DALLAS, TEXAS — Within view of the infamous Dealey Plaza – where gunmen ambushed President John F. Kennedy 50 years ago – in a courtroom on the 6th floor of what locals call the “New Tower,” a Texas woman who claims she was injured by plastic mesh sewn into pelvic muscles in her vagina had her first day in court this week. She is suing Johnson & Johnson’s Ethicon division, the largest medical device maker in the world.
The now 64-year-old woman has undergone two revision surgeries after being implanted with a transvaginal mesh sling made by Ethicon. She continues to experience pain and dyspareunia (pain during sex) which she says is caused by Ethicon’s transobturator sling (TVT-O). Surgeons put the sling in her in 2011 to treat stress urinary incontinence and urge incontinence. The case, Batiste vs. Johnson & Johnson, is scheduled to run at least two weeks in the court of Judge Ken Molberg, in the 95th Judicial District Court at the George L. Allen, Sr. Courts Building. – 600 Commerce Street, 6th Floor New Tower, Dallas, TX 75202. The trial began at 9:00 Tuesday, March 18, and is scheduled to run at least two weeks.
Attorney Rich Freese of Freese & Goss opened for the plaintiff, Ms. Batiste. He told the jury she was suing Ethicon because the company had failed to follow basic safety principles.
Mr. Freese said that a company must put the safety of its patient first. A company must first make sure its products are reasonably safe. It must provide adequate warnings. It must investigate any warning signs. Mr. Freese showed Ethicon’s credo on a giant monitor facing the jury. He yellow-highlighted J & J’s language that included, “We believe our first responsibility is to the doctors, nurses, and patients. . . “ He also pointed out that the company’s language at the end of its credo states that the company’s “final responsibility is to the stockholders.” Mr. Freese said that Ethicon violated its own credo with its TVT-O product, that the company put the wealth of its stockholders above the health of its patients.
The story starts in 1974, said Mr. Freese, when Ethicon was putting prolene (plastic) mesh in people’s stomachs for hernia repair. In 1990 the company began to promote and use the mesh for Laparoscopy, or lap band surgery. At the same time, Ethicon found problems with the hernia mesh, he said. People needed revision surgeries; they needed to have the mesh removed.
Mr. Freese said that Ethicon hired scientists to investigate these problems, the pain and revisions. They learned the mesh was too heavy, the pores too small. Ethicon decided the heavyweight mesh with small pores was the problem. So they redesigned the hernia mesh, made it lighter and larger pored for better integration in human tissues. When they started selling the new mesh, they stopped selling the old, Mr. Freese said. They started selling the newer, lighter weight mesh with larger pores.
At this time, said Mr. Freese, a Swedish inventor told Ethicon that he was using the company’s older mesh product for pelvic floor repair in women. J & J paid the inventor millions of dollars, said Mr. Freese, then started putting the old prolene mesh into women’s vaginas themselves.
Fast forward to 2011, said Mr. Freese. A patient with mesh has pain during sex and returns to her doctor and says the mesh she was implanted with is causing her pain, and pain during sex. Her doctor removes what he can of the mesh, but he can’t get it all.
“This is 1974 heavyweight, small-pore mesh,” Mr. Freese said, and held up the TVT-O product to the jury. The product was a strip of plastic material an inch wide and about eight inches long with what looked like a shoelace attached to each end. Then Mr. Freese showed a picture on the monitor of the tightly pored mesh, the holes or pores of which looked about the size of those on window screen.
There are three reasons why the mesh is defective, said Mr. Freese. 1.) It’s outdated, designed for the stomach; it’s too heavy and the holes are too small. 2.) When cut, it leaves ragged edges. It ropes and frays when pulled, loses particles, blue particles fall off of it. 3.) It degrades over time.
Mr. Freese said Ethicon was aware of all these risks, these problems, when it started putting the mesh in women in 1998. At that time, there was already a better mesh with pores 600 times bigger and a weight 70 percent lighter than the prolene mesh, the old hernia mesh, that Ethicon began putting in women.
