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Inside the Ebaugh v. Ethicon Pelvic Mesh Trial

Ethicon discovery

Mesh Medical Device News Desk, August 23, 2017 ~ The trial of Ella Ebaugh got underway earlier this month and the pelvic mesh case is close to going to the jury.

Ebaugh, 51, was implanted with two pelvic meshes made by the defendant Ethicon, (Johnson & Johnson) – the TVT-SECUR and the TVT (tension-free vaginal tape).

The case is the latest and the sixth pelvic mesh product liability case to be heard before jurors in the Philadelphia Court of Common Pleas, which has been a favorable venue to plaintiffs in the past.

Johnson & Johnson has not had a good week.

It began with a record $417 million verdict in the plaintiffs’ favor in a talcum powder-ovarian cancer case in California. See the Mesh News Desk story here.

J&J vows to appeal, despite the fact that the plaintiff, Eva Echeverria, is suffering end stage ovarian cancer.

Now another case is getting close to being wrapped up, this one a pelvic mesh defective product case.

Ebaugh v Ethicon, Case # 130700866 is being held in the same Philadelphia court that has seen five of six juries delivering compensatory damages to the mesh-injured plaintiffs.

Mesh News Desk has transcripts from inside the courtroom and will deliver a series of reports leading up to the verdict, which could come as early as next week.

Philadelphia Court of Common Pleas

 

THE PLAINTIFF

Ebaugh, photo contest entry, York, PA

Ms Ella Ebaugh, and her husband, Marvin, live in Pennsylvania. By age 39, she had delivered five children vaginally and was experiencing incontinence.

She had a TVT- Secur sling made by Ethicon (J&J) implanted on May 31, 2007, at Apple Hill Surgical Center in York PA by Paul Douglass, MD.  He reasoned since she was so young and had a very active lifestyle, it was the most minimally-invasive procedure that would allow her to get back playing sports, like softball, with her children.

Dr. Douglass retired in 2011, but not before he implanted close to one hundred TVT products, according to the defense.

Ms. Ebaugh had to have corrective surgery because of a mid-urethral erosion on July 12, 2007.  At that time, she was implanted with another mesh, a TVT.

On June 14, 2011, she had a corrective surgery, due to mesh complications, done by Howard Mirsky, MD at York Hospital in Pennsylvania. On March 14, 2102 she had her fourth surgery, and third corrective procedure, at the University of Maryland Medical Center with surgeon, Dr. Toby Chai.

Dr. Chai did an ultrascope and thought mesh was in her bladder. He didn’t find any but removed a few strands of mesh from the urethra. Finally, in 2016, a Dr. Wright did surgery to remove more mesh because she was still experiencing complications.

The Ebaugh trail began July 31 in the Philadelphia Court of Common Pleas where there have been four victories and one partial victory for mesh-injured women.

The action alleges design defect, negligence on the park of J&J, product liability. It does not include a failure to warn. (*Correction from earlier post).

Dr. Tom Margolis, female pelvic surgeon , expert for PL

Some of the experts we’ve seen in previous pelvic mesh trials will appear here as well – M. Tom Margolis, MD, Dr. Bruce Rozenzweig, MD, Dr. Uwe Klinge, MD,  Peggy Pence, Vladimir Iakovlev, Chevron MSDS, and Daniel Elliott, MD.

J&J wanted allegations of spoliation  (destruction of documents by J&J) out of the trial and Judge Michael Erdos agreed.

The judge also ordered plaintiffs not to introduce evidence that the IFU (instructions for use) was defective, however, they may introduce evidence related to the IFU – its risks and warnings in general. The plaintiffs may not introduce evidence of a “David and Goliath” argument, however plaintiffs may introduce evidence of the defendant’s sales figures and profit motive.

Lawyers for the defense include Melissa Merck of Drinker Biddle & Reath LLP, Philadelphia;  Kat Gallagher and W. Curt Webb of Beck Redden, Houston, TX.; Phillip Combs and Daniel Higginbotham of Thomas Combs and Spann, Charleston WV;  Julie Callsen of Tucker Ellis, Cleveland; Jordan Walker of Butler Snow.

