HACKENSACK, N.J. (Legal Newsline) – The attorney for the plaintiff went after a defendant's star witness on April 3, downplaying the urologist and reconstruction surgeon specialist’s experience with a pelvic mesh implant device the plaintiff alleged damaged her life and resulted in excruciating pain.

Streaming video coverage of the trial in the New Jersey Superior Court in Bergen County was provided to Legal Newsline by Courtroom View Network.  

Mary McGinnis, of North Carolina, sued New Jersey-based C.R. Bard, the maker of implants Avaulta and Align, in New Jersey Superior Court for the pain the device allegedly caused her after the implant in 2009.

The devices were supposed to support a sagging bladder condition called a prolapse. The plaintiff's procedure instead resulted in alleged tissue inflammation and the formation of scar tissue in the area of the implant. Subsequent surgeries allegedly had to be performed over a period of years to remove the mesh implant, a clear plastic-looking device made of polypropylene.

The lawsuit contended that C.R. Bard went ahead and began marketing the devices in 2007 knowing there were questions about their safety and without proper clinical studies performed beforehand.

During testimony, Adam Slater of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, McGinnis’ attorney, asked Dr. Michael Kennelly about his professional experience with the Avaulta and Align devices, noting that it was not extensive. Kennelly earlier testified he had installed the devices in cadavers but not live patients.

“You never looked at a woman across the table, a woman with a prolapse and said, ‘I think the best option for you is the Avaulta,'” Slater said. “Never once have you ever done that, then followed through to put it in her body, correct?”

“I have not placed the Avaulta in a (live) patient,” Kennelly said.

Slater also repeated an assertion he has made during the trial that the pelvic mesh contracted, changed shape and distorted once it was inside of McGinnis’ body, causing tissue inflammation and pain.

“Do you agree mesh will contract?” he asked Kennelly.

“I do not believe mesh contracts,” Kennelly answered.

“The scar tissue when it contracts, contracts the mesh down with it," Slater said. “You agree?”

“The mesh does not contract,” Kennelly persisted. “It will conform to the surrounding environment.”

“Which means the mesh will be deformed and have less of an area, correct?” Slater asked.

“If outside forces put pressure on it,” Kennelly said.

Slater contended McGinnis did not receive proper warnings before signing a consent form to have the implant put in, including the possibility of pain, contraction, scarring and dyspareunia (painful intercourse).

Consistently throughout the trial, the attorney for C.R. Bard, Lori Cohen of Greenberg Traurig of Miami, intended to show that the source of McGinnis’ pain was not the implant, but pre-existing medical conditions the woman had, including progressive osteoarthritis of the hip, back and spine.

In addition, an accidental perforation in the pelvic tissue during the implant procedure called “buttonholing” was alleged to have led to erosion in the area of the surgery, allegedly further exacerbating McGinnis’ painful condition.

Slater cited documents he said showed that employees of C.R. Bard who were handling the Avaulta device had been warned it was not for use as a permanent implant in the body.

“Can we agree the language says don’t put this permanently in the body?” Slater asked.

“That’s what the verbiage says on the form,” Kennelly responded.

Slater also questioned Kennelly about a statement from Dr. Elizabeth Barbee, the North Carolina gynecologist who used the Avaulta implant on McGinnis, that she would not have done it if she had known about such warnings.

“That’s what she stated,” Kennelly said.

Under cross-examination from Cohen, Kennelly said the Avaulta and Align implants had been widely studied for a number of years before McGinnis’ 2009 implant and that there was enough existing body of evidence regarding mesh slings to use such devices.

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