If the lawyers working for Boston Scientific need to convince a jury that polypropylene pelvic mesh is the “standard of care” that is the accepted norm by most in the medical community, then a series of obstacles were thrown in path of that argument in a Miami federal court Friday November 7th.
The plaintiffs’ case wound down with a rapid succession of doctors, both on tape and in person, who disagree with the use of polypropylene pelvic mesh.
Remember that the Pinnacle – the now recalled mesh kit used to treat pelvic organ prolapse – was implanted in all four women who have their cases consolidated in this federal court. The Pinnacle Pelvic Floor Repair Kit has been off the marked since May 10, 2011 when the company issued a voluntary recall because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.” See it here.
What the Jury Can’t Hear
But that information has not been allowed before this jury of nine, and was not heard unless they were paying attention on Wednesday, November 5. That’s when Dr. Konstantin Walmsley testifying for the plaintiffs broke from the polypropylene pack mentality.
Dr. Walmsley testified that he had attended cadaveric labs to train on mesh placement and met with “key opinion leaders” (another name for consultant/doctors who are paid to sell other doctors on a procedure and product). He had used mesh kits, specifically the Bard Avaulta in 2005, and thought there might be a benefit to the patient:
“My initial experience in ’05 and ’06 with what I experienced, these kits did provide questionable outcomes, the support at the apex of the vagina, which happens to be the critical part of the repair.. ie apical support.. the apical support was sub optimal. In a small number of patients I treated, I started to see mesh related complications.”~ Dr. Konstantin Walmsley
Dr. Walmsley told the jurors he saw patients experience pelvic pain, discomfort with intimacy, mesh erosion or extrusion. “I felt uncomfortable managing them, not just technically, but because of the moral responsibility I felt to these injuries” he said.
“A doctor shouldn’t be implanting something unless they know it’s safe.”
The defense objected.
Has that experience changed and if so how much, he was asked by attorney Jim Perdue.
“We can say there are not many TVM (transvaginal mesh) kits on the market anymore.”
Objection, shouted the attorneys for Boston Scientific. Judge Joseph Goodwin instructed the jury to disregard the statement. “What’s on the market is way outside his expertise.”
Everyone knows a jury is going to pay special attention to anything they’ve been told to disregard.
The handsome urologist with a fellowship in female urology and voiding dysfunction says he’s seen severe complication from the placement of polypropylene mesh kits such as the Pinnacle. He pointed the Abbott study, published in February of 2014 that concluded most of the women with complications after pelvic mesh for prolapse or incontinence have severe complications and nearly 60% went on to surgical intervention and sought out treatment from different doctors than the implanting physician, who may never know there was a complication.
So it was no surprise then when first thing Friday morning (November 7) just what the jury could hear about the Pinnacle was at the top of the agenda. Judge Joseph Goodwin told the court (with the jury absent) that while we want to encourage manufacturers to withdraw a product if there are clinical reasons to do so, the potential for prejudicing the jury outweighs the probative value. And then there is a question of time. Judge Goodwin wants to allow no more than two weeks for the 67,000 pelvic mesh cases consolidated in his court.
“I’m not going to allow it to be pursued. “I’m going to try this case. You’ve been allowed to get more in this time than in other cases than I would have preferred,” he said. That was the end of the issue.
Dr. Linda Kiley
Urogynecologist, Dr. Linda Kiley, took the stand Friday morning. She was the treating physician for AE and removed the majority of her Pinnacle mesh. Dr. Kiley sees two to four major cases a week at her Boca Raton office, cases such as prolapsing organs, fistulas, and incontinence. Has she ever used transvaginal mesh, she was asked by plaintiffs’ attorney Joseph Osborne (Babbit, Johnson Osborne & LeClainche) flaw firm).
“No I believe the risks exceed the benefits. The results are not different with TVM than without mesh but the complication rate was 18 percent and that’s unacceptable to me.” Dr. Kiley, who graduated from UCLA, told the jury she sat in a surgery when a Pinnacle was implanted.
“I was somewhat horrified with the way it went in and that there was a large amount of it. The bleeding seemed excessive and I did not find it was an elegant repair to me.”~ Dr. Linda Kiley
She called the fixations without mesh the “Gold Standard” that is, sacrocolpopexy performed laparoscopically. For the last six or seven years she’s removed mesh due to complications. The Pinnacle, like any mesh kit with arms to affix to the pelvic area, is particularly difficult to remove. “Like scraping sand paper” Dr. Kiley said. She says it is not unusual to spend three to four hours removing a mesh using her fingers to scrape it away from the body rather than use scissors.