Kila Baldwin, Kline Specter

Lawyers for Ms. Ebaugh include Lee Balefsky, Kila Baldwin, who delivered the opening to jurors, Christopher Gomez and Tracie Palmer of Kline & Specter, Philadelphia.

The jury is made up of all African Americans, six female and six males, mostly middle-aged.

 

Plaintiffs’ Open

On August 4, Ms. Ebaugh’s attorney Kila Baldwin delivered her opening statement to the 12 jurors.

Judge Erdos reminded the jurors that the plaintiffs have the burden of proof based on the credibility, truthfulness, accuracy and weight of the testimony and other evidence. The jurors were instructed not to talk about the case, even to each other and even in a casual setting, and not to do any independent research, including an Internet search.

Jurors are allowed to take notes during the proceedings, but not the opening or closing statements, however, they cannot take the notes out of the courtroom.

Friday afternoon, Ms. Baldwin reminded the jurors the TVT-Secur was sold only from 2006 until 2012 when it was removed from the market. The TVT is still sold. See the 510(k) approval to sell clearance by the FDA here.

“These defective products have literally mangled Ella Ebaugh’s urethra,” said Ms. Baldwin.  Pain, incontinence will cause her to suffer with this for the rest of her life.

Ethicon is a company worth $70,418,000, said Baldwin, while Ethicon is worth $2,762,000, she said.  This defendant makes decisions with money in mind. She showed a logo from “Ethicon’s Women’s Health and Urology. Show me the money,” internal documents from the marketing department in 2007.

“This is what Ethicon was concerned about when it marketed its TVT line of products, which includes the two that are at issue in this case.

In the case of TVT-S they never tested it in humans in a robust study before the y put it on the market.   In the case of TVT, they paid for the results and never verified the underlying data, said Baldwin.

“Ella Ebaugh is a casualty of the reckless conduct.”

Ethicon produced a different mesh with larger pores that didn’t cause scar plate formation. Ultrapro is made of half polypropylene and half Monocryl, absorbable mesh. Its larger pore size avoids scar plate formation and bridging fibrosis, a larger solid scar plate that causes mesh to shrink.

Ethicon has another mesh with medium sized pores, Dynamesh, which was also never used in the TVT line of products.

Scar plate formation is the first indication the mesh is defective, chronic inflammation is the second defect, said Baldwin. Inflammation is the body’s reaction to a foreign body, in this case the Prolene plastic that is not inert. The reaction does not fade over time. This chronic foreign body response is also known as giant cell reaction which comes with more mesh in the body as compared to a tiny suture, jurors were told.

Erosion, mesh migration are also indication the mesh is defective. Ebaugh had three erosions with five perforations to her urethra. The jurors are shown blue inside her urethra along with calcium deposits.

TVT SEcur from Russian website

The TVT-S also has felt tips to hold it in place. They aren’t working, said Baldwin. The mesh migrates around the body and can easily get out of place increasing the risk of erosion.  TVT-S is a laser cut mesh, which is three time as rigid as mechanical cut mesh, making it more likely to erode.

Before mesh there was a Burch procedure, using stitches to hold up the vagina and support the urethra.  There is another surgical option, the MMK procedure using animal tissues a porcine graft or a cadaver tissue or tissues from your own body to provide a sling support. If they don’t work there are almost no long-term problems, she said.

TVT, TVT-S 

TVT was launched after Ethicon bought the device for $24 million, paid to developer to Ulf Ulmsten, MD, whose name has been mentioned in many of these product liability mesh trials.  That was 1996. By 2004, the TVT was worth $100 million to the company, or 91% profit.

It was a good investment, Baldwin said.

TVT-S was developed by Dan Smith, an Ethicon engineer, in order for Ethicon not to lose market share with its competitors.

It couldn’t be tested before marketing because of budget constraints. What was done on the TVT-S was five weeks of randomized control trial on 31 women.  The results were never published, Baldwin said, in thirty percent of the women, it failed within five weeks.  Ethicon launched the product anyway.

