JEFFERSON CITY — Attorney General Eric Schmitt has announced a settlement of $120 million with Medical Device Business Inc. (formerly known as DePuy), and its parent company Johnson & Johnson, regarding unlawful promotion of Medical Device Business' hip implant devices.
The settlement, which was also reached by other 44 states, will pay the state a total of $2.2 million for the unlawful promotion regarding the SR XL and the Pinnacle Ultamet.
As stated in a press release issued on Jan. 23, "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," as some of the receiving 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 in 2010, and the Pinnacle Ultamet was discontinued in 2013.
There were some requirements in the settlement that DePuy will have to comply with.
"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 release said.
In addition to Missouri, the states that entered a settlement with DePuy were Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia and Washington.
The attorneys general of Florida, Indiana, North Carolina, Ohio, Pennsylvania, and Washington were part of the executive committee of the settlement, with Texas and South Carolina leading the investigation.