January 18, 2013 ~ Thanks again to Courtroom View Network (CVN) for the courtroom access and images. Dr. Anne Weber was qualified as an expert witness for plaintiff Linda Gross on Thursday. Friday, January 18, was Day 7 of the trial of Linda Gross v Ethicon in Superior Court of New Jersey. The trial is expected to last at least one month.
Day 7 of the Linda Gross v. Ethicon trial had Dr. Anne Weber on the stand for a second day to continue with damaging testimony showing the train that Ethicon had barreling down the tracks toward a March 2005 scheduled launch of the Prolift®Pelvic Floor Repair System.
Prolift was the revolutionary new product using the Prolene soft mesh that would be sent to doctors pre-cut in a kit along with a set of tools to implant the mesh to treat pelvic floor dysfunction, a common condition in at least one-third of women as they age.
This was the first mesh kit to be marketed in the field of urogynecology.
Polypropylene mesh (PP) would be chosen, Gynemesh PS hernia mesh would be used and Ethicon, a division of Johnson & Johnson would “justify a premium price” when compared to mesh just sold in sheets which the surgeon had to cut to fit the patient. And Ethicon was eager to jump into the market with its mesh kit ahead of any competitors.
Dr. Weber testified for plaintiff Linda Gross, 47, of South Dakota who was implanted with Prolift in July 2006. Her doctor established she is permanently disabled in graphic testimony on Monday.
Dr. Weber says bridging fibrosis and scar plate created by the mesh have contributed to her injuries.
What was Linda Gross’ condition in 2006, asked plaintiff attorney Adam Slater of Weber who has reviewed at least a half-million documents in the trial as an expert witness.
Gross, then 35, had heavy menstrual bleeding and had been having incontinence.
She and her surgeon, Dr. Benson decided the best course would be a hysterectomy and Burch colposuspension, a surgical treatment for incontinence performed with a small incision above the pubic bone and placing an absorbable stitch behind the uterus to prevent any subsequent prolapse. Gross prolapse was a Grade 2 inside the vaginal bulge, a bulge Linda was not aware of in that it was not a significant prolapse, said Dr Weber.
In June 2006, one month before her Prolift surgery, she went to see Dr. Benson again. She had a rectocele and was manually pushing back on her rectum to help defecate. Dr. Weber said she experienced no pain in contrast to the dire condition painted by Ethicon attorney Christy Jones during opening arguments who said Gross was experiencing “extensive medical problems.”
“This is not what was represented to you as the state of her prolapse,” said Dr. Weber referring to Monday’s testimony by Jones.
Without second guessing Dr. Benson, Dr. Weber said Gross was a candidate for a less invasive surgery but Dr. Benson did not have all that he needed to make an informed decision. He did not have all the information Ethicon had at the time.
Weber said, “Ethicon knew this would happen to some women and they didn’t tell the doctors and they didn’t tell the patients.”
What Ethicon Knew and When
What Ethicon knew and when it knew it is one focus of this product liability trial.
Behind the scenes both before and after the launch of Prolift in 2005, the French doctors working on Prolift were calling for a different material to be used in the new Prolift, something other than the Gynemesh PS which was showing a high complication rate.
In an email November 29, 2006 David Robinson MD, the Medical Director, WorldWide for Ethicon wrote to Clifford Volpe, an Associate Director at Ethicon/ J&J on the subject off Dr. Michel Cosson. “Once again are pressing for more changes to be made in Prolift other than just the mesh. Yet, of course, the want the new mesh tomorrow…”
Medical Director Charlotte Owens was in charge of reviewing all safety and efficacy issues on the Gynemesh PS prior to launching Prolift and to consider alternatives, especially if her research team was waving the warning flag. But that didn’t happen.
Slater asked Anne Weber what should have happened.
“At the very least they should never have launched the Prolift. They should have studied the ULTRAPRO. There really are two things at issue, the mesh material and the procedure. They needed to study the mesh material and they needed to study the procedure,” the doctor said.
Slater: “In your opinion did Charlotte Owens fulfill her duty? Weber:”She absolutely did not.”
