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An Ongoing Series of Informational Entries from Pevic Mesh Trials I Watched

Opening Statements in Suzanne Emmett Trial

December 16, 2018

Blog: Observations from Suzanne Emmett Pelvic Mesh Trial

         The trial is held in Courtroom 275 of the Philadelphia Court of Common Pleas, Judge Kenneth J. Powell, presiding.

Plaintiff Opening Statement

         One of the products at issue in this case is called “Prolift,” which is supposed to support weak tissues in the pelvic floor, and to relieve symptoms from pelvic organ prolapse, aka “POP.”

       Some of the complications from the Prolift which Suzanne Emmett experienced are:

•multiple erosions where the mesh lacerated, perforated and sawed into her vagina,

•scarring (aka fibrosis, scar plating),

•vaginal deformation (when mesh contracts it can entrap nerves causing pain), and

•vaginal retraction.

       Did the implanting doctor violate the standard of care and industry standards by using defective medical devices? The implanting doctor was Dr. Patricia Reddy. No claims were brought by Suzanne Emmett against Dr. Reddy.

       The standard of care is Plaintiff’s burden, to articulate and prove it was not met.

       The main trial attorney defending J & J and Ethicon, the manufacturers of the mesh, is Mr. Tarek Ismail, a partner of the Chicago based law firm of Goldman, Ismail, Tomaselli, Brennan & Baum.

       Plaintiff claims she was irreparably harmed when Prolift and Gynamesh -- used to repair anterior (front) and posterior (rear) prolapse -- sawed through and exposed in her vagina 14 different times, requiring 9 different erosion surgeries to extract the eroded mesh piece by piece.

       The mesh caused inflamed tissue, and chemically burned her vagina.

She cannot have sex anymore.

       She suffers from bladder spasms -- at times similar to the pain women experience during child birth.

       She has these painful spasms 5-6 times per night, and sometimes feels as if she were birthing a baby.

       She loses the contents of her bladder, wears a diaper and black pants every day since her mesh implants.

       The other product implanted was a TVT-O -- aka TVT Obturator, because it is implanted in an inside out procedure, passing the TVT-O mesh sling through her obturator foramen. The sling is used to support her urethra to cure her stress urinary incontinence (aka “SUI”), which occurs when she coughs, sneezes, walks or does any type of exercise or physical activity.

       The theories of liability are:

•Defective product;


•Failure to give adequate warnings,

•Conscious disregard of known risks – company emails and sales materials evidence what the manufacturers knew; J & J and Ethicon put defective products on the market knowing that they would harm women.

       The need for prolapse repair occurs when connective tissues stretch and sag in the vagina, which sometimes occurs from child birth. Plaintiff’s son born 21 years before her mesh implant was over 10 lbs. when he was born, and her daughter was over 8 lbs. when she was born. Large babies and vaginal births have been known to cause symptoms from pelvic organ prolapse.

       However, in Plaintiff’s case, her prolapse was asymptomatic and was not causing her any problems at the time that Dr. Reddy recommended that she have Prolift and Gynamesh implanted to help cure her pelvic organ prolapse.

       The mesh implant surgery was a major invasive surgical procedure, the surgeon dissected through tissue in front of Plaintiff’s bladder.

       The type of material used is polypropylene plastic mesh which is constructed similar to a basketball net, and was used to lift Plaintiff’s bladder off of her vagina.

       The posterior prolapse repair was performed to lift Plaintiff’s rectum off of her vagina, the tissue was dissected in the back wall of her vagina and Gynamesh was placed to maintain space between her rectum and her vagina.

       The surgeon diagnosed Plaintiff’s urethra as being hypermobile and that she suffered from an intrinsic sphincter deficiency, which was causing her stress urinary incontinence.

       At the time of her mesh implants Suzanne Emmett was dripping urine almost every day, and she had to wear light pads.

       The TVT-O mesh sling implant was passed through the obturator foramen space – this was a major invasive surgical procedure. The tissue near her obturator was dissected and the mesh was looped through her obturator foramen space.

       The pore size – relating to the size of the space between the mesh strands – was small. You need larger pore size so the mesh can grow between the mesh pores so it can integrate with the tissue. Because of small mesh pore size there was bridging fibrosis and scar plating, which encapsulated the mesh, causing the mesh to contract. Since the tissue could not grow between the small pores, dense, hard scar tissue formed around the mesh, which makes the area not capable of stretching.

       The vagina needs to be elastic and flexible to stretch to accommodate the size of a baby or a man’s penis during sex.

       The bladder also needs to be capable of stretching to hold the urine and contract so the urine can pass out. The rectum needs to be capable of stretching to contain the feces.

       Because of the hard tissue and scarring, causing the mesh to contract, Plaintiff suffered pain and nerve entrapment.

       When the scar tissue contracts, the mesh contracts along with it, and ends up rolling or folding, or crumpling up like a potato chip.

       The mesh contracts to approximately 30% of its original size.

       This prevents the vagina, rectum and bladder from being able to expand and contract and to perform normally, the way they are supposed to function.

       The erosions Suzanne Emmett experienced occurred when the mesh sawed through and entered her vagina, this is also known as an exposure.

       When the nerve endings are trapped this causes pain.

       Bacteria is trapped in the small mesh pores, and this makes Suzanne Emmett suffer from frequent urinary tract infections and inflammation.           There is a foreign body reaction which is chronic and never ending, where the body never stops fighting the foreign plastic substance inside the pelvic area and vagina.

       If it were a few small sutures of polypropylene the foreign body reaction would not be a big deal, the more mesh the more foreign body reaction.

       The total Prolift mesh is 260 yards or 780 feet – Ms. Emmett did not receive a total Prolift, the surgeon cut what she believed was the right amount of mesh needed to correct Ms. Emmett’s rectal prolapse. She used 90 feet of polypropylene, which is almost 500 feet, the size of a football field, and that is not counting the Gynamesh.

        The mesh cannot be safely removed in total – it is a permanent implant.

        The Prolift was introduced to the market in 2005 and was withdrawn from the market voluntarily in 2012. In 2002 the Gynamesh was introduced to the market, and was later pulled off the market because of bad side effects, it is no longer used in vaginal applications.

         Other options are the Burch native tissue repairs procedure, and Raz Needle Suspension.

          Burch colposuspension is effective in stress urinary incontinence in women without simultaneous uterovaginal descent. 

          Using biologic grafts from cadavers or animals do not cause any foreign body response.

          Bulking agents could be used to support the prolapsed organs – which is better than shrink wrapping pelvic organs with mesh.

          There is a risk of recurrence of the stress urinary incontinence. 

           There is no permanent painful sex as when using mesh, just during post-op period following a surgical procedure using native tissue or biologic grafts.

           The best mesh is no mesh.

           The TVT was described as a cash cow for J & J and Ethicon. The Prolift was expected to generate review of $300 million. The TVT expected to generate $60 billion.

          The mesh implants were described as experimental, and there was no need for the products as other safer procedures were available.

           Defendants paid $20 million to Professor Olmstead to use his mesh designs for TVT products.

            Internal company documents described the weak point was the polypropylene plastic mesh. The company internal documents show doctors suggesting to stop selling and do more testing.

