Northern California Record

Sunday, October 20, 2019

Ethicon complaint reviewer says in J&J trial that patients felt vaginal mesh instructions fell short of explaining risks

State Court

By John Sammon | Aug 1, 2019


Chen

SAN DIEGO – In a trial to determine if Johnson & Johnson officials sold vaginal mesh implant kits to doctors to make profits knowing the devices were harming women, a complaint reviewer on Wednesday said some sling patients had felt misled about the risks.

“I saw there were (complaint) patterns,” said Dr. Meng Chen, a San Francisco doctor and former medical director for surveillance safety at Ethicon, a J&J subsidiary that made the vaginal mesh that is the subject of the suit.

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 a pelvic mesh device called Prolift, made by 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.

Daniel Osborn, deputy attorney general for the California Department of Justice, asked Chen how complaints generated from users of the slings were handled.

“We (Ethicon) had an established company mechanism where we discussed (complaints) in weekly review meetings,” Chen said. “This was not a report, but to communicate.”

Chen said her job in part was to spot patterns of developing complaints. Noted complaints were produced on forms called Med Watch Reports that indicated adverse events. One such report in 2007 exhibited by Osborn recalled a woman who six weeks after implantation of a sling device experienced erosion of the device. At 10 weeks, her husband reportedly experienced a cut penis during intercourse.

The woman needed additional surgeries.

On one of the forms regarding complaints Chen had written to Ethicon colleagues, “We need to cry wolf.”

"Does 'cry wolf' mean raising a false alarm?” Osborn asked.

“Yes," Chen said.

“Were you raising a false alarm?”

“No.”

Chen said she was simply raising awareness of the complaint trends she saw to company officials.

“I had a hunch,” she said. “It didn’t mean it was a false alarm. It was to get their (managers) attention and say we need to pay attention to this.”

Osborn asked Chen about meetings to discuss complaints made by patients. Some complained that they had not been adequately warned about the risks of the mesh sling devices. The meetings were held to consider if updating of instructions for use, called an IFU, for the Prolift sling device should be considered.

In one exhibited email document in 2009, Chen reported, “It should be spelled out that transitory local irritation at the wound site and transitory foreign body response to the tape may occur. The response could result in tape extrusion, tape erosion, fistula formation or inflammation.”

In another email statement, Chen wrote, “From what I see each day, these patient experiences are not transitory at all.”

Another statement from Chen after reviewing complaints read, “Patients did not feel there was adequate pre-op consent or risk/benefit assessment.”

“Did I read that right?” Osborn said.

“Yes,” Chen answered.

However, Chen said she was not responsible for updating IFUs for sling products.

“Just to bring up my impressions,” she said.“Not whether IFUs should be updated. I did not have an opinion whether the IFUs were not conveying information. It didn’t mean I identified any deficiencies. If I saw a pattern (complaints) I would raise it with my colleagues.”

In 2009, the Prolift IFU was updated to include the possible complication of urinal obstruction.

Chen was asked if her recommendations had a part in the IFU addition.

“Yes, I was a part of the effort,” she said. “It was very important to change the IFU.”

“The complaints you were seeing matched the FDA’s health notification?”

“Yes,” Chen said.

Prolift was introduced by Ethicon in 2005 but the Food & Drug Administration issued a public health notification in 2008 expressing concern after reports of complications from the use of vaginal mesh devices. The FDA ordered Ethicon and other manufacturers to cease production until further testing could be made. In 2012, Johnson & Johnson removed Prolift from the market.

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