C.R. Bard Transvaginal Mesh Case Week 2 – Bard Avaulta Never Studied in Humans
As the trial of Donna Cisson v. C.R. Bard moves into its second week, Mesh Medical Device News Desk (MDND) is exploring the documents filed in the case so far. MDND readers can help dig deeper by reading the multi-page depositions which appears throughout the story.
The Donna Cisson trial began July 29 after a mistrial was declared July 10, three days after its start.
Donna Cisson, 55, was implanted with a polypropylene (PP) mesh to treat pelvic organ prolapse in May 2009. Her lawyers say her Bard Avaulta Plus Posterior BioSynthetic Support System is defective in its manufacture , its design and in a failure to warn doctors who are considered the end users.
Hers is the first of four bellwether trials that will test legal theories naming defendant C.R. Bard. These are the first of more than 4,000 cases filed against Bard, one of six defendants, in this Charleston, West Virginia federal court.
Last week there were 27,602 lawsuits pending in this federal court. Judge Joseph R. Goodwin is overseeing all of the cases. He promises the Cisson case will take about 12 days.
Who Has Appeared So Far
The Material Safety Data Sheet for polypropylene presented in court last week, including the warning it is not to be used in medical devices intended for implantation in the human body. Bard Exhibits #200-1 Marlex Mesh MSDS 10 pages 20113073699.
C.R. Bard knew it had a problem with the plastic mesh material which was being used for pelvic floor as well as hernia mesh, as revealed by an exchange of emails in Exhibit #200 concerning the raw material, a plastic Marlex resin. Judge Goodwin ruled June 4 that the e-mails raised a genuine issue “whether Bard was aware its conduct was practically certain to cause injuries.”
Last Friday, Douglas Evans appeared in a videotaped deposition. He was an engineer and team leader for Bard and has a patent application in his name on behalf of Bard June 14, 2002 for a sling-type product made from a biologic material. This would be an alternative to polypropylene (PP) because the plastic had problems of inflammation and encapsulation that did not subside after some time in animal studies.
The deposition conducted by Henry Garrard said the rationale for the new type of sling is “some doctors prefer not to use them due to potential infection, urethral or vaginal wall erosion because the mesh – can unravel, creating a fishing line effect, slicing through the patient’s tissue.”
“Did you ever say to your boss,” Boss if it’s known that synthetic mesh sling kids might unravel and create a fishing line effect, I don’t think we ought to be selling this product? Did you ever do that?”
“I don’t recall a specific conversation on that,” said Evans.
Anthony Brennan Ph.D appeared on the stand Friday for more than 3 hours, reports DrugWatch (here). He is a University of Florida professor of Materials Science and Engineering who studied the Avaulta Plus for the plaintiff’s side collecting about $200,000 for his work. He compared PP to a rubber tire that ages and cracks with time. In the body, free radicals break down the PP further.
“When you put an implant in, it’s seen as a foreign body,” Brennan said. “The body will try to encapsulate it. … The problem is it continues forming an inflammatory response. If you use free radicals to make it, you use free radicals to break it down.”
Since Brennan is not a medical doctor he could not testify about medical issues and his testimony was continuously objected to by the defense team.
“Polypropylene degrades in the body,” he said, including the Avaulta Plus Polypropylene mesh.
As a materials expert Brennan discussed the pore size of mesh which should be between 2 mm and 3.5 mm, but the Avaulta pores were smaller. In addition, the arms of the mesh can overlap when they are implanted deep in the pelvis, deforming and reducing the pore size further.
He told the eight jurors the overall design of the Avaulta Plus was flawed.
Thursday Jennifer Mercuri appeared via videotaped deposition Exhibit #200-58 Deposition of Jennifer Mercuri on Bard Animal studies Doc 200 20113073758.
She worked with Robert H. Orr on animal studies involving the Bard meshes and their implantation in sheep, rabbits and rats. The rat studies were conducted at Emory University in Atlanta in 2006 and the projects were called Corkscrew and Summit. Sheep were chosen because they more closely resembled the female human body.
Deposed by attorney Fred Thompson, Mercuri said, “Normally you’re going to see a fairly high inflammatory response with any type of foreign body that you put into the — into the human body. How it – as long as that is reduced over a certain period of time – then it’s – then you can have a favorable response, even if you have a high inflammatory response at the beginning—as long as you don’t have that same high inflammatory response at the end.”
Future studies that are more clinically relevant will be needed, she concludes.
In the deposition, pathologist, Paul Termin appeared critical about the inflammatory response and host-implant integration. He said, “it appears that the implant will be surrounded by host tissue (P.81) without significant ingrowth to the implant matrix. Encapsulation is the likely outcome for this material.”
Attorney Thompson asked Mercuri if encapsulation is a good outcome for a mesh implant? “I don’t remember what the ideal outcome is for it,” said Mercuri in her deposition.
Also after the 90-day and 30-day rat study, the summary says DEHI was noted indicating dehiscence, a surgical wound that breaks open (P. 90).
After the rats were euthanized at seven days there were two hematomas, two liver adhesions, one seroma, one no weight gain: hybrid, three hematomas, one liver adhesion, one late dehiscence. Avaulta had two minor previous dehiscences; Pelvisoft, one no weight gain, one liver adhesion and hematoma, one seroma with two major dehiscences.
Thompson asks “is this not a large number of abnormal findings based on six rats per – per group?
Objection says the lawyer for the other side. I wasn’t the one who made that call Mercuri said, adding she didn’t know what was considered normal.
Judge Goodwin has ruled Bard performed animal testing which failed to support the safety of the product but marketed the products anyway. And despite the advice of its chief medical advisor, Dr. Ross, Bard chose not to conduct clinical studies of the Avaulta mesh products.
That was part of the reason Judge Goodwin denied Bard’s motion for a Summary Judgment in June 4, 2013. (See Exhibit #273 Bard Exhibit #273 Bards Partial Motion for Summary Judgment June 2013 20113207440).
Jim Ross, the medical director for Bard appeared via videotape deposition on Friday. His deposition appears in Exhibit #200-61 (Bard Exhibit #200-61 Jim Ross deposition 20113073761).
The Salinas, California gynecologist proposed doing clinical trials of the devices but Bard declined largely because the field was evolving so rapidly that test results would be outdated when they were published three years later.
The Avaulta was taken off the market last June after the FDA required mesh makers to conduct a three-year post-approval monitoring of women already implanted to assess their adverse events. The company said it was making a business decision not to invest in the clinical trials for the Avaulta. #
**Note the “Medical Application Caution” put on by resin manufacturer Phillips Sumika, a division of Chevron Phillips. Marlex polypropylene is a petroleum-based chemical and is used in hernia and prolapse implants. #