            The Defendants paid for good results on what testing was performed.

            The IFU (information for use) product brochure does not state that there is a difficulty removing eroded mesh, surgeons need to use an electric knife to try to remove the eroded mesh in pieces.

            Professor De Laval did not test the TVT products on women, it took 9 months from start to finish before TVT was introduced to market.

            Axel Arnon said the mesh was over designed and that lighter mesh was needed, he said the mesh was too heavy and that it would cause erosions to be very common. The mesh gets very hard as a rock, and rolls like a potato chip.

            An alternative material was Ultrapro – a disappearing suture. In 2005 it was less expensive, it was a pricing point, Defendants could make more money selling a mesh implant made from polypropylene. Vicro had a 17% erosion rate, which was too high. The Prolift had a 33% complications rate, and a 19% erosion rate. It was sold for 7 years before Defendants removed it from the market.

             The complication of anatomical distortion of the vagina – was not mentioned as a risk warning in the product IFU. An internal company document states that the doctor at Ethicon would not want the mesh implanted in his own wife.

             Ethicon paid Dr. Lucente, the doctor who performed erosion surgeries on Suzanne Emmett, $2 million dollars. Dr. Lucente was a paid consultant. In return for being paid millions by mesh manufacturers he opined that the mesh implants are the “gold standard” for treatment of SUI.

             Professional societies were paid off by Ethicon.

             In 2006, Suzanne Emmett was diagnosed with intrinsic spincter deficiency and SUI – which are not life threatening conditions.

Her children were born in 1986 (son) and in 1992 (daughter).

             Dr. Ready found prolapse in all 4 compartments, although they were asymptomatic at the time of diagnosis.

              In 2007, Dr. Ready took out Ms. Emmett’s uterus, and implanted TVT-O for SUI, and Prolift and Gynamesh to treat anterior and posterior pelvic organ prolapse.

              She had her first mesh erosion surgery on August 1, 2007, and her second erosion surgery on October 10, 2007. The mesh was found to be bunched up when it was removed in part.

               She developed urge incontinence, and lost the entire contents of her bladder, something that had not occurred prior to her mesh implants.

In 2009, the mesh eroded in two different locations in her vagina.

In 2011, the mesh eroded into her anterior vagina and posterior vagina.

               She had to have chemical cauterizations to treat granulation tissue, which occurs when the mesh is eroding.

               Silver nitrate was used for the chemical cauterization. She also had Botox injected into her bladder, and electrical shocks up her leg, which only provided a temporary fix.

               Dr. Patricia Reddy had 5 trainings with Ethicon, and believed the risks of the mesh were temporary and could be treated.

              Suzanne Emmett went to her doctors repeatedly and was never told by any of them that her mesh was defective.

                Dr. Lucente told her it was not the mesh causing her complications – such as painful bladder spasms.

                Plaintiff’s medical conditions include high cholesterol, high blood pressure, diarrhea, diverticulitis, constipation. She had atrophy for a few years, and regularly used estrogen cream for that, which resolved the atrophy.

               Her erosions were not near her hysterectomy scar.

               She travelled to Ireland, and abroad for her work.

               Dr. Tom Margolis, Plaintiff’s expert, was paid $600,000 for his testimony and for reviewing medical records, etc. in various cases he has worked on.

               Defendant’s expert elected not to examine Ms. Emmett, Dr. Margolis examined her.

Defense Opening Statement

              Ms. Emmett had multiple medical problems, the mesh worked to fix her problems for 11 years.

              She was warned of the risks. None of her treating doctors said her complications were caused by the mesh.

              In 2007, Ms. Emmett had extensive surgery, 6 different procedures.

              She had injuries and POP from having delivered two large babies.

Her vaginal births of large babies weakened and damaged her pelvic floor.

Her son was 10 lbs. and 12 ounces. She had to have stitches after he was born. Her daughter  weighed 9 lbs. at birth.

              SUI results from increased pressure in the abdomen – when she bends over and lifts groceries, when dancing.

              Ms. Emmett suffered from chronic SUI for 20 years, had bad leakage which interfered with her activities and adversely affected her quality of life. She had problems with defecation because of a lax anal sphincter.

              Dr. Reddy, a pelvic floor surgeon in Harrisburg, is not connected with Ethicon.

              She found multiple organs pushing on Plaintiff’s vagina, bladder prolapse (front of pelvic floor), urethra weak and falling into her vagina, intrinsic sphincter deficiency, her urethra could not hold back her urine, her rectum was passing into her vagina, she had damage to the back of her pelvic floor.

             Her uterus was falling down and creating a bulge into her vagina.

             All the risks were explained to her including mesh exposure, chronic pain with sex, chronic pelvic pain;

             In July of 2006 she took a family vacation to Mexico.

             She works handling workers’ compensation cases since 1988, she is a company vice president.

             At the time of her implants she was 45 years old, she had been wearing pads daily for decades, and suffered from fecal leakage.

             Plaintiff had 6 different procedures using 3 different mesh products, her doctor thought the mesh was the best option for her, and had been used by Dr. Reddy in hundreds of patients previously.

             The suture repair was not as durable, she didn’t want the procedure to fail within a few years. Dr. Reddy had success with the mesh, and very few complications, it was durable, effective and safe, but it was not free of complications.

             Complications are not the same as a defect of the product.

             The hysterectomy Plaintiff had has all the same risks as the mesh except for mesh exposure.

             The vast majority of women treated with mesh have no erosion.

             Her mesh surgery was May 16, 2007. She was told to rest, refrain from sex and heavy lifting. In June of 2007 she felt very good. She flew to Maine for her job.

             She had her first mesh exposure 6/26/2007.

             She took a 2-week trip to Ireland. Her mesh erosion got worse.

She had exposed mesh removed 8/1/2007. The end of Aug. 2007 she had a larger mesh exposure in the same place. She was referred to Dr. Vincent Lucente. On 9/12/2007 he removed a 3 x 1 cm piece of eroded mesh.

             On 10/9/2007 she had more eroded mesh removed.

             Dr. Lucente treated her for 8 years, told Plaintiff mesh was not defective and only removed exposed mesh.

             She was treated with silver nitrate and had Botox injections and electrical nerve stimulation, to treat her overactive bladder and urge incontinence.

              She was aging and losing estrogen.

              Plaintiff traveled to London 10 times for her job, and made trips to Disney with her granddaughter. Plaintiff is relatively healthy as of 2018, in Plaintiff’s own words.

              She has not criticized her doctors, her doctors have not criticized the mesh or called it defective.

              Dr. Margolis destroyed some of his invoices. He examined Plaintiff twice in April of 2018, 5 years after Plaintiff filed her lawsuit.

              Dr. Elliot, Plaintiff’s expert, makes money on the side by testifying for plaintiffs in pelvic mesh cases.

              Dr. Bruce Rosensweig, another Plaintiff expert, made $1.5 million on plaintiff litigation, and did not review any of her records.

              You cannot eliminate risks of pelvic floor surgery, there is no perfect solution. The mesh surgery is only performed by doctors experienced in pelvic floor surgery and anatomy.

              With native tissue repairs, using already damaged tissue, this procedure fails half the time.

