CVN screenshot of California Deputy Attorney General Jinsook Ohta delivering her opening statement
San Diego, CA - Johnson & Johnson faces potentially $1 billion in damages at a trial that began this week in California state court in a lawsuit brought by the state’s attorney general over allegedy defective pelvic mesh implants manufactured by the company’s Ethicon unit.
The case, the first of its kind to go to trial, involves allegations that Ethicon used deceptive marketing to induce nearly 50,000 women and their doctors to use pelvic mesh implants to treat conditions like stress urinary incontinence and pelvic organ prolapse. All other pelvic mesh trials to date involved product liability and personal injury claims brought by individual plaintiffs.
The state claims Ethicon violated unfair competition and false advertising laws by withholding information about the risks associated with mesh implantation. Thousands of women claim mesh implants left them suffering from chronic severe pain, infections, and requiring numerous additional surgeries in sometimes futile attempts to fully remove the mesh later.
Each of the alleged violations entails a $2,500 fine, which means the company (currently valued at over $70 billion) could face potential damages of nearly $1 billion.
Ethicon maintains they adequately informed patients and doctors about the risks associated with mesh implants, and that the devices offer a safer alternative to invasive surgeries.
The full trial, which is taking place before San Diego County Superior Court Judge Eddie Sturgeon, is being heard without a jury, and the full proceedings are being webcast gavel-to-gavel by Courtroom View Network.
During her opening statement on behalf of the state, Deputy Attorney General Jinsook Ohta argued that treatment for afflictions she described as “lifestyle conditions that are not life-threatening” should not leave women with more serious medical complications than before receiving the device.
She claimed Ethicon “chose to deceive doctors and patients” about the potential for a chemical in the mesh, polypropylene, to cause an adverse reaction with bodily fluids and tissue that can lead to chronic inflammation and scarring.
“[They] blamed the doctors, blamed the women, blamed the surgery, they blamed everything they could think of besides the mesh itself,” Ohta said.
Ohta argued that many women treat conditions like incontinence with sanitary pads and other over-the-counter options, and that they only opted for mesh implantation only because of a concerted marketing approach to tout the surgery as a “quick, easy, minimally invasive” outpatient procedure.
“Truthful advertising under California law means you have to give the good with the bad,” she said.
Representing Ethicon, Carolyn Kubota of Covington & Burling argued during her opening statement that the risks associated with mesh implantation are well-known to the medical community. She claimed Ethicon provided adequate warnings in the instructions that come with the devices, suggesting that doctors learn about the risks of a procedure from their hand-on training.
“You can’t fit a whole medical education on a document that comes in a box,” Kubota said.
She disagreed with Ohta’s characterization of conditions like incontinence and organ prolapse “lifestyle conditions” and said they seriously impacted women’s quality of life.
“It probably goes without saying wearing diapers as an adult woman causes a lot of shame and embarrassment,” Kubota said.
While continuing to defend the safety of their mesh devices in court, Ethicon and other mesh manufactures have voluntarily withdrawn their pelvic mesh products from US markets in recent years for treatment of incontinence and organ prolapse. It is still used to treat other conditions like hernias.
In April the U.S. Food & Drug Administration ordered the only two companies still selling mesh products for transvaginal use, Boston Scientific and Coloplast, to halt their distribution citing safety concerns.
Two weeks prior to that decision, a lawsuit brought by Washington State similar to the pending California action settled on the eve of trial, with Ethicon agreeing to pay $9.9 million while not having to admit any wrongdoing.
The ongoing trial in San Diego could take up to two months to complete.
The case is captioned The People of the State of California v. Johnson & Johnson, case number 37-2016-00017229-CU-MC-CTL in the Superior Court of the State of California, County of San Diego.
Email David Siegel at dsiegel@cvn.com