Release date:
1/25/2019
(RALEIGH) Attorney General Josh Stein today announced that he and 45 other Attorneys General 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. North Carolina will receive $4,179,837.53.
“Patients and their doctors need accurate information,” said Attorney General Josh Stein. “It is unacceptable for companies to misrepresent their products ever, but particularly when people’s health is at stake. This settlement will ensure that doctors have the right information when making decisions with 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 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 three-year-revision rate in 2009 increasing to a 4.28 percent five-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, and tissue necrosis, as well as a buildup 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 will:
- Base claims of longevity, 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.
- 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.
Attorney General Stein is joined in this settlement by the Attorneys General of Texas, South Carolina, Florida, Indiana, 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, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.
A copy of the complaint can be found here.
A copy of the consent judgment can be found here.
Contact:
Laura Brewer (919) 716-6484
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