Northern California Record

Monday, September 16, 2019

Former Ethicon sales rep says in J&J trial that minimizing risks of pelvic mesh never attempted

State Court

By John Sammon | Aug 28, 2019


Kubota

SAN DIEGO – In a trial to decide if Johnson & Johnson allegedly marketed medical devices knowing they caused harm to women, a former sales rep with Ethicon, the pelvic mesh-making subsidiary of J&J, said on Tuesday he never hid the potential complications of the devices from doctors.

“Did you ever intentionally minimize the risk of the TVT or Prolift?” asked Carolyn Kubota, an attorney for J&J.

“No,” responded Scott Jones, formerly with Ethicon and today a group products marketing director with Janssen Pharmaceuticals of New Jersey, a Johnson & Johnson subsidiary that markets opioids.

“Did you see anyone else intentionally minimize risks?”

“I never saw anyone minimize or downplay the risk (of pelvic mesh),” Jones said.

Attorneys for the California Attorney General's Office later in the day played an Ethicon video made in 2010 in which company officials were seen pledging to recapture doctors who formerly used its pelvic mesh devices and regain a sagging market share.

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.

Jones told Kubota he was with Ethicon for 14 years and involved in the marketing of the company’s TVT and Prolift slings.

“I felt there was an unmet need in women,” he said when asked why he joined the company. “It felt entrepreneurial, that I could come in and help.”  

Kubota asked Jones why he remained with Johnson & Johnson and took a job with Janssen Pharmaceutical.

“I had a vision of rising through the ranks and thought this would be the best way to do it,” he said. “I came to appreciate the (company) business model.”

“What was the goal of the sales function?” Kubota asked.

“To interface between the company and health care providers to find out their needs,” Jones said.

“Did you have a personal (sales) approach?” Kubota asked.

“It was straightforward,” Jones said. “You uncover (doctors’) needs and talk about the (product) benefits. You create a dialog and find a way to meet needs.”

Jones said company sales materials were approved beforehand to be shared with customers.

“Did you try to give a consistent message to customers?”

“I did,” Jones said. “You try to be factual and consistent so you don’t confuse the issue. Standing for the (product) brand was important.”

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

Jones agreed he had received training in the instructions for use (IFUs) that came with product packaging.

“It (IFU) was a labeling document including steps (product use), risks and (potential) adverse events,” he said.

Jones added it was rare for a doctor to ask about an IFU. He agreed the IFUs did not list every possible complication.

He was asked if he would attempt to avoid talking about the possible risks of mesh with a doctor.

“I don’t think it would help to avoid talking about risks,” Jones said. “Just the opposite. You want the doctor to have confidence in the product. If he does, he will use the product again. I would not think about avoiding a risk that would compromise patient outcome.”     

“In seven years in sales, did anyone at Ethicon advise you to minimize risk?” Kubota asked.

“No,” Jones said.

"Did you engage in a deliberate marketing scheme to deceive doctors and patients about the efficacy, risks and complications of the Prolift device?"

"No, I did not," Jones said.

"Are you aware of anyone else (at the company) who did?"

"I am not."

Under cross-examination, a state’s attorney asked Jones if he had believed in the Ethicon products.

“I did,” Jones said.

“Did Ethicon train you in competitive selling?”

“Objection,” the attorney for J&J called.

“Sustained,” ruled San Diego Superior Court Judge Eddie Sturgeon.

Jones was asked if he told doctors about adverse events not mentioned in the product IFU.

“I’m not aware of any,” he said.

“Were physicians targeted as an element of (product) launch strategy?”

“That could happen,” Jones said.

“The marketing message was a piece of information you wanted to communicate in a specific manner?”

Jones agreed.

Jones said sales reps talked with patients in a manner different than they did with health care providers.

“Could scientific data, testimonials and (product) brand be a reason to believe?” he was asked.

“I think so,” Jones answered.

"You were required (company policy) to report adverse events?"

"Correct," Jones answered.

State attorneys asked Sturgeon for permission to exhibit for the court an Ethicon video produced in 2010 designed to recapture what company officials had judged to be a declining share of the pelvic mesh market. The video was titled "Think Again."

"This video retrained reps on competitive selling?" Jones was asked.

"Correct," he said. "It was to take doctors no longer using Prolift and get them to come back."

"The video was shown to sales reps?"

"It would have been," Jones said.

The video featured company personnel declaring their intention to out-sell other mesh companies using sales aids and promotional opportunities.

"'Think Again' means regaining market share," a company officer said in the film.

"We're not taking no for an answer," another said. 

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. 

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