Allegations of pelvic mesh shrinkage considered in C.R. Bard trial

By John Sammon | Apr 11, 2018

HACKENSACK, N.J. (Legal Newsline) – An attorney for Mary McGinnis in her lawsuit against C.R. Bard said during trial that the pelvic mesh McGinnis had installed in her pelvic region in 2009 shrunk and distorted, while the defendant contends it can be tissues attempting to heal that causes mesh shape change, not the mesh.

“You don’t disagree that mesh contracts over time do you?” McGinnis’ attorney, Adam Slater of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, asked Dr. Marta Villarraga, a noted biomaterials interaction and biomechanics scientist. "You told the jury you agree that with the concept of mesh contraction - scar tissue contracts and deforms the mesh down with it. You agree that’s a real process, right?”

“I explained to the jury the tissue contracting brings the mesh with it,” Villarraga said.

Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.  

McGinnis is suing New Jersey-based C.R. Bard in New Jersey Superior Court in Bergen County for its Avaulta and Align pelvic implant devices that were supposed to support bladder prolapse, but instead allegedly caused inflamed tissue and scarring that caused intense pain, damaged McGinnis' quality of life and had to be surgically removed, causing her more harm.

In addition, the suit contends the company began marketing the products in 2007 and was more interested in selling them than making sure they were safe by doing proper clinical studies beforehand. The devices are made of clear polypropylene.

A sticking point of the trial from the beginning has been the plaintiff’s allegation that the pelvic mesh, in addition to risk from its polypropylene and resin chemical makeup, shrinks and deforms, causing the body to develop unacceptable amounts of scar tissue in an effort to reject it. The attorneys for the defendant maintained it was McGinnis’ arthritic back and hip conditions that pre-dated the implant that caused her pain.

During the April 9 session, Slater sought to minimize the expertise of Villarraga, who was called as a witness for the defendant.

“You’ve never been involved in the development or testing of a mesh product, correct?” he asked.

“No, I have not,” Villarraga answered.

“You’ve never given a lecture or presentation regarding synthetic mesh, correct?”

“That’s correct,” Villarraga said.

“You’re not a physician or expert in gynecology?” Slater asked.

“That’s correct,” Villarraga said.

However under cross-examination by Melissa Geist, an attorney for C.R. Bard, Villarraga said no design of any such implant device is risk-free.

“There is always knowledge of potential complications,” she said. “There is some degree of wound contraction (from implant surgery) in the first few months.”

“Isn’t that consistent with what you testified to?” Geist asked.

“Yes,” Villarraga said.

“Were you objective in reaching your opinions?” Geist asked.

“Absolutely,” Villarraga said.

Geist also attacked Slater’s portrayal that Villarraga lacked expertise in the matter.

“Do you need to have experience in these devices to have an opinion whether they were defective in any way?” she asked.

“No,” Villarraga responded. “I use my training, background and experience to make that assessment.”

Geist asked Villarraga if she had an opinion whether C.R. Bard had met reasonable standards in putting the implant devices on the market starting in 2007.

“Yes, based on my review they (C.R. Bard) acted reasonably to bring this product to market,” Villarraga said.

“C.R. Bard’s conduct was consistent with industry standards?” Geist asked.

“Yes,” Villarraga answered.

Dr. John Heller, an orthopedic surgeon from Atlanta, called as a witness for the defendant said McGinnis suffered from a number of pre-implant arthritic conditions that were progressive in nature.

“She (McGinnis) has a lot going on and has been going on for decades,” Heller said. "There are troubles with the spine and some degree of change between the vertebrae.”

A projected document recounted the alleged conditions including degenerative disc disease, lumbar joint arthritis, femoral impingement and pubic symphysitis (pelvic inflammation).

“I think she had clinically significant stenosis, which is responsible for the symptoms (pain) and that’s been evolving steadily over time,” Heller said.

Lori Cohen, attorney for C.R. Bard with Greenberg Traurig, asked Heller if the implant devices caused the symptoms.

“It has nothing to do with them,” Heller said. “These are treatable conditions.”

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