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# J&J, DePuy Settle with 46 States on Hip Devices
- URL: https://www.fdaweb.com/j-j-depuy-settle-with-46-states-on-hip-devices/
- Published: 2019-01-23T12:00:00.000Z
- Updated: 2026-09-15T00:56:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143201

Attorneys general in 46 states have reached a $120 million settlement with Johnson & Johnson and DePuy to resolve allegations that the medical device company unlawfully promoted two metal-on-metal hip implant devices—the ASR XL and the Pinnacle Ultamet. An announcement by New York State attorney general **Letitia James** said the states alleged that DePuy made misleading claims as to the longevity (survivorship) of the metal-on-metal hip implants.

James says that 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 and DePuy discontinued sale of the Pinnacle Ultamet in 2013.

Under a consent decree reached by the states with the company, DePuy is to reform how it markets and promotes its hip implants. The company is to: 

- 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 postmarket surveillance and complaint handling programs;
- · 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.