr James Hart, Ethicon

Dr James Hart, Ethicon

Dr. Hart

Dr. Hart is a general and cardiovorasic surgeon who was hired by Johnson & Johnson where he worked in medical affairs for Ethicon from 2005 to 2007.  He began testimony via videotape for the plaintiffs’ in the morning.

Dr. Ulm Ulmsten from Sweden had initiated a new application for an old Prolene mesh, a small pore heavy weight polypropylene mesh used for hernia repair. His invention, the TVT would be used in women to shore up a sagging urethra and prevent urine leakage.  In 1997 he sold his patent and the TVT product to Ethicon and was  eventually paid in excess of $25 million.  However, the second payment ($400,000) depended on the doctor delivering studies, which he oversaw, that had to reach certain benchmarks. On videotape the plaintiffs’ attorney asked Dr. Hart if that was a conflict of interest?

Dr. Hart admitted it would be a conflict today but back in 1998,  “It wouldn’t have been a conflict ten years ago.

Dr. Ulmsten had $400-thousand reasons to make sure his studies met the benchmark, am I correct? said the attorney for Ms. Lewis.

It’s a conflict and it’s unavoidable. They were not the only studies done for the TVT. It’s a conflict yes,” Dr. Hart said. When asked, he was unaware that Dr. Ulmsten owned MedScan, the company that eventually sold its TVT patent to Johnson & Johnson.

The new CEO of Johnson & Johnson, Alex Gorsky,  in 2009 initiated a transparency initiative that would disallow company support for studies where the scientist had an economic stake in the product or to rely on studies with a predetermined conclusion.

23 Comments

  1. Mary Pat says:

    Hi Jane,

    I just donated to the cause. I hope it helps. PLEASE, everyone out there, SUPPORT JANE!!!!!! We need her.

    Jane, keep up the good work. Words will never be able to thank you for your effort and your support.

    God bless you!

  2. charles h says:

    i am glad I found this website commentary. my wife was implanted with mentor mesh which has already been removed from the market and j and j bought mentor. will j and j be responsible for mentor now? mentor already settled out of court years ago for undisclosed amount. my problem with all of this is the foreign body response . I think my wife is slowly dying from this and we are not able to be taken seriously. we have seen many mds and I believe the word is out and no one wants to be involved suppose we settle and she dies from this mess ? any suggestions pls?

    • Kristine says:

      Your wife has a right to request that the mesh be removed from her body. I’ve been fighting for two years. I’m finally seeing doctors who are going to remove it. I spoke to an advocate within my insurance company. She told me they can re route a referral to Dr. Raz at UCLA medical center if needed. Keep fighting. I’m so sorry about your wife. I’m in the same situation as my fellow sufferers. Pelvic groin pain butt pain leg cramps. Constant infections. I’m on antibiotics at least once a month. Their is so much more to tell. Nerve damage is real mine is pretty bad. Keep fighting. Life as I knew it will never be the same but if taking the mesh out helps. Which it will I’m all for it. God bless your family and your wife.

  3. Aaron Leigh says:

    Great reporting JANE! THANK YOU!!!!

  4. Allan says:

    Part of day 4 is missing. The middle is gone.

    • Jane Akre says:

      I have to file something… then I go back in and complete it… that’s what happens when you file in the am … then again in the pm… it should be all there now.

  5. Kay Heard says:

    Thank you so much Jane for keeping us informed about the cases!

  6. Linda says:

    Thank you for such awesome writing skills. Hope you are safe from the storm.

  7. Shirley says:

    The arms they are talking about cannot be removed surgically I still have them inside me I sympathize with all the women who have been affected by this product where deceptive practices relinquish women right to understand what complications we would have to endure for life. Thank You so much for updating us on what is taking place within the division of litigation against the defendants…

    • Jaramillo says:

      Dr. Ra was able to remove the arms in mine. He said he got it all out. I did go back a year later for re-construction of my eurethra due to the damage the mesh caused. I also had 2 bladder hernias as a result of the damage from the mesh. He also repaired those. Reconstruction was not nearly as painful as removal. Plan on resting for a good long time after removal.