An executive at Ethicon in Germany said “The more procedures, the more problems” referring to TVT-S. The TVT-S validation studies are referred to as a big steaming pile of dot, dot dot, said internal Ethicon documents. Another says TVT-S is “pretty awful.”

“How can we spin it?” referring to the data…”How can we jazz it up?” says another exhibit.

TVT-S was pulled from the market in Australia in 2006 by the Ethicon medical director, Aran Maree, MD, but it continued to be sold in the U.S. until mid 2012.

Key opinion leader Dr. Vincent Lucente, who was paid more than $2 million by Ethicon, had a horrible failure rate, 60% with TVT-S, but that data was never published, the jurors were told.

Dr. Paul Douglass, implanted Ebaugh

When the TVT-S didn’t work, put in another mesh right on top, recommended the company.

Dr. Douglass, who implanted Ms. Ebaugh, is quoted as saying, ‘Yeah, I like the TVT, I like to do it in outpatient centers because that way I could put more products in in one day.”

Ethicon/ Johnson & Johnson had an $800 million prelaunch marketing budget for the TVT-S, some of that money going to pay key opinion leaders such as Lucente, and to sponsor industry events such as AUGS, the American Urogynecologic Society; the Society of Urodynamics; Female Pelvic Medicine; and Urogenital Reconstruction.

Ebaugh today has a mangled urethra, covered in scar tissue near the opening and middle. She has almost no control and has been diagnosed with Intrinsic Sphincter Deficiency, which includes uncontrolled spasms of the bladder.

She cannot get a good night’s sleep because she has to urinate during the night.  She’s a prisoner of her house now.

“What she wants is a normal life.” ###

 

23 Comments

  1. Dani S. says:

    The mangnitude of damages done to this poor woman and others who were implanted this faulty produc is devastating. Waooo, you do not have to go to medical school to figure out that a piece of plastic, whether is called a sling or mesh, can actually function is an area that is full of nerves and so delicate. Where is the common sense of these so call doctors ?

  2. Disgusted says:

    It’s SHOW ME THE MONEY! I feel for Ms. Ebaugh and the rest of us. I can’t for the life of me understand why they are still using it. Except, profit. I have a mangled urethra too. Every year since 2009 I have suffered with UTI’s at least 6 in a year, many years more, this year I’m at 6 so far. I’m doing everything to prevent them I know. I have to cath 75% of the time. No one can tell me why some times I can go and others I cannot. I hate cathing because it causes me extreme urethral pain. I’ve seen over 8 urologists since 2009 and they can’t even be consistent in the answers. One say’s I need my bladder removed. Others say that is ridiculous and then the infections could be worse. 4 of the 8 are highly regarded specialist’s in their field. Even they do not agree with each other. Until they figure out how to handle the complications, this needs to stop period. I live 50-75% of my time in bed (awake hours). I only had the TVT-O. The gold standard of the industry, that has stolen my life, my sex life included. They cannot steal my joy – that is God given. I have joy when I see my grandson playing. Reading him a book. I try to look to what I can do and not focus on what I can’t do. Because I get too depressed when I count all my losses. I am no earthly good to anyone in that condition. I do struggle every day to keep a good attitude (some days are better than others). I pray Ms. Ebaugh gets the justice she deserves. It will not give her her life back. I pray it will mirror the last verdict with the powder and get the media attention it deserves. Women are being deluded into being implanted with transvaginal mesh every day. Some are listening and avoiding this. Kudos to them. There are so many reasons that this is a bad idea. Not just the polypropylene, although it isn’t meant in the body. Even if they found a substitute that was truly inert , there are still more issues to look at.

    I do not understand why the judges consistently block information from being given. It would be worthwhile to show that J&J destroyed evidence. It is a fact. Let them present the reason, someone accidentally destroyed it. I’ve heard women say that this is similar to a rape trial and I agree!

  3. Bejah Blue says:

    Common sense is easily displaced by greed which distorts the mind…it is manifest in those who have sold their souls and many I expect would not necessarily even be consciously aware of it, using self serving justifications, and other methods of defending their choices.