              Using autologous strip of tissue from the thigh or abdomen, this is an invasive procedure and there is a long recovery time.

              Mid-urethral slings hold up the urethra, the TVT-O was placed in a Hammock style U-shape, procedure took less than 30 minutes.

Plaintiff was hospitalized for 2 nights because many procedures were performed. The mesh used has an acceptable risk profile. The benefits outweigh the risks, it is a first line approach to treat SUI and POP.

               The products used were tested on between 500 and 800 women.

Ethicon was not hiding the ball, included risks in IFU, and risks known by surgeons from medical school, residency, Dr. Reddy kept up with the medical literature.

               Dr. Reddy’s results have been fabulous.

               Plaintiff will show “cherry picked” marketing materials and presentations.

              The mesh products were vigorously discussed and the Defendants discussed ways of improving the products.

              There were over 2,000 studies.

              There are emails from the company; Marty Weisberg, a company employee, apologized for joking that having sex with a woman with mesh was like having sex with a wire brush.

              He and Ethicon want to do better and improve women’s health.

              The case was brought too late; in 2007 Plaintiff already had multiple erosion surgeries. Her husband stated that having sex with Plaintiff in 2009 felt like he was stabbed on barbed wire.

             Plaintiff knew she had problems, she knew well before seeing an attorney ad on television.

             Dr. Lucente stated the mesh was not bad, but she filed a lawsuit any way.

             Memories fade, there are changes in medicine and science. She filed a lawsuit 6 years after her mesh implant surgery.

             There are no defects in the mesh that caused her complications. Her claims are time barred.

End of Opening Statements; Next Blog will be Examination of Plaintiff's expert, Dr. Thomas Margolis.

Second Blog Entry - Testimony of Dr. Thomas Margolis

December 22, 2018

Dr. Thomas Margolis, direct exam

     He was called as a witness in attorney general investigations, in an action initiated by the attorney general. He has not only been called as a paid plaintiff’s expert.

     He graduated from medical school in 1987. His sub-specialty is uro-gynecology, he is a pelvic floor surgeon, he treats women with stress urinary incontinence (“SUI”) and prolapse (vagina and uterus).

     He has done about 10 surgeries per week since 1992.

     He has 4 prolapse repair surgeries scheduled for Friday.

     He works between 80 and 100 hours per week in his medical practice.

     For less than 10 years he has been an expert in pelvic floor mesh litigation, he spends about 95% of his time each week treating patients, and about 5% of his time doing litigation work.

     Most surgery he performs is for patients suffering from pelvic organ prolapse.

     He treats SUI with an organic sling made from cow skin. He does Burch procedures laparoscopically, and also does an open Burch procedure through an incision. He gives collagen injections. He does anterior repair surgeries (where rectum is prolapsing).

     He has read the IFU of various mesh products, literature and has watched many videos regarding the Prolift device and regarding Gynemesh. He has never implanted any mesh products transvaginally.

     He has treated vaginal prolapse with mesh using an open abdominal approach but has never implanted mesh through the vagina.

     Dr. Margolis has removed transvaginal mesh (“TVM”) around 600 times over the past 20 years, including slings and prolapse mesh. 20% of his surgeries in his surgical practice involves removal of TVM slings.

     He attended Bethany College in Kansas and the University of Kansas medical school. He has done a fellowship in pelvic surgery in Atlanta, Georgia from 1991-1992.

     He considers the Burch procedure to be the “gold standard” of treating women with SUI.

     He does not “cherry pick” what he reads in medical literature, he reads the good and the bad, providing him with a balanced opinion. He has read approximately 2,000 articles concerning TVM, reads as much as he can.

     He has reviewed all of Plaintiff Suzanne Emmett’s medical records. He has read the depositions of her treating doctors, the pleadings and the fact sheets, as well as the defense medical reports.

     Dr. Margolis personally examined Ms. Emmett in his Burlingame, CA. office, as if she was his patient. He did not treat her differently because she is involved in a lawsuit.

     He took her history and performed a physical exam.

     He feels competent in giving his opinion and testimony in the field of uro-gynecology, and concerning how defective mesh products injured Mrs. Emmett.

     Dr. Margolis was proffered as an expert in the fields of uro-gynecology, reconstructive surgery, and the defective nature of the Prolift (mesh product used to treat pelvic organ prolapse (“POP”), Gynecare and the TVT-O (“Obturator”).

     He examined an opened box of the Prolift mesh kit, and showed the jury, testified it consists of 260 yards of suture material, 780 feet if unraveled, the length of 2 football fields.

     He said the device includes trocars and introducers.

     He explained how the mesh sits in a woman’s body showing the jury a flip chart of the sagittal side view of a woman’s anatomy.

     He gave the jury a primer on prolapse, as follows.

  • Cystocele is where the bladder prolapses or goes down, pushing through the anterior or front of the vaginal wall.
  • Rectocele is where the rectum backs up into the vaginal wall.
  • A stage 4 prolapse – the pelvic organs are completely outside of the vagina.

     He uses absorbable sutures to support the vaginal wall.

     A sacropinous ligament fixation is a surgical procedure used to correct bulging of the vagina, also known as prolapse of the vagina. No mesh is needed. Dr. Margolis uses only 5 inches of suture material, whereas the mesh implant devices are 500 feet, and it works just as well as the mesh implants do.

     Dr. Margolis testified that the Prolift is defective, said the risks outweigh its benefits, and said the same about Gynamesh and the TVT-O (mesh sling used for treatment of SUI), he said all 3 products do not meet his expectations.

     He said these mesh products will never be capable of removal entirely, saying they are like pouring cement over rebar, once they are fixed in place they are there for life, these are permanent and irreversible, cemented into place.

     You cannot sterilize the vagina, it is a contaminated field with bacteria. The mesh which is in a woman’s body for life picks up bacteria, which is entrapped and likewise there for life, hence this is why many women suffer from chronic recurring urinary tract infections as a complication of the mesh implants.

     When a synthetic field gets infected you can never get rid of the infected tissue, not when the bacteria and infected tissue are hidden in the plastic mesh. You cannot get rid of the inorganic material, and you cannot get rid of the bacteria trapped in that material.

      When you are using mesh for a hernia repair in the abdomen, you can use betadine solution to kill all the bacteria, and the tissue around the mesh never gets infected.

     In the vagina, by contrast, a contaminated field, bacteria can hide between the pores of the mesh, and immune cells cannot get in, which is why women with mesh have a higher rate of infection, including UTI’s.

     Fibroblast cells form, the mesh has decreased pore size, and contracts the mesh, making the pores even smaller. The contracted mesh entraps the nerves and causes great havoc and chronic pain.

     If the mesh were macroporous – and had large pores, the tissue could grow between the larger pores of the mesh. Since the mesh has small pores and is not macroporous fibroblasts move in and encapsulate the tissue.

     Gynecare and Prolift are dangerous, you would have to take Ms. Emmett apart to get the mesh out of her.

     The vagina is meant to expand and contract, with elasticity, to properly perform its intended function, to accommodate the passage of a baby during child birth, and to accommodate a man’s penis during sexual activity.

     Polypropylene is not inert. Steel is inert. The body knows the mesh is there. The immune system would not recognize that steel is there.

