HARRISBURG — Attorney General Josh Shapiro announced today 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. Under the settlement, Pennsylvania will receive $4,624,948.73.
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 making misleading claims as to the longevity, also known as survivorship, of the 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 7% revision rate at three years. Similarly, DePuy promoted the Pinnacle Ultamet as having a survivorship of 99.8% and 99.9% survivorship at five years when the National Joint Registry of England and Wales reported a 2.2% 3-year-revision rate in 2009 increasing to a 4.28% 5-year-revision rate in 2012. Simply stated: DePuy was advertising that its’ hip implants had higher longevity rates for patients than surveys show they actually did.
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.
“Accurate, reliable and up-to-date information for both doctors and patients is vitally important for appropriate health care decisions,” said Attorney General Shapiro. “Patients need to have the best information possible so that they can advocate for themselves and expect a positive outcome. The settlement announced today will ensure that vital information about these hip replacement systems, a major component of individuals’ mobility and independence, gets into the hands of doctors, who can then advise patients about using these devices.”
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, determine the cause and alter promotional practices as appropriate.
The settlement has been filed and requires court approval to become final.
The investigation was led by the Attorneys General of Texas and South Carolina with an Executive Committee consisting of the Attorneys General of Florida, Indiana, North Carolina, Ohio, Pennsylvania, and Washington. Also participating in the settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Dakota, Oklahoma, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.