It was a big news day in Charleston, West Virginia but not for the first day of a product liability trial that put healthcare giant Johnson & Johnson on the hot seat. Charleston held a public hearing about Freedom Industries, the coal cleaning operation and chemicals it inadvertently dumped into the Elk River. The satellite news trucks were parked outside to cover the hearing and apparently that’s where the reporters were too.
This was Day One of the transvaginal mesh case of Plaintiff Carolyn Lewis (CL) and her husband Kenenth. CL was implanted with a polypropylene tape or sling made by Ethicon, a unit of J&J. The TVT (tension-free vaginal tape) was implanted in 2009 in Dallas by Dr. Muriel Boreham, of Texas Urogynecology Associates to treat stress urinary incontinence (SUI) that Lewis had been suffering with for more than a decade.
Judge Joseph Goodwin is overseeing 15,000 product liability cases filed against Ethicon alone and 50,000 pending against all six mesh manufacturers. On this first day for one of the largest mesh makers, he promised the potential jurors the trial would last no more than nine days.
“It won’t take near the time of other places,” he promised the pool of 30 potential jurors assembled, referring to other jurisdictions that can take days to choose a jury.
Carolyn Lewis, 59, sat in the second row in a grey sweater. Her husband had his armed wrapped around her the entire day. At one point the attorney representing Ethicon, Christy Jones (Butler Snow) approached and leaned in introducing herself.
“I know this is an uncomfortable situation,” she said offering her to make it less so.
Thomas Cartmell of Wagstaff Cartmell, Kansas City, Missouri represents Lewis. He was flanked by Richard Freese (Freese and Goss) and Ben Anderson (Anderson Law).
As is standard, Judge Goodwin thanked the jurors assembled for their presence reminding them “jurors are the most important people in our system of justice.” The task this morning was to eliminate those who had any conflicts, so Judge Goodwin asked if any individuals had any association with Ethicon, the lawyers present, any lawyers, any doctors etc.
One by one they were called into a small circle of lawyers. A switch was pulled and white noise blasted in the courtroom so others could not hear the discussion. By noon both sides had agreed to 10 jurors, five women and five men. Ultimately six will be needed to render a decision in this defective product case, the rest are alternates.
After lunch, Judge Goodwin finally told the ten what this case is about.
Defective product litigation involves defective manufacture, design and negligence by the defendant. Negligence is defined as a failure to use ordinary care that a person of ordinary prudence would or would not have done. A proximate cause of injuries is something that a person using ordinary care would have foreseen. The burden of proof is on the plaintiff. The proof is arrived at by the preponderance of evidence.
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Plaintiff Opening – Mesh Too Heavy, Pores Too Small
Thomas Cartmell had practiced his opening. He repeatedly referred to the mesh that would eventually be used to create TVT as causing “problems in the stomach” in hernia patients.
In 1974 Ethicon began selling its heavy weight, small pore mesh. Ethicon sees patients are having problems with pain and repeat surgeries to remove the mesh. Ethicon hired world renowned experts to find out why mesh was causing problems in the stomach and how to design a new mesh. Ethicon learned the Prolene (polypropylene) mesh was too heavy and the pores were too small. Ethicon thought it could design a new mesh with larger holes and a lighter weight and stop selling the old mesh.
That all changed, said Cartmell, when a Swedish inventor, Dr. Ulm Ulmsten, began cutting up the old mesh and putting into the pelvic area.
The Gynecare TVT polypropylene bladder suspension sling was invented offering a petroleum-based reinforcement to suspend a sagging urethra, the cause of the stress urinary incontinence. For his work, Dr. Ulmsten was paid millions.
The problem with the old mesh used in this new application was three-fold, said Cartmell in defining defective. A- it was outdated. The 1974 mesh designed for the stomach not a women’s pelvis was too heavy and the pores were not big enough. B-the TVT mesh was machine cut causing the mesh to rope, fray and curl up when under any tension in woman’s pelvic area and C- the mesh degrades inside a woman’s body with the outer layer of a polypropylene falling off the mesh.
