California AG's Trial to Begin Over J&J's Pelvic Mesh Devices
California Attorney General Xavier Becerra goes up against Johnson & Johnson's Ethicon unit in the first trial involving a state's claims over pelvic mesh products. Washington Attorney General Bob Ferguson reached a $9.9 million settlement just before his trial April 22.
July 08, 2019 at 03:30 AM
4 minute read
The first transvaginal mesh trial involving a state attorney general starts this month, with the state of California suing Johnson & Johnson's Ethicon Inc.
The bench trial, with opening statements set to begin July 15 in San Diego County Superior Court, features the same defense team that represented Johnson & Johnson in a similar case brought by Washington Attorney General Bob Ferguson that settled for nearly $10 million on April 22, the first day of trial.
In a lawsuit filed in 2016, California Attorney General Xavier Becerra alleges that Johnson & Johnson misrepresented the safety of its mesh devices to doctors and their patients.
“J&J deceptively marketed its surgical mesh devices as safe with minimal risk when in fact these devices exposed women to a host of dangerous complications,” wrote California Deputy Attorney General Jinsook Ohta, in the complaint. “J&J did this despite being urged by its own medical advisers and employees to warn doctors and patients of pain with intercourse, sexual dysfunction, and impact on quality of life.”
Ohta is among a team of lawyers at the California Attorney General's Office handling the case.
The complaint seeks an unspecified amount of statutory damages under California's unfair competition and false advertising laws. According to a press release the California Attorney General's Office issued when it filed the complaint, J&J sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California.
Ethicon has turned to Butler Snow's William Gage, a partner in Jackson, Mississippi; Carolyn Kubota, a partner at Covington & Burling in Los Angeles; 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.
“The attorney general's position is at odds with the views of leading doctors and medical groups both in California and around the world, as well as the FDA,” wrote Ethicon spokeswoman Mindy Tinsley. “The evidence presented will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products.”
Ethicon is one of several companies facing numerous trials over its transvaginal mesh devices, which treat incontinence and pelvic organ prolapse. 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.
In the state of Washington case, the attorney general had planned to argue that Ethicon's product brochures misrepresented the safety of the pelvic mesh to doctors and that it promoted sales of the devices through marketing to patients.
Ethicon had insisted that doctors were aware of the risks and relied on their own medical judgment—a similar argument raised in a failed demurrer the company filed in the California case.
Prior to the Washington trial, 63 surgeons in the state, including three retained by Ethicon in the case, wrote a letter to Ferguson insisting that he drop the lawsuit. The $9.9 million settlement with the state of Washington sets up a claims process that compensates women who had pelvic mesh devices surgically implanted in them. It also prohibits Johnson & Johnson from making false or deceptive statements about the risks of its mesh products.
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