Day Five: Lewis v Ethicon: Ticking Time Bomb
Lawyers for the plaintiff Carolyn Lewis (C.L.) wrapped up their defective product case against Ethicon (Johnson & Johnson) on Friday, February 14th, Valentine’s Day, capping off the day with C.L. on the stand. Before that there was more testimony via videotape from scientists working with Ethicon to show the company knew it had a problem but opted not to change out the Prolene (polypropylene ) mesh that made up the TVT (tension-free tape), an incontinence treatment that Lewis had implanted in 2009.
C.L. is the first of four bellwether cases selected to gauge legal theories before a jury and just one of more than 15,000 defective product cases filed against Ethicon, a subsidiary of Johnson & Johnson, in this federal court in the So. District of WV.
She is represented by Tom Cartmell (Wagstaff Cartmell), Ben Anderson (Anderson Law) and Richard Freese (Freese & Goss).
Since she is from Texas, Texas law applies in this case. The standards for proof by a plaintiff are very high in Texas, a state that has wholly embraced the tort reform movement in the name of limiting “frivolous lawsuits” while at the same time protecting corporate interests, the same interests behind the tort reform movement. (See SourceWatch, The Center for Media & Democracy here).
Under Texas law one must show that another product existed that was a safer alternative to the defective product used. It creates a higher burden of proof for the plaintiff, C.L.
Your Editor, Akre is not an attorney so lawyers should feel free to join in the discussions about the law presented in this story. Law firms following this litigation via the Mesh News Desk are asked to make a contribution via PayPal on page one of the website for the research, court reporting and links provided. See here bottom right hand of the page.
In the Morning- Dan Lamont, Director of Post Marketing Surveillance, Ethicon
As much of this trial has been conducted, Dan Lamont appeared to the 10 jurors via videotaped deposition. He worked for Ethicon (Johnson & Johnson) as a quality engineer during the time the company began producing laser cut mesh to minimize the sharp tangs left from a mechanical cut version. Polypropylene mesh (PP) was cut using a sharp blade but that left exposed edges, not unlike a softer version of a window screen that could irritate delicate pelvic tissue. In an effort to improve the product and minimize waste, as was said on the stand yesterday, the company experimented with laser or ultrasound cutting of the mesh sheets.
Lamont was asked: “Ethicon continued to sell the mechanically cut TVT knowing it had the potential to fray, rope and send off particles right? Lamont admitted the potential for those defects can exist but to make TVT fray and rope it would have to be elongated 50 percent, an extreme test that would not represent clinical use (ie, in a patient).
He added he did not see trending reports on those defects that would require any investigation into the two types of mesh products.
David Robinson- Worldwide Medical Director Ethicon
David Robinson, MD might be familiar to Mesh News Desk readers.
He appeared via videotape in the Linda Gross Ethicon trial in New Jersey one year ago. Before working for Ethicon, Dr. Robinson was a Topeka, Kansas-based paid consultant for Ethicon and the ob-gyn was early on approached about using the new tape. At first he wasn’t interested but then saw how a colleague was benefiting from the association. The colleague had an all-expense paid trip to Sweden, where TVT was developed in the late 90’s, to be trained on the new procedure. Those initial hand-picked doctors would then become trainers or preceptors for others when they returned to the states.
Dr. Robinson decided to jump on board and he was glad he did. In his videotaped deposition he said “It was revolutionary and changed my practice immensely.” He said he went from 20 Burch procedures a year, a basic method to sew up the sagging pelvic organs with suture, to 100 TVT procedures annually. Dr. Robinson said he was poised to grow his practice and that happened coincidentally at the same time he began offering the TVT.
Allison London Brown, a marketer at Ethicon, asked Dr. Robinson to help sell the product, “without overtly admitting the current product may have some aesthetic problems,” a memo said.
In 2005, Dr. Robinson was employed by Ethicon in charge of TVT products for Ethicon and he had learned about its risks – vaginal scarring, chronic pain, dyspareunia (painful sex). All surgeries have risks, he said, but admitted the company had those reports.
