Johnson & Johnson will pay Vermont $1.37 million for misrepresenting the safety and effectiveness of a surgical mesh product it sold, and failing to sufficiently disclose its risks.
The multistate investigation resulted in 41 states and the District of Columbia receiving a total of $116.86 million for deceptive marketing of the transvaginal surgical mesh devices in violation of the Consumer Protection Act.
The mesh is used by doctors to repair weakened or damaged tissue in a woman’s bladder or pelvic area, treating things like urinary incontinence or pelvic organ prolapse. The term “transvaginal” refers to the surgical technique of implanting the mesh through the vagina.
Restitution for individual women affected by the misleading marketing is still pending in class action cases, according to a press release from the Attorney General’s Office.
Assistant Attorney General Merideth Chaudoir said privacy reasons make it hard for the state to know exactly how many Vermonters were affected by the mesh, but said her office received complaints from 15 different women.
“Those are just the people we know about,” she said. “There could be others out there.”
The investigation found that Johnson & Johnson, and its subsidiary Ethicon Inc. failed to adequately disclose side effects like chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring.
“Johnson & Johnson’s deceptive acts caused women to suffer in profoundly personal ways,” Attorney General TJ Donovan said in a statement. “My office will continue to hold companies who harm Vermonters accountable for misrepresenting the safety and efficacy of their products.”
The Attorney General’s Office noted that there is evidence showing the companies were aware of the possibility of serious complications, but did not provide sufficient warning about those complications.
“The non-mesh surgical alternatives are effective and do not pose the same risks as Surgical Mesh,” the AG’s complaint notes. “Complications resulting from transvaginal mesh surgery can have a crippling effect on a woman’s daily activities, quality of life, sex life, and ability to work.”
The FDA allowed the mesh to be marketed as substantially similar to a previously legalized device, but it never went through the FDA’s formal premarket approval process.
“We have no idea why the FDA allowed them to do that,” Chaudoir said.
“By claiming that their Surgical Mesh devices were FDA approved, when they were not, the Defendants misled doctors and patients into believing that their surgical mesh devices had been well studied, undergone clinical trials, and were scrutinized robustly by the FDA,” the complaint states.
After the FDA reclassified the mesh as a high risk device in 2016, Johnson & Johnson stopped marketing and selling one of its mesh products that the company had previously marketed the mesh as being “minimally invasive with minimal risk.” Another mesh product remains on the market.
Along with the monetary restitutions called for in the case, the company has agreed to provide full disclosure of the devices’ risks, and accurate information on promotional material and package inserts, as well as refraining from referring to the mesh as “FDA approved.”
“We’re investigating other companies that did the same thing,” Chaudoir said. “This is just the first of a couple cases like this. But Johnson & Johnson and Ethicon definitely had the largest share of the market.”
