J&J, Attorneys General Settle Hip Implant Allegations for $120m
Posted 22 January 2019 | By
Johnson & Johnson (J&J) and subsidiary DePuy reached a $120 million settlement agreement to resolve allegations that the company unlawfully promoted two metal-on-metal hip implant devices.
The attorneys general alleged 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, or survivorship, of the implants.
According to the attorneys general, DePuy advertised that the ASR XL hip implant had a survivorship of 99.2% at three years when the National Joint Registry of England and Wales reported a 7% revision rate at three years. Similarly, DePuy was said to have promoted the Pinnacle Ultamet as having a survivorship of 99.8% and 99.9% survivorship at five years when the National Joint Registry of England and Wales reported a 2.2% 3-year-revision rate in 2009 increasing to a 4.28% 5-year-revision rate in 2012.
The ASR XL was recalled from the market in 2010, and DePuy discontinued its sale of the Pinnacle Ultamet in 2013.
DePuy told Focus
that the settlement resolves the investigation into its marketing of the two previously marketed devices and it involves no admission of liability or misconduct on the part of the companies.
As part of the agreement, DePuy also has agreed to reform how it markets and promotes its hip implants. DePuy is required 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 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.”