Still TVT offered significant advantages, according to Robinson – it was stronger and more reliable than a Burch procedure with a 90 percent effectiveness rate, a shorter recovery time and TVT was less invasive. On tape, Cartmell showed a study that showed the Burch procedure and TVT had an equal rate of cure.
Cartmell: “Is it your testimony that TVT has a longer cure rate than the Burch?”
Robinson: “There are papers that say that, yes.”
Cartmell: “There are also papers that say it does not, right?”
Robinson: “I’m sure. I watched it evolve to the gold standard. I think it’s clear.”
But the TVT mesh (Prolene) had been shown to shrink up to 30 percent after implanted causing foreign body response (FBR), inflammation and contraction. That is what would be expected said Dr. Robinson but “you have to know if it’s microscopic and whether it’s clinically important,” said Robinson. He believes clinically FBR goes away.
Since incontinence is a quality of life issue, someone might not be willing to take as much risk with a medical treatment as a cancer patient right? Robinson agreed.
Since the 1990s the gold standard for research was being conducted by Dr. Ulf Ulmsten MD of Karolinska Institute in Stockholm, Sweden. An ob-gyn, Dr. Ulmsten went to Uppsala University Hospital in Uppsala, Sweden where he was Professor and Chairman until his retirement in 2003.
Dr Ulmsten died on March 4, 2004 at the age of 66 but his work was continued by his colleague Carl Gustaf Nilsson MD of Helsinki University, Finland. Together the two men would establish six locations for trials on the Prolene mesh that would eventually be expanded from hernia use to the TVT. Ethicon today refers to the Ulmsten/Nilsson studies as providing proof of the highest level of safety and efficacy for the TVT.
Cartmell asked Dr. Robinson if he was aware the longest study on Prolene lasted seven years. The seven-year study showed a cure rate of 81.3 percent for the 80 women available then. Prolapse had returned in 7.8 percent, urge symptoms (incontinence) in 6.3 percent and urinary tract infections were reported in 7.5 percent. Had Dr. Robinson seen the actual data? Was the mesh tested even the same mesh, asked Cartmell.
“I don’t believe it to be significantly different,” said Robinson, I believe it was Type One macroporous mesh.” The classification for surgical meshes in 1997 was “imperfect and disputable” scientists have stated in recent years. See Classification for Surgical Meshes here.
If Dr. Ulmsten was paid millions of dollars if his studies showed positive outcomes such as low complication rates and high efficacy; could that be a case for bias? Potentially, yes, agreed Robinson.
Previous testimony had established that Dr. Ulmsten was paid in excess of $25 million to deliver the TVT patent and six clinical studies on TVT- all for using an old heavy weight hernia mesh with small pores and for a now application- the TVT. See background story here.
Dr. Piet Hinoul, a medical director for Ethicon, expressed some frustration to Dr. Robinson in an email shown to the jury. He had written a paper and submitted it to a professional journal for publication but the editor had declined to publish the paper because Dr. Hinoul worked for Ethicon. Robinson told Hinoul he wondered what the editor’s reaction would have been if Hinoul was only a consultant rather than an employee of Ethicon.
You were suggesting working for the company versus being just a consultant is a fine line, asked Cartmell. Yes, Robinson agreed.
In the memo, Robinson said to Hinoul it would be interesting to see if Dennis Miller’s manuscript is published. Miller is credited with creating the Boston Scientific Pinnacle Pelvic Floor Repair Kit, a polypropylene cradle of mesh to secure sagging pelvic floor organs.
Boston Scientific and Ethicon are two of the six manufacturers who are the subject of the more than 50,000 product liability cases filed in this court, more than have ever been amassed in any one court in history.
Dan Smith- Engineering Fellow Ethicon
Dan Smith worked for Ethicon for 36 years as an engineering fellow. His job was to find new materials to use for improved outcomes for women, essentially the next generation of TVT.
Animal studies on a lighter weight, large pore mesh would reflect better tissue integration and not much foreign body response when compared to the heavy weight small pore mesh that was Prolene used in the TVT.
Within the company Project Scion was created to find an alternative to the TVT mesh that was shrinking 30 percent due to excessive scarring. An animal test on rabbits in 2003 found the low weight, large pore mesh could replace Prolene.
