Northern California Record

Monday, November 18, 2019

State witness in J&J pelvic mesh trial says doctors get doctored studies about mesh devices

State Court

By John Sammon | Aug 15, 2019

Fugh berman

SAN DIEGO – In a trial to decide if Johnson & Johnson allegedly sold pelvic mesh devices knowing they were dangerous, a witness for the California Attorney General’s Office on Wednesday testified the industry alters study findings to influence doctors to purchase and use the mesh.

Dr. Adriane Fugh-Berman, professor of pharmaceutical and medical practices with the Georgetown University School of Medicine, said the altering of reports to support industry goals in marketing of pelvic mesh devices extended to making an addition or editing out of one line of information.  

“People (mesh device industry insiders) are hired just to write the last line of an abstract for an article,” Fugh-Berman said.

An abstract is a one-paragraph summary of the findings in a scientific article.

However, attorneys defending Johnson & Johnson countered that Fugh-Berman did not have the background expertise to make such contentions.

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 slings.

The Prolift Gynecare device was introduced in 2008.

In 2012, the Food and Drug Administration 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.

Fugh-Berman appeared as a witness for the state to explain the marketing tactics used by Johnson & Johnson to sell the pelvic mesh devices.

Ali Mojibi, an attorney for J&J, objected to Fugh-Berman’s suitability as an expert witness, saying she had experience in pharmacology but not extensive knowledge of medical devices and could not meaningfully contrast the two.

“Her sample data (medical devices) is very small,” Mojibi said. “It’s speculative – one industry about another.”

In addition, Mojibi said Fugh-Berman had refused to turn over a list of confidential industry insiders who had provided information for a report. Fugh-Berman said she had promised confidentiality to those interviewed but was willing to provide a list to legitimate researchers.  

Superior Court Judge Eddie Sturgeon allowed Fugh-Berman as an expert witness and ordered the testimony to continue.

Jinsook Ohta, an attorney with the Attorney General’s Office, exhibited a chart that stated pelvic mesh industry marketer techniques included use of studies that supported marketing goals, retaining the right to review or even edit sponsored studies, paying consultants to publish favorable studies and refusing to fund studies that did not support industry goals.

The impact on doctors, Fugh-Berman said, was to create in their minds a strong sense of scientific legitimacy. She added that key opinion leaders were also used to influence doctors and promote a community that was "hierarchical" in nature.

Added techniques included use of medical conferences to promote products, building relationships with doctors by gift-giving, treating them to meals, and use of preceptors (mesh implant teachers).

The techniques persuade doctors to use the mesh products, Fugh-Berman explained.

She said J&J used many of the mentioned marketing techniques.

“Can doctors obtain an objective view (of a study) by reading medical literature?” Ohta asked.

“They can, but when it’s co-opted by the (device) industry, it’s not that reliable a source,” Fugh-Berman said.

She said the medical device industry could influence what funding would go to finance a study or back studies that support industry goals even if the studies were biased or incomplete.

“Studies not supportive of the marketing goals of the industry might not get published,” Fugh-Berman said. “They (industry) sponsor studies that are more likely to find favorable results. These can be widely promoted and what reaches physicians can be pro-industry materials.”

In one case, a report that painful intercourse in women who received implants had been removed from an abstract. Thirty-four percent of women in one test group and 51 percent in another reported pain.

“This (percent rate) would be pretty important for physicians to see,” Fugh-Berman said.

Ohta exhibited a draft document from Ethicon that read the "key to successful customer intimacy is in creating emotional loyalty."

Fugh-Berman said sales reps were trained in handling objections from customer doctors.

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