SAN DIEGO – Trial opened Monday in a lawsuit filed by California Attorney General Xavier Becerra accusing Johnson & Johnson and its pelvic mesh device called “Prolift,” made by subsidiary Ethicon, of causing vaginal injuries in women and said the company had engaged in deceptive marketing practices.
Defense attorneys argued the mesh implant was a highly regulated state-of-the-art device for a sagging bladder that came with risk warnings.
“Midurethal slings have become the gold standard for women with stress urinary incontinence (SUI),” said Carolyn Kubota, attorney for Johnson & Johnson with the law firm of Covington & Burling in Los Angeles.
The trial in the Superior Court of California Central Courthouse is being streamed live courtesy of Courtroom View Network.
Since 2012, numerous lawsuits have been filed by individual women who had mesh devices implanted who later alleged they suffered intense pain and side effects that required the devices to be surgically removed with great difficulty.
Washington State sued Johnson & Johnson earlier this year in a similar case but the company agreed to pay $9.9 million to settle with no admission of wrongdoing. The case at trial in San Diego is the first filed by a state attorney general over the implant devices and seeks damages under unfair competition and false advertising laws.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014, designed to help a condition called “pelvic organ prolapse” or POP.
During opening remarks, deputy attorney general Jinsook Ohta, one of a team of in-house attorneys serving in the AG’s office, said Ethicon products had been misrepresented to doctors through deceptive marketing. She said the devices were prone to shrinking and contracting once implanted in the body, causing inflammation and the release of acids damaging tissue as the body tried to reject the device.
“Johnson & Johnson misrepresented the permanent foreign body reaction,” Ohta said.
The result she said could be the formation of a stiff scar plate in the vaginal region. The device also caused colonization of bacteria at the site of the implant.
“It leads to a host of harms,” Ohta said. “Polypropylene is reactive to the body and can crack and physically de-form causing loose (breaking off) particles to lodge in vaginal tissue creating pain. These are dramatic and severe consequences for women including the possibility of a permanently destroyed vagina.”
Women have described it like having glass shards inside them, and after lovemaking a husband reported suffering scratches on his penis, according to testimony.
“Removal of the devices is like removing (concrete) rebar on a sidewalk,” Ohta said. “The removal is exceedingly difficult. J&J sold these (implants) to doctors without an exit (removal) strategy.”
Ohta said the company knew the risks but concealed the information from doctors and patients.
She said product instructions for use (IFU’s) minimized risks to give the impression the products were no more dangerous than non-mesh treatments.
“The company (J&J) sold the products for 17 years before 2015 by lying about the dangerous properties of the mesh," Ohta said. "You have to give the good news with the bad and fully portray the risks.”
She alleged that the company misled doctors during trainings to teach how to implant the devices and used key opinion leaders (KOL’s) to influence the idea the devices were less risky than they were.
“Brochures said it was quick and easy, no big deal, that erosion was the only unique risk of the mesh and it was a minimally invasive procedure,” Ohta said.
In rebuttal, Kubota said the mesh devices had helped thousands of women to improve their quality of life.
“Doctors learn about the risks from their training and not the IFU,” she said. “The (state attorneys) will say the risks were not expressed strongly enough. Our risk disclosures disclosed the risk, just not what the attorney general wants.”
Kubota said the state is required to prove deception by Johnson & Johnson.
“Product documents are not likely to deceive doctors,” she said. “Ethicon adequately disclosed the risks.”
Kubota said left untreated stress urinary incontinence can ruin a person’s life.
“The muscles are no longer strong enough to support the urethra,” she said. “This has the effect of putting a woman on a leash.”
She added that elderly women are placed in rest homes because without the bladder control offered by the products people tire of cleaning up their urine.
The mesh devices became available in kit form in the late 1990s. Kubota said the devices offered women huge advantages. The implant could be inserted in a narrower region of the vagina rather than a larger hip-to-hip surgical procedure.
“A woman having one put in could walk out (of the doctor’s office) the same day,” Kubota said. “Do doctors know the risk of erosion, absolutely.”
Kubota indicated that IFU’s a slip of paper with limited space for instructions were never intended to take the place of a doctor’s medical education.