Mesh Medical Device News Desk, April 9, 2018 ~ The final days of the Mary McGinnis defective transvaginal mesh trial in New Jersey brought out the experts for the defense.
Their contention is that McGinnis was not harmed by the Avaulta and Align transvaginal meshes implanted to treat incontinence and prolapse.
Instead, attorneys for defendant, C.R. Bard say that McGinnis ‘ injuries were preexisting.
Adam Slater of Mazie Slater Katz & Freeman represents Mary McGinnis.
The plaintiff contends that physicians (end users of the devices) did not receive adequate warnings about the dangers, that the meshes are defective and that manufacturer, C.R. Bard of Murray Hill, New Jersey, did little research before launching them into the marketplace.
McGinnis says she suffers from pain and nerve damage. She feels the mesh scar tissue and mesh implant shrinkage through her back legs, arms, neck and groin.
She has undergone a removal surgery by Dr. Shlomo Raz of UCLA who reported that the arms of Align and Avaulta had fused together into a polypropylene plastic mass that was cemented into her pubic bone.
The lead defense attorney is Lori Cohen of Greenberg Traurig, who contends Ms. McGinnis suffers from osteoarthritis of her hips and spine and that causes her pain, not her implants.
On April 5, Dr. Peter Rosenblatt was called to testify. Dr. Rosenblatt has had a long term relationship with Boston Scientific, a competitor to CR Bard and ran its cadaver implant clinic.
Mesh New Desk has also reported he fronted the booth at the 2016 AUGS conference for Boston Scientific.
Slater asked Rosenblatt about an opinion the doctor authored in 2007 that said, “It is possible the use of synthetic mesh will become more common. Limited data is available supporting the use of synthetic mesh for the repair of pelvic organ prolapse (sagging bladder).”
Defense argues there was adequate background clinical studies done of Avaulta and Align mesh implants before McGinnis was implanted in 2009.
So which was it, Slater asked Rosenblatt.
Slater: “Was there plenty (data) or limited?”
Rosenblatt: “We used the word limited.”
Slater: “Do you think plenty and limited are the same thing?
Rosenblatt: “I won’t quibble over semantics. There are lots of (prolapse) articles. Doctors always want more data.”
Dr. Rosenblatt also said the Instructions for Use (IFU) were complete.
Slater played a video clip of implanting physician Dr. Elizabeth Barbee who told jurors “I don’t think it’s a complete (instructions) list.”
Rosenblatt also echoed that the mesh does not shrink and the Avaulta did not cause McGinnis any harm.
Dr. Michael Kennelly, a urologist, was another star witness for the defendant.
On April 3, Slater challenged him about his professional experience. Kennelly testified he had experience with the Avaulta and Align made by Bard but only implanted the Avaulta in cadavers, not live patients.
“You never looked at a woman across the table, a woman with prolapse and said, ‘I think the best option for you is the Avaulta,” Slater said. “I have not place the Avaulta in a (live) patient,” said Kennelly.
When further questioned whether mesh in a live body can contract, change shape, distort, cause pain and tissue inflammation Kennelly said, “I do not believe mesh contracts.”
(Editors Note* This is a oft heard semantic discussion. Mesh itself without a surrounding body may not on its own contract, but when tissue is inflamed and responding to a foreign body, these product liability trials have shown mesh shrinkage has been found to be as high as 50%.)
The conversation continued according to LegalNewsLine which has access to a Courtroom View Network feed, Slater said.
Slater: “The scar tissue when it contracts, contracts the mesh down with it…you agree?”
Kennelly: “The mesh does not contract,” …It will conform to the surrounding environment.”
Slater: “Which means the mesh will be deformed and have less of an area, correct?”
Kennelly “If outside forces put pressure on it.”
Lori Cohen also pointed out the implant procedure led to an accidental perforation in the pelvic tissue.
Known as “buttonholing” Cohen contends it led to erosion at the surgical site and further harmed Ms. McGinnis.
Buttonholing is the injury to the vaginal wall during an implant by the trocar passage, or steel surgical too.
On the stand, Kennelly criticized the implanting doctor, Dr. Elizabeth Barbee and the buttonholing that resulted from the surgical implantation.
Judge James DeLuca cautioned the witness not to use the word “error” because Dr. Barbee is not the defendant. In doing so, he knowingly takes some blame away from the manufacturer.
Kennelly admitted the buttonholing issue, “did cause or contributed to erosion of the vaginal wall.”
He calls McGinnis a “nerve-type pain,” that did not relate to the Avaulta device.
Slater reminded Kennelly that Dr. Barbee, a North Carolina gynecologist, said she would have not chosen an Avaulta if she had known all of the complications.
“That’s what she stated,” Kennelly said.
Kennelly echoed the defense contention that Ms. McGinnis has back and spine issues that have progressed over time.
LegalNewsLine reports that Dr. Kennelly produced a training video and program for C.R. Bard that taught implanting physician Barbee about the Avaulta and Align implant. She reportedly attended three times.
In the industry, Kennelly would be known as a preceptor or trainer/ consultant for industry.
C.R. Bard removed its Avaulta pelvic organ prolapse from the market in 2012. Align was taken from the market in 2016.
McGinnis v C.R. Bard is case No. L01754314 being heard in Bergen County state court, New Jersey Superior Court, before Judge James DeLuca. It began March 19th. ###
ProPublica Dollars for Doctors, Look up your physicians’ relationship with industry.
Kennelly, a urologist from Charlotte, NC, reports he received 318 payments from 16 companies totaling $242,704 in 2015. Rosenblatt, an OB-Gyn from Cambridge, Mass. is listed as receiving $65,000 in 2015.
MND, May 10, 2017, Appeals Court Backs BSC Win in NC Pelvic Mesh Lawsuit
Dr. Kennelly was the physician for Martha Carlson who lost her pelvic mesh trial before a Statesville, North Carolina Jury in October 2015. He had told jurors any warnings from Boston Scientific were inadequate.
MND, June 3, 2014, A Serious Concern as Doctors Divide (featuring Kennelly)
MND, March 13, 2018, McGinnis Mesh Trial to Start Monday
MND, March 21, 2018, What We Know from Past TVM Trials