Northern California Record

Sunday, November 17, 2019

Designer of J&J pelvic mesh product says sling was 'wonderful performer'; State's objection to description sustained by judge

State Court

By John Sammon | Aug 29, 2019

Johnson

SAN DIEGO – In a trial to decide if Johnson & Johnson allegedly sold pelvic mesh implant kits that harmed women to make money while ignoring the dangers, a company director on Wednesday held aloft a patch of the white mesh and stretched it in two directors to show its flexibility.  

“I can testify that it (mesh) stretches in both directions,” said Scott Ciarrocca, research and development director for Ethicon, J&J’s pelvic mesh subsidiary.

Later on cross-examination, attorneys with the California Attorney General’s Office sought to establish that company officials left warnings out of the mesh instructions for use, called IFUs, including one proposed that said care should be taken when implanting the devices in sexually active women.

State’s attorneys have maintained during the trial the implants caused dyspareunia (painful intercourse) among other complications.

The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.

The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over the Prolift pelvic mesh device, made by its subsidiary Ethicon, for allegedly causing vaginal injuries in women and allegedly for selling the product through the use of deceptive marketing practices. Prolift is a clear polypropylene mesh with eight thin connecting arms.

Ciarrocca has been with Ethicon for 22 years. 

He told the court he was involved in the design of the Prolift, introduced in 2005, and the Gynemesh PS device, introduced in 2002, used to treat pelvic organ prolapse, or POP.

He described the products as a “wonderful performers.”

Attorneys for the state objected to the term wonderful and asked that it be stricken. Superior Court Judge Eddie Sturgeon sustained the objection.

Ciarrocca said the Prolift and Gynemesh products came about to standardize treatment for POP and to provide more durable and effective treatments.

Mesh made of the substance polypropylene, known under the brand name Prolene, is described as a knitted, non-absorbable synthetic material and was touted by its designers to be “biocompatible” when implanted in the human body.

Mattie Hutton, a J&J attorney, asked Ciarrocca if use of the material was appropriate.

“Yes,” Ciarrocca responded.

Ciarrocca explained that Prolene had been used in previous years for hernia repairs.

A document exhibited for the court by Hutton stated: “In all cases, the results of the sling material were acceptable.”

“Do you agree?” Hutton asked.

“Yes,” Ciarrocca responded.

Further descriptions said the material for the slings were “non-reactive” and could retain strength indefinitely.

Ciarrocca said the Prolene had been used in sutures since 1969 and had proved itself effective under the most-demanding circumstances.

State attorneys contend the warnings on product packaging for the mesh devices were not complete in describing possible complications, for example not including the terms "life-long" and "life-changing." One printed list of possible adverse reactions on company materials cited the possibility of punctures, transitory local irritation; potential for existing infection, temporary or permanent lower urinary tract obstructions, extrusion, erosion, fistula formation and inflammation.  

“Did you ever see anybody at Ethicon try to limit the risk information?” Hutton asked.

“No,” Ciarrocca said.

“Did you consult with outside surgeons on the Prolift?”

“Yes,” Ciarrocca answered. “In excess of 75 (surgeons) were made familiar with the concept.”

“Did anyone tell you the information in the IFU was insufficient?”

“No.”

When Ciarrocca referred to Prolene as the “Cadillac” of non-absorbing sutures, state attorneys objected saying there was no foundation for such a description.

Sturgeon sustained the objection and the remark was stricken.

Hutton asked Ciarrocca if he was proud of the company's efforts to develop Prolift.

"Absolutely," he said. "Our team overcame significant challenges and provided a really wonderful product to the market."    

On cross-examination, Daniel Osborn, an attorney with the California Attorney General's Office, exhibited a request for an IFU addition proposed to company officials in 2005.

The request read: “I propose to add the following to the new version of the IFU: WARNING (in all caps), early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction, which may result in anatomical distortion of the vaginal cavity that can interfere with sexual intercourse. This must be taken into consideration when the procedure is planned in a sexually active woman."

“This warning (sexually active woman) never made it into the IFU, correct? At the (product) launch in 2005?" Osborn asked.

“The exact verbiage was not included in the IFU, correct,” Ciarrocca said.

On redirect, Hutton exhibited an IFU for Prolift from 2009 that mentioned under an adverse reactions section the possibility of pelvic pain or painful intercourse.

The case in San Diego is the first at trial by a state attorney general and seeks damages over allegations of unfair competition and violation of false advertising laws.

The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014. The mesh is designed to help a sagging bladder condition called pelvic organ prolapse, or POP.

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Organizations in this Story

California Attorney GeneralSan Diego Superior CourtJohnson & Johnson

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