But Ethicon decided not to put any new products in the continence field. It was a “business decision,” said Smith.
Smith was involved in the Matrix Project, again looking for a TVT mesh replacement. Matrix focused on the TVT-O PA (partially absorbable), which was his invention but the TVT-O PA project died in 2012. Even though it was fifty percent lighter than the Prolene mesh, in the cadaver lab testing in Morristown, New Jersey in 2011, it was found to be too stretchy.
“Again it was a side project, it was determined not to put resources into that,” said Smith. “Your work with Matrix was a low priority, right?”
“It was considered low priority, yes,” said Smith who added that the budget for a discovering the next generation of TVT was extremely limited.
In direct examination on videotape Smith was asked if the light weight mesh offered more flexibility and less scar tissue, increased the quality of life of the recipient. Smith agreed.
On cross exam, Smith said the TVT classic (Prolene) is the only mesh that been used in the 15 to 16 years of the TVT. The Gynemesh PS (Prolene Soft), developed during this time, had limited stretching characteristics and not enough elongation properties and the UltraPro, a large pore mesh roped and narrowed when it was stretched.
Earlier in the week, Dr. Bruce Rosenzweig had testified there were no studies ever done on TVT with the primary end point as safety.
Dr. Axel Arnaud, the medical affairs director for Europe the Mideast and Africa taken during a deposition July 2013 said, in his deposition read to the jurors, that the company didn’t want to change out the TVT for an alternative because the company would “would reduce the value of the clinical trials,” referring to the Ulmsted/Nilsson data which was the cornerstone of the company’s marketing efforts and gave Ethicon the bragging rights for its TVT.
C.L. Takes the Stand
If there is any star of the show in a trial it is certainly the plaintiff and at 1:25 on Friday, C.L. slowly walked to the stand.
Born May 30, 1954, C.L. lives in about 55 miles south of Dallas with her husband, a truck driver. She had on a grey sweater, slightly darker than her pulled-back grey hair. Her voice was pleasant and smooth with a slight southern accent. She had worked as a waitress, at a bank and worked at a coal mine in Fairfield, Texas, the same place she met her husband.
Together they liked to travel in an RV, go fishing and hunting, “normal stuff,” she said. They have six cats and two dogs and at various times have kept livestock- sheep, goats, pigs, calves, pheasants. She kept the family finances and together they would chop and haul wood for heating the home. The couple has a son.
The jury seemed attentive to everything she said.
In telling her story C.L. seemed like a nice lady, the sort of pleasant neighbor you might befriend, not someone who might file a lawsuit for personal gain after hearing lawyer ads as the defense suggested in its opening statement.
C.L. was not the picture of health. Standing about five feet tall she was heavy, had suffered back pain and had surgery for a bulging disk, went to a dermatologist for psoriasis and a cardiologist for an irregular heartbeat. An ear, nose and throat doctor was treating her for Meniere’s disease, a disorder of the inner ear that causes dizziness. She told the jury she attributed many of her ailments to “getting old” even though she is just 59.
At some point her incontinence got progressively worse and she lived with it for about a decade before deciding to do something about it around 2005. A friend recommended urogynecologist Dr. Muriel Boreham who worked at Baylor University. The doctor diagnosed stress urinary incontinence (SUI) and suggested they could put in a “tape” so she did not leak.
Recall that a “failure to warn” is off the table in these proceedings so any questions about what C.L. was or was not told in the form of a warning was strenuously objected to. The judge sustained the objections.
What was allowed was her understanding about what would happen.
“What I understood was she’d go in and it was a fast procedure, minimally invasive, in and out with no problems” C.L. told the jurors.
But the reality was not the same thing. C.L. had to have an overnight hospital stay because her bladder had been poked during the procedure with a needle by a surgical assistant. She was told to take it easy for six weeks – no lifting, housework, no sexual activity.
“I love my husband dearly,” she said when asked, “We had a very active sex life.”
At a six-week checkup she was told there was more healing to go. Sweeping or housework was difficult. C.L. said she had pain when she moved and she didn’t feel like loading wood. Sex was painful and made her cry. She took hydrocodone for pain. When asked, C.L. said she could distinguish between the back pain she still occasionally felt and the sharp pain in her abdomen.
