(COLUMBUS, Ohio)—Attorney General Dave Yost announced today that he and 45 other Attorneys General reached a $120 million settlement with Johnson & Johnson and Johnson & Johnson owned companies Medical Device Business Services, Inc. (formerly DePuy, Inc.), DePuy Products, Inc., DePuy Synthes Inc., and DePuy Synthes Sales, Inc. to resolve allegations that DePuy unlawfully promoted their metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet.
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 their 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 (surgery performed to replace or compensate for a failed implant) 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 three-year-revision rate in 2009 increasing to a 4.28 percent five-year-revision rate in 2012.
“Accurate and up to date information for both doctors and patient/consumers is critical for appropriate health care,” said Attorney General Yost. “Surgeons who implant devices like these need to have the most accurate information concerning patient outcomes, and today’s settlement helps ensure that vital information will be provided to doctors, so they can properly treat their patients.”
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 settlement, an Agreed Entry and Final Judgment Order presented to the Franklin County Common Pleas Court for approval, 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 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.
Under the settlement, Ohio will receive $4,423,334.71 from the $120 million total multistate settlement amount.
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 the Attorneys General of 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.