    • Suzanne McClain says:

      Shirley, Dr. Raz was able to remove the arms, and in fact all the mesh from my body last September. He had to scrape my pubic bone to get the arms out, and he had to cut through muscles to remove part of the mesh; the remaining mesh was dissected from my tissues. Not sure where you went, but I would strongly recommend consulting with Dr. Raz if you still have the arms implanted in you. In my opinion, Dr. Raz is a wonderful surgeon, and now that I am leaking again, I am making arrangements to go back to him for an autologous repair. Unlike other doctors, Dr. Raz refuses to use mesh in women.

  8. David Sawyer says:

    It must be very frustrationg for you to sit there quiet Jane knowing what you know. As always Thank you for all your time, hardwork, and devotion to this cause and your reporting. Without you many would still be suffering in silence.

    • Jane Akre says:

      Yes its frustrating because I can’t hear all of the testimony I fear I’m missing much…. can’t imagine how much the jurors are absorbing….

  9. Kristine says:

    Thank you Jane. I look forward to reading about this daily. It gives me hope.

  10. Beth says:

    Jane were you there for jury selection and can you tell us anything about who is on the jury?

    Thank you for being there for all of us!!

  11. Laura Stanley says:

    I just want to thank you Jane for the great reporting job. I can’t imagine sitting there and listening to how many things are still being covered up or knowing some of the things that are not allowed to be talked about in court . I would just want to stand up and scream out to stop covering for these corporations and really take a good long look at how many lives have been destroyed by these products. Again, thank you so much for the great job you do. Without you, we wouldn’t know anything coming out of those courtrooms. Bless you and I hope you keep up the great work.

  12. Jane Akre says:

    There is hope, always…

  13. Jane Akre says:

    More to come on this story. I posted and it didn’t stick… we had Gene Kammerer via videotape (see him in the Linda Gross case) a Dr. Chen who was in charge of adverse events for Ethicon, also a a Dr. Urich Holsta–(spelling?) who was a vet in Germany consulting on the explants. Need to find their depositions when I get home so I will expand on these stories and fine tune later…! Thank you…

  14. Mary Pat says:

    Jane – do you realize that you are the sole person who has given mesh injured people a voice? You continue to bring the truth to light in a world of corruption and darkness. When we, mesh injured people, need to educate others, we can direct them to your site. Your site legitimizes the catastrophic and tragic realities that mesh injured people live with that seem so foreign and unbelievable to others. Without your painstaking research and incredible journalistic skills, mesh injured people would be alone in this world attempting to tell their shocking and unbelievable stories. Your reporting says it all. You are the voice of mesh injured people. You are the voice that is educating the world about the horrors of mesh. You are making history. Someday you will be famous for what you are doing. Until the entire world recognizes you, please know, you are our hero, a “rockstar” of a journalist, you are the absolute best! I think I can speak for all mesh injured people when it comes to praising and thanking you. We are grateful.

  15. Paul. P says:

    Thank you so much Jane for your award winning reporting of this messed up mess. I take care if my wife with a meshed up body. With out you we would be completely in the dark with this suite. I have helped her with two removal surgeries here in Utah. Again thank you so much.

    Paul

  16. HE says:

    Thank you Jane! I looked and searched for hours for any other news on this trial. Practically non-existent, and you have much more detail than any other site. To me this is such a sad statement, because we know the pain, torture and horrors that mesh has caused to the individual, families and communities. I am praying the jury can see through the smoke screen the defense is putting out and will see the truth. It is hard to believe that Judge Goodwin isn’t biased for the defense, but I felt the same way following the Linda Gross trial and that case did prevail. It seems horrible that 15,000 cases will be largely determined by 4 bellwethers. We are in an MDL because all our cases are not the same! Anyway keep up the good work!

  17. Sandy says:

    Thank you too Jane for being there for me. Ladies I wish I had the time and money to go Washington and raise a fit! How in the world do all theses medical companies get away with this. I am a two year sufferer. I was lucky enough to have friends convince me early on to get a second opinion. I have had my mesh removed but a year later After the removal i am still in pain. Nerve damage that can not ever be repaired. So now I am going to have additional surgeries to try to help with the pain. What defense do these companies have. How can they make a product and market it, when they know it can and more than likely will cause damage, and still go forward all in the name of making money. That should be criminal! And in the end ladies we won’t ever be commensated what we should be for having to live the rest of our lives with this disabiliting injury. There’s days I can barley walk due to pain. I like to see them in jail who knew and still did this. But that won’t happen. So I guess the next best thing is to make them pay. But how can you out a dollar figure on spending the next 20-30 years in pain? I just pray God helps every woman out there get justice.

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