Northern California Record

Saturday, February 22, 2020

State attorneys quibble with defendants over FDA clearance of mesh products in J&J trial

State Court

By John Sammon | Aug 13, 2019


SAN DIEGO – Attorneys for the state of California and those defending Johnson & Johnson accused each other on Monday of misusing studies in a trial to determine if the company sold pelvic mesh devices allegedly knowing they were harming women.

“They are saying fraudulent (study) data is being supplied for this company to rely on,” said William Gage, the attorney representing Johnson & Johnson. “The allegations the state is making are not true.”

“We are going way outside the scope of my examination,” countered Jinsook Ohta, the attorney with the California Attorney General’s Office. “Mr. Gage is going way out on a limb.”

The trial 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.

Dr. Piet Hinoul, global head for clinical and medical affairs of mesh products at Ethicon, appeared for a third day of testimony explaining his role in making certain that company literature and product labels for the pelvic devices were accurate in describing the potential risks.

Ohta exhibited for the court a letter from the Food and Drug Administration (FDA) in 2007 asking for more information from Ethicon on its Prolift device for approval to market under a 510K designation. The 510K says it’s OK to market a device if it’s like other devices already legally on the market with no significant or new differences.

The Prolift Gynecare device was introduced in 2008.

In 2012, the FDA 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.  

“We cannot determine if the device (Prolift) is equivalent to a legally marketed device because you did not completely respond to deficiencies listed in our Aug. 24 (2007) letter," the FDA letter said. "You may not market the device until you have provided adequate information and you have received a letter from FDA allowing you to do so.”

According to exhibited documents, the FDA questioned the Prolift device’s reported greater flexibility and different shape from other pelvic mesh devices.

Ohta also exhibited a document from the FDA that noted that Prolift “had not been demonstrated in clinical trials.”   

Hinoul earlier testified that Ethicon continued to sell the Prolift because company officials believed they had clearance as a result of another pelvic device already on the market.

“At no point did you stop selling Prolift during the (510K) clearance process?” Ohta asked.

“No,” Hinoul agreed.

“That would also apply to Prosima?”


Gage exhibited a memo in 2012 from Hinoul to J&J officials stating that he believed the company had appropriately followed FDA guidance in the matter.

Hinoul said the possibility of chronic pain from an implant could result after transection of nerves took place but if it persisted it could be a specific physical problem with the patient.

“There should be alarm bells going off (prolonged pain),” he said. “A transection of a nerve can heal slowly. That it can become chronic is implied (warnings).”

Gage cited studies that he said showed that chronic pain from devices like the tension-free vaginal tape (TVT) did not persist with a large number of patients. He accused the state of portraying that every patient gets chronic groin pain from pelvic devices.            

A 2014 study by International Urogynecology found that of 124 women tested, 83.5 percent had cure rates.

“A large cohort of patients followed (in studies) did not get long-term pain,” Hinoul said.

Ohta asked Superior Court Judge Eddie Sturgeon to strike Hinoul’s testimony.

“It is not based on (warning) labeling prior to 2013,” she said.

“Overruled,” Sturgeon said.

"To what extent did you or Ethicon intend to mislead with the pelvic mesh instructions for use (IFU's)?" Gage asked.

"It was never our intent to mislead," Hinoul said.

Hinoul added that neither did company marketing materials intend to mislead doctors.  

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San Diego Superior CourtJohnson & Johnson

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