January 17, 2013 ~ Thanks goes out to Courtroom View Network for access to the first Ethicon New Jersey mesh trial. A defective product case can include defective warnings, the focus of today’s testimony. The case is expected to continue for at least one month. There are close to 2,000 other plaintiffs in this jurisdiction who have filed similar actions against Ethicon, a Johnson & Johnson company. Last year the Prolift mesh was removed from the market.
On this Day 6 of the Linda Gross v Ethicon trial, Anne M. Weber MD took the stand all day. It was the job of plaintiff attorney Adam Slater to qualify her as a witness and that process alone took close to an hour. Weber, a urogynecologist helped define the subspecialty. Pelvic floor disorders previously were treated, if at all, by a general gynecologist at the time of a yearly exam.
Her resume was lengthy. Weber is not only a medical doctor but did a one year fellowship in advanced pelvic surgery at the Cleveland Clinic and was a resident in obstetrics and gynecology there. After receiving a Masters Degree in Clinical Research Design and Statistical Analysis, Dr. Weber helped solicit National Institutes of Health funding for the emerging specialty of urogynecology while at the McGee Womans Hospital in Pittsburgh.
Dr. Weber was in charge of anNIH initiative which led to clinical trials and much needed research, designing clinical studies and working with professional societies would give much needed answers about which procedures were working and which weren’t.
On cross examination, Ethicon attorney Christy Jones was more interested in what Weber had not accomplished establishing Dr. Weber had never implanted Prolift, had done no research with Prolift and had never seen an surgical operation for Prolift. She also has never attended any courses sponsored by Ethicon, had not been involved in a 510(k) medical device review, or device design safety assessment.
In fact, before the lawsuit, which she is now a medical consultant, she had never even read FDA regulations about medical devices.
To prepare for the case, Dr. Weber reviewed a half to one million pieces of documents and 700 medical articles relative to mesh issues. She produced 523 pages of research along with 10 supplemental reports.
Judge Carol Higbee agreed Dr. Weber should be qualified as an expert.
Reasonable Degree of Medical Probability
Plaintiff attorney Adam Slater of Mazie Slater Katz & Freeman asked witness Weber to answer all questions with a reasonable degree of medical probability. When asked why she review so many documents spending about 2,000 hours over three years.
“I felt in order to offer a reliable opinion to a reasonable degree of medical probability I had to fully understand the background leading up to the Prolift product and procedure. What Ethicon knew, what they were transmitting in terms of communicating with physicians and potential patients are opinions I have drawn.”
Collectively doctors would never have the sort of insider information about a product that the company had said Weber. Adverse events reports to the FDA database were rare and Ethicon sales reps would receive complication reports from the field that were not generally available to surgeons, even those using the Prolift.
Even a doctor who had time to keep up with all of the medical literature will not know what those at Ethicon would, Weber said.
“That’s no substitute for the collective body of information that Ethicon had. It was receiving these complaints on a regular basis and they needed to be translated for physicians and patients while the Prolift was being put in everyday,” she said.
Risk Benefit Ratio
Dr Weber had performed hundreds of anterior colporrhaphy pelvic repairs using the woman’s own tissues and sutures. It was a common procedure used for more than 100 years she said until synthetic transvaginal mesh came into the picture in the late 1990s.
In authoring an American College of Gynecologist Practice Bulletin as late as February 2007 Weber said it was impossible to draw a conclusion about the risk/benefit ratio of the product used in anterior colporrhaphy.
Slater reads: “… because of heterogeneticy of material studies, small sample sizes and short term follow-up it is not possible to draw definitive conclusions about the risk versus the benefit of absorbable or permanent synthetic materials in anterior colporrhaphy.”
“My opinion is the risks of the Prolift outweigh the benefits to such an extent it never should have been marketed,” she told the jury adding that neither Linda Gross or her surgeon Dr. Benson had any knowledge of the information Ethicon knew at the time of the Prolift launch in March 2005 and later during her surgery in July 2006.
In fact there is still so little information on Prolift women today remain in the dark.
“The fact of the matter is there is no safe time after Prolift has been implanted to tell a woman you are free from the risk of complications. She carries that risk of complications for the rest of her life.”
Instead Ethicon should have alerted hospitals and doctors what it know about synthetic mesh based on studies conducted by the TVM group in France and the U.S. and based on complication reports coming in.
Best of a Bad Lot
Slater showed the jury an email from Jonathan Meeks, a worldwide marketing director at Ethicon calling polypropylene, the petroleum-based synthetic mesh material the “best of a bad lot” in one email.
