San Diego Hall of Justice, 330 West Broadway, San Diego (Photo: Shutterstock.com)

A lawyer for the state of California asked a San Diego judge Monday to impose more than $700 million in civil penalties against Johnson & Johnson over its transvaginal mesh devices.

The bench trial is the first between a state attorney general and a manufacturer of transvaginal mesh devices, implanted in women to treat pelvic organ prolapse and urinary problems. The 2016 case alleges that Johnson & Johnson's Ethicon Inc. misrepresented the safety of its mesh devices to doctors and their patients.

“We're here today because Johnson & Johnson, and its wholly-owned subsidiaries, Ethicon Inc. and Ethicon U.S. LLC, misrepresented to doctors and misrepresented to patients the dangerous properties of their mesh material that leads to serious complications,” said California Deputy Attorney General Jinsook Ohta in her opening statement, broadcast by Courtroom View Network. “They did this despite the fact that the company knew the risks, but they went ahead and misled the public and ignored the internal warning signs they could have heeded to stop their deceptive behavior.”

She sought $704 million in statutory penalties against the New Jersey-based company.

Johnson & Johnson attorney Carolyn Kubota, a Los Angeles partner at Covington & Burling, refuted those allegations in her own opening statement.

“Ethicon adequately disclosed the risks of our products, and they did so in a way that was clear to doctors and clear to patients,” she said. She told the judge that 2,000 studies have looked at the safety of mesh products and that a “cottage industry” of plaintiffs lawyers and experts were behind California Attorney General Xavier Becerra's lawsuit.

She noted that 82 “leading doctors” in California had written a letter to Becerra opposing his lawsuit and endorsing Ethicon's mesh products, which are the “gold standard” in the medical community.

A similar case brought against Ethicon by Washington Attorney General Bob Ferguson settled April 22 for $9.9 million just hours before opening statements were set to begin.

The trial in San Diego County Superior Court features the same defense team as in the Washington state case: In addition to Kubota, the team includes Butler Snow's William Gage, a partner in Jackson, Mississippi; and Steve Brody, head of the products liability and mass torts practice at O'Melveny & Myers, where he is a partner in Washington, D.C.

Ethicon is one of several companies facing numerous trials over its transvaginal mesh devices. It also has settled thousands of cases brought by women alleging that the devices caused pain during sex and urinary problems that, in most cases, required surgical removal. Verdicts have reached as high as $120 million, but Ethicon also has won some trials.

In addition to Washington and California, the states of Mississippi and Kentucky also have sued Ethicon.

Ohta told San Diego County Superior Court Judge Eddie Sturgeon that Johnson & Johnson used “aggressive and deceptive” advertising, recruited “key opinion leaders” and lobbied professional organizations to convince doctors and patients to use transvaginal mesh devices, despite ignoring its own medical directors who flagged serious complications for 18 years.

“The company knew from the time of launch that these mesh devices carried significant and long-term risks but lied about them,” she said.

The company disclosed in its instruction materials a potential risk of erosion but failed to list a “whole host of unique dangers,” which included chronic pain during sex, urinary problems and complicated surgeries to remove the mesh, she said. She said women would testify during the trial about having a “permanently destroyed vagina,” or her husband having “scratch marks on his penis.”

Kubota, in response, called the risk warnings a matter of wording.

“First of all, our risk disclosure absolutely discloses the risks of our devices,” she said. “They just don't do so in the words the attorney general would prefer.”

The U.S. Food and Drug Administration issued warnings about the devices in 2008 and 2011. More than 50,000 women in California had the devices implanted in them, Ohta said.

She based her damages request on $5,000 per violation in statutory damages under both California's unfair competition law and false advertising law. A state's expert would testify that Johnson & Johnson circulated its deceptive messages 196,204 times, she said. She also said that $704 million would be reasonable based on Johnson & Johnson's conduct over so many years, and its assets of $70.4 billion.

“The company had the truth since 1998, when they were the only source of this information, and they did everything to cover it up with their deceptive marketing,” she said. “While the discretion will rest with the court in terms of penalties, the people contend the conduct and high stakes concerning women's health merits maximum penalties.”