    Bejah

  4. Bejah Blue says:

    Dear Sisters, I wanted to share with you something I did yesterday but first I want to call out thanks to Dr. Margolis for standing by us yet again. Bravo Dr. Margolis for your courage and steadfastness. I went to the drug store with my friend and I bought some happy things. I purchased coconut oil for the first time, GNC, 29 oz., organic, extra virgin and on sale at Rite-Aid. I forget what I paid. I opened it and the fragrance was so heavenly (I love coconut everything anyway). I decided to try an experiment. My little woowoo was suffering from so much burning pain from Vulvadynia I expect…I scooped up a little of the coconut oil and applied it there and it helped…it stopped the burning and it was very soothing. Any of you who have this pain may want to try this as well. I can’t imagine that it would have any adverse effect unless you are allergic to coconut perhaps. I also got pure organic lavendar oil and peppermint oil. I am not really sure what to do with any of this yet. I think I need to refrigerate the coconut oil which is said to be a good substitute for other oils in cooking. I enter the learning curve. Appreciate any ideas. Need to research the essential oils as well. I do have a diffuser so that is one thing but I know there are others including dabbing some on the end of my nose! I also indulged in Caress body washes…try Sheer Twilight…intoxicating, gorgeous. This one was not availbale at the drug store but is at Target evidently or one can buy it online…ship chg waived with order often. I bought two others (Two for one I think), got the “Love Forever” (One of the 12 hr fragrance release ones) and the classic “Daily Silk” (White peach and Orange Blossom). A couple of the 12 hour fragrance release ones some people have complained about. I do not know if it is incompatible with their body chemistry or the product age (This is a new line) so be careful, maybe read comments on the Caress website. All things considered expect to feel beautiful and comforted by these bath additions.

    Love,

    Bejah

    • Bejah Blue says:

      I learned today that the coconut oil should NOT be refrigerated. I took some and put it in a different glass container and used some of that to massage into the dogs fur. They loved it! Makes their coats look beautiful. It is not cheap though. This cost me $20 on sale. I think it is well worth it, however.

      B

  5. Bejah Blue says:

    Physician Paul Douglass pictured in this article looks like a rabbit…I could see him wanting an exotic car and money…to enhance his self image…what a creep. I wonder where he went to medical school and what his standing was in his class. I think class standing should be public information because of the nature of the physician/patient relationship. I doubt any of us would want to be seen by a doctor who graduated at the bottom of his or her class but clearly many do.

    Bejah

  6. Bejah Blue says:

    Here is the little scoop on Dr. Paul Douglass. He is an obstetrician-gynecologist in York, Pennsylvania. He received his medical degree from Sidney Kimmel Medical College (Ranked in 50th percentile only). He has been in practice for more than 20 years. Data on his ranking in his grad class does not seem to be readily available. This is the kind of person who is easily “incentivized” methnks. Carrots anyone? Oh I am such a wicked woman. Are you laughing Kitty?

    Bejah

    • Jane Akre says:

      He looks young but he has stopped practicing medicine… He did not appear at trial…..raises some questions. You are such an investigator!

      • Bejah Blue says:

        Jane, My name seems to default to the wrong thing and it is hard for me to always remember to change it. Can you tech folk help? Thanks. I suppose those who monitor already know but it is always good to plug the leak.

        I think we can always dig deeper and often that is where the rally thick muck is…we must be like water in digging as deep as possible. I would like to see us volunteer to research each piece you prepare and see what we can uncover. If we all do this rather than just be passive readers, turning the data over to you we might uncover some interesting material. Who knows where that could lead. This would be a good way for those of us who cannot move much to make a meaningful contribution, to take action rather than only comment (not discounting commentary at all because it is good therapy and helps others to some degree). Lets think about this, try it. You see people, this little look I took into the background of rabbitface helped us learn some things that were interesting about this individual (what I call people I do not like). Who knows where it could lead. I think it is profound that this creature stopped practicing medicine. What could make someone do this? I am going to look to see if he has any actions or judgements against him.

        What say you people…who will volunteer to look at other articles in this way?

        Bejah

        • Jane Akre says:

          All research is welcome, I like you idea about being active participants and not passive readers. I usually try to post the legal documents if I can….. look at the bottom of the story or sometimes also within the story. Sometimes makes for interesting reading……Thank YOu!!!

