Mesh Medical Device News Desk, October 12, 2016 ~ There was much anticipation about the Thursday afternoon Mesh on Trial: Defendant and Plaintiff Perspectives at the 37th annual meeting of AUGS, the American Urogynecologic Society.
This would be the first time the 1,300 urogynecologists, urologists and gynecologists would be presented with a full explanation of the issues involved in pelvic mesh litigation. An attorney representing mesh manufacturers would explain industry’s defense of allegations of a defective product, while a plaintiffs’ attorney would reveal what industry knew before it marketed its pelvic mesh products, and when it knew it.
There had been some discussion in previous day sessions about the late night television ads soliciting pelvic mesh clients, and most doctors thought bottom-feeding trial attorneys and their legal referral services had ended up hurting patients.
Doctors believed that because of litigation, there were now fewer options on the table to correct incontinence (SUI) and pelvic organ prolapse (POP).
After pelvic mesh makers had suffered the majority of losses at trial, Prolift (made by J&J), Pinnacle (by Boston Scientific), and a host of other meshes were all taken off the market. The Food and Drug Administration now required a review of all POP mesh outcomes and a reclassification of the larger mesh kits for POP as either high risk or class III. The “business decision” to take many meshes off the market made sense to mesh makers.
None of these doctors had presumably ever sat in a trial, and from the previous day’s session, Current Status (See story here), those present did not seem to be aware of even the basics of mesh litigation, certainly not in its scope and in the fact that the 100,000 women who have filed defective product actions in this country still suffer life-altering injuries to varying degrees. Some will never be the same.
Instead, some of the doctors who sat in the Current Status session indicated women were seeking a “payday.”
So Mesh on Trial would be an eye opener. It was scheduled for the biggest space, Exhibit Hall A, that could seat nearly all of those in attendance.
The moderator was scheduled to be Pam Moalli, MD PhD, of the University of Pittsburgh; panel members included Miles Murphy, MD MSPH (and expert witness at the Linda Gross trial for defendant, J&J); Donald Ostergard, MD, who founded AUGS; Janna Nugent, a defense attorney with Greenberg Traurig (Lori Cohen’s law firm); Derek Potts, plaintiff’s attorney, and urogynecologist Dennis Miller, MD.
Just before the scheduled 4 pm start, a crowd gravitated toward the Hall A. Then I got a text message from a doctor in attendance:
“They just cancelled the mesh debate.”
“Why?” I asked.
The reason I was given was that it was “a legal issue of exposure for the society.”
An AUGS representative explained some slides for the presentation weren’t ready in time. But attorney Derek Potts said that was not true. They asked for the slides to be in at 10 am. He made sure they were in by 10 am.
“Fear got to them. They wanted to review the presentation and they didn’t like what they saw,” Potts said. His comments on suicides and divorces that followed mesh implants were too much, Potts said. See the comment here.
“It’s the truth. The sad fact is the leadership is in bed with manufacturers and they are trying to protect them. They saw the debate as a threat,” Potts explained.
Given that the exhibit hall was full of banners and booths from Medtronic, Allergan, Boston Scientific, Caldera Medical, Ethicon, Coloplast, Astellas, CooperSurgical, among others, and that more than half of the revenue supporting this conference came from industry, according to the AUGS president, Potts likely wasn’t far off.
So as it turns out, our session the previous evening on Current Status and Future Potential for the Use of Mesh was as close as the participants would come to a debate by this medical society.
Unfortunately the 20 or so in the room for Current Status were the only ones to gain some understanding of the issues.
Within an hour, the buzz was making it around the conference exhibit hall as to why this session was cancelled. Some claimed that Attorney Potts was out of control the night before and had thrown out incendiary statements like women’s husbands had divorced them and women were committing suicide.
“Okay. And what if that is true,” I asked one doctor. “There have been divorces and suicides,” I offered.
“Then you’re biased! People like you are biased,” he said in an accusatory tone.