     Scar tissue is rigid, not elastic. It’s like leather. As the mesh pores collapse, the mesh shrinks, ropes, curls and wads  up.

     The mesh pulls on nerves,  muscles and surrounding tissue, causing pain. 

     The loss of elasticity prevents the vagina from expanding and contracting, preventing the vagina from functioning normally.

     An erosion occurs when the mesh sticks into the vaginal canal, cutting its way through the vaginal wall.

     Granulation tissue forms, which is an early erosion. This inflammatory tissue surrounds the opening.

     This is a dose dependent phenomena. When a woman has a hysterectomy, she has a small suture, this procedure does not have the same risks as a mesh implant. That is a ludicrous statement.

     With native tissue repairs, done with small sutures, there are not the same risks, because not as much foreign material is left behind.

     The mesh implants are not effective even where the woman no longer has prolapse or SUI. The risk/benefit ratio must be considered. You can fix the problem but leave the patient worse off than when she went in. This is not a low risk product.

     Ms. Emmett had a 4-compartment prolapse and SUI. But she was not bad off, she did not have any symptoms from her prolapse before the mesh was implanted. Her prolapse was “garden variety.”

     As of 2012, the Prolift and using Gynamesh for prolapse were off the market. Actually, Johnson and Johnson, and Ethicon, voluntarily withdrew these products because of the bad side effects and complications women were experiencing.

     You can still buy Gynamesh, but cannot use it vaginally, it is no longer used for vaginal applications.

     Sacrocolpopexy is the gold standard, abdominally or laproscopically (no big abdominal incision).

     Dr. Margolis has removed mesh from women in 600 surgeries, mesh like the Prolift.

     It comes out in pieces and chunks, and the mesh is distorted when it comes out, it has a different appearance from when it was first implanted. When the mesh is encased in scar tissue, it does not lay flat and smooth. 

     It is folded, wrinkled, roped and crinkled, it is wadded up and distorted from its original architecture. There is inflammatory tissue attached to the mesh when it is removed.

     In Medieval times women suffering from prolapse were hung upside down, but in modern times this is considered inhumane.

     In Dr. Margolis’ opinion, using Prolift is also barbaric. It was used from 2005-2012, and caused women terrible complications.

     He is paid $3,000 per day of trial testimony. He is paid $400/hour to review medical records, depositions, expert reports and time spent with the attorneys who hired him.

     Ms. Emmett’s husband Tucker was also injured by the transvaginal mesh.

     All of the women in the lawsuits Dr. Margolis worked on suffered injuries caused by TVM.

     The money he charged in lawsuits he worked on related to women who allegedly suffered injuries as a result of the TVM.

     He charges $500 for an independent medical exam (“IME”) on one patient.

     The Department of Justice, and Attorney Generals, have filed lawsuits for women injured in their respective states, and he charged the Attorney Generals that hired him to testify in those cases.

     Over 10 years he earned $604,126.84 on pelvic mesh cases he worked on, and this sum was confirmed by his accountant.

     This amount is a small percentage of his overall income, only represents 5% of his overall income.

     He goes on annual trips which he funds himself, to provide medical services to the poor in Uganda.

     He has spent $500,000 on these self-funded trips to Uganda over a period of 14 years.

     Dr. Margolis has told hospitals he goes to and that he is on staff at, and has given lectures, of the dangers of using mesh transvaginally.

      He has communicated his deep concern about the dangers of using TVM to professional societies and to presidents of such societies, has told them he believes the mesh implants are defective. 

     He has told this to fellow urologists and colleagues.

     In the Bay area many doctors no longer use TVM, and do not stock mesh or slings.

     He has consulted with doctors across the Globe, and reviewed internal company documents, Ethicon documents.

     The vagina is a class two contaminated field. The pores of mesh are where bacteria hide.

     The interstices and micropores are where bacteria hides.

     The mesh must incorporate into the surrounding tissues instead of encapsulating scar tissue.

     The mesh must not shrink – the mesh could deteriorate and be painful when it pulls on adjacent tissues.

     You cannot avoid mesh shrinkage, it’s an inflammatory reaction to the presence of the foreign body.

     The prolene mesh is the weak point of the design submitted by Dr. Olmstead.

     In order to excise or explant prolene mesh you have to use an electric cauterizing device, which is an electric knife, this was confirmed by Ethicon employee, Laura Angelini.  

     She does not want the IFU to state that the mesh may need to be explanted, said putting that warning in the IFU would be like “digging her own grave.”

          She states in her email that the company must avoid “over information.”

     There is a concern about competitors, and statement that Ethicon’s business must be protected.

     Ethicon documents express concern about over-tensioning, which can cause erosion, and could “choke off” the urethra, if the mesh it tensioned or put in too tight.

     Once the mesh is implanted you cannot adjust its positioning. Once the mesh is in place the sleeves are removed, and the mesh is cemented in place.

     Dr. Wang was not a paid plaintiff expert. He implanted 600 TVT’s and his data showed an adverse pattern of complications, a rejection of the prolene mesh, a delay in healing even two months post-operative, bleeding, dysuria (painful urination) and dyspareunia (painful sex), exposed mesh, granulation tissue, there were 25 cases of mesh rejection, where revision surgery failed in 2 weeks, requiring more revision surgery.

     Ms. Emmett’s symptoms include: chronic inflammation, milky discharge which is usually associated with an infection, bleeding, pain.

     There has not been a study done that addressed the concerns raised by Dr. Wang, and his concerns were brought to the attention of Ethicon.

      Fibrotic scarring occurs and scar tissue causes the mesh to shrink. The mesh is pulled into a smaller surface area.

     There is a 30% shrinkage rate as a rule of thumb.

     Wound healing problems are common, occurring as much as 50% of the time.

     The IFU does not state the following warnings:

•Adjusting mesh is not possible;

•Electric knife necessary to remove the mesh;

•Chronic inflammation;

•Rejection of mesh;

•Scar tissue shrinks the mesh, fibrotic scarring.

     Dr. Delavaugh invented the TVT-O approach, it was completed and marketed within only 9 months.

     The disorders are not life threatening, the prolapse is not urgent, you can live with it, it does not kill you.

     There was no problem using a biologic graft which is absorbed. With a native tissue repair you do not even need a biologic graft.

     Prolift causes significant irreversible inflammation like the terminator, causes an excessive fibrotic reaction, which has a negative impact on sexual function.

     Large babies do not stop sexual function.

     Mesh shrinkage is common after a prolapse repair; Ms. Emmett’s prolapse recurred, which is a major contributing factor to Ms. Emmett’s problems.

     A hysterectomy carries a small risk of dyspareunia, sexual dysfunction is rare after a hysterectomy. It is normally non-problematic, and the incision usually heals well. There is no scar at the apex of the vagina, where the uterus used to be.

     If you reduce the mesh, there is less inflammation and less scarring.

      Clinical evidence of efficacy and complications were lacking back in 2003 regarding the use of mesh in the vagina.

     An internal Ethicon document from 2004 states that mesh implants produce a high level of scar formation, scar tissue is hard, non-elastic, contracts, and can lead to post-operative complications. The mesh does not meet Ethicon’s own standards.

