ATTORNEY GENERAL TONG ANNOUNCES $120 MILLION MULTISTATE SETTLEMENT REGARDING UNFAIR AND DECEPTIVE MARKETING OF HIP IMPLANT DEVICES
Attorney General Tong Announces Connecticut To Receive $1.8 Million In Multistate Hip Replacement Settlement with Johnson & Johnson and DePuy, Inc.
Attorney General William Tong announced today a $120 million multistate settlement with 45 other attorneys general resolving allegations of unfair and deceptive marketing of metal-on-metal hip implant devices by Johnson & Johnson and DePuy, Inc. Connecticut will receive $1.8 million, to be deposited in the general fund.
The states alleged that Johnson & Johnson and DePuy, Inc. violated state consumer protection laws by unlawfully promoting its ASR XL and Pinnacle Ultamet metal-on-metal hip replacement devices, making misleading claims as to longevity and survivorship of the implants.
"Patients put their trust in Johnson & Johnson and DePuy that the hip implants they were receiving were safe and reliable, and these manufacturers unconscionably and systematically violated that trust. The $120 million settlement today will help ensure that doctors and patients have access to the full facts and information they need to make informed medical choices," Attorney General Tong said.
The multi-state investigation found that DePuy advertised the ASR XL hip implant as having 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 over 99 percent at five years when the National Joint Registry of England and Wales reported a mere 2.2 percent 3-year-revision rate in 2009, and a 4.28 percent 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 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 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.
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. In addition to Connecticut, Alabama, Alaska, Arizona, Arkansas, California, Colorado, 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 also participated in the settlement.
Assistant Attorney General Ann-Marie DeGraffenreidt and Consumer Protection Department Head Mike Wertheimer assisted the Attorney General with this matter.