Johnson & Johnson has agreed to resolve four legal cases involving its vaginal-mesh implants, including one that was being tried last week in Missouri, in the company's first settlements of claims that the devices harmed thousands of women.
The details of the settlements are confidential, said Adam Slater, a lawyer for the Missouri women who settled their state court claims. The women allege the implants made by J&J's Ethicon unit left them in pain; one woman's family said an infection led to her death.
The devices are used to bolster sagging organs and to treat incontinence.
Since 2012, Johnson & Johnson - which has several major divisions in the Philadelphia region, including Tylenol-maker McNeil Consumer Healthcare in Fort Washington - has refused to join settlement talks between plaintiffs' lawyers and other insert-makers seeking a global resolution of the litigation, said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.
J&J faces more than 23,000 lawsuits over the devices.
"It's only four cases, but it's a start," said Tobias, who has been following the vaginal-mesh litigation. "There's still a long way to go to get the whole thing resolved."
The company's agreement to resolve the four cases isn't an admission it engaged in any wrongdoing in connection with the development or marketing of the mesh, J&J said.
"Lawsuits are examined individually in light of the individual nature of the claims," Samantha Lucas, an Ethicon spokeswoman, said in an e-mail. "In some individual cases, the company may consider whether settlement is appropriate."
The Food and Drug Administration ordered J&J, Boston Scientific Corp., and other vaginal-mesh makers in 2012 to study rates of organ damage and complications linked to the implants after the companies faced a wave of lawsuits over the devices.
The women contend, for example, that the mesh in Ethicon's Prolift insert erodes, or shrinks, once it is implanted and damages organs, causing constant pain and making sexual intercourse difficult. J&J agreed in June 2012 to pull four lines of inserts off the market, including Prolift.
U.S. District Judge Joseph Goodwin in Charleston, W. Va., is overseeing all federal mesh suits against J&J, C.R. Bard Inc., and the other insert-makers, which have been consolidated for pretrial information exchanges.
Juries have found that some devices made by J&J, Bard, and Boston Scientific have design flaws and that company officials did not properly warn women about the risks.
Goodwin has been pushing manufacturers to consider settling the cases before they face billions in jury awards.
Another mesh-insert maker, Ireland-based Endo International P.L.C., whose corporate leadership operates out of Malvern, has set aside more than $1.2 billion to cover settlements of claims its devices injured women.
Bard officials agreed to pay more than $21 million to resolve more than 500 suits in that company's first large-scale settlement of vaginal-mesh claims, people familiar with the accords told Bloomberg News in October.