     Back in 2004 Ultra Pro was available, a lighter material, with larger pores, with an absorbable coating, like absorbing sutures. There would be less inflammation.

     There are no mesh products using Ultra Pro.

     Potato chip folding phenomena – mesh folds, wrinkles, rolls, ropes, changes its architecture to any form you can imagine – none of this is mentioned in the IFU, literature or instructional videos. 

     Nor is it mentioned that the mesh becomes hard as a rock when it shrinks, or that you need an electric cauterization knife to remove it, or that the body attacks the mesh, creating fibroblasts that make scar tissue, which encases the mesh in a rock like mass.

3rd Blog Entry - Dr. Daniel Elliott, Urologist

Plaintiff expert

January 4, 2019

Dr. Daniel Elliott's testimony was presented to the jury via video on 12/6/2018.

Dr. Daniel Elliott has treated prolapse with mesh sutures, transabdominal or robotic approach.

He uses absorbable mesh sutures.

He has never implanted Prolift mesh to treat prolapse.

He has attended training about transvaginal mesh (aka “TVM”).

He has used cadavers to learn about prolapse repair.

From 2006-2007 he has treated women with complications from Prolift that was implanted to repair prolapse.

The complications he has heard about and treated include erosion, pain.

He is familiar with the Prolift system, and has chosen not to implant or place the product.

He manages complications from Prolift.

He has read the IFU (product brochure), and has had conversations with colleagues, and read manuscripts.

The product IFU did not help Dr. Elliott in his treatment of complications in his patients.

He sees between 3-5 women per week that are suffering from complications of the mesh, including Prolift.

He has spoken before SUFU - the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, on managing complications from mesh implants.

He has reviewed medical literature, J & J internal documents and surgical videos, J & J and Ethicon employee video depositions, product and marketing documents. His reliance list contained in his expert report includes internal documents which are not publicly available.

The severity of the complications is not known to the average doctor on the street.

Dr. Elliott does not see a need for Prolift. There is a low recurrence rate when using sutures to repair prolapse.

Gynamesh was sold in a sheet, not as part of a kit, and then trimmed and tailored to repair prolapse, and then placed in Plaintiff’s vagina. That is safer than a kit using arms, but still not safe because of the sheer volume of the mesh. The trocars with arms goes through the tissue and muscles.

He testified that the new technique using Prolift for prolapse repair is quite unsafe, the arms are counter-productive, goes through muscles, fixes in the vagina, causes pain, pulls on muscles and other structures.

While called “tension free” in reality it is impossible in real life, or the prolapse would still exist. The actual use in the body cannot be tension free.

The vagina moves, and the mesh moves when the patient lifts and walks. There is tension and contraction and a foreign body reaction. The surgeons tension the mesh too tight.

The tension of the mesh and the contraction of the mesh cause women pain, the mesh collapses.

This causes pain, incontinence and erosion.

While a woman might be pleased that the symptoms of her prolapse have been relieved, she is unhappy that her sexual function has been decreased. Help comes but at what cost to the patient.

The true recurrence and reoperation rate is 6-12% when using mesh to repair prolapse.

There is a 12.6% failure rate after 6 months, fast recurrence of prolapse symptoms.

There is vaginal retraction, scarring of the mesh which is visible or palpable.

The Prolift is neither safe nor effective.

There is a 20.7% exposure (erosion) rate, this is the true incidence of exposure, which is not a safe rate, this leads to reoperations.

There were adequate alternatives, the Prolift mesh implant was not needed, suture repairs could have been used to repair the prolapsed organs.

Dr. Elliott is board certified in urology, gynecology and reconstructive surgery.

Questioning by Attorney Adam M. Slater

The one size fits all design of the mesh kit causes mesh to bunch up, not lay flat, the arms pull on the mesh.

The pelvis is a dynamic structure, the internal organs have to move, which leads to extrusion. Because the cannula is used to place the mesh the mesh won’t be flat after passing through a small narrow cannula.

Explanting mesh is a very difficult surgery, a cauter is used to burn through the mesh, which is encapsulated or encased in scar tissue. The mesh feels firm, it is not soft at all.

When using the Prolift to repair prolapse, anatomical success is not quality of life, if the patient’s life is devastated, that is not a successful resolution.

Erosion – when mesh comes through the vagina.

Extrusion – when mesh cuts through other organs

The rates of erosion, extrusion and exposure have never been below 5%.

The unsafe characteristics of the Prolift are:

•Tension is unavoidable;

•Pores collapse, as part of the foreign body response, causing scarring and pain;

•The mesh does not lay flat;

•It is a poorly designed product;

•Causes chronic urinary dysfunction and permanent inflammation, which cannot be fixed; and

•The mesh removal operations cause wear and tear on the human body.

The warnings listed in the IFU are not adequate, not mention severity and frequency.

Doctors need to relate expected risks to their patients!

Cauterization and Spinal Stimulator, pain management injections, pelvic floor physical therapy – none of these cure the complications, there is no way to permanently fix what is a permanent situation.

There is bladder dysfunction, there is a problem urinating because of contractions.

The Prolift IFU is deficient as the risks and complications are permanent and progressive, and not minimal and transient.

The skin cannot pass through the small pores of the mesh, the thick scar tissue which encapsulates the mesh causes the mesh to bunch up and become firm and rigid. The tissue and the mesh does not remain soft and pliable.

The risks are not rare, but rather common. There is a very common risk of exposure. The IFU does not state that the Prolift is only appropriate for high grade recurrent prolapse patients.

Cross examination of Dr. Elliott

Dr. Elliot never did a Prolift implant by choice, never received any training.

He works at the Mayo Clinic. He is paid $700/hour for his time as an expert, has been paid $302,550 for his work testifying for plaintiffs in mesh cases.

The symptoms of prolapse are bothersome, the grading of prolapse is determined by how far the organs descend beyond the opening of the vagina. The symptoms adversely affect the patient’s quality of life, can be debilitating and troublesome, including sensation of heaviness and pressure, a bulge or protrusion from the vagina, making it hard to walk or sit.

POP can also cause dyspareunia (painful sex). Prolapse can cause discomfort with sexual activity.

While rare, POP can cause trouble emptying the bladder.

Native tissue repairs bring together tissues that have thinned, there is a high rate of failure with native tissue repairs.

There is anatomic recurrence – the organs re-descend, patient has same symptoms again, the patient is not happy, the quality of life is adversely affected.

Dr. Elliott does not agree with reports of failure rates using native tissue repairs of 30-40%, does not consider those reports to be accurate.

Dr. Elliott uses polypropylene when performing an abdominal sacrocolpopexy, and this material has a well-established track record in hernia repairs.

There is less morbidity with transvaginal mesh than open abdominal incisions, there are fewer peri-operative complications occurring around the time of the surgery.

The mesh placed abdominally is stable and durable.

Exposure: mesh becomes visible or palpable

An exposure can be asymptomatic, can try conservative treatment. Dr. Elliot agrees, if the exposure is small. 50% of exposures can be treated conservatively with topical estrogen cream rather than excising exposed mesh.

Erosion: mesh enters adjacent organ

Urinary dysfunction – severity and frequency different but ability to treat, and can also occur with prolapse surgeries other than the Prolift.