People like you, I repeated to myself. What does that mean? Even though I had introduced myself to this doctor, he clearly didn’t know who I was or that I write about the patient perspective of mesh injuries. I had spent my own money to attend AUGS to learn what doctors in the field are experiencing first hand.
Since I was an eyewitness to yesterday’s session, I suggested that Dr. Cassidenti was the only one in the room for Current Status who raised his voice and seemed agitated, like he was ready to cross two rows of chairs to get at Mr. Potts.
No. The doctor insisted it was Potts who was out of control.
The demonizing of Derek Potts was easy to do because there were so few there to experience the session first hand.
And that would be the buzz created as an explanation for the Mesh Debate cancellation, and presumably believed.
While Mr. Potts kept a low key response to critics at the last session, and did not engage or raise his voice, my only criticism was his suit was too nice. With a sharp blue tie, he looked like he was about to launch into an opening before a jury.
The crowd at AUGS was generally more casually clad, like a college professor, unless you were a preceptor.
Preceptors wore nice suits and looked like the leaders of the conference.
In fact, the early adopters, the technology trendsetters, were just that. They were the doctors who had gravitated toward the manufacturers early on, the “early adopters” who bought the promises of a “minimally invasive procedure” that would improve their options for their patients and their practice in the treatment of incontinence and pelvic organ prolapse.
And you could teach other doctors, hold clinics and travel to nice places to do so, all for compensation.
What is a preceptor?
In a university setting, a preceptor assists the professor and teaching assistant to design and impart certain lessons.
In the medical device world, a preceptor is one who teaches other doctors about a particular device in a weekend cadaver clinic, through industry-supported training and/or as a consultant with a device manufacturer.
AUGS was full of preceptors. In fact, some of the key opinion leaders (KOL), as industry designates them, were there. KOLs and preceptors are considered an integral part of introducing a device to market and very valuable cheerleaders for a company.
On the flip side, preceptors and the conflicts of interest they represent, have become a red flag issue for juries, who tend to side with an injured plaintiff when they learn of the millions of dollars doctors are paid to carry the water for a company.
Some preceptors have had to endure long hours of depositions at the hands of plaintiff’s attorneys. As an example, see the deposition of Dennis Miller here.
Society KOLs had created the A Time to Rethink position statement after the FDA issued its two warnings about the risk versus the benefit of pelvic mesh.
Many preceptors at AUGS are also the same names you’ve heard at pelvic mesh trials.
Dr. Vincent Lucente, MD was the $1.7 million preceptor for Ethicon (Johnson & Johnson), mentioned in the Linda Gross trial and Joan Budke case against J&J. Dr. Lucente trained Mrs. Budke’s implanting physician, who placed a Prolift mesh in Mrs. Budke, who later died of a raging infection. (See the stories here and here).
The case settled for an undisclosed amount on the eve of going to the jury after Mr. Budke, a stoic, 93-year-old widower cried, “I lost my bride.”
Dr. Lucente was front and center at AUGS, delivering Industry Expert opinion for Allergan, the maker of Botox®, which now makes a nasal spray for nocturia, or nighttime urination; for American Medical Systems; Coloplast and Medtronic.
Dr. Lucente and Dr. Andrew Cassidenti, a preceptor for AMS, see the story here, presented for Boston Scientific to promote the transition from the Elevate (AMS) to Uphold by Boston Scientific, when AMS folded its mesh-making division in March.
Kevin Benson, MD was there too.
The South Dakotan was the implanting surgeon for Linda Gross, who was awarded $11.1 million before a New Jersey jury and who has undergone in excess of 20 surgeries to remove and correct what was left behind by her Prolift implant. (See a story here).
In its Conflict of Interest Policy, AUGS requires disclosures about corporate sponsorship deemed relevant by the Program Committee, and doctors list their consulting arrangements, often without specifying their fees.
These would be some of the names juries have heard at trial, but the 1,300 physicians who attended this AUGS 37th annual conference would never hear them in that context at the Denver Convention Center. ###
Up Next~ The AUGS Presidential Address