By Tina Bellon
(Reuters) – Johnson & Johnson and its DePuy Orthopaedics unit have agreed to pay $120 million to resolve deceptive marketing claims by several U.S. states over the company’s metal-on-metal hip implants.
Attorneys general of 46 U.S. states announced the settlement agreement in statements on Tuesday. They alleged DePuy engaged in unfair and deceptive practices in the promotion of its ASR XL and Pinnacle Ultamet hip implant devices.
DePuy in a statement said the settlement involves no admission of liability or misconduct on the part of the companies.
“DePuy Synthes remains committed to meeting the current and future needs of orthopedic surgeons and patients,” the company said.
The states claimed J&J made misleading claims about the longevity of its metal-on-metal hip implants, with patients frequently having to undergo a revision surgery before the company’s advertised timeframe of five years.
Under Tuesday’s settlement agreement, DePuy is required to maintain a post-market surveillance program and update procedures to track complaints over the hip implants, according to a statement by New York Attorney General Letitia James.
DePuy in 2010 announced a worldwide voluntary recall of 93,000 of its ASR hip implant systems, saying that 12 percent of them failed within five years. Saying it would pay at least $2.47 billion, the company has since settled thousands of lawsuits by patients who had to have the ASR implant removed.
In 2013, DePuy ceased selling the Pinnacle devices after the U.S. Food and Drug Administration strengthened its artificial hip regulations.
Metal-on-metal hip implants have also come under scrutiny over allegations that the products cause a build-up of metal ions in the blood, causing groin pain, allergic reactions, bone erosion and tissue death.
The company faces some 10,400 lawsuits in the United States over its Pinnacle device in connection with those claims.
J&J denies consumer claims related to its Pinnacle products, saying the company acted appropriately and responsibly in the development, testing, and marketing of the devices.
(Reporting by Tina Bellon in New York; Editing by Chizu Nomiyama and James Dalgleish)