SAN DIEGO (CN) – In the first pelvic mesh trial brought by a state attorney general, attorneys for the state of California said Monday that Johnson & Johnson deceived up to 50,000 California women and doctors into treating incontinence and organ prolapse with the risky treatment and asked for nearly $1 billion in damages.
California Deputy Attorney General Jinsook Ohta told Superior Court Judge Eddie Sturgeon during opening statements of the bench trial that Johnson & Johnson’s Ethicon Inc. used deceptive marketing to convince 50,000 California women and their doctors to use the company’s pelvic mesh “ready-made kits” in surgical procedures to treat stress urinary incontinence and pelvic organ prolapse, common conditions which affect up to 50% of women over age 50.
California claims Johnson & Johnson and Ethicon violated state unfair competition and false advertising laws. Each violation comes with a $2,500 fine, which means if Sturgeon finds Johnson & Johnson violated the laws for all 50,000 California women who received the devices, it could have to pay $250 million on top of a requested $704 million penalty for violating the unfair competition law.
A similar case brought by Washington state Attorney General Bob Ferguson settled for nearly $10 million on the first day of trial this past April.
Johnson & Johnson is valued at over $70.4 billion.
Ohta called the common conditions “lifestyle conditions that are not life-threatening,” noting many women do not opt for surgery to treat the conditions and instead wear diapers or pads. But for those who choose to address the conditions with surgery, Ohta said the treatment should not introduce complications more serious that the original condition.
But Ethicon “chose to deceive doctors and patients,” Ohta said, by failing to disclose dangerous risks associated with pelvic mesh surgical procedures including chronic inflammation, chronic foreign body reaction, the formation of stiff scar tissue which causes chronic pain, mesh degradation, painful sex and sexual dysfunction, and incontinence, among other complications.
“[They were] gambling with their sex life, rolling the dice with their quality of life,” Ohta said.
The state says it will call patients who’ve suffered painful sex since having the pelvic mesh procedures, including a woman whose husband’s penis suffered scratches during sex following her pelvic mesh surgery.
Ohta said Johnson & Johnson did not disclose the appropriate risks on the “Instructions for Use” documentation provided to doctors with the medical devices.
“Truthful advertising under California law means you have to give the good with the bad,” Ohta said.
Ohta said the only complication Johnson & Johnson disclosed to doctors was that the mesh could erode. She also said when doctors and patients came forward about complications, their complaints were ignored.
“[They] blamed the doctors, blamed the women, blamed the surgery, they blamed everything they could think of besides the mesh itself,” Ohta said.
Johnson & Johnson engaged in a campaign called “surround sound marketing,” Ohta said, where it convinced women who would have otherwise not gotten the surgery to go under the knife based on claims in brochures touting the surgery as a “quick, easy, minimally invasive” outpatient procedure.
Ohta said Johnson & Johnson’s “deceptive” marketing messages were distributed in California over 196,000 times.
But Ethicon attorney Carolyn Kubota of Covington & Burling in Los Angeles said “not a stone has been left unturned in assessing the risks and complications” of the devices. She said the surgeries which use Johnson & Johnson products are the “most studied incontinence procedures in history” with over 2,000 publications on the treatments.
Kubota said Johnson & Johnson would call doctors to testify about having provided thousands of California women with relief through pelvic mesh surgery.
Disputing the “Instructions for Use” document did not properly identify risks associated with the device, Kubota said doctors learn about procedure risks from medical training, not reading the instruction manual.
She said the document discloses the risks, “just not in the words the attorney general would prefer” and “that’s not an unfair competition law violation.”
“You can’t fit a whole medical education on a document that comes in a box,” Kubota said.
Kubota disagreed stress urinary incontinence and pelvic organ prolapse are “lifestyle conditions,” saying left untreated the conditions “can ruin your life.”
“It probably goes without saying wearing diapers as an adult woman causes a lot of shame and embarrassment,” Kubota said.
Modern pelvic mesh devices sold by Ethicon were originally developed by doctors who utilized products used in hernia surgeries to treat the conditions common among older female patients.
Ethicon brought standardization and design and manufacturing know-how to what doctors were already doing, Kubota said.
“These products are not the result of a bunch of marketing executives sitting around a table and dreaming up products to sell to doctors,” Kubota said.
The trial is expected to last between seven and eight weeks.