Northern California Record

Sunday, October 20, 2019

Ethicon doctor says 20 percent erosion rate okay, sales manager says company reps honest

State Court

By John Sammon | Jul 29, 2019


Kubota

SAN DIEGO – On Thursday, a doctor for Ethicon, a subsidiary for Johnson & Johnson, said he thought a 20 percent erosion rate for women was acceptable, while a company sales manager said sales reps had been honest about the risks of the company's pelvic mesh devices.

“We’re not about taking short cuts,” Michele Garrison, division sales manager with Ethicon, told the San Diego Superior Court. “We wanted to protect doctors and patients.”

“Did you ever conceal or downplay the (mesh implant) risks to a customer?” asked Carolyn Kubota of Covington & Burling, the attorney for Johnson & Johnson.

“No,” Garrison said. “I may have even made a bigger deal of it.”

Kubota said the state was making the case that Ethicon had undertaken an aggressive sales campaign minimizing the risks of mesh implants to make sales.

“Is this true?” she asked.

“Not based on my experience,” Garrison said.

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 a pelvic mesh device called Prolift, made by 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. The case in San Diego is the first at trial by a state attorney general over the implant devices and seeks damages under unfair competition and false advertising laws.

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

Garrison appeared as a witness for a second day to tell the court how the company sold its mesh devices, explaining sales rep assignments and procedures.

She told Kubota that sales reps received mandatory annual compliance training to make sure health care laws were being followed, including guidelines for reps that each sales person had to acknowledge in writing to prove they understood the requirements.

Two goals exhibited by Kubota on a chart stated the reps would conduct themselves in a manner that reflected a positive image of the company, and that reps would only promote “on-label” uses of company products.

“Positive image meant we were stewards of the organization,” Garrison said. “I saw myself as a consultant. The goal was to engage the customer and leave a positive impression.”

Garrison said the sales efforts including distributed printed materials had to feature statements that had been pre-approved by the company.

“It was intended to make sure the statements were accurate and there was also uniformity among the reps,” she said.

Garrison explained sales reps would take doctors to dinners or lunches to explain the products because this was the only free time the doctors usually had during a busy day. She said she did not want to interfere with a doctor’s 8-to-5 schedule.

“I didn’t want to be the reason a patient had to wait 10 minutes longer,” Garrison said. 

Garrison added that most of the time sales information was conveyed during lunches. She said two of her favored restaurants to talk to doctors about the products included Jimmy Johns, a fast-food outlet, and Olive Garden. The cost of meals had a limit and could be only for business, she added.

The company made a requirement that negative comments or complaints about its products were required to be reported to company officials and if need be relayed to appropriate health organizations such as the Food & Drug Administration (FDA).

Scripts were not used by sales reps, but talking points Garrison said helped reps to avoid fumbling a response to a question from a doctor.

“We wanted a continuity of message, but it was recognized each rep would say it in their own way,” she said.

Garrison said at no time did she or any of the reps she managed withhold information about the possible risks of the mesh devices.

“If that happened we would lose credibility," she said. "In a small town they would say ‘Michelle (Garrison) is not truthful.' I had more to lose by holding (information) back.”

State attorneys and their expert witness contend that the polypropylene mesh devices contract when implanted in the body, causing scarring as the body tries to reject the material. They said the devices can fragment into particles, shrink, reshape themselves into rope forms, resulting in chronic pain, vaginal tissue damage and painful intercourse.

In a deposition tape played for the court filmed in 2012, Dr. Axel Arnaud, Ethicon's medical director for Europe, told attorneys for the state that anything to do with the vagina involving an implant can lead to (mesh) retraction and sexual complications.

"Complications are possible with any surgical procedure," he said.

"Are you saying that when Prolift was launched, you didn't know that some women would end up with very serious life-long complications, that you only learned that over the course of time after Prolift had been on the market for years?" a state's attorney asked. "Is that what you're telling me?"

"All surgical procedures can give complications, some minor, some terrible," Arnaud said. "So why would I have thought in 2004 that Prolift would be the only procedure in the world that would not give any serious complications?"

"Nobody asked you that," the state attorney said.

He asked a clerk to repeat the question to Arnaud.

"I did not imagine there would be something that cannot be improved by anybody," Arnaud said. "That women would end up in a condition so severe that their life would be completely disturbed."

The attorney said an Ethicon-sponsored study had shown a 20.7 percent erosion rate among women who had the implants during the first year.

"Is that acceptable to you?" the attorney asked.

"Yes," Arnaud said. "The 20 percent of erosion is not a killer for a project."

Since 2012, numerous lawsuits have been filed by individual women who had mesh devices implanted and later alleged they suffered intense pain and side effects that required the devices to be surgically removed with great difficulty.

Washington state sued Johnson & Johnson earlier this year in a similar case, but the company agreed to pay $9.9 million to settle with no admission of wrongdoing. 

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