          • Still Standing says:

            It is not good therapy to call
            someone names like rabbit face, for it is the moral job of every human being, even those who are mesh injured to be impeccable with our words, and use them to create peace . We can’t change others, just ourselves. Name calling is not necessary to carry the truth. That’s whatmakes news desk more than a gossip column. Jane is a journalist and understands it .

          • Bejah Blue says:

            Absolutely Jane and thanks for the backstories and background data and links. You are so good.

      • Still standing says:

        Dr. Douglass got his medical license in 1971 and retired in 2016, so he was in practice for 45 years.

        • bejah says:

          SS You are right. I am sorry. It is out of character for me and I am appropriately embarrassed. I must thank you for calling me out…I was just feeling so angry and frustrated. Please forgive me. Posted fm Rancho Mirage library.

          B

          • Still Standing says:

            I know that was out of character for you. We must remind each other that even in terrible pain, we can impact the world by moving through it with dignity and honor. Since you are a reader, I want to suggest two books that influence how I try to react. One is by Victor Frankl, Man’s Search for Meaning. He spent years in German concentration camps and underwent severe conditions and inhumanity, yet he developed a mindset that made him persist and with joy and thanksgiving. It is a triumphant story. The other book is The Four Agreements by Don Miguel Ruiz. I fall back on that wisdom many days. One more book I think you will like is Desperate Women of the Bible by Jo Kadlecek. Each chapter tells the story of a Biblical woman who risked everything to get to Jesus for healing. A friend gave it to me for Christmas the same month I had my mesh implant. I put it aside and one day several months later and I was in so much pain. I dropped something off the bed. When I reached under the bed to find it, I pulled out this book. It had a profound impact on me. I’m open to inspirational reading recommendations from you and others as well. We need those impactful messages as we experience pain.

    • Still standing says:

      Coconut oil,is great for vaginal dryness as long as you make sure you are really dry before you rub it in. Don’t travel,with it as Imlearned that melts very quickly and oozes out on everything. Another things I love is tea tree oil. Some of you kightvknow that after mesh, I developed a serious ulcerating of my vagina and vulva, mouth and now my throat. I ulcerated all the way through and had to have half of vagina removed. I have a constant battle to keep the ulcerations at bay. I take methotrexate injections, apply high dose corticosteroids. I have started using tea tree oil mixed with coconut oil. A little goes a long way. I think it may be helping. It is a natural antiseptic . By the way, doctors don’t get graded in med school, so there will be no rankings. They either pass or fail.

      • Bejah Blue says:

        Dear SS, I was so hoping you would comment. I am truly sick at what you are going through, and still you are there for us. You are an extraordinary person. I focus on your every word. I pray for you.

        I finally ran out of the rest of the Oxycontin last night. I am in agony. I realize that I might take my own life if I have to wait until Sept. 5 for my pain mgt. appt…10 days or so. My friend told me to call my primary care doctor and tell him and he could do something to help. FIrst I called my pain mgt. doctor. They said “Come in tomorrow at 11am!” I will, of course…thank GOD. What would I do if the Federal Gov.’t no longer allowed me to have this medicine. It is such a hardship for me to have to go every month, seems so unfair. I have to take a special bus that goes down the mountain to Palm Springs (Cost $10) and it does not take me home until 6pm and it takes an hour…such a long day.

        I really hate shallow drug seeking people because they are why I have to go through this. Curse them.

        Bejah

        • Jane Akre says:

          Bejah- please tell them it is an emergency and do what you need to do to obtain the appropriate pain medication. I’m sorry.

