(Boise) – Attorney General Lawrence Wasden announced today that he and 45 other state attorneys general have reached a $120 million settlement with Johnson & Johnson and subsidiary DePuy. The settlement resolves allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet.
Under the settlement, the companies will pay $1.47 million to the state of Idaho. As directed by state law, the money will be deposited into the Consumer Protection Fund.
The attorneys general allege that DePuy (pronounced “da-pew”) engaged in unfair and deceptive practices while promoting 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 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 that 7% of the implants needed revision within three years. Similarly, DePuy promoted the Pinnacle Ultamet had a survivorship of 99.8% at five years when the National Joint Registry of England and Wales reported a 2.2% 3-year-revision rate in 2009. The rate increased to a 4.28% 5-year-revision rate in 2012.
“Despite information to the contrary, the companies consistently overstated the performance of these artificial joints,” Wasden said. “That meant patients and surgeons were making extremely important treatment decisions with misleading data. Accuracy in healthcare is essential and that’s what makes this behavior unacceptable.”
Some patients who required 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.
As part of the settlement, DePuy has agreed to reform how it markets and promotes hip implants. Going forward, DePuy shall:
- Base claims of survivorship, stability or dislocations on scientific information and the most recent data available.
- Maintain a post market surveillance 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.
- Maintain a quality assurance program that includes an audit procedure for tracking complaints regarding DePuy Products that do not rise to the level of a Medical Device Reportable Event, but that may indicate a device-related serious injury or malfunction.
- 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.