The states and DC alleged that J&J and subsidiary Ethicon broke state consumer protection laws by misrepresenting the safety and effectiveness of its mesh devices, which are designed to treat pelvic organ prolapse and stress urinary incontinence in women, and failed to adequately disclose their risks.
The $116.9 million settlement is the result of a multi-state investigation that found that J&J concealed potential adverse events including chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations and vaginal scarring. It requires full disclosure of pelvic mesh risks, including in promotional materials and the devices’ instructions for use.
“Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices,” according to a press release from Ohio AG Dave Yost.
“Patients can’t make the best decision for their health unless they and their health care providers know all the pros and cons of a product,” Yost said. “These companies didn’t paint a clear picture of the device’s medical risks, preventing patients from making well-informed decisions.”
In addition to Ohio and DC, the states included in the settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia and Wisconsin.