Carr and 45 Attorneys General Nationwide Reach a $120 Million Settlement Regarding False and Misleading Statements Concerning Medical Devices
ATLANTA, GA – Attorney General Chris Carr announced today that he and 45 other attorneys general have 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.
“Physicians and patients depend on accurate, up-to-date information in order to make healthcare decisions that are sound, safe and suitable,” said Attorney General Chris Carr. “Today’s settlement helps to ensure that doctors receive the critical information needed to properly care for their patients.”
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 metal-on-metal hip implants. DePuy advertised that the ASR XL hip implant had a survivorship of 99.2 percent at three years when the National Joint Registry of England and Wales reported a 7 percent revision rate at three years. Similarly, DePuy promoted the Pinnacle Ultamet as having a survivorship of 99.8 percent and 99.9 percent survivorship at five years when the National Joint Registry of England and Wales reported a 2.2 percent 3-year-revision rate in 2009 increasing to a 4.28 percent 5-year-revision rate in 2012.
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.
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; and
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.
Under the settlement Georgia shall receive $3,007,253.13.
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. Along with Georgia, the following states also participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, 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, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.