Document Input from Ethicon
Plaintiff attorney Adam Slater continued with her testimony Friday to show the influence of Ethicon in making sure scientific articles would paint a glowing picture of the new mesh, among them, an article published in the New England Journal of Medicine (NEJM), authored by Daniel Altman MD and published in May 2011 (here).
A series of emails shown by Slater, top executives at Ethicon and Medical Affairs were pleased with the favorable EBM (evidence based medicine) results that those women who had transvaginal mesh repair for prolapse had higher short-term successful treatments over tradition sutures alone. There was the downside of painful sex, dyspareunia, that showed up at one year or before and the rates of bladder puncture and hemorrhage were higher.
Ethicon execs wanted to make changes.
Looking at the internal Ethicon documents, Weber observed the group made 72 comments to the Altman study. One email acknowledged the study must remain independent but “I had to fight to keep sexual function outside of publication,” said Medical Director David Robinson.
According an email from Piet Hinoul, Medical Affairs Director WorldWide at Ethicon to Dr. Altman, “Overall the team feels that the sexuality part of the manuscript still lacks accuracy.”
Dr. Weber explained that a study Abstract is the study highlights reduced to an easy-to-read summary. It’s what most busy doctors will read to get to the bottom line of a scientific study. In the end, reports of dyspareunia were omitted from the Altman article.
This went outside the normal peer review common with scientific literature. Weber said Ethicon went to the extent to tell Dr. Altman if he didn’t make the required changes he would not get the funding to perform the study.
“That is the interference the Ethicon employees provided for the content of this manuscript,” said Dr. Weber.
On cross examination Christy Jones for Ethicon asked Ann Weber to look at an email from David Robinson of Ethicon to study author, David Altman. “Please use our comments at your discretion.”
Q-“He (Altman) determined whether to accept or reject and put those comments in the manuscript. Right?”
A- “And that’s exactly what he did! He didn’t put dyspareunia in the Abstract, he kept it out exactly!!
Corporate influence over scientific literature influence didn’t stop there.
During the afternoon in a long list of articles Jones used to illustrate the success of mesh pelvic surgeries, Slater highlighted the conflict of interest disclosures that accompany most published literature.
At least five scientists had either consulting agreements with Ethicon or were part of the speaker’s bureau, even those who claimed no conflict, he said.
PROTOCOL VIOLATIONS/ Catastrophic Outcomes
Over the course of the afternoon, a quick series of studies were shown involving the success of the new synthetic mesh when compared to traditional repairs. Dr. Weber told the jury she found repeated violations of the basic protocol of the French TVM study. She said her suspicions of the data made her suspect of the conclusions.
And besides, the criteria had changed. Initially researchers considered anatomically correctly positioned of organs with the use of mesh the gauge of successful surgery. But Dr. Weber pointed out a Quality of Life outcome was defined by most women as success. If your uterus was in perfect position and your pain scale was on a 10 – was that a successful surgery?
During the morning, Dr. Weber had told the jury she was compensated for her time retained by the Mazie, Slater Katz & Freeman law firm. Initially she charged $250 an hour and raised her rate to $350. She had spent about 2,000 hours reviewing at least a half-million documents since she was retained in February 2010.
Jones did the math. Q: “Is it fair to say you’ve now been paid closer to $600-thousand than $500-thousand?”
A: I don’t know the exact figure.
Q: You told us you thought it was necessary to spend that much time so you could understand the issues in this case?”
Jones apologized for suffering from a respiratory infection as she looked for documents. She showed a graphic of an article by Dr. Weber which said “Successful treatment of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery.”
The article says the high rate of recurrence led to the development of mesh.
In fact, Dr. Weber had herself used synthetic mesh at one time, Jones pointed out to the jury. Originally the type of tissue involved before mesh would be a strip harvested from a woman’s leg to suture to the vagina for support.
During her training in abdominal sacrocolpopexy, a surgical technique to repair pelvic organ prolapse, another faculty member had trained Dr. Weber in the use of mesh in the 1990s. She didn’t know what kind of mesh.
Jones Q: “Was there a risk at the time you were using it?
Q: At the time you were using it was there a risk for infection?
Q: “A possibility of fistula development?
At the end of the day, Slater tried to establish that Dr. Weber’s testimony was the first to reveal confidential information that only Ethicon previously knew. Defense objected and Judge Carol Higbee called it a day. #