“Key point: PP is the best of a bad lot re integration, retraction and there is a need to develop grafts that mimic the human tissue mechanical properties.”
Dr. Weber says that shows that Ethicon knew before the product was launched that the Gynemesh PS used in the Prolift would cause an inordinate number of complications.
“The best of a bad lot is that what you’d like to have permanently implanted in your body? The best of a bad lot? I don’t think so,” said Dr. Weber on the stand.
Another damaging document came from the head of Medical Affairs David Robinson to Meeks. According to Dr. Weber, the doctors in France studying transvaginal mesh were telling Ethicon about the complications that would occur with the Prolift System two to three years before it was marketed in the U.S. Documents from earlier in the week indicated they sought a new replacement material.
Instead of stopping the scheduled launch of Prolift for March 2006, Robinson, in an email with Meek, discussed a proposed patient registry. While a registry can allow a company to gain immediate feedback on the likely success of a product as well as early problems, Robinson, on the same day as Linda Gross’ surgery asked about the “legal risk if someone captures data?”
The answer – “If none of our competitors are keeping registries we may be increasingly accurate with decreasing appeal.”
Dr. Weber took on a professorial role when she showed slides using a pointer in the afternoon playing an Ethicon training video. The imprecise nature of the instructions to surgeons (2 to 3 fingers, 2 to 3 cm), a visual of the insertion device being jammed into the woman’s pelvis to pass the bone in a blind procedure, was graphic.
She described mesh erosion and complications to the jury. After a mesh implant as the healing occurs, the tissue scrunches down on the mesh, she said. Once the tissue connects to itself it forms fibrosis or scar plate. It’s this scar plate that can interfere in every bodily function, urination, defecation, intercourse. And Dr. Weber said it doesn’t stop. The presence of the mesh fosters an inflammatory reaction that makes the fibrosis keep going.
Those who experience a chronic pain condition may be susceptible to the insult of chronic inflammatory reaction the mesh incites releasing chemicals through the body in a system already sensitized, she theorizes.
Removing the mesh and its arms are dangerously close to major blood vessels and deeper in the internal pelvis, the pudendal nerve, sacrospinous ligament as well as veins.
“If it’s too dangerous to remove it why isn’t it too dangerous to put it in? she asked the jury.
Patient Brochure- Are They True?
Dr. Weber exhibited patient brochures with promises, “Be informed make your best decision.”
The brochure was notable for what it did not say she told jurors.
Dr. Weber prepared a list of 26 items that she believed patients received no warning about in the Prolift brochure. There was no reference to dyspareunia, painful sex. It didn’t mention erosion or repeated surgeries. It was impossible to predict who would have a chronic inflammatory reaction. Even the Instructions for Use (IFU) made no mention that a woman with complications may have to self-catheterize for the rest of her life to urinate, as does Linda Gross.
Is Gynecare Prolift right for me? The brochure asked… The answer “appropriate for almost all patients.”
“ Performance Animal studies show that implantation of Gynemesh ps mesh elicits a minimum to slight inflammatory reaction that is transient..”
“Remains soft and pliable, chronic inflammatory reaction may be severe, mesh does not remain soft and pliable after implantation.
In hernia repair a surgeon will intentionally leave 5 cm on each side of the hernia to account for the amount of mesh contraction and still leave the hernia covered. Showing a graphic she told jurors that is not possible in the pelvis even though mesh there could shrink 20 to 50%.
Dr. Weber said the information is not fair and balanced giving enough adequate information for a patient to make an informed decision balancing risk and benefit. Even Dr. Benson, Linda Gross’ surgeon did not have access to Ethicon’s proprietary information, and he was a trainer for the company.
Representing a major mind shift, the Prolift was different from all previous meshes. It came pre-cut in a box, with cannulas and a retrieval device. It had never been tested on a patient population and its safety and efficacy had never been demonstrated in randomized controlled clinical trials.
Should it be used at all? Dr. Weber said, if Prolift mesh is used at all it should be a “very restricted population, certainly not for all patients.”
Ultimately the law states it is the physician who is the “learned intermediary” whose job it is to inform the patient, but it is the patient who may suffer permanently said Weber.
“Adverse events from TVM studies were not only alarming they were horrifying. The number of adverse events that Ethicon ignored did not change their decision about launch. They kept marketing the Prolift. There is no long term data. This is a permanent implant, designed to be in a woman’s body for her life. Who knows what’s going to happen, nobody.
“Who will find out? The women who had it implanted!”