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Maine Joins Multistate Settlement with DePuy and Johnson & Johnson
January 23, 2019
AUGUSTA - Attorney General Aaron M. Frey announced today that he and 45 other Attorneys General have reached a $120 million Consent Judgment with Medical Device Business Services, Inc., f/k/a DePuy Inc. DePuy Orthopaedics, Inc., and DePuy Orthopaedics, Inc.; DePuy Products, Inc.; DePuy Synthes, Inc.; DePuy Synthes Sales, Inc. (collectively referred to as "DePuy") and Johnson & Johnson to resolve allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet. Maine will receive $1.4 million as its share of the settlement.
"Accurate and up-to-date information is important to both doctors and patients in making health care decisions," said Attorney General Frey. "This settlement will help ensure that surgeons who implant hip replacement devices will have accurate and current information concerning patient outcomes in assessing whether a particular device should be used on their patients."
The Attorneys General allege that DePuy engaged in unfair and deceptive practices in promoting the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to the longevity, or survivorship, of metal-on-metal hip implants.
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 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, which increased to a 4.28% 5-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, 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 Consent Judgment, DePuy has agreed to reform its marketing and promotion practices for its hip implants, which include:
- Basing claims of survivorship, stability or dislocations on scientific information and the most recent dataset available from a registry for any DePuy hip implant device.
- Maintaining a post market surveillance program and complaint handling program.
- Updating and maintaining internal product complaint handling operating procedures, including training complaint reviewers.
- Maintaining a quality assurance program that includes an audit procedure for tracking complaints of DePuy products that don't rise to the level of a Medical Device Reportable Event, but that may indicate a device-related serious injury or malfunction.
- Performing quarterly reviews of complaints. If a subgroup of patients is identified that has a higher incidence of adverse events than the full patient population, DePuy shall determine the cause and alter its promotional practices as appropriate.