Vaginal atropy can lead to dyspareunia, if untreated can get worse, increases with age.

Re-direct examination by Plaintiff’s attorney 

Without mesh there is no erosion.

Without mesh there is no contraction.

Suture surgeries do not have mesh related risks.

There is a 16.7% risk of dyspareunia with mesh implants.

A 2008 Abstract states that with Prolift there is a 24% dyspareunia rate.


4th Blog Entry: Testimony of Dr. Vincente Lucente

January 13, 2019

              Dr. Lucente claimed at the end of his video tape deposition that Suzanne Emmett’s over active bladder (aka OAB) and recurrent chronic urinary tract infections (aka UTI’s) were NOT related to the mesh.

              He said her UTI’s were caused by bacteria. Dr. Lucente testified that, in order to avoid UTI’s, a woman must have normal vaginal flora or micro-organisms. He testified that when a women urinates frequently due to OAB, the urine flow does not come out in a steady stream which would push the bacteria out, but instead, comes out in drips and small drops, allowing the bacteria to go up the urethra and into the bladder, causing a bladder or urinary tract infection.

               Dr. Lucente testified that he would NEVER attribute UTI’s to the presence of mesh devices. He said the lack of estrogen in post-menopausal women changes the normal flora in the vagina, making a woman more prone to having UTI’s.

               He said only her mesh exposures and bleeding due to those exposures are mesh related complications. And, he claimed that exposures are more connected with how deeply the implanting surgeon placed the mesh device. When the mesh implant is not implanted deeply enough below the surface of the skin or vaginal wall the mesh tends to erode more easily. Also where the vaginal tissue thins due to atrophy the mesh tends to erode more easily.

               Dr. Lucente stated that Suzanne Emmett was a “fairly intelligent” patient who was capable of appreciating the benefits she received, and knew the mesh was helping her. She never demanded that Dr. Lucente remove all the mesh, like some of his patients do, when they think of the mesh as a ticking time bomb waiting to explode, and that a defective product is inside them waiting to erode.

                 He testified that the mesh cured Ms. Emmett’s stress urinary incontinence, and her organ proplase.

                 He acknowledged that from his treatment notes at his last visit with Ms. Emmett that she had vaginal pain with intercourse and some bleeding. He said she had no nocturia (night time need to urinate), no urgency, normal frequency, no granulation tissues (precursor to erosions), and that she was only mildly atrophic.

                  He said she had a long road to get there, but that she was doing very well, and doing fine at her last visit with him.

                   He claimed that her dyspareunia (aka painful sex) was due to scarring which occurs with every surgery, and thus was a scarring issue and not a mesh issue.

                   He claimed that scarring also occurs with non-mesh surgical procedures performed to fix SUI and POP.

                    Plaintiff's counsel said that Dr. Lucente's testimony and opinions were central to the case, crucial to Ms. Emmett's case against Ethicon, and that Dr. Lucente's opinions were clearly biased.

                   Dr. Lucente admitted at his video deposition trial testimony that he spoke with Ethicon. Presumably Ethicon gave him Ms. Emmett’s deposition transcript prior to his deposition, at least no one from the law firm of Plaintiff's counsel gave Ms. Emmett's deposition transcript to Dr. Lucente.

                    Plaintiff's counsel told Judge Powell that Ethicon arranged for an attorney that had represented Dr. Lucente previously to represent Dr. Lucente at his deposition, and to prepare him for his deposition.

                    When asked who was paying his lawyer, and whether he had paid anything to his lawyer to date, Dr. Lucente said Ethicon told him that perhaps he may not end up paying anything for his attorney that Ethicon arranged, that “it depends,” noting Ethicon did not tell him what it would depend on.

                   Plaintiff's counsel told Judge Powell that the statement “it depends” did not relate to the undergarment women suffering from incontinence wear, rather, that Ethicon was improperly conditioning payment of Dr. Lucente’s attorney fees on what he said at his deposition, and whether his deposition testimony proved to be favorable or not to Ethicon.

                     Plaintiff's counsel asked Judge Powell to allow Plaintiff’s attorneys to play for the jury Dr. Lucente’s video deposition testimony in this regard, and Judge Powell allowed it, because Plaintiff's counsel had told Judge Powell that this testimony proves bias.

                     Plaintiff's counsel told Judge Powell that it was improper for Ethicon, who knowingly was adverse in its position to Ms. Emmett, to have communications with Ms. Emmett’s treating doctor, Dr. Lucente, to hire him a lawyer and pay for it, and to condition payment of his attorney's legal fees on what Dr. Lucente testified to at his deposition, on whether that testimony would be favorable or not to Ethicon.

                      Following Dr. Lucente’s deposition testimony being played to the jury Plaintiff's counsel told Judge Powell that he was moving to subpoena a corporate designee from Ethicon as a means to enable Plaintiff to show the jury documents that evidence all the non-attorney/client communications between Dr. Lucente and Ethicon, between Ethicon and the lawyer Ethicon hired for Dr. Lucente, and any payments Ethicon made to that lawyer.

                       The lawyer Ethicon referred Dr. Lucente to is Attorney Anthony Vale, of Pepper Hamilton, from Pepper’s so-called health sciences department. Attorney Vale was asked by Ethicon to represent Dr. Lucente after Dr. Lucente asked Ethicon what he should do about legal representation.

                        This Ethicon-paid lawyer presumably prepared Dr. Lucente for his deposition, and Ethicon presumably gave Ms. Emmett’s deposition transcript to Dr. Lucente as part of that preparation, which Plaintiff's counsel said was legally improper and made Dr. Lucente’s testimony biased.

                         Plaintiff's counsel had earlier read to the jury testimony during a prior trial from Ethicon employee Martina Scheich, which she gave on 5/16/2017, at another trial before Judge Powell. Ms. Scheich was a corporate designee for Johnson & Johnson, and for Ethicon, and she provided documentary evidence in the form of a flow chart showing year by year payments Ethicon made to Dr. Lucente, which payments totaled $2,292,257, in excess of $2 million dollars, as of the last payment made to him on 4/6/2012.

                        They read the jury this testimony to prove that Dr. Lucente’s testimony concerning the mesh not being defective is biased because he is in a relationship with Ethicon, which he never revealed to Ms. Emmett during the 8 years she treated with him, for various complications she experienced.

                       Dr. Lucente told her she was experiencing wound healing problems and never told her that the mesh was defective and that was the reason for her many erosions over the years.

                       He admitted he did not want Ms. Emmett to be alarmed or think she had a ticking time bomb inside her, or that the mesh was defective and would have to be removed.

                       Dr. Lucente testified again and again at his video trial testimony that Ms. Emmett was getting benefits from the TVT-O (curing her stress urinary incontinence), the Prolift (anterior mesh kit to correct her pelvic organ prolapse), and the Gynamesh (posterior mesh placed to correct her rectocele, or rectum that was prolapsing into her vagina).

                       What only later became apparent, at least to myself, was that Dr. Lucente also had a financial motive in view of his relationship with Ethicon, and the over $2 million dollars they paid him, to testify and tell his patients that the mesh was a good product and was not defective.

                       Dr. Lucente admitted he never revealed his relationship with Ethicon to Ms. Emmett - which would have been in furtherance of whatever full disclosure might have required him to do.

