The first Cisson trial, which began July 8, ended in a mistrial two days later.
Drugwatch reports on the second day of testimony in the trial which began July 29. See the story here.
Lawyers for Donna Cisson, 55, say her Bard Avaulta Plus Posterior BioSynthetic Support System is defective in its manufacture, design and in a failure to warn doctors who are considered the end users. Defendant C.R. Bard and its division Bard Urological designed marketed packaged labeled and sold the product which is made in Covington, Georgia and Bard’s principal place of business is New Jersey.
The Honorable Judge Joseph R. Goodwin is overseeing this, the first of more than 4,000 cases consolidated in the Charleston, West Virginia federal court naming C.R. Bard and its mesh products.
On the stand Tuesday was Dr. Brian Raybon, Cisson’s implanting surgeon. She received the mesh May 8, 2009 in Toccoa, Georgia at Stephens County Hospital. Cisson suffered from pelvic organ prolapse, specifically a rectocele.
MDND covered the initial trial of Cisson v. Bard before it ended in a mistrial July 10. See background story here. Just as in the first at the trial, Dr. Raybon was qualified as an expert in women’s urogynecology.
Dr. Raybon testified he should have been told by defendant C.R. Bard that the polypropylene material used to make petroleum-based plastic mesh should never be implanted in humans. He was particularly adamant because he was a consultant for the company and a “preceptor,”a doctor trained to teach other doctors on the use of a particular medical device.
He is credited as the first surgeon to implant the Avaulta mesh in the U.S.
Drugwatch quotes Dr. Raybon “I liked it,” “I felt like it was a good system at the time, and I thought it was appropriate for Mrs. Cisson.”
The doctor told the 8 jurors after patients began experiencing complications he discovered the mesh resin was not intended to be used in medical devices implanted in humans.
“How could (Bard) use it with that (warning)? “That’s the part that really concerns me about this. I was astounded when I saw (the warning).”
Lori Cohen, an attorney for Bard asked Dr. Raybon why he didn’t ask Bard about the warning once he was alerted to it. Drugwatch says that’s when Dr. Raybon became visibly agitated.
“As someone who spent four or five years at Bard teaching other physicians (about Bard products), and there’s this MSDS sheet around, I’m really concerned I’ve put something in these patients that shouldn’t have been put in. I’m sorry … it was a little irritating to work with someone four or five years, and they didn’t tell me.”
MSDS is a Material Safety Data Sheet that was uncovered in the discover process pre-trial. Executives for Bard knew the resin they were using was not intended for medical implants and discuss not revealing that to the source of the raw material, Chevron Phillips.
Just as in the first trial, Dr. Lennox Hoyte was also called to the stand on behalf of Ms. Cisson.
The professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, used 3 –D model he develop to explain to the jury how a mesh is placed.
The doctor said increasingly he is explanting mesh procedures gone wrong, about 400 so far with approximately 100 of them involving the Bard Avaulta products.
Dr. Hoyte says the mesh arms are the problem and most difficult to remove because they are anchored deep within a woman’s pelvis in muscle, tissues and frequently in or near nerves.
“Armed transvaginial mesh is a bad idea. It never made sense to me, I always had a feeling the mesh would shrink and cause pain to patients.”
The Bard Avaulta Plus was taken off the market last year by the company. It was that revelation by Dr. Hoyte during the first trial that resulted in the mistrial. Both the defense and plaintiffs had filed motions asking to limit testimony about the U.S. Food and Drug Administration or its 510(k) process that allows mesh on the market with no clinical trials. Judge Goodwin agreed.
When the FDA announced in January 2012 that it was ordering 33 mesh makers to post-approval monitoring of transvaginal and incontinence mesh, (see story here) both Bard and Ethicon (J&J) removed their mesh kits from the market. Mesh kits are thought to be largely responsible for the five-fold jump in complications the FDA noted in 2011 before issuing its stern warning about the use of mesh.
Bard manufacturers Avaulta synthetic surgical mesh, Avaulta BioSynthetic, Avaulta Plus and Avaulta Solo, as well as pelvic repair meshes, including PelviSoft, PelviLace, Pelvitex, Uretex, Align, Acellular Collagen Matrix, Faslata Allograft and Pelvicol.
As of July 15 there were 4,135 cases filed against just Bard in this multidistrict litigation. The Cisson trial is expected to take 12 days.
Motions in Limine
So. District of West Virginia
Drugwatch report, July 31, 2013
See Documents in the case: Motions in Limine Docket #302
July 10 Mistrial declared, Mesh Medical Device News Desk
Opening Arguments in Bard Case July 9, Mesh Medical Device News Desk