Philadelphia Court of Common Pleas
Mesh Medical Device News Desk, **UPDATE September 24, 2018 ~ Lawyers for Susan McFarland rested their product liability case Monday, September 10th and the next day, Tracie Palmer (Kline Specter) delivered closing arguments.
TVT and TVT-O, surology.com
The jurors spent Wednesday, September 20th, Thursday and Friday deliberating. Instead of the not infrequent Friday verdict, jurors opted to return to the courtroom to continue deliberations Monday.
Mesh News Desk will deliver a verdict as soon as it is announced.
See McFarland coverage on MND here and here.
Among items the defense, Ethicon ( Johnson & Johnson) presented were:
Ethicon called Katrin Elbert as a live witness.
She was an Ethicon engineer and they called her an expert in the design process of the TVT-O. She was involved in the R&D process, but was not involved in the clinical component of the product development, such as performing clinical trials on the TVT-O.
Ethicon called Elizabeth Mueller as the general expert. She is a urogynecologist in the Chicago area.
Notably, she claimed that the IFU, Surgeon’s Monograph, and Professional Education material were adequate and accurate. She also opined she never reviewed those materials.
Dr. Mueller was brought in to be the Ethicon medical literature expert (saying the literature supports her opinion that the TVT-O is safe and effective). Also, she recently authored a mesh advocacy piece where she questioned the legitimacy of mesh lawsuits and advocated for the use of midurethral slings.
Mueller’s article appearing in the Journal of Urology in October 2017 and in it she says that 57.1% of pelvic mesh lawsuits involve the retropubic or the transobturator mid urethral sling.
"However, settlement amounts, which average around $40,000 per plaintiff, will continue to incentivize aggressive recruitment efforts by law firms.”
In that article, she did not disclose her conflict of interest with Ethicon.
You may recall Dr. Mueller who offered a deposition in the case of Huskey v Ethicon in 2014. She had examined Jo Huskey one time but didn’t remember her. In her deposition, she admits mesh left behind can cause residual pain here.
Elizabeth Mueller, Urogyn Medical Expert for Defense
As part of the Urinary Incontinence Treatment Network, a group of doctors put in 600 slings, including 300 TVT-O, as part of a randomized study of 597 women. She admitted in the deposition with the TVT, “there is more bladder perforations and with the TVT-O there is more groin pain postoperatively.”
She participated in something called the ToMUS trial into midurethral slings (MUS) which supported their use. More on ToMUS here.
Dr. Mueller considers a fascial sling a “salvage procedure after a synthetic sling.” She says it is easier to make the fascial sling the second procedure in case a woman can’t void after surgery, a mesh sling can be more easily released than a fascia. She also does not operate for chronic pain following a mesh procedure because she doesn’t believe it’s related to the mesh.
“It’s related to a musculoskeletal problem like a back problem or something else, because those are the things that continue for three or four days.”
ProPublica's Dollars for Doctors on Dr. Mueller here.
Robert M Rogers, MD
Ethicon called Robert M. Rogers is a urogynecologist from rural Montana who works as an Ethicon expert witness, and he worked as an Ethicon consultant for about 13-14 years. He was involved in the development of the TVT-O, including travelling to Belgium to do work on cadavers and training Ethicon sales people.
Dr. Rogers is a case-specific expert in over 25 cases and has always found that the mesh was not the cause of any injuries. He believes that Mrs. McFarland’s symptoms are from atrophy. He has made hundreds of thousands of dollars for his expert work for Ethicon over the last two years.
ProPublica's Dollars for Doctors on Dr. Rogers here.
Juries typically deliver verdicts on Friday just before the weekend.
MND, McFarland Pelvic Mesh Case, September 10, 2018
MND, McFarland v Ethicon makes TVT-O Design the Focus in Philadelphia of Pelvic Mesh Case, August 21,2018
MND, Ella E Remembers her Philadelphia Mesh Trial as McFarland Winds Down, September 14, 2018