Northern California Record

Sunday, November 17, 2019

Ethicon official argues benefits outweighed risks in pelvic mesh trial; State rests case

State Court

By John Sammon | Aug 20, 2019


SAN DIEGO – In a trial to determine if Johnson & Johnson officials allegedly caused women pelvic injuries knowing its prolapse mesh devices were harmful, officials of the company in a taped deposition testimony on Monday said there were risks with the devices but the benefits outweighed them.

“What made you decide to go to work for Ethicon?” an attorney for the California Attorney General’s Office asked Dr. Aaron Kirkemo in a video filmed in 2013.

“I had been using Ethicon products since 1998,” said Kirkemo, Ethicon associate medical director in the company’s medical Affairs Department. “I really liked their products. I liked the company and the folks I was working with. Some of the products at Ethicon were absolutely transformational for women. It positively changed women’s lives.”

Kirkemo, a urologist, joined Ethicon in 2008.

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. 

Attorneys noted that dyspareunia (painful intercourse) in some women caused by the mesh implants were not mentioned in adverse possible reaction warning instructions with the Prolift product.

“Are there mechanisms listed in the adverse reactions that could possibly bring about dyspareunia?” Kirkemo was asked.

“Yes, they’re talking about the potential of nerve injuries,” Kirkemo answered. “They talk about if the wound doesn’t heal well, you know, that you could end up with exposure, an extrusion or erosion of the mesh, which would add inflammation, which would create a sore point down there which could cause pain with intercourse.

"When I was in practice, it (list of possible reactions) told me enough to know what I needed to know to counsel the patients. When I got into industry, I didn’t feel this portion (dyspareunia) needed to be addressed on subsequent (instruction) updates,” Kirkemo said.

Jinsook Ohta, an attorney with the California Attorney General’s Office, in a separate recorded deposition asked Dr. Axel Arnaud, medical affairs director at Ethicon, about an email he had written in 2005. Ohta asked Arnaud to read his email on the tape.

He proposed adding to instructions for use of the Prolift mesh a warning that stated that “occasionally and uncommonly” vaginal erosion and retraction of the mesh could occur, resulting in an “anatomical distortion” of the vaginal capacity that can interfere with sexual intercourse.

“This should be taken into consideration when the (implant) procedure is planned in a sexually active woman,” Arnaud had written in the email.

Arnaud said Prolift had been used after clinical trials of the product had been performed and that mesh had been used for a long time.

“It was no surprise that one of the possibilities was a complication called erosion," he said. "From time to time, you might have more-important shrinkage that would lead to retraction, so no, it is nothing really new. I was asked to write this warning but there is nothing extraordinary in it.”

Arnaud said he could have written the warning before the Prolift product was launched in 2005. Prolift's subsequent Gynecare mesh device was introduced in 2008.

“Each surgery has specific complications,” Arnaud said. “These were not discovered with the Prolift project, they were already known. The goal was to understand better the complications which were already known in order to try and avoid them, of course.”

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. Two of the products at issue are called Prolift and TVT slings.

In 2012, the Food and Drug Administration ordered further study by mesh manufacturers after receiving 3,874 reports of injuries to women who had mesh devices implanted. Ethicon officials decided to discontinue selling the Prolift, Prosima and TVT SECUR mesh devices.

The trial, now going into its second month, wrapped up live testimony of witnesses for the state on Monday, which leaves lawyers for Johnson & Johnson to call their own expert witnesses. Monday afternoon Johnson & Johnson called as its witness Dr. Charles Nager, a San Diego gynecologist.

Nager said reasonable California doctors did not use product manufacturer instructions, patient brochures or marketing materials as a source of information in making patient treatment decisions.    

Superior Court Judge Eddie Sturgeon is presiding.

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