PHOENIX -- Attorney General Mark Brnovich announced today that DePuy Orthopedics, Inc. and its parent company Johnson & Johnson, have agreed to pay $2.4 million to Arizona and to reform how DePuy markets hip implants. The settlement with the Arizona Attorney General’s Office is part of a larger $120 million settlement with 45 other Attorneys General to resolve allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet.
The lawsuit filed by the Arizona Attorney General’s Office, alleges 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. DePuy advertised that the ASR XL hip implant had a survivorship of 99.2% at three years, when the National Joint Registry of England and Wales reported a 93% survivorship rate at three years. Similarly, DePuy promoted the Pinnacle Ultamet as having a 99.8% survivorship rate at five years, when the National Joint Registry of England and Wales reported a 95.75% survivorship rate at five years in 2012.
The Complaint alleges 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. DePuy discontinued its sale of the Pinnacle Ultamet in 2013.
“Companies must be truthful and accurate in their advertising, especially when it comes to health care and medical equipment,” said Attorney General Mark Brnovich. “Consumers can only make informed decisions about their health care when companies are fully transparent and tell the truth. This settlement addresses past misconduct, and ensures that doctors and patients have access to accurate information in the future.”
As part of the Consent Judgment, DePuy has agreed to reform how it markets and promotes its hip implants. Among other things, the Consent Judgment requires DePuy to:
- Base claims of survivorship, stability or dislocations on scientific information, and on the most recent dataset available from a registry for any DePuy 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.
- Update and maintain processes and procedures to track and analyze product complaints that do not meet the definition of Medical Device Reportable Events.
- 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.
Assistant Attorney General Mitchell Allee handled the investigation for Arizona.
Copy of complaint.