AE had a pelvic floor repair in 2008. When she went to see Dr. Kiley the doctor says the patient complained of a sharp, stabling and tearing pain. She had difficulty evacuating her bowel and had to assist manually. An exposed area of mesh was on the posterior side between the vagina and the rectum where there was granulation and tissue inflammation.
On August 29, 2012, AE underwent removal surgery. With a large display board, Dr. Kiley pointed out the mesh erosion and where she had to make an incision and scissor the mesh. Mesh remains on the posterior and anterior side. The explanted mesh was shown in a blown up photo to the jury. The bloody dark piece had one arm intact and one shortened, the rest of it was left behind in the patient.
AE received a biologic tissue graft to support her rectum. Besides taking some antibiotic and a chemical cautery of silver nitrate to help healing.
Matthew Keenan, for Boston Scientific (Shook Bacon) on cross-exam established Dr. Kiley still uses polypropylene to treat stress urinary incontinence but with an abdominal approach primarily because it leaves behind a smaller incision for the mesh to stick to. Using a midurethral sling she’s seen about five percent complication rate since mesh will affix to the incision.
Like Dr. Walmsley, Dr. Kiley said she likes the Capio device (tool in the Pinnacle kit) to enable the surgeon to reach deep into the pelvic to attach a prolapsing organs.
Dr. Brian Raybon
Dr. Brian Raybon was next on the stand. He may seem familiar. He was the treat physician for Donna Cisson in her federal trial against C.R. Bard. Board certified in female pelvic medicine and gynecology, Dr. Raybon practices in Northeast Georgia and Gainesville, he was brought in to review the medical records of Ms. Dotres.
Under direct examination by Jim Perdue, Dr. Raybon said the patient’s failure to void was the direct result of the Pinnacle mesh kit.
The doctor then stood before the jury with a Pinnacle mesh in his hands to demonstrate its use. It was not lost on the jury that as Dr. Raybon, a large man at least 6’ 2” and at least 225 lb, held the Pinnacle anterior and posterior mesh it seemed like a limp two-foot wide limp octopus with its dangling, tapered arms.
Was there any problem with the implanting technique of Dr. Salom? No, said Dr. Raybon, it as in concert with the IFU (instructions for use).
Plaintiff Margarita Dotres (MD) had the Pinnacle implanted October 8, 2008 and by 2010 she reported discomfort. Could it be the IUD causing discomfort? No, said Dr. Raybon. Her symptoms increased and by June 2011 she had mesh erosion and a pin prick sensation as well as pain with urination. By March 2013 she had scarification, mixed incontinence, urge symptoms an overactive bladder, something very common where there is scarring around the bladder offered Dr. Raybon. Both leakage and urinary retention can co-exist at the same time, said the doctor.
“The only thing causing this is the placement of the mesh,” ~ Dr. Brian Raybon.
Defense attorney Molly Craig (Hood Law) had to rebut the witness on cross-examination. Was MD the appropriate candidate for transvaginal POP repair in 2008? Yes, said the doctor. She had a grade two uterine prolapse and grade three rectocele prolapse.
Then came the traditional question about money. Dr. Raybon had been compensated about $400 an hour and it took 40 hours to review the documents. He charges $700 for trial testimony. Craig inferred he was now taking cases referred to him by plaintiffs’ attorneys. “No said, Dr. Raybon. These women are not necessarily plaintiffs in a case. Their cases are complex and most no longer have insurance. I don’t get compensated, I do them pro bono.”
Dr. Raybon added that using mesh in 2008 was a “reasonable choice” and that even on occasions he does use polypropylene transvaginal mesh to treat pelvic organ prolapse.
Jim Perdue jumped up “Do you use Pinnacle transvaginal mesh in your practice?” “No sir.”
Dr. G. Willy Davila
Many readers of Mesh News Desk are familiar with the urogynecologist Dr. G. Willy Davila who works with the Cleveland Clinic in Florida. MD first visited him in August 14, of this year, referred by her law firm, Blasingame, Burch, Garrard & Ashley.
Dr. Davila appeared via videotape and commented he has not used vaginal mesh for prolapse since 2000 or 2001. (MND editor, spoke just today to a woman who was implanted with POP mesh kit by Dr. Davila in 2007! Another Mesh News Desk reader says Dr. Davila was a TVM kit proctor post 2004.) Additionally, a brochure from the 2009 AUGS meeting shows Davila along with Micky Karem answering questions on the use of the Anterior Elevate (AMS) mesh kit used to treat pelvic organ prolapse. Can one answer questions about a mesh kit if they do not use it? See it here, page 26.
