South Carolina Attorney General (AG) Alan Wilson on Thursday announced Johnson & Johnson (J&J) and its medical device unit, Ethicon, have agreed to pay nearly $116.9 million to settle a multistate lawsuit alleging the companies deceptively marketed vaginal mesh implants.

The settlement comes as J&J faces a number of lawsuits over the company's marketing of opioids, baby powder, and other products, as well as additional lawsuits over vaginal mesh implants. J&J has faced some costly court losses and settlements, but has also garnered some wins, the Wall Street Journal reports.

Background

Millions of women around the world have received mesh implants for transvaginal repair of pelvic organ prolapse and urinary incontinence. FDA in 2002 approved the mesh implants as moderate-risk devices, but in 2016 the agency moved the mesh implants into the high-risk category to recognize risks associated with the implants.

Studies have found up to 15% of women with mesh implants encounter problems. For instance, several woman have said the mesh implants led to bleeding and discomfort during sex. However, removal of the device is not recommended in every case.

The complaints of serious side effects have spurred several lawsuits against mesh manufacturers, including Boston Scientific, Ethicon, and J&J. Overall, more than 100,000 plaintiffs have sued mesh implant manufacturers in federal court.

J&J and several other manufacturers already have stopped selling vaginal mesh implants. FDA said some of the manufacturers removed their implants from the market in 2018 because they did not submit premarket approval applications to demonstrate their products were safe and effective. FDA in April ordered the two remaining manufacturers of vaginal mesh implants to immediately stop selling and distributing the products in the United States, citing safety concerns.

Settlement details

The settlement announced Thursday applies to a lawsuit brought by AGs from Washington, D.C. and 41 states. The lawsuit alleged J&J and Ethicon violated consumer protection laws by misrepresenting the safety and effectiveness of the mesh implants, according to Reuters.

The AGs in the lawsuit claimed J&J and Ethicon had understood the risks of mesh implants—including inflammation, mesh erosion, and pain—but had failed to adequately warn patients and surgeons about those risks.

The settlement—which includes Alabama, Connecticut, Indiana, Ohio, and Wisconsin—resolves the allegations brought by the 41 states and Washington, D.C. An Ethicon spokesperson said the settlement includes no admission of liability or misconduct by Ethicon. The spokesperson noted Ethicon "remains focused on meeting the significant surgical care needs of health care providers and patients."

However, the settlement does not resolve pending lawsuits brought against J&J, Ethicon, and other mesh implant manufacturers by California, Kentucky, Mississippi, and West Virginia, Reuters reports.

Comments

Wilson said, "Women in South Carolina and across the country were injured by the deceptive marketing of this product when they trusted that they were being helped. This settlement holds the companies accountable for violating state law and will prevent this deception from continuing."

Ohio AG Dave Yost said, "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. These companies didn't paint a clear picture of the device's medical risks, preventing patients from making well-informed decisions" (Sebastian, Wall Street Journal, 10/17; Mathias/Raymond, Reuters, 10/17; Wilson announcement, 10/17).