On January 23, 2019, Georgia’s Attorney General Chris Carr announced that he and forty-five (45) other attorneys general reached a $120 million Consent Judgment with Johnson & Johnson and DePuy, regarding allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet. Under the settlement, Georgia will receive over $3 million.
The Attorneys General alleged that DePuy engaged in unfair and deceptive practices in the marketing of the metal-on-metal hip implants; specifically, regarding the devices’ longevity (also known as “survivorship”). According to the AG’s press release, DePuy had advertised that the ASR XL hip implant had a 99.2% survivorship at three (3) years and that the Pinnacle Ultamet had a survivorship of 99.8% and 99.9% at five (5) years. But the National Joint Registry of England and Wales reported a 7% revision rate for the ASR XL after three (3) years, and a 2.2% three (3) year revision rate for the Pinnacle Ultamet, increasing to a 4.28% five (5) year revision rate. The ASR XL was recalled from the market in 2010 and DePuy discontinued its sale of the Pinnacle Ultamet in 2013.
DePuy agreed, as part of the Consent Judgment, to reform how it markets and promotes its hip implants, including:
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.
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.
For more information, please contact Barbara J. Rogers.