                      Dr. Lucente does not believe that the mesh implants are the cause of Ms. Emmett's overactive bladder (OAB). Rather, he thinks her OAB may be caused by the aging process, genetics or the vaginal deliveries of her son and daughter, both of whom were large babies.

                       He has not seen any medical records documenting any doctor's belief that her mesh implants caused her OAB symptoms.

                      Dr. Lucente testified that the mesh did not erode into Ms. Emmett's bladder, said he would have seen this when he examined her numerous times. Dr. Lucente did not notice any partial obstruction of Ms. Emmett's urethra, something that Dr. Margolis found when he examined her.

                      As part of so-called "stipulated" evidence, one of Plaintiff's lawyers, read to the jury that Johnson & Johnson paid the lawyer, Attorney Anthony Vale of Pepper Hamilton, $650 per hour, for a total of $20,540, to prepare and represent Dr. Vincente Lucente at his deposition.                  

                      Plaintiff's counsel implied to Judge Powell that Johnson & Johnson and Ethicon paid for the testimony of Dr. Lucente, a key witness in the case, and that Attorney Vale was hired by Johnson & Johnson and Ethicon, that Attorney Vale was, therefore, really their lawyer, and that the jury was entitled to know this influenced Dr. Lucente's testimony and made him a biased witness.


Fifth Blog Entry: Testimony of Dr. Katrin Elbert of Ethicon

January 19, 2019

     Dr. Katrin Elbert has a Ph.D. and is a senior engineer at Ethicon.

She’s been at Ethicon for 17 years this Spring, 2019.

     She was examined by Attorney Joseph O’Neil of Lavan, O’Neil & Cedrone.

      She claims safety underlies everything “we do as a company.”

      She is a perky witness, smiles in a weird way at inappropriate times, comes across as “loonie-tunes,” in my opinion.

     Whenever possible she tries to give the Ethicon "party line,"  by saying how safety is so important to Ethicon, and to her, and that they made sure the mesh products have greater benefits than risks, and that Ethicn does what it can to minimize risks. 

      Her testimony is disingenuous, where Elbert admitted that she never, herself, asked Ethicon to devote more money to test the mesh products in live women before launching those products internationally.

     She admitted knowing how much Ethicon spent on marketing compared to the small amount Ethicon was willing to spend on research and development.

     Plaintiff's counsel asked Elbert whether the discrepancy in funds spent on marketing versus research and development was indicative of what Ethicon as a company truly valued. They agreed the numbers speak for themselves.

     Plaintiff's counsel asked Elbert whether a person being able to afford a Mercedes may nonetheless decide to purchase a more economy car like a KIA. Implying that a person spends money on what is truly valued.

     Hard to argue Ethicon valued safety when unwilling to fund a clinical trial to insert the TVT-O into a single live woman prior to a worldwide launch of the mesh product.

     Ethicon launched TVT-O, invented by Professor Jean de Leval, when Ethicon only had a small number of short-term results on TVT-O implanted in only one study by only one doctor, the inventor, de Leval.

     The inventor had a financial stake in the success of the TVT-O, because his university collected royalties on every TVT-O sold, pursuant to a licensing agreement Plaintiff's counsel read to the jury.

     Elbert testified that Ultrapro, a partially absorbable mesh, was not suitable for placement in the mid-urethral area for treatment of SUI. She claimed that they had been unable to place Ultrapro in the mid-urethral area of a cadaver because the mesh was too large, with larger pores.

      They never tried to place the Ultrapro near the mid-urethra in a live woman.

      When Dr. Elbert claimed Ultrapro was too large to place, Plaintiff's counsel objected, saying she’s not a doctor, and hence, was unable to try placing the Ultrapro in anything but a dead woman's body.

      Elbert gave a bunch of boring testimony about her design file, like she did in the Susan McFarland case, none of which shows anything about how the mesh would perform in live women, or what complications might occur in the real world. There were no long term results to review.

      Yet, Elbert testified that her design file proved that product safety was important to Ethicon, that there were internal standards in place. This testimony from the perspective of a biomedical engineer with zero experience placing mesh transvaginally in women. Notwithstanding, Elbert became the product lead for Gynamesh PS (soft) used for prolapse repairs, and for the TVT-O.

      The TVT-O was launched in only 9 months, without Ethicon doing any clinical testing beyond the one test of a small group of women by the inventor, de Leval.

      Elbert did not even know who Dr. Bernard Jacquetin was when Plaintiff's counsel asked whether Jacquetin was a surgeon whose opinion Ethicon valued, nor did she know he was the inventor of the Prolift.

     Professor Jacquetin had expressed concern to Ethicon when he told them they should not launch the TVT-O until they had longer term results from more clinical studies where the performance of the TVT-O could be compared against other types of mesh products on the market that were being used in the area of the mid-urethra for treatment of SUI.

      When Plaintiff's counsel read this to Dr. Elbert and asked whether Dr. Jacquetin was a surgeon whose opinion Ethicon valued, she did not know.

      Ethicon ignored Dr. Jacquetin's concerns when rushing the TVT-O to market, in a worldwide launch in just 9 months, without performing any clinical trials where the mesh was implanted into a single live woman.

     Professor Bernard Jacquetin, an eminent French gynecologist whose early study on TVT-Secur had led to misgivings among J & J management, said the company had acted “irresponsibly” by launching the device without adequate evidence.

     Ahead of the device’s original launch, Jacquetin was invited to the U.S. to give advice on the new design, but was taken aback when he was presented with a boxed-up product ready for release. Jacquetin and colleagues later carried out a study in 40 patients, which found success rates of 77% two months after surgery, compared to the roughly 85-90% success rate commonly reported for Ethicon’s original TVT mesh device.

      Plaintiff's counsel told Dr. Elbert that Professor Jacquetin said there was a need for longer term results, that there needed to be trials comparing alternatives to support alter-basic positioning. Elbert did not understand this surgeon’s term, she is an engineer, not a physician or surgeon.

     Alter-basic positioning refers to patient positioning during surgery which should be considered during the preoperative evaluation.

     Plaintiff's counsel asked Elbert if she knew at the time, from reading to her an Ethicon internal document, that Ethicon was looking to lock in surgeons against using competitors’ products.

      Ethicon needed the feedback of its key opinion leaders on the clinical safety of the TVT-O.

     Professor Jacquetin told Ethicon in a document read by Plaintiff's counsel that there was a need for multi-centered trials, and a need to reproduce the procedure on a far larger scale, which was never done pre-launch, against Jacquetin’s advice. Jacquetin stated he would not want the Prolift he invented implanted in his own wife!

     Plaintiff's counsel told Dr. Elbert that Jacquentin’s opinions were highly regarded by Ethicon, and yet they ignored his advice that they delay launch until conducting multi-centered trials. 

      Instead, there was only one trial done by one doctor, Professor de Laval, who invented the product. In this one trial, he only used his prototype invention.

     Elbert admitted Ethicon had to make extensive revisions and adjustments, that the product needed significant development before making a real product out of his invention. Yet Ethicon launched the TVT-O without doing any clinical trials of their own, relying on the data from the one trial conducted by Professor de Laval, the inventor, using only his prototype.

