Dr. Shlomo Raz, UCLA Urologist
Mesh Medical Device News Desk, March 31, 2018 ~ As the second week of the latest C.R. Bard transvaginal mesh wraps up in New Jersey, jurors appear to be impressed with the North Carolina plaintiff and her husband.
Mary McGinnis testified Thursday in the second week of her product liability transvaginal mesh trial being held in Bergen Co. New Jersey. She is represented by Adam Slater of Mazie, Slater, Katz & Freeman.
McGinnis, 62, was implanted with two meshes made by C.R. Bard, a Murray Hill, New Jersey company. The two polypropylene implants – Avaulta and Align - were used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Avaulta is intended to treat stage 3 or 4 POP. McGinnis is reported to have had stage 2.
McGinnis claims she lives in chronic pain from the implants and pudendal neuralgia nerve damage and that Bard failed to warn the doctors who implant them in patients. Defense claims Ms. McGinnis had preexisting conditions that cause her pelvic pain.
Bard Avaulta mesh
On Thursday, McGinnis took the stand.
She carefully explained to the jury about the childcare business she runs out of her North Carolina home. The eight-person jury listened to her description of the advanced, nurturing environment she tries to create for the children she cares for.
More of her personality unfolded as she described her relationship with her husband, Tom. She and Tom have been together since they were 15-years-old.
Tom testified Wednesday about what his wife is going through and their relationship today. In order to sleep, Mary has to have an ice pack to stop the burning that accompanies her nerve pain.
The five men and three women who make up the jury, reportedly seemed moved by the testimony.
PELVIC MESH LITERATURE ON SAFETY
Dr. Anne Weber, from Linda Gross trial
On Monday, March 26, and Tuesday, March 27, plaintiff expert witness, Dr. Anne Weber, MD, a urogynecologist, who appeared at the Budke trial in Missouri and the Gross trial in New Jersey, provided an overview of key literature available before Bard sold the products.
All of the authors she cited said there was not enough data to support the safety of the transvaginal mesh implants.
A clinical evaluation report, prepared to sell a device oversees, showed articles cited for mesh use that didn't support safety, such as literature by Drs. Michel Cosson, Daniel Altman, and the French TVM group. The meshes in this trial are intended for prolapse stage 3 or 4. Mary had stage 2.
You may recall, Dr. Weber called out the ACOG practice bulletin after it eliminated the word “experimental” in the description of the use of pelvic mesh implants, clearing the way for insurance coverage.
DR. SHLOMO RAZ
Dr. S. Rax, UCLA Urology
Back to the Bergen Co. courtroom, a video of Dr. Shlomo Raz was played Wednesday. He testified the polypropylene meshes are very dangerous and he's never used a transobturator mesh with trocars. Instead, Dr. Raz used to cut his own mesh into strips from polypropylene mesh sheets. He stopped using mesh when he saw repeated long-term complications.
Dr. Raz did a groin removal of Mary's meshes. The arms of the Align and Avaulta had fused together into a mass that was cemented into her pubic bone.
The world-famous mesh removal doctor reportedly got them out.
He said most doctors won’t use the products anymore because of long-term complications.
On cross-examination, an orthopedist called by the plaintiff, Dr. Samuel Snyder, countered the defense argument that McGinnis' injury is due to arthritis.
Lori Cohen, attorney for C.R. Bard
Lori Cohen, a defense attorney with Greenberg Traurig, also said McGinnis refused to go for treatment to an orthopedist. However, it was revealed that the appointments were to treat a rotator cuff injury and tendonitis in McGinnis' shoulder!
Roger Darois, VP Bard
(Mesh News Desk has reported on Darois and his insistence that a third party company, Red Oaks, purchase raw polypropylene resin from the petroleum supplier Phillips Sumika for Bard, because Philips stated it didn’t want its resin to be used for implantable medical devices).
Dr. Elizabeth Barbee
Implanting doctor, gynecologist, Dr. Elizabeth Barbee of Raleigh, North Carolina told jurors if she knew what Bard knew she would not have used the devices.
Under cross-examination from Lori Cohen, Barbee testified the device had not rolled or curled during the implant procedure. Dr. Barbee admitted there are risks associated with any surgery and that such mesh devices were referred to as the "gold standard" for POP and SUI in 2009.
Dr. Barbee was the implanting doctor in the Queen case, heard in Charleston, West Virginia in August 2013. Ms. Queen also received a Bard Avaulta. The case ended with an undisclosed settlement.
FIRST DAY OF TRIAL
According to Legal Newsline, on the opening day of trial, Slater told the jury the chemicals in the polypropylene devices caused vaginal tissue to become inflamed causing the body to attack the foreign invader.
Adam Slater in Gross trial 2013, Courtesy CVN
“The body reacts to it,” Slater said. “Cells attack the foreign invader. Scar tissue forms and the reaction is permanent.”
The plaintiffs wrapped up their case Thursday.
Bard Align and Adjust
What’s’ not allowed to be mentioned in this trial is that both Bard meshes, the Avaulta and Align, are off the market.
The jury will decide, perhaps as early as next week, whether each mesh was defectively designed and whether Dr. Barbee was adequately warned in order to be able to warn her patients.
Expect the defense case to pick up on Monday.
McGinnis v C.R. Bard is case No. L01754314 being heard in Bergen County state court, New Jersey Superior Court, before Judge James DeLuca. ###
MND, August 18, 2013, Queen Trial Day one
MND, March 21, 2018, McGinnis v C.E. Bard- What We Know form Past TVM Trials
MND, April 7, 2016, Dr. Raz Tells Docs Why He Will Not use Synthetic Mesh Slings!
MND, Bard Execs Sell off Stock. February 22, 2015
MND, January 13, 2015, Urogynecologist Credibility Under Attack in Missouri Pelvic Mesh Death Trial,
MND December 10, 2015, Witnesses in Philadelphia Mesh Trial Tell Tale of Prolift Mesh Marketing