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Bard Ignored Internal Memos and Doctors’ Concerns Over Avaulta Vaginal Mesh

Lady Justice with Bard logo watermark and mesh

By Doug Allen

CHARLESTON, W.Va. – Some jurors closed their eyes and bowed their heads, at times appearing to fall asleep, during a lengthy deposition Tuesday of a former president of the Bard division that developed and marketed the Avaulta mesh line. Mark Downey admitted he did nothing to address concerns over complications with the mesh products, on Day 7 of the first federal trial over transvaginal mesh devices.

A jury of four women and four men sat through seven hours of videotaped testimony. More than 23,000 similar lawsuits have been combined in the U.S. District Court for the Southern District of West Virginia, in Charleston.

In Cisson v. C.R. Bard Inc., plaintiff Donna Cisson claims an Avaulta device implanted to treat pelvic organ prolapse caused her pain and permanent injury. The Avualta line of products is made from a resin called polypropylene, which the resin’s manufacturer warned Bard should not be permanently implanted in humans.

Bard voluntarily withdrew the Avaulta line from the market last year rather than meet stringent testing requirements the U.S. Food and Drug Administration (FDA) required for its continued marketing. Judge Joseph R. Goodwin, who has been assigned to manage all 23,000 cases, ruled in pretrial motions that the voluntary withdrawal and FDA requirements could not be presented to the jury.

Former President of Bard Urological Division Ignored Warnings

Downey was the president of Bard Urological Division (BUD), the Bard division responsible for the Avaulta product line, from 2005 to 2009. He had been a district sales manager and then vice president of sales before being elevated to president. Prior to his work at Bard, he was in computer software sales.

In the videotaped deposition taken June 21, defense attorney Henry Garrard produced one internal Bard document after another citing complications from Avaulta products going back as far as 2006. The testimony also highlighted Downey’s lack of knowledge about the products he was responsible for.

The company used a porcine collagen coating on the body of the Avualta products, but not on the arms, which anchor the mesh in place. The porcine was intended to be a barrier to reduce the body’s inflammatory response and adhesions between the polypropylene resin and tissue. Gerrard asked Downey what the purpose of the coating was.

“I’m sure the R&D people knew,” Downey said. “I knew it was a barrier that was on there.”

Gerrard presented a Bard document from 2006 called a “Gap” analysis. It was intended to highlight the “gaps” in Bard’s research and development as related to the Avaulta product line.

“We have no expertise in mesh development,“ Gerrard read. “No facility for mesh design. … Limited R&D testing facilities for mesh. No infrastructure for processing large sheets of mesh. No expertise in tissue development.”

‘A Futile Attempt’

Another document from a sales manager in Florida highlighted issues doctors had with Avaulta products. The memo, from 2007, specifically questioned the lack of porcine coating on the products’ arms.

“(The doctor) thought Avaulta Plus concept was interesting but wonders why barrier is not extended to the ends of the mesh,” Gerrard read from the memo.

The sales manager asked for any significant clinical data the company had on porcine collagen, writing, “what we offer is a futile attempt at best.”

“What is there to protect the mucosa from (the arms) when they’re not covered in the porcine barrier?” Gerrard asked Downey. “Did you ask anyone?”

“I don’t recall any questions I asked on this,” Downey replied.

Another email from the same year stated:

“Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them.

“We’re trying to fight some battles around lack of data around kits, and on Avaulta in particular. … We’ve been chided by thought leaders. … Still waiting on data on our kit. Why are we afraid to publish any data?”

Gerrard asked Downey what he did, as president of the Urological Division, to address the concerns of physicians outlined in the email.

“I don’t recall doing anything about it,” Downey replied.

Doctors Had Significant Concerns About Avaulta

In a September 2008 internal market research memo, Bard executives again highlighted what they call “barriers to adoption,” or reasons many physicians refused to use Avaulta products — mostly pertaining to complications seen in patients.

“This additional analysis shows in spades the importance of reducing complications,” the report read. Gerrard asked Downey what he did with the report.

“I didn’t do anything personally,” Downey said. “It wasn’t my responsibility to reduce complications.”

“Did you ask what they were doing about it?” Gerrard countered.

“At this point in time, we were looking at the next-generation products,” Downey replied.

Another internal company memo titled “The Reality of Complications” addressed complication rates from the Avaulta products, including dyspareunia (painful sexual intercourse), erosion and chronic post-operative pain. The memo compiled market research on doctors who didn’t want to use the Avaulta line.

According to the document, 65 percent of physicians surveyed said they had significant concerns about dyspareunia with pelvic floor products, 58 percent had significant concerns about chronic post-operative pain, and 62 percent had significant concerns with erosion.

Mesh Was ‘Sawing at Tissue’

Gerrard pointed out that Bard medical director Dr. James Ross recommended that Bard do random controlled trials before they took Avaulta products to market, but they did not do that. Downey replied that, by that time, Bard was focused on the next generation of products rather than going back and looking at the products already on the market.

Gerrard asked about several documents that cited physician concerns that the arms of Avaulta were “sawing at tissue” in patients, and asked if Downey did anything to address that concern.

“Not that I recall,” Downey said. “Sawing of tissue is not an issue that was of concern.”

In another email, a salesman said “the flesh sawing issue came up again last week with a physician” and asked if Bard planned on adding the porcine coating to the device’s arms.

Adam Silver, marketing manager for BUD’s women’s health division, replied by email.

“We’re not going to put (the coating) on our arms any time soon,” he wrote. “We don’t believe it’s needed.”

Gerrard also asked Downey if it was appropriate to use the word “revolutionary” in marketing materials for a product that had never undergone testing in humans.

“We never used that word,” Downey said.

Gerrard then produced two separate Bard documents that described “revolutionary mesh” and “revolutionary tools” in relation to the Avaulta product line. Downey appeared as though he’d never seen the documents before.

Doug Allen is a freelance reporter based in Aspen, Colo. His work has appeared in local and national print and radio outlets, including The Washington Post and Aspen Public Radio.

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