Attorneys General allege company engaged in fair, deceptive practices and misleading claims regarding longevity of devices
Missouri Attorney General Eric Schmitt announced Wednesday that Missouri and 45 other states reached a $120 million Consent Judgment with Medical Device Business Inc. (formerly known as DePuy) and its parent company, Johnson & Johnson, to resolve allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet. Under the settlement, Missouri will receive over $2.2 million.
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. 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.
“Doctors and their patients must have accurate and up-to-date information when making health care decisions,” AG Schmitt said. “Any attempt to mislead doctors or their patients for the sake of profit is inexcusable.”
As part of the Consent Judgment, DePuy has agreed to reform how it markets and promotes its hip implants. DePuy must base claims of survivorship, stability or dislocations on scientific information and the most recent dataset available for the DePuy hip implant device. Additionally, DePuy must maintain a post market surveillance and complaint handling program. DePuy is required to train its reviewers, update its product complaint handling procedures, and maintain a quality assurance program to audit these complaint tracking procedures. Additionally, DePuy must perform quarterly reviews of complaints to determine if certain subgroups of patients have higher incidences of adverse events than the full patient population and, if so, 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. 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, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Dakota, Oklahoma, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia and Wisconsin.