Indiana Attorney General Curtis Hill announced Tuesday that he and 45 other attorneys general reached a $120 million consent judgment with Johnson & Johnson and DePuy to resolve allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet.
The attorneys general allege that DePuy engaged in unfair and deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by overstating the longevity (also known as survivorship) of metal-on-metal hip implants. Some patients who required hip implant revision surgery to replace a failed ASR XL or Pinnacle Ultamet implant experienced persistent groin pain, allergic reactions and 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.
Hill
“Products and services related to health care are among the most important consumer items purchased by Hoosiers,” Hill said. “We will always put a high priority on holding accountable those involved in all aspects of the health-care industry. These entities must be honest and transparent in their marketing practices. Both doctors and patients need to be able to trust the information they receive from these providers of goods and services. The settlement announced today helps advance this cause.”
As part of the consent judgment, DePuy has agreed to reform how it markets and promotes its hip implants. Under the consent judgment, DePuy shall:
- Base claims of survivorship, stability or dislocations on scientific information and 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.
- 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.
Under the settlement, Indiana shall receive $3.5 million.
Indiana was one of eight states on the executive committee for this investigation, which was led by South Carolina and Texas. Click here to read the settlement.