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Prolene mesh
DAY ONE CONTINUES ~Afternoon Session~
Information contained in a missing box of Johnson & Johnson (J&J) documents, thought to have been destroyed, led the afternoon session in this opening day of Huskey v. Ethicon, a defective product trial that puts Johnson & Johnson and its controversial transvaginal mesh products on the global spotlight.
The case number is 2:12-cv-05201.
This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.
J&J has acknowledged it lost or destroyed hundreds of thousands of pages of documents that were under a litigation hold in preparation for the thousands of product liability cases involving injuries from pelvic mesh. (See background story on Mesh News Desk here). But since the Carolyn Lewis case, heard in this federal court last April, a missing box of documents was produced by defendant J&J.
The box was significant because it contained some of the special added ingredients that make J&J’s polypropylene (PP) mesh (Prolene) different from other polypropylene meshes made by competitors C.R. Bard and Boston Scientific, among others. No details were offered on how this box of documents previously requested in discovery was produced or where it had been.
Scott Guelcher Ph.D
Experts for the Plaintiff
Scott Guelcher Ph.D. a biomaterials expert from Vanderbilt Univeristy (Assistant Professor of Chemical and Biomolecular Engineering, Chemical & Biomolecular Engineering, with a research focus on polymer science and engineering, biomaterials.) See more here.
Dr. Guelcher told the jury he does not believe the antioxidant and lubricant additives - Sandonox R (an antioxidant), calcium stearate (a lubricant) and the chemical additive (antioxidant) DLTPD - serve to stabilize the pelvic mesh. Instead, cells secrete reactive oxygen which starts the chemical and physical breakdown of the mesh making it brittle and causing it to crack. Dr. Guelcher said the foreign body response to mesh begins three days after it is implanted and does not stop, ever. Chronic inflammatory response is a foreign body reaction, according to the PhD.
“It’s best to minimize the polypropylene in the mesh,” he concludes.
“Are you anti polypropylene?” asked attorney Ed Wallace. “No” said Dr. Guelcher, “I’m not against the option to use polypropylene in the body.”
Dave Thomas, attorney J&J
On cross examination, Dave Thomas for J&J (Thomas Combs and Spann (here) made sure jurors understood that the raw polypropylene material comes from Sunoco but is processed in nearby Kenova, WV plant (here), one of the largest in the world that makes polypropylene. Hasn't J&J overseen quality for decades, Thomas asked during his cross examination.
“Do you know how many prolene sutures have been implanted?” Thomas asks the witness. Answering himself, Thomas said “billions” and the witness acknowledged that could be true. Prior to this litigation you never studies polypropylene did you, Thomas asked. His was an aggressive and confrontational style.
Not true, said the professor who tried to explain further. His professorial style clashed with Thomas who wanted short responsive answers and a judge who was willing to accommodate. Judge Goodwin did allow the expert to say he had developed a course on polymer science at Vanderbilt University.
He never examined the explanted mesh from Mrs. Huskey. No one has because it was never preserved.
Dr. Brigetta Helhammer appeared in the afternoon via videotaped deposition. Now retired, the MD worked in R&D for Ethicon in the later 1990’s she would write literature reviews for the company and was a project leader over the Ethicon project “TVT Star.”
Its mission was to come up with new ideas for pelvic floor prolapse treatments. Gynemesh Vycro was developed during time using a lighter weight and large pore mesh. Prolene mesh worked well with no problems and by 1999-2000 a decision was made by the company not to change the TVT product line based, in part, on the Scandinavian studies done by Dr. Ulf Ulmsten, credited with inventing the TVT (transvaginal tape). Ulmsten also profited royally by selling his patent for TVT to J&J, a fact revealed in the Lewis case.
Bruce Rosenzweig MD
At the end of the day, Dr. Bruce Rosenzweig was called as an expert witness for Mrs. Huskey. In his Chicago practice he explants mesh and has removed about 250, 40 to 50 of them Ethicon slings. He told jurors only about 10 percent of stress urinary incontinence is severe, which he describes as leaking more than once a day. Though he has used PP mesh in the past, today the doctor does the Burch Procedure which involves stitching up the neck of the bladder to treat incontinence. He says there is no difference in success rates among the Burch, fascia slings and mid-urethral PP slings.
Attorney Jeff Kuntz (Wagstaff Cartmell) established how much the doctor has been paid $5,000 a day for testimony and at least $60,000 to review documents. That rate is calculated by determining the days the doctor is away from his practice. It is customary of both sides to raise the question of compensation for expert witnesses to raise questions about their credibility. #
Learn More:
Mesh News Desk, December 8, 2013 ~ What Was Lost in J&J Purge of Documents?
https://www.meshmedicaldevicenewsdesk.com/featured-articles/lost-jj-purge-ethicon-documents/
Santonox R
http://www.chemcas.com/msds112/cas/816/96-69-5.asp
The Rheumatologist on Adjuvants June 2011
Lewis Case 2:12-cv-04301 Doc# 248-2, filed 2/05/14 pg 5 of 39, Mentions Spin Finish in mesh using Santonox-R & DLTDP as anti-oxidates identified in Mesh by Jordi Labs.