TVT was marketed by Ethicon in 1998, the same year that it had developed Vypro mesh with holes 600 times larger and 70 percent lighter than the TVT. A lighter weight mesh with larger pores allows for more even tissue integration minimizing the bridging fibrosis, or scar tissue formation that causes mesh to harden, become rigid, entrap nerves, causes chronic inflammation and to shrink up to 50 percent.
Ethicon violated the first principal of patient safety, said Cartmell to the jurors, “We believe they put their own interests first.”
Lewis never returned to Dr. Boreham after her TVT implant. She had chronic pain and suffered from dyspareunia (painful sex). She went to a number of doctors for other health situations including a ruptured disk in her back, but never again complained of her pelvic pain or dyspareunia. She decided to live with it, said her lawyer until she and her husband saw a commercial on television soliciting clients for transvaginal mesh lawsuits.
“They had never been involved in a lawsuit. They learned they were not alone,” said Cartmell.
Months later she had Dr. Philippe Zimmern remove her TVT mesh but the arms were left behind and remain there today. Her lawyer says Lewis is 85 percent better.
Defense Opening – TVT the Gold Standard
Christy Jones launched into a defense of the company she represents. TVT was a “remarkable advantage” over its competitors, she told the jury. Before TVT was brought to the market, women suffering from SUI would have to undergo anesthesia and recovery in a hospital to receive a Burch suspension surgery or a vaginal sling made from one’s own tissue.
Prolene (polypropylene) mesh is used in sutures and in surgery on the heart, eyes and pelvic areas and has been used in the body for over 30 years, she said. TVT implantation is taught in schools all around the country. That’s why it is considered the “gold standard” said Jones.
“Look at studies that show how women’s sex function has improved after receiving the TVT,” she said.
Ms. Lewis actually told her implanting physician she was pleased with the outcome of her TVT surgery as late as January 2010, and two years later she filed this lawsuit, according to Jones.
“During this time she did not see any other medical doctor about any complications she filed in this lawsuit. She asked the TVT be taken out nine months after she filed this lawsuit, three years after she last saw Dr. Boreham. During this time she talked to not one doctor about complications of pelvic pain, urinary frequency and retention and painful sex. Over this period she saw over 30 doctors and not one record says she ever discussed the symptoms you will hear about today. I have no doubt Ms. Lewis believes she had pain because of the TVT but my job as a lawyer is to question the evidence and the fact of the matter is their doctors don’t show any of these complaints.”
Just a minority of doctors don’t like TVT, Jones admitted putting Dr. Zimmern in that category. She asked jurors to keep an open mind as they will hear a week of damaging evidence before defense gets to make its case.
“The product is not defective and it has nothing to do with Ms. Lewis’ problems. It’s a good product,” she concluded.
Plaintiff presented the first witness, a videotaped deposition of Dr. Bernd Klosterhalfen, a surgeon and pathologist who has collected about 1,000 explanted hernia meshes and 500 explanted or removed meshes from women where it was used for pelvic organ repair.
Dr. Klosterhalfen collaborated with Ethicon to create the lighter weight large pore Vypro mesh, which he calls Class I and much more suitable for implantation than polypropylene (Class 2). The modern improved meshes have a pore size of 2 to 3 millimeters. The Marlex (polypropylene) mesh has a 1mm pore size and after implantation with the tension produced by the body, it shrinks even further. Whether in an animal or human, bridging fibrosis or scar tissue, rigidity, and shrinkage up to 50 percent causing pain were all observed in his studies.
“Pore size and distribution of pore size is the most important for integration of mesh in the body.”
“The reason Ethicon launched the product was they were convinced large pore had advantages for the patient. Obviously they knew this.”
A lawyer on the videotape asked, “Do you mean the Vypro?”
Dr. Klosterhalfen answered “yes.”
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