     Dr. Elbert testified disingenuously that there were design procedures in place to assess the product's safety and benefits, and also the risks, before bringing new mesh products to their surgeons.

      Plaintiff's counsel got Elbert to admit that Ethicon made a worldwide launch without ever implanting a single TVT-O in a live human being, only in cadavers.

     Elbert testified on direct examination by Ethicon defense attorney Joseph O’Neil that there were design process steps in place, and that they never skipped any steps, claiming the goal was safety and efficacy, making sure the benefits outweighed the risks.

      Elbert claimed skipping steps was not an option. However, it was later revealed during cross-examination by Plaintiff's counsel that it was more a case of speed and not safety, when Ethicon launched the TVT-O within 9 months, with the motivation that Ethicon’s competitors not get a jump on them with a mesh product that is inserted in a trans-obturator approach, lest those competitors steal potential sales from Ethicon.

     When asked whether the design history file is also known as “DHF,” Elbert testified yes, saying that in her world at Ethicon, they “shorthand a lot of things.” Query whether this also includes shorthanding patient safety.

     Describing the design file as a snapshot documenting the complete process of designing a mesh product, Dr. Elbert was smiling in a weird inappropriate manner, making me think she was “looney-tunes!"

     Dr. Elbert said there were three binders of the DHF for the Prolift, and for the TVT-O there were 7 binders, with over 3,600 pages. For Gynamesh PS (soft), the DHF was comprised of 3 binders with more than 2,000 pages.

     As if, somehow, the number of pages in a design history file in any way demonstrates that Ethicon was willing to spend adequate funding to ensure that the product being designed was truly a safe product, when Ethicon did not fund any clinical trials to test the TVT-O in a single live woman.

     Ethicon would not spend over $20,000 on a lawyer for Dr. Lucente to prepare him for his deposition if Ethicon did not consider his testimony important to defeat Ms. Emmett’s claims in this lawsuit.

     Too bad they were unwilling to spend comparable funding on a study to ensure the product was safe before launching it.

     Elbert testified that there were meetings, testing, structures and a sequence of events in place as part of the internal design control process at Ethicon, showing an elaborate flow chart setting forth the sequence of steps that must take place in product development.

     She claimed that during the design review process that the cross functional team got together along with an independent observer, usually an Ethicon employee not assigned to the project at issue.

     There were 5 meetings minimally. There was safety risk assessment, cadaver testing, bench testing to make sure the product stretched properly and was adequately strong, making sure the mesh was bio-compatible and appropriate for implant in the human body, toxicology testing, and surgeon feedback was important in the design validation process.

      Elbert claimed the TVT-O was invented to meet the need of surgeons, the customers, to meet an unmet need. Plaintiff's counsel challenged this claim, stating that, instead, Ethicon was motivated to beat out its competitors, who were undercutting Ethicon's TVT product by selling “me too” versions that cost less. 

    Plaintiff's counsel read an internal Ethicon document stating that Ethicon was on the verge of losing millions of dollars on its TVT business unless it offered a trans-obturator approach mesh implant product before its competitors could steal more business from Ethicon.

     When Judge Powell asked Elbert what bench testing is, she said it is machine testing the properties of the mesh, said the filament is fabric knitted out of a pattern, which develops the ultimate properties, including pore size.

     She claimed surgeon feedback was essential to ensure that this product is the correct product, all part of the design validation process.

      Yet, Ethicon ignored the advice of Professor Jacquetin, the inventor of the Prolift, who told Ethicon that the TVT-O should be tested more to obtain longer term results and that more studies should compare the results to other mesh products already being used.

     Dr. Elbert spent 5 days preparing for her trial testimony. She is on the payroll of Ethicon. She met with Attorneys Joe O’Neil and Camille Esterbrook.

     When she was made project lead at Ethicon, Dr. Elbert had no prior experience with female pelvic floor mesh products.

      She had 11-years of experience at a medical device company called Striker, which dealt with hip products. Plaintiff's counsel asked her whether she had also invented products while at Striker that were later withdrawn from the market. Like mesh products that were later withdrawn from the market by Ethicon (TVT-O, TVT-S and Prolift).

       Dr. Elbert admitted she was not involved in clinical safety, those decisions were made by others, who were doctors. The team lead was Dan Smith, since retired from Ethicon.

     Dr. Marty Weisberg signed off on the project, also since retired from Ethicon.

     Janet Burns was in charge of marketing.

     Sean O’brien was in charge of quality assurance.

     Dr. Elbert was not a signatory, Dan Smith signed off on the project, on behalf of research and development. He was the project lead.

    From Plaintiff's counsel's questioning it became apparent from various documents he read to Dr. Elbert that the decision to proceed with the TVT-O was motivated by money and not by the needs of surgeons for another mesh product to satisfy unmet needs.

Sixth Blog Entry: $41 Million Dollar Verdict!!

$15 million for Suzzane Emmett, $1 million for her husband Michael - $16 million total compensatory damages, plus $25 million in punitive damages!

January 31, 2019

Spoke with young nice black American female juror, Ms. West, who gave me her thoughts regarding what influenced the jury to award both Plaintiffs a whopping $41 million combined verdict.

This is what she told me:

The Ethicon company emails heavy influenced the jury to conclude that Johnson and Johnson and Ethicon were both negligent.

That they cared more about money than patient safety. 

The list of 20 surgeons whose feedback Ethicon sought -many had grave concerns with the rate of serious complications. 

These surgeons bought large amounts of Ethicon mesh products, had financial incentives to do these mesh surgeries yet they told Ethicon that the rates of erosions and dyspareunia were unacceptably high!

The jury did not believe Mrs. Emmett knew the mesh was defective, she went to her doctor, Dr. Lucente, again and again, and he never told her the mesh was defective. Because he was getting millions of dollars from Ethicon, and was motivated not to disclose the truth to his own patient, Ms. Emmett.

Even though the 20 surgeons Ethicon consulted with expressed their concern with the mesh complications Ethicon rushed to launch these products to worldwide market without spending money to perform a single clinical study where the mesh products were implanted into a live woman’s  vagina.

The jury wants to send a message to J and J by awarding $25 million dollars in punitive damages.

The young black American juror I spoke with said she wanted to award $30 million in punitive damages, and more in compensatory damages to Michael Emmett because their inability to have sex anymore harmed their relationship and hurt their marriage.

Mrs. Emmett was separated from her husband for 3 long years, when she needed him the most, when she was suffering terribly with painful complications from the mesh.

The juror told me she knows how painful contractions are, and can’t imagine how terrible it is for Mrs. Emmett to suffer painful contractions like in childbirth at any given moment.

The jury liked Dr. Margolis’ testimony. She thought that Doctors Lucente and Rogers were influenced by the millions of dollars they received from Ethicon.

She has heard in the news how J and J products have hurt and even killed people. The verdict was intended to send a message to the company to put patient safety in front of its desire for corporate profits.

The mesh implants took care of one problem and created a long list of other problems. In the future the mesh could erode into her organs.

The jury wanted Mrs. Emmett and her husband to have the financial means to live comfortably in the future, and to compensate Mrs. Emmett for her terrible past suffering and for any future harm she may suffer from the mesh implants.

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