Mr. Freese then outlined some of the experts he said he will call to the stand to prove his case. He showed a picture of Dr. Bernd Klosterhalfen, said he was hired by Ethicon to fix the problems of the heavy mesh before the company ever sold TVT. Before TVT was ever on the market, Dr. K told Ethicon the heavy mesh should not be used in women’s vaginas.
Dr. Boris Batke will also give a mesh presentation, said Mr. Freese. He will show the mesh has:
• Excessive foreign body reaction
• Chronic inflammation
• Unorganized fibrocallagenous ingrowth
• Scar plate formation
• Shrinkage from bridging fibrosis
• Stiffness leading to abdominal wall restriction
Mr. Freese then held up a basketball net (a touch of March madness in the air) to help show a larger example of the differences in larger vs. smaller pored mesh. The company had discovered, he reminded jurors, that larger pored mesh was better for tissue integration.
Mr. Freese said J & J’s Dr. Holster in his deposition on July 29, 2013 admits that smaller pored mesh has greater inflammatory reaction. Mr. Freese also said he would show deposition material of Ethicon’s Dr. Piet Hinoul from Jan. 2014 in which he states that nobody today would bring a heavyweight or a microporous mesh to market.
Mr. Freese said “major damage control” began in Feb. 2004 when implanting doctors began to see blue pieces of the mesh loose inside women’s vaginas. In one email, an Ethicon employee suggested they needed to make the mesh clear so that doctors wouldn’t see the mesh pieces that broke off, wouldn’t see the problem. Mr. Freese said company documents would show they knew there was an important difference in fraying and roping between laser cut mesh and machine cut mesh, but Ethicon was slow to act on its own research, or else it suspended research studies which didn’t help show the product was safe.
Mr. Freese said that in 1992 Ethicon began a 10-year dog study in which it found the mesh was degraded after five years, and further degraded after seven years, at which time Ethicon simply stopped the study; and never showed doctors these results.
Mr. Freese reminded jurors that Ethicon failed to give adequate warnings with TVT-O. He said that Ethicon’s IFU – Instructions for Use – for the mesh were inadequate. Physicians need the IFU to make decisions, and Ethicon failed to flesh out all the problems in the IFU. Mr. Freese listed what those risks not in the IFU are:
• Mesh degrades, shrinks, produces chronic foreign body reaction
• Chronic inflammation, dyspareunia, groin pain
• Difficulty removing all the mesh
• Machine Cut Mesh vs. Laser Cut Mesh
• Particle Loss
Mr. Freese said Ethicon doesn’t go out in the real world and discover how their products are doing; he they wait and see, take a passive rather than an active approach to safety.
Mr. Freese closed by telling the jury he will bring evidence to show Ethicon did no long-term studies of chronic pain, and he reminded jurors of his initial claim that Ms. Batiste’s injuries were caused by Ethicon’s failures to follow safety principles.
Attorney Karen “Kay” Deming of Troutman Sanders in Atlanta opened for the defense. A full-figured blonde in a light blue knit skirt and matching top with white piping and big white buttons that matched her earrings, Ms. Deming began by calling Ethicon’s TVT product “revolutionary.”
“Let me be clear,” she said. “The TVT is safe. The TVT-O is safe and effective and it has helped many women with this problem (SUI).”
Ms. Deming then put on the monitor a detailed anatomical blowup of the bladder and vagina, showing their proximity and explaining the difference between stress urinary incontinence (SUI) and urge incontinence. “Urge incontinence is different,” she said, “[It’s] where you’ve got to go and can’t quite make it.”
“The TVT-O is designed to treat SUI, not urge incontinence. When you have both, it’s called mixed incontinence.” She said the plaintiff Ms. Batiste had both.
