PHOENIX — DePuy Orthopedics, and its parent company Johnson & Johnson, have agreed to pay $2.4 million to the state of Arizona and to reform how DePuy markets hip implants.
The settlement is part of a larger $120 million settlement with 46 Attorneys General, said a news release from the Arizona attorney general’s office.
The settlement with the attorneys general resolves allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices: the ASR XL and the Pinnacle Ultamet.
The attorneys general alleged that “DePuy engaged in unfair and deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to the longevity, also known as survivorship, of metal-on-metal hip implants.”
Deputy allegedly advertised that the ASR XL hip implant lasted for three years in 99.2% of cases, although the National Joint Registry of England and Wales reported a 93% survivorship rate for that time period. Similarly, DePuy promoted the Pinnacle Ultamet as lasting for five years in 99.8% of cases, although that British registry reported in 2012 a 95.75% survivorship rate at the five-year mark.
In their complaint, the attorneys general alleged that “some patients, who required hip implant revision surgery to replace a failed ASR XL or Pinnacle Ultamet implant, experienced persistent groin pain, allergic reactions, tissue necrosis, as well as a build-up of metal ions in the blood.”
The ASR XL was recalled from the market in 2010 and DePuy discontinued its sale of the Pinnacle Ultamet in 2013.
Assistant Attorney General Mitchell Allee represented Arizona’s interests during the investigation.
The Consent Judgment requires DePuy to reform how it markets and promotes its hip implants as well as:
- Base claims of survivorship, stability or dislocations on scientific information, and on the most recent data available from a registry for any hip implant device.
- Maintain a post-market surveillance program and complaint-handling program.
- Update and maintain internal product complaint-handling operating procedures, including training of complaint reviewers.
- Perform quarterly reviews of complaints and if a subgroup of patients is identified that has a higher incidence of adverse events than the full patient population, determine the cause and alter promotional practices as appropriate.