Northern California Record

Sunday, November 17, 2019

Former FDA commissioner says in J&J pelvic mesh trial that approval process based on raising of safety concerns

State Court

By John Sammon | Aug 6, 2019

Kessler2
Kessler

SAN DIEGO – In a trial to determine if Johnson & Johnson harmed women by selling pelvic mesh devices it allegedly knew were dangerous, a former Food and Drug Administration (FDA) commissioner told a court on Monday the FDA approval process was based on whether a product raised new safety issues.

“The theory is look, if it's already on the market (similar product) and you don’t raise any new issues, we (FDA) will let you go on the market,” said Dr. David Kessler, a San Francisco pediatrician. “That’s the 510K standard that’s evolved over time. Then there’s the PMA (pre-market approval) process. That’s an independent determination of safety and effectiveness.”

The 510K requires a submission to FDA to demonstrate a new device is as safe and effective as similar devices already on the market. It is less stringent in its requirements than a PMA, Kessler 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. 

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 (tension-free vaginal tape) slings.

Kessler, who was called as an expert witness by state attorneys, said FDA officials use bench testing, comparative trials and judgment about technical characteristics of sling products to determine if they are suitable for market.

“If a product is found to be sub-equivalent (to an already marketed product), then it is cleared for marketing,” Kessler said.

Kessler said that even if a product was accepted for marketing through the 510K process, it was not an automatic, independent determination the device was safe and effective.

The instruction labeling of mesh sling devices is made according to adverse events. Devices cleared by the FDA for marketing included the TVT sling in 1998, the TVT obturator mid-urethral sling used for female stress urinary incontinence in 2003, the Gynecare Prosima pelvic floor repair system in 2007 and the Prolift Gynecare in 2008.

In 2015, the FDA issued orders to pelvic mesh manufacturers to submit plans supporting the safety and effectiveness of surgical mesh for transvaginal repair.

“What were the reasons the FDA issued the orders?” the state's attorney asked.

“Because of safety concerns after the devices were on the market,” Kessler said.

According to an FDA news release, the number of adverse events for POP devices went up significantly in recent years. An advisory panel of experts recommended in 2011 that more data was needed to establish the safety of the devices.

Several study plans submitted by Johnson & Johnson were subsequently disapproved by the FDA. Kessler said J&J ceased commercialization of three of the devices and changed their intended conditions for use.

On April 16, the FDA ordered manufacturers to stop selling mesh for transvaginal repair of prolapse. In 2017, Ethicon officials decided to discontinue selling the Prolift and Prosima mesh devices.

Potential complications from such devices exhibited in court included foreign body response, erosion, fistula formation, inflammation and infection.

Kessler said FDA clearance to market the pelvic mesh devices did not authorize J&J to exclude potential complications from the labeling.

Under cross-examination, William Gage, the attorney for Johnson & Johnson, questioned Kessler about the frequency of his testimony as a plaintiff witness.

“You’ve been an expert witness 40 times, primarily on the plaintiff’s side?” he asked.

“Correct,” Kessler said.

“As a litigation (witness) expert, you’ve earned millions from that work?”

“Correct.”

Kessler agreed he was not charging California this time but was testifying as a public service.

“You don’t hold yourself as a lawyer; you’re not a pelvic surgeon?”

“Correct,” Kessler said.

“You’ve never performed anti-incontinence surgery?”

“Absolutely not.”

“You’ve never done a clinical study of pelvic mesh devices?”

“Correct.”

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