Morrisey filed a consumer protection case against the company in September, saying it misrepresented the risks and effectiveness of the medical implant. The federal Food and Drug Administration stopped sales of the synthetic mesh in April 2019 after years of injury reports as well as tens of thousands of lawsuits from women who said they had bleeding, severe pain and infection from the products, also called transvaginal mesh. Several major manufacturers, including Johnson & Johnson, had previously stopped making the implants.
The suit in West Virginia accused Johnson & Johnson and its subsidiaries of sending out misleading information about the mesh, sometimes using studies written by paid consultants. “The improper marketing of medical products can put the health of consumers at risk,” Morrisey said. “This settlement demonstrates our office’s commitment to hold accountable corporations who ignore potential risks and side effects or omit such crucial details from the materials provided to doctors and patients.”
The settlement also resolved allegations against Johnson & Johnson that deceptive marketing practices were used involving metal-on-metal hip replacement systems. A spokeswoman for New Brunswick, New Jersey-based Johnson & Johnson didn’t immediately reply to a request for comment on the settlement.
In January, a judge in San Diego ordered Johnson & Johnson to pay nearly $344 million in penalties over the marketing of the pelvic mesh devices in a lawsuit brought by California. The company in October also agreed to a $117 million settlement involving similar allegations with 41 others states and the District of Columbia.
Gynecologists in the 1990s starting adapting surgical mesh to treat pelvic collapse in women, which can cause the bladder or reproductive organs to move, leading to pain and urinary issues. The FDA approved the mesh specifically for such usage in 2002.
But the FDA received thousands of reports of injuries and issued a series of warnings. The mesh can sometimes shift out of place, damaging internal organs or the abdomen wall, requiring multiple surgeries to fix. In 2016, the agency reclassified the mesh as high-risk.
As with most medical devices on the market, the FDA approved pelvic mesh through a regulatory pathway that reviews new products based on their similarities to decades-old devices already on the market, rather than new testing in patients.
Last November, the FDA announced plans to revamp that system so that medical devices would use more up-to-date technology.