DAY THREE: The Father of the Pinnacle Mesh Kit
Mesh News Desk thanks the many donors and Herman Gerel Law and Saunders & Walker for their contributions to this coverage!
Dr. Dennis Miller is a Wisconsin based medical doctor. While he has extensive training as a urogynecologist, Dr. Miller also has another role – he works extensively with medical device manufacturers and is the inventor of the Pinnacle Pelvic mesh kit, made by Boston Scientific (BSC) which is the subject of a defective product litigation in a Miami federal courtroom.
Four women claim the Pinnacle, the largest mesh kit used to treat pelvic organ prolapse, caused complications including “erosion, mesh contraction, infection, fistula inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain.” Pretrial Order #91.
The plaintiffs allege negligence, design defect, manufacturing defect, failure to warn, breach of express warranty, breach of implied warranty, and punitive damages.” [Document #246].
Judge Joseph Goodwin oversees 66-thousand of product liability cases over mesh made by seven manufacturers. His Charleston, WV courtroom is the scene of another Boston Scientific trial over the Obtryx mid-urethral sling as this Miami case is underway.
Dr. Miller appeared via videotape before the nine jurors chosen for this trial, five men and four women. Most appear to be paying attention with the possible exception of a blonde woman who sits in a slouched position and looks disinterested.
Dr. Miller said he actually developed the delivery system for the mesh that would be called the Pinnacle. He brought the idea of using the Polyform mesh (a sheet of Marlex) and combine it with the Capio, a small hooked device with better access deep into the pelvis to more effectively affix the prolapsing organs. Using the Capio, one could avoid passing trocars or long needles through the pelvic space in a blind procedure.
“In medicine less is more and you want to move forward with less complexity,” he said on videotape.
Miller approached the company in August of 2005 and the idea went into production. The Pinnacle was ready to launch in January of 2008.
Since then, Dr. Miller said he’s implanted 250 to 300 Pinnacle kits with “really good outcomes and satisfied patients by large.” He clams to still use polypropylene and implants as much as most surgeons in this country.
For his work and eventual patent of the Pinnacle, Dr. Miller would receive quarterly wire transfers into his bank account. Pinnacle made him a millionaire. Miller would be paid $2.97 million for his invention which doesn’t include the $375 an hour he would be paid to consult with BSC and work with doctors in gearing up marketing for Pinnacle.
In providing his bio, Dr. Miller said there were no doctors in his family. “We had all salesmen in our family, no doctors.’
Despite the fact that polypropylene was subject to shrinkage and degradation, there were no clinical trials on humans before the Pinnacle was marketed. “That’s correct,” said Dr. Miller.
To “keep things moving,” Dr. Miller would be joined by Drs. Nager, Rovner, Goldman and Tulikangas in forming a task force to craft a statement paper by the American Urogynecologic Society (AUGS) on mid-urethral slings (here).
Miller admitted he had no experience with using the transvaginal tape-obturator. His personal favorite slings were the Advantage and the Ethicon TVT.
“That’s why it’s important to have five draftees and to work with a large organization,” he said.
And what about complications?
Miller says when he removes mesh he has not seen mesh degrading. When pulling on it, it does not come apart. “We do not see clinical degradation of the mesh.”
Peggy Pence appeared on the stand in the afternoon. Seen in the Linda Gross trial, Pence, a PhD is a consultant to the medical device and pharmaceutical industry helping companies develop their products for market. She as worked for 80 companies in her 40 year career. Dr. Pence advises companies on what sort of testing they will need to prove a product is safe and effective before its marketed.
Bench testing of a product and biologic compatibility- is that enough to test an implanted medical device? No said Pence, even animal studies alone would not be enough. Randomized controlled clinical trials in humans must be conducted to assure safety and efficacy.
Reminded of the ProteGen failure, Dr. Pence agreed the BSC had conducted an internal evaluation that resulted in the realization they needed to do clinical testing before marketing a new product.
Did they do that?, asked plaintiffs’ attorney Shelly Hutson.
“Objection,” shouted Molly Craig for BSC.
Overruled, said Judge Goodwin.
“No they did not,” said Pence.
On cross examination, Matthew Keenan, an attorney for BSC brought up the money issue – how much had she made in consulting for the plaintiffs’ attorneys in this litigation and in other cases?
Pence has appeared in at least three other cases as an expert including the Linda Gross trial in New Jersey last year.
“Your rate is $500 an hour?”
“That’s what my company charges,” she said.
Working with a display board, he added up the numbers. About $825-thousand in fees he figured she’d been paid as an expert in mesh litigation.
Dr. Pence was unapologetic. She said that was compensation for her time which has involved about 500 hours.
Dr. Konstantin Walmsley,a urogynecologist from New York City appeared on the stand in the afternoon… … more as our coverage continues. Thursday brings Dr. M. Tom Margolis to the stand for the plaintiffs via videotape!! Stay tuned!