Northern California Record

Monday, September 16, 2019

J&J witness says complications rate for mesh low, big success with women in Ethicon pelvic mesh trial

State Court

By John Sammon | Aug 22, 2019


Kahn

SAN DIEGO – In a trial to decide if officials at Johnson & Johnson allegedly injured women with pelvic mesh devices to realize profits, on Wednesday J&J attorneys, through a fact witness, again hammered away at their contention that mesh has done far more good than bad.

“It’s a huge advancement in the care of women,” said Dr. Bruce Kahn, a Scripps Clinic San Diego gynecologist.

Lawyers for the California Attorney General’s Office objected, saying Kahn was not qualified to make such a pronouncement.

“Sustained,” Superior Court Judge Eddie Sturgeon ruled.

"Are you aware of a better treatment for incontinence than the mid-urethral sling?" asked William Gage, an attorney for Johnson & Johnson.

"I don't think I have a better option for surgical treatment of incontinence for my patients," Kahn 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 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.

Called as a fact witness by J&J attorneys, Kahn said he billed $550 per hour for his testimony and to date, including preparation work, had billed $5,000 on the case so far.

He said he treats patients for two of the most common urinary problems, stress incontinence, urine leakage in women caused by physical activities such as coughing, sneezing and jumping, and urgent incontinence. He said treatments, in addition to implant surgery, included physical therapy, injections, and working with muscles and vaginal nerves.

“What is the impact of stress urinary incontinence (SUI)?” Gage asked.     

“It’s huge,” Kahn responded. “A lot of women won’t talk about it, they’re embarrassed. They’re not able to do things, to go out running and people want to be active, or doing things with their children. A lot of money is wasted on (anti-leak) pads. It has been kept quieter than it should have been.”

Before the introduction of tension-free vaginal tape (TVT) to deal with SUI, Kahn said in the 1990s, doctors used what is called the Burch Procedure and suspended a leaking bladder with sutures.

He said the development of the new sling technology meant that instead of a three-day stay in a hospital after an implant with perhaps a six-week recovery period, TVT mesh can be implanted in 20 minutes in an out-patient setting and the patient can go home.

“There is shorter recovery and a shorter period before they can get back to their lives,” Kahn said.   

Kahn told Gage his success rate with the implants was at least 80 percent.

“What about chronic long-term pain?” he was asked.

“Very few,” Kahn said.

“Out of 200 patients with follow-up?” Gage asked.

“There was one (with complications) that I know of,” Kahn said.

Kahn said in the single case, a woman sued him accusing him of positioning her implant wrongly and causing her to experience vaginal pain. The case went to court but was decided in favor of Kahn after the woman's allegations were successfully challenged. 

Gage asked Kahn what percentage of his patients experienced painful intercourse after receiving an implant.

“Very infrequent,” Kahn said.

Kahn added that mesh exposure can occur, but is usually treated by removal of the exposed portion of the mesh and the problem solved.

“What about erosions?” Gage asked.

“I have not had that,” Kahn said.

“Vaginal tightening (mid-urethral sling)?”

“None.”

"Urinary tract infections?”

“Very infrequent, I don’t think the mesh caused it.”

“Curling (mesh)?”

“I’ve not seen it.”

“Chronic foreign body rejection?”

“I have not seen it.”

Kahn authored a letter that was sent to the Attorney General's Office earlier in 2019 and signed by 84 California surgeons expressing concern that the lawsuit against Ethicon and J&J could eliminate the mid-urethral sling as a treatment option for women. He said the state's case took the position that doctors and patients had been deceived because of incomplete product warnings.

"We do not rely on the instructions for use (IFU) to counsel our patients," Kahn said in the letter.

Kahn said the state had not bothered to solicit his opinion or those of other doctors.

During cross-examination by state attorneys, Kahn was asked if Ethicon was paying him to testify.

“Yes,” Kahn said.

He explained he was appearing as a fact witness and not an expert witness.

“You could be here without being paid, right?”

“I’m a private practice,” Kahn said. “I put in a lot of volunteer hours without being paid.”

“But you could be here without getting paid?”

“Sure.”

Kahn agreed he had never appeared as a witness for plaintiffs in mesh lawsuits.

“You’ve attended meals (complimentary) from mesh manufacturers?”

“Yes,” Kahn said.

“Pretty nice restaurants?”

“Yes and no,” Kahn said.

Kahn said he had not used any Ethicon products for 15 years.

He was asked if it was important for a doctor to know the cause of complications.

“Any good surgeon will investigate what’s causing it and fix the problem,” Kahn responded.

State attorneys contend the warnings on product packaging for the mesh devices are 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.

The same warning appeared on a number of different company documents, including a brochure.    

“The adverse reactions appear the same,” Kahn was told by a state attorney.

“Yes,” he agreed.

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.

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Organizations in this Story

California Attorney General Johnson & Johnson San Diego Superior Court

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