Johnson & Johnson’s Ethicon Inc. unit has agreed to pay nearly $10 million to Washington Attorney General Bob Ferguson to settle the first lawsuit brought by a state over its transvaginal mesh devices.
The $9.9 million settlement, announced just as the trial was set to begin Monday in Seattle, 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.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” Ferguson said in a press release Monday. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct—and look forward to providing millions of dollars in relief to assist those who were harmed.”
Ethicon has faced numerous trials and settled thousands of cases brought by women alleging that the devices, which treat incontinence and pelvic organ prolapse, caused pain during sex and urinary problems that, in most cases, required surgical removal. Verdicts have reached as high as $57.1 million, but Ethicon also has won some trials.
Washington is one of four states that have sued over transvaginal mesh devices. Another case, brought against Ethicon by California Attorney General Xavier Becerra, starts July 12 in San Diego County Superior Court. The states of Mississippi and Kentucky also have sued.
Monday’s trial was expected to last five weeks.
According to a trial brief filed in King County Superior Court, lawyers for the state had planned to argue that Ethicon’s product brochures misrepresented the safety of the devices to doctors. Ethicon also allegedly promoted sales of the devices through marketing to patients.
Ferguson’s office, which handled the case without outside counsel, had asked for disgorgement of at least $16.7 million in net revenues that Ethicon earned from the sale of the devices to 14,000 women in Washington, plus statutory damages of up to $2,000 per violation under Washington’s Consumer Protection Act.
Ethicon had brought in Seattle’s Calfo Eakes & Ostrovsky—in particular, Patty Eakes and Angelo Calfo—as well as Butler Snow’s William Gage, a partner in Jacksonville, Mississippi; Carolyn Kubota, a partner at Covington & Burling in Los Angeles; and Steve Brody, head of the product liability and mass torts practice at O’Melveny & Myers, where he is a partner in Washington, D.C.
“Ethicon is pleased to have reached a settlement with the Washington state attorney general to resolve the pending litigation,” wrote Johnson & Johnson spokeswoman Mindy Tinsley. “Ethicon’s devices for treatment of incontinence are recognized as the standard of care by surgeons and medical professional societies in Washington and around the world. Any contrary allegations are at odds with the views of leading doctors and medical groups, as well as the FDA."
In its trial brief, Ethicon had insisted that doctors were aware of the risks of the products, and, furthermore, relied on their own medical judgment, not just product brochures, to determine whether to recommend them to their patients.
Ethicon had received support from an unusual group: doctors. On Dec. 9, Ferguson received a letter from 63 surgeons in the state of Washington, including three retained by Ethicon in the case, insisting that he drop the lawsuit. The letter said doctors do not look at just the “instructions for use” on pamphlets to determine the risks associated with medical devices.
“It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group,” they wrote.
Tinsley, in her statement about today’s settlement, recognized their support.
“We appreciate the advocacy of the Washington State medical community, many of whom publicly disagreed with the allegations in this lawsuit and supported maintaining options for patients who suffer with the debilitating effects of stress urinary incontinence and pelvic organ prolapse,” she wrote.