He has scheduled another surgery for MD next month. On videotape Dr. Davila said while others say you should remove the entire mesh, he doesn’t share that opinion. “My patients do well,” he added. The patient had one excision surgery in 2011 and likely she will have another in the future. The doctor agreed no one knows what happens after several years and in the long-term to mesh patients.
Dr. Emery Salom
Dr. Emery Salom, board certified in gynecology and urogynecology was the doctor who implanted plaintiffs Nunez and MD. As is the case in this defective product litigation, the plaintiffs must prove the doctors had inadequate information from the manufacturer to establish the instructions for use were defective.
Brought to court by the plaintiffs, Dr. Salom said he relied on the directions for use (DFU) before implanting both women in 2008. At the time he believed the risk of erosion, of pelvic pain and of dyspareunia was rare, however, his feelings changed over time. Today he does not use polypropylene mesh to treat pelvic organ prolapse.
Plaintiff attorney Shelly Hutson (Clark, Love Hutson) questioned Dr. Salom – If you had known in 2008 the severity of complications for dyspareunia, erosion, mesh exposure and pelvic pain, would you have used the Pinnacle on Ms. Nunez? If you had known the chemical company stated NOT to use it for permanent implants would you have used it in MD? If you had known how difficult it would be to remove the mesh would you have used it on these women? No, he said to all three questions.
Under cross-examination, attorney Matthew Keenan (Shook Bacon & Hardy) established that in 2008 Dr. Salom believed the Pinnacle was safe and effective and was the best choice for these women.
Dr. M. Tom Margolis
The last urogynecologist to appear in the courtroom for the plaintiffs appeared via videotape.
Dr. M. Tom Margolis is a San Francisco area specialist in female pelvic medicine and reconstructive surgery who coined the phrase “clean-contaminated.” As he told a Food and Drug Administration expert panel in September 2011, transvaginal mesh passes through a clean-contaminated field that introduced bacteria into the implant. Dr. Margolis said he does about ten major surgeries a week of all sorts and about 500 a year. In the last year or two he said transvaginal mesh complications have “exploded” and now constitute about one quarter of his work.
Were the complications foreseeable? “Of course it was foreseeable!” he raised his voice. Dr. Margolis said mesh cannot be explanted in its entirety.
“Polypropylene mesh is plastic cross-hatched mesh like a window screen. Scarification is the problem. Scar cells and fibroblasts cement the mesh into place into the tissue exactly like rebar cemented into place in a side walk. Mesh is cemented into place. Its designed to be permanent!”
And Dr. Margolis said the complications can occur right away or many years down the road.
The directions for use (DFU) were inadequate he said and failed to warn doctors about several risks – there is no mention, for example, that a patient may need multiple operations to attempt to remove the mesh. Every surgery becomes exponentially more difficult to remove mesh as well as more risky on the patient. Every surgery requires portions of normal healthy tissue be removed including the vaginal wall, bladder and bowel.
Again the money question was raised on cross-examination. “Lawyers hired you?
“I’ve been retained to offer expert opinion on the use of pelvic mesh,” he said calmly then listed the firms who he has worked for, the first being attorney Adam Slater in 2012. And again the compensation rate was revealed – $350 an hour for review of documents, $500 an hour for a deposition, trial testimony brings $2,000 a day.
Instead of life-altering, the degree of complications defense dramatically painted for patients suffering from prolapse, Dr. Margolis called the condition “annoying,” and for his difficult repairs, Dr. Margolis uses Gortex a chemical polymer, different from polypropylene, and he implants is laparoscopically. He used polypropylene in stitches only and a bovine mesh called Xenform. Interestingly, Xenform is made by Boston Scientific.
The Natick, Massachusetts-based company has faced three other trials so far winning at the state court level in Mass. but suffered the largest win so far for any pelvic mesh plaintiff- $73.5 million in the case of Martha Salazar before a Dallas jury in September. See the story here.
This trial is being held in Miami before Judge Goodwin as his federal court in West Virginia is the scene of another Boston Scientific trial being conducted at the same time over the company’s Obtryx midurethral sling.
The outcome of both trials will likely have an impact on whether or not the company will settle with 23,000 plaintiffs who have filed product liability actions against Boston Scientific. #