Northern California Record

Saturday, December 14, 2019

State attorneys argue J&J missed adequate label warnings in pelvic mesh trial

State Court

By John Sammon | Aug 8, 2019

Hinout
Hinoul

SAN DIEGO – In a trial to decide if Johnson & Johnson sold pelvic mesh implants allegedly knowing they could harm women, state attorneys on Wednesday attempted to get a top company official to admit that risk warnings on the products had been lacking.

Jinsook Ohta, the attorney with the state's attorney general's office, asked if the words “life-long erosion” and possible “re-occurrence” were cited in the warnings of potential risk.

“Re-occurrence and life-long (complications) are not cited,” said Dr. Piet Hinoul, global head for clinical and medical affairs of mesh products at Johnson & Johnson.

“Does the warning say life-long dyspareunia (painful intercourse)?” Ohta asked.

“Not in those words, no,” Hinoul said.

“Debilitating and life-changing?”

“No.”

“Does it say the need for possible (mesh) removal?”

“It does not.”

“Is life-long exposure included?”

 “I don’t see it, no.”

Attorneys defending Johnson & Johnson however maintained that no such wording had been requested by the Food and Drug Administration (FDA).

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.

Hinoul, a gynecologist, was responsible for development of the mesh products produced by Ethicon and as part of its Medical Affairs Department, tasked with insuring the accuracy of marketing materials.

Ohta asked him if it was possible implanted mesh could erode and become visible inside the vagina.

“That’s correct,” Hinoul said.

“It can also erode into other organs?”

“Correct.”

“Is there life-long risk with tension-free vaginal tape mesh?”

Hinoul agreed it was a possibility.

“There is a recurring risk, correct?”

“It can reoccur,” Hinoul said.

“TVT may need to be removed because of pain and dyspareunia?”

“In rare circumstances, yes,” Hinoul said.

“Pain can be debilitating?”

“In rare occurrences,” Hinoul said.

Hinoul cautioned against overstating the possibility of complications that he said would be misleading.

Ohta listed other possible complications of the mesh devices including contraction, scarring and pelvic pain.

“Can these become permanent?” she asked.

“Possibly, yes,” Hinoul said.

Ohta exhibited a J&J brochure for mesh that was titled “Stop Coping Start Living.”

One warning directed the reader to go to another source for a “complete description of the risks,” while another label advised the reader to “discuss carefully with your physician” a decision to have a mesh implant.

“Would a patient assume this was a complete description of the risks and everything was true?” Ohta asked.

Hinoul agreed, but qualified that some of the labeling was intended for doctors and not patients who would not have the same expertise. He indicated a description of the mesh as a “minimally invasive procedure” was not an attempt to sell the product, but to advise.

“Did the company decide to leave out complications from the instructions for use because the complications happened infrequently?” Ohta asked.

“No,” Hinoul responded.

“Because they were known to doctors?”

“Yes.”

Hinoul explained that some of the instructions for use were for doctors familiar with the surgical procedures.

“We didn’t leave it out because we assumed it was otherwise known,” he said.

Under cross-examination, Hinoul told William Gage, the attorney defending Johnson & Johnson, that FDA warnings about the mesh implant devices corresponded to those the company used.

Gage presented a table of adverse events reported on an FDA chart during the period 2008 to 2010.

“Do you see shrinkage of mesh (wording on FDA chart)?” Gage asked.

“No,” Hinoul said.

“Migration (of mesh)?”

“No.”

“Balling of mesh?”

“No.”

"Folding of mesh?"

"No."

The FDA table listed possible complications including pain, erosion, infection, urinary problems, organ prolapse, incontinence, bleeding, dyspareunia, neuromuscular problems and vaginal scarring.

“In your role as (Ethicon) medical director, were you instructed (by FDA) to make improvements to (product) labeling of any kind?”

Hinoul said no such request had been made.

“I would have been consulted,” he said.

“At any time did the FDA communicate to Ethicon that with respect to the TVT line of devices, that improvements in physician labeling were necessary?”

“No,” Hinoul said.

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