Ms. Deming explained to the jury that she and her team of lawyers would have to ask Ms. Batiste personal questions, (but) “Please don’t hold that against us if we have to ask personal questions.” Ms. Deming explained that with age the elasticity of the vagina wears out, then gravity takes over and an older woman has less estrogen so that her tissues break down, and weight can also be a factor.
Ms. Deming said that stress and urge incontinence affect many women, and with apologies she went into the kind of excruciating detail that such a trial on this central issue simply cannot avoid, in explaining Ms. Batiste’s issues regarding both stress and urge incontinence. She also explained that the TVT-O is a hammock for the bladder, to keep it from pressing into the vagina.
Ms. Deming then gave some detail on other procedures which are options for SUI treatment:
• Kelly plication (anterior repair);
• Needle Urethopexy;
• Burch Colposuspension (a 4”-6” incision through the abdominal wall, though it can also be performed laporoscopically;
• Fascial sling (harvested from cadaver or animals).
Ms. Deming said the TVT-O sling procedure was just as effective as any of the other, older methods and less invasive than most, and it offers faster recovery times. She also said that, admittedly, mesh has a greater chance to erode than Burch or Fascial sling, and that it is not unusual for mesh to come through the vaginal wall, to erode.
Ms. Deming then returned to Ms. Batiste’s particular physical condition. She detailed Ms. Batiste’s other health problems that could all contribute to her pain, including obesity.
Ms. Deming then faced the jurors straight on and said that though Ms. Batiste was smaller now (seated in the courtroom, jurors could see Ms. Batiste for themselves), when she had had her sling installed in 2011, she was about the size Ms. Deming herself was now. “I’m considered obese,” Ms. Deming said, thereby becoming perhaps the first woman in history to make such an announcement to a roomful of people in the stylish and famously style-conscious city of Dallas, Texas.
Ms. Deming further explained that Ms. Batiste also had an anterior colporrhaphy, and she also had a hysterectomy. She said Ms. Batiste also had a cystocele, which occurs when tissue between the bladder and vaginal wall weakens and stretches; thus the bladder bulges into the vagina. (A cystocele is also called a prolapsed bladder.) Ms. Deming said the operation for cystocele carries the same risks – dyspareunia, chronic pain – as the TVT-O and that that particular surgery was performed on the same day that Ms. Batiste was implanted with TVT-O.
Ms. Batiste also had had at least two strokes, Ms. Deming said, which could affect her memory. She reminded the jury that plaintiffs need to prove that failure to warn caused Ms. Batiste’s injury.
Ms. Deming said that the TVT-O patient brochure says that “all surgical procedures present some risks, difficulty urinating, pain, scarring, pain with intercourse, mesh being exposed. She told the jury that all the other options for SUI surgery carry the same risks, except for erosion.
Ms. Deming said there was no evidence that fraying, roping mesh or particles caused Ms. Batiste’s pain. She said, “Polypropylene has been used in millions of people for at least 30 years and is still being used.”
“Let’s talk about problems that Ms. Batiste actually had,” said Ms. Deming. She listed debilitating incontinence, three back surgeries, nine abdominal surgeries, diabetes that can evolve into neuropathy, poly neuropathy, all the nerve problems that can affect in Jan. 2011 the pelvic mesh surgery, then seven months later, back surgery, then heart surgery with a stent a month later.
Ms. Batiste saw 14 providers in 32 visits at one point and did not report pelvic or groin pain or dispareunia . Ms. Deming said there is no clinical evidence that all of Mr. Freese’s look at mesh problems caused Ms. Batiste’s pain.
Ms. Deming closed by saying that some 100 randomized studies on TVT and thousands of studies showed it to be safe, that it was one of the most studied devices ever and is still being used today. She reminded jurors that Ms. Batiste had “signivficant, life-altering incontinence problems” and they were not caused by TVT-O.
The First J & J TVT Sling Trial
Johnson & Johnson won the first TVT trial in West Virginia last month in the federal multi-district litigation court after Judge Joseph Goodwin disallowed Texas plaintiff Carolyn Lewis’s warnings claim and later threw her case out of court.