Attorneys for C.R. Bard examine woman’s medical history in implant mesh trial

By John Sammon | Apr 5, 2018

HACKENSACK, N.J. (Legal Newsline) – Attorneys for defendant C.R. Bard on April 2 called their own witness, a urologist and pelvic reconstruction surgeon specialist, who said the cause of plaintiff Mary McGinnis’ painful symptoms were not a result of a defective vaginal mesh implant, but her pre-history of arthritis.

“Mrs. McGinnis had a lot of back and spine issues that progressed over time,” Dr. Michael Kennelly told a jury during testimony.

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

McGinnis, of North Carolina, is suing C.R. Bard, the New Jersey manufacturer of pelvic implant devices called the Avaulta and Align, in New Jersey Superior Court.

The implant devices were supposed to alleviate a sagging bladder and incontinence problems McGinnis had. Instead, she alleges in her suit the implant used on her in 2009 caused excruciating pain from the development of inflamed, hardened vaginal tissue that damaged her quality of life. Over a period of almost 10 years, she alleges additional surgeries had to be performed, including removal of the mesh implant with great difficulty.

The Avaulta mesh device is a clear and plastic-like and is made of polypropylene.

The suit also states C.R. Bard rushed to sell the products without proper clinical backup study.

Kennelly performed more than 250 mesh implants for prolapse (sagging bladder) and said he had done approximately 30 such procedures using the Avaulta device on cadavers. He had also produced an instructional video that was viewed by Dr. Elizabeth Barbee, the North Carolina gynecologist who performed the implant on McGinnis.

“The video was used to train doctors?” Lori Cohen of Greenberg Traurig, the attorney for C.R. Bard, asked.

“Yes,” Kennelly said.

“She (Barbee) heard your voice on the video?” Cohen asked.

“Yes,” Kennelly responded.

Kennelly, who described a training program run by C.R. Bard in the use of the Avaulta and Align implant that Barbee attended three times to be “robust,” disagreed the products were unsafe. He agreed with a statement the mesh sling had become one of the most popular and effective treatments for prolapse worldwide.

In addition, Kennelly said the Avaulta was an appropriate treatment because McGinnis had what is called a lateral cystocele, a vaginal condition different from a central cystocele, and required the added support the Avaulta could offer.

Kennelly said he disagreed with some of the surgical techniques used by Barbee to implant the device in McGinnis, including what he alleged resulted in “buttonholing,” a thinning of vaginal tissue in which a small hidden opening in the tissue is created, which can result in erosion into the area of the surgery.

Superior Court Judge James DeLuca cautioned counsel and the witness (Kennelly) not to use the word “error” in reference to the procedure Barbee performed on McGinnis.

“Dr. Barbee is not a defendant in this action,” DeLuca said.

Cohen asked, “On three technical surgical issues (including buttonholing), do you have an opinion to a reasonable amount of certainty, whether those issues caused or contributed to Mrs. McGinnis’ alleged damage in this case?”

“Yes, I do believe they did cause or contributed to erosion of the vaginal wall,” Kennelly answered.

Kennelly ruled out the implant Avaulta product for causing McGinnis’ alleged complaints. A document posted by the defendant's counsel contended the vaginal pain had started three years after the implant in 2012.

The defense listed the factors responsible for McGinnis’ pain alleging pre-implant conditions including osteoarthritis, degenerative spinal disc disease and an over-active bladder. On the medical side, the implant procedure allegedly causing the buttonholing was noted, as well as posterior repair (repair of tissue) later performed.  

Kennelly indicated the pain described by McGinnis did not relate to the Avaulta device.

“What Mrs. McGinnis described was a nerve-type pain,” he said.

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