          • bejah says:

            Dear Jane, I called pain mgt yesterday and told them I feared I might (truly) resort to suicide if I had to wait until Sept 6. They asked if I could come in this morning (Tuesday) at 8am or 11am. I took the 9am bus down to Palm Springs and was there by 10:30am. My BP was 174/126 or so! Pain elevates BP and I was also out of all four BP meds (high BP is also fm renal malformation). I also called my Cardiologist…office said he was at hospital doing rounds and they could not give me anything for BP that high…told me to go to ER. Pain Mgt “doctor”, Paul is a really great person and very warm and caring. He left me to rest and try to calm then took BP again and it had plummeted to about 95/54…really strange…I was shaking and freezing cold (outside it was 114 degrees!). My BP does this sometimes; do not know why. Any ideas? JHe let me go with the script. I took it to the hospital pharmacy (out patient) just across the way and left it telling them I needed to fill it STAT then I walked over to hospital to look for my cardiologist, Ronald Himmelman (He is also a wonderful painter and his offices are covered with his paintings). Someone at reception took me to the Cardio office even offering a wheelchair which I declined. The admin person called his office (They had told me to go to ER) and then paged him for me. He called and wanted to talk to me…he is so good to me. We agreed that I would ask the pharmacy to give me enough Clonidine to last until Friday, Sept 1 when I could pay for all my prescriptions. He is so good to me. I was leaving when a patient waiting to be seen came up to me with cash (almost $20) and insisted I take it to help pay for my medicine. She would not let me refuge. I was able to pay for the script for the month for the Clonidine, pay the co pay for the OxyContin and repay dear Ram, the pharmacist who had paid for my pain med. last month out of his own pocket, literally. I think Bejah needs to get better control of her finances! To pay it forward, and because I vowed over a year ago to do GODs work for the rest of my life I cared for two homeless people I encountered today, a woman and a man…prayed for them and gave them food and drink. I also did it for the man I love. I know he would be pleased. We must take care of each other, forgive and love each other. We all fall short, we all make mistakes, we are all imperfect. I thank you all for being there for me, for correcting me when I am wrong, for enlightening me when I do not see far enough ahead. It is after 3pm. At about 4:30pm I will take the bus back to Palm Springs and wait for the bus home at 6pm. By 7pm I will be home. My love came over yesterday…woke me from a nap…I did not even hear the doorbell but I guess it must have awakened me. I had been in very bad pain so took a warm bath with the beautiful Caress, washed my hair and gone to bed with the stereo on (Italian Opera). When he came and while he was there I swear I could not feel the pain…it seems like a miracle. How is it possible that he has that kind of power. How beautiful. How lucky I am.. If only GOD could make me 20 9years younger. Still I am so blessed. Now I have my pain medicine and the medicine that will slow my heart (2-3 day). I also take Verapimil, Coreg, Mixod…. (Can’t recall) and low dose aspirin, so five BP meds each day. I have only 10 minutes left on the library computer so farewell dear friends. Take care. Love, Bejah

        • Kitty says:

          I think Dr Douglas could use Dog biscuits?? Spelling ha yes im laughing. Sorry about your pain meds Bejah. I have to pick up my script every month. I know if an elderly woman on managed care that is in considerable pain and the “Gestapo” has now cut her Vicadin to 1tablet 1x per day. They upped her p pychotropics.

          • Kitty says:

            Bejah…i didn’t understand your apology. For what?? Why would u think a Dr that runs a mesh mill needs glorification or genuflection. Carrots anyone???

          • Bejah Blue says:

            Thanks Kitty…so sad about the woman who was changed to wrong class of meds but it does not surprise me.

            We must all try to stay out of the medical care “system” in order to stay healthy and alive.

            When I had that implant surgery at UCLA they damaged my cornea in left eye and scraped my abdomen (wounded me in more ways than one and gave no explanation for either, just sent me home with medication for my eye and also rather than the script for the strong pain medicine I was told by the surgeon I was getting they gave me a script for higher dose of acetemenaphen (an OTC pain med.!!!) I did not look at the script until I got back to the desert, 125 miles east of UCLA. Lies. Lies. Lies. Bejah

      • BejahBlue says:

        Dear SS, I just read your posts….I will go and get these recommended books as soon as I can, wrote them in my planner. Thank you so much. I will recommend books for you (and everyone interested) in the coming days. I will also get some Tea Tree oil. I have seen it for sale. I can not imagine what you are going through or the courage it takes to be in your life. You are such an inspiration, to us all I am certain. Bless you. Bejah

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