Northern California Record

Monday, September 16, 2019

J&J witness in mesh trial says warnings on devices are adequate, give women chance to lead 'normal lives'

State Court

By John Sammon | Aug 21, 2019


Nager

SAN DIEGO – In a trial to decide if Johnson & Johnson allegedly marketed pelvic mesh devices in a fraudulent manner harming women, an expert witness for J&J on Tuesday said the benefits to women of the devices far outweighed the risks of major complications that he said were a low percentage of cases.

Dr. Charles Nager, a San Diego gynecologist and obstetrician, added that attempting to warn of every possible complication from mesh implantation on labels and brochures would be impossible, requiring page after page of information. He also indicated instructions for use (IFUs) on pelvic mesh kits were only intended to give a brief overview of the implant procedures and not information doctors would rely upon in treating patients with urinary dysfunction.   

“Was (warning) information adequate for what was intended?” asked Carolyn Kubota of Covington and Burling, a J&J attorney.

“It was,” Nager said.

Attorneys for the California Attorney General's Office contended Nager exhibited a conflict of interest as a paid consultant for the mesh industry.

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.

Nager appeared for a second day as the first witness called by J&J attorneys after the state rested its case on Monday.

Kubota asked Nager what percentage of patients coming to him had stress urinary incontinence (SUI). He estimated 30 percent.

Nager said the implanting of mesh devices had given women suffering from incontinence and vaginal conditions a chance to lead normal lives.

“What is the physical toll of stress urinary incontinence?” Kubota asked.

“Patients come to see us because they’re bothered,” Nager said. “They have to use pads and diapers (urine leakage) and they’re so relieved there is a specialty (mesh) that will help them. They smell like urine and because of it they’re ostracized and they’ve become desperate. Pads and (anti-leak) garments are expensive they can cost $1,000 or more.”

The impacts of suffering from SUI and other pelvic conditions can be devastating, Nager said.

“Women give up exercise because of fear of urine leakage and become sedentary, they’re afraid to laugh because it might set off a leaking event and stop having sexual intercourse,” he explained.

In one case, Nager said a champion woman weight lifter retired from the sport because of incontinence but after the implantation of a mid-urethral sling, was able to resume her competition.

“She’s incredibly grateful for this,” Nager said.  

Kubota exhibited for the court an informed consent form used by Nager and other doctors to discuss with patients before a mesh implant surgery. Complications listed on the form included bleeding, infection, possible damage to organs, mesh erosion, painful intercourse, pelvic and back pain, possible long-term complications, difficulty urinating and possible worsening urinary incontinence.

“When do you use this?” Kubota asked.

“Twice,” Nager said. “During the talk-about (with patient) and then during a pre-operative visit.”

“Are all the risks covered?”

“No," Nager said. "That would be impossible. It would be confusing rather than helpful.”

An exhibited patient brochure stated “For a complete description of the risks, see the attached product information.”

“Do you give patients brochures?” Kubota asked.

“I do,” Nager said.

“Would you if you considered the brochures to be misleading?”

“No.”

“What if I was a patient and said I wanted surgery, would you?”

“No,” Nager said. “Discussion with the patient would be long and careful so she understood the options.”

“Whose responsibility is it to advise of the risks?”

“The physician,” Nager said.

Nager said IFUs are not used by doctors to gain consent from patients for surgery. He indicated the IFU was simply a brief walk-through description of the procedure. He said doctors rely on evidence and what has been learned from scientific published studies to advise patients.

In earlier testimony, lawyers for the state questioned why potential “life-changing” or “life-long” complications were not part of the warnings. Nager disagreed the term "life-changing" was a separate complication from the possible “chronic pain” listed in such warnings.

“What kind of surgery can result in chronic complications?” Kubota asked.

“Any I do,” Nager answered.

Under cross-examination, Jinsook Ohta, an attorney with the Attorney General's Office, attempted to establish that Nager's testimony denying he had a conflict of interest with the mesh industry was contradictory. She questioned him about a 2014 position paper he co-authored called "Advancing Female Pelvic Medicine & Reconstructive Surgery" for the American Urogynecologic Society (AUGS). The Maryland-based organization's mission is to treat female pelvic disorders.

“You were a preceptor (paid teacher of mesh implants) for Ethicon,” Ohta said.

“Yes,” Nager agreed.

“Why didn’t you stay a preceptor for the company?” Ohta asked.

“I don’t recall, I ran out of time or energy,” Nager said.

“You didn’t leave because they (Ethicon) refused to fund a study you requested?”

“I have no recollection of that,” Nager said.

Nager told Ohta he was one of five co-authors of the AUGS position paper.

"Were you aware that other co-authors were paid industry consultants?”

“I learned about it later,” Nager said.

"Were you aware Dr. Howard Goldman (AUGS position paper co-author) was a paid consultant for Ethicon and was paid more than $177,000?" Ohta asked.

"No," Nager said.

"Were you aware that Dr. Dennis Miller (co-author) had a relationship with Boston Scientific (mesh manufacturer)?" 

"Yes," Nager said. "He was involved in design of one of the mesh devices." 

"The Pinnacle POP?" Ohta asked.

"That's correct," Nager said.

According to the law firm of Levin Simes Abrams, some of the Pinnacle devices were recalled last May over safety concerns about low tensile strength between a needle and suture. Approximately 540 of the Pinnacle pelvic floor kits had been distributed.

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