C.L. never went back to Dr. Boreham but over the next three years she did visit her doctors for her skin, the rash on her hands and feet, her heart, her inner ear. The defense suggested in its open that she visited 30 doctors and never once complained of her chronic abdominal pain to a single doctor.
C.L. was asked if she complained of pelvic pain to her dermatologist? No. Why not? “Because he was looking at my feet!” she explained highlighting the absurdity of the question. Did you cardiologist give you a pelvic exam? No. Was he trained in gynecologist? No. Your orthopedic doctor for your knee, did you complain of pelvic pain? No. Is he a gynecologist? No. Did he suggest a pelvic exam? No. Did you ask him? No.
Richard Freese stood at the podium and asked C.L. if she had seen lawyer ads for mesh injuries. Her husband did and brought it to her attention, but she didn’t do anything for several months. Eventually in 2012 she called a Texas law firm and filed her defective product lawsuit. She had never filed a lawsuit before.
The stabbing pelvic pain continued and her incontinence returned. Her sex life with her husband did not. Eventually C.L. was referred to Dr. Philippe Zimmern in Texas. He drew on a white board the anatomy of a woman.
Freese: “Did you discuss what would happen if you did not have it (TVT) removed?
Jones for the defense: “Objection”
Judge Goodwin: “I’m going to allow it”
C.L. : “He said if I didn’t get it removed it’s like a ticking time bomb.”
Ticking time bomb is the same expression used by attorney Henry Garrard in the first C.R. Bard case which yielded a $2 million jury verdict in favor of the plaintiff. There is consensus among mesh critics that no one can predict what polypropylene does in the body long-term.
Surgically Dr. Zimmern said he would take as much out under the urethra that he reasonably could and he discussed the general risks of surgery, scarring, infection and death. She and her husband decided that day to proceed with the surgery.
In September of 2013 C.L. underwent surgery at the University of Texas Southwestern Hospital. Dr. Zimmern remained all but the arms of the TVT mesh which remain embedded in her pelvis. Today she is not 100 percent better she said but the pain is “tolerable.” Unlike her past, her sex life is “bearable” now.
“I have no idea what the future holds,” she told the jurors.
Christy Jones stepped up to the podium for the cross-examination of C.L. Jones is feisty, sharp- tongued and quick, not someone you would want to tangle with. She had to be careful not to bully the kindly C.L. but in defense of Ethicon had to poke holes in her story and credibility.
C.L. held her own and lightened up the proceedings by asking Jones to use the wireless microphone. “I can’t hear as good without my glasses,” she said. The jury chuckled.
You never went back to the implanting physician Boreham about any of the issues you complain about is in this lawsuit did you, asked Jones. “That’s correct.”
You didn’t seek any doctors for what you’re here for today? “Correct”
“I must have made a mistake when I said in my open you’d seen 30 doctors, you have 30 visits,” Jones corrected herself. C.L. was agreeable with Jones about the correction and acknowledged one or two of the visits was with an associate not a doctor. This was not the sort of exchange in the Linda Gross Ethicon trial in New Jersey last year where Jones drove Gross to tears and shouting, upset at the aggressive questions.
Jones pointed out questionnaires that C.L. had filled out upon visiting the doctor as well as anatomical drawings where she circled the areas giving her pain. C.L. agreed she didn’t talk about her abdominal pain, urinary retention or her other symptoms.
Q: “After you saw the commercials you didn’t go to a doctor to see what was causing your symptoms?
Q: “After Dr. Zimmern, did you see any doctor or another doctor for a second opinion?”
A: “No I did not.”
The implication was she didn’t go to another doctor she instead sought out the help of a lawyer.
On re-direct examination Freese asked, “Have you exaggerated anything you’ve testified to today?”
“No, I have not,” she said.
Monday February 17th is President’s Day. Beginning on Tuesday, the defense gets to put on its case to the jury and if Judge Goodwin keeps his promise the case will wrap up and go to the jury for a decision on Friday. Stay tuned.