Attorneys in C.R. Bard mesh trial spar over wording

By John Sammon | Apr 9, 2018

HACKENSACK, N.J. (Legal Newsline) – Adam Slater, the attorney for plaintiff Mary McGinnis, attempted to use the previously published words of a noted female pelvic specialist serving as a witness for defendant C.R. Bard to refute the contention that mesh implant devices were safe.

Slater - of Mazie, Slater, Katz & Freeman in Roseland, New Jerse - maintained there was insufficient background clinical study done on the Avaulta and Align mesh implant devices McGinnis had implanted in 2009 to treat bladder issues that she alleges caused her to suffer severe inflammation and pain. The mesh had to be removed.

McGinnis sued New Jersey-based C.R. Bard, the manufacturer of the pelvic implant devices, in New Jersey Superior Court in Bergen County. In addition to the pain and suffering, she alleges the company was more interested in marketing the devices than it was in making sure they were safe before they were first offered to the public in 2007.

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

During the April 5 session, Slater produced an opinion authored by Dr. Peter Rosenblatt, a Massachusetts female pelvic and reconstructive surgery specialist called to testify in the trial on behalf of C.R. Bard. 

A passage in the document, written in 2007 just before the Avaulta went to market, read, “It is possible the use of synthetic mesh will become more common. Limited data is available supporting the use of synthetic mesh for the repair of pelvic organ prolapse (sagging bladder).”

“You wrote this, right?” Slater asked.

“Yes,” Rosenblatt answered.

“Was there plenty (data) or limited?” Slater asked.

“We used the word 'limited,'” Rosenblatt said.

“Do you think (words) 'plenty' and 'limited' are the same thing?” Slater said.

“I won’t quibble over semantics,” Rosenblatt said. “There are lots of (prolapse) articles. Doctors always want more data.”

Slater also challenged that McGinnis received proper warning of the risks of using the Avaulta and Align devices, a contention of the plaintiff from the start of the trial. Though doctors had used pelvic mesh support devices they had fashioned themselves previous to the Avaulta, the device, a mesh of clear polypropylene with connecting arms, was among the first to come in kit form in a box.

“You said it’s a great IFU (instructions for use on the kit), right?” Slater asked.

“It is,” Rosenblatt answered.

Slater then had projected a film clip of Dr. Elizabeth Barbee, the North Carolina gynecologist who implanted the defendant's mesh in McGinnis in 2009.

“I don’t think it’s a complete (instructions) list,” Barbee said on tape.

Asked about her comment, Rosenblatt responded, “That’s what she said.”

During cross-examination the attorney for C.R. Bard, Lori Cohen of Greenberg Traurig challenged the plaintiff's contention that the mesh, once inside McGinnis’ body, contracted, changed shape and deformed, causing constriction, excessive inflammation and the formation of stiff, scarring tissue resulting in intense pain.

Rosenblatt agreed the mesh did not shrink.

“The mesh is an innocent bystander,” he said. “Mesh does not have contractible elements. It does not shrink like a T-shirt.”

Rosenblatt also said he saw no evidence that using a lighter-weight mesh would be any safer or cause fewer problems, refuting another allegation the implant device was too large, causing tissue damage when McGinnis’ body tried to reject it.  

“Do you have an opinion that the Avaulta caused Mary McGinnis any harm?” Cohen asked.

“These did not cause her any harm,” Rosenblatt said.

“Were there any safer alternatives to the Avaulta?” Cohen asked.

“There were not,” Rosenblatt answered.

“You don’t believe there was contraction?” Cohen asked.

“No,” Rosenblatt said.

“Do you believe the adverse reactions (warnings) were appropriate?” Cohen asked.

“Completely,” Rosenblatt responded.

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