WASHINGTON, D.C. – Attorney General Karl A. Racine and 45 other state attorneys general today announced they have reached a $120 million settlement with Johnson & Johnson and its subsidiary, DePuy, to resolve allegations that the companies made false claims about reliability in promoting two hip implant devices. While the companies claimed success rates near 100 percent for the ASR XL and Pinnacle Ultamet devices, the real rates were actually much lower. As a result, consumers in the District and elsewhere in the country had to have surgery to fix the failed implants due to side effects including persistent pain and allergic reactions. The District will receive a payment of $1,295,903.69 as part of the settlement.
The attorneys general alleged that DePuy and its parent company engaged in unfair and deceptive practices in marketing the ASR XL and Pinnacle Ultamet hip implant devices, which replaced hip joints for patients who had arthritis or other problems. DePuy made misleading claims as to the longevity, also known as survivorship, of the metal-on-metal hip implants. The alleged violations of the District’s Consumer Protection Procedures Act (CPPA) and similar laws in other states included:
- ASR XL: DePuy advertised that the ASR XL hip implant had a survivorship of 99.2 percent at three years. However, the National Joint Registry of England and Wales reported that, at three years, 7 percent of the devices needed to be revised or replaced. The companies began to market the ASR XL in 2005 and began receiving complaints from surgeons about the devices beginning to come loose as early as 2006, resulting in early failure. And, as early as 2007, the company was aware that it was necessary to implant the device at a precise angle that was difficult for surgeons to achieve consistently. Despite this, the company did not redesign the device, and ultimately recalled the ASR XL from the market in 2010 because of the high number of patients requiring replacement surgery.
- Pinnacle Ultamet: DePuy advertised the Pinnacle Ultamet as having a survivorship rate of up to 99.9 percent at five years. However, the National Joint Registry of England and Wales reported a 2.2 percent three-year-revision rate in 2009, increasing by 2012 to a five-year revision rate of 4.28 percent. The companies became aware of problems with the Pinnacle Ultamet as early as 2009, and stopped selling that device in 2013.
The companies began to market the ASR XL in 2005 and began receiving complaints from surgeons about the devices beginning to come loose as early as 2006, resulting in early failure. And, as early as 2007, the company was aware that it was necessary to implant the device at a precise angle that was difficult for surgeons to achieve consistently. Despite this, the company did not redesign the device, and ultimately recalled the ASR XL from the market in 2010 because of the high number of patients requiring replacement surgery. The companies became aware of problems with the Pinnacle Ultamet as early as 2009, and stopped selling that device in 2013.
Some patients who received ASR XL or Pinnacle Ultamet implant devices that failed early experienced problems including persistent groin pain, allergic reactions, tissue necrosis, and a build-up of ions that had leeched into the blood from the broken parts of the metal devices.
As part of the settlment, DePuy has agreed to reform how it markets and promotes its hip implants. Under the Consent Judgment, DePuy is required to:
- Pay $120 million: The companies will pay a total amount of $120 million to the states to resolve the allegations, including $1,295,903.69 to the District.
- Rely on scientific information for future device claims: Johnson & Johnson and DePuy are required, in their marketing, to base all claims about survivorship, stability, or dislocations related to their hip devices on scientific information and the most recent dataset available from a registry.
- Create a program for monitoring product quality and handling complaints: The companies must establish and maintain a program to receive, analyze, and respond to complaints from victims of the devices. They must also establish and maintain best-practice procedures for handling the complaints, including training for customer service representatives.
- Analyze complaint patterns and respond to emerging problems: Johnson & Johnson and DePuy must perform quarterly reviews of complaints. If the reviews identify groups of patients with a higher incidence of adverse events than the full patient population, the companies must determine the cause and, as appropriate, adjust their marketing practices.
Individual consumers harmed by the implants are part of separate actions for restitution.
The investigation was led by the Attorneys General of Texas and South Carolina. Participating states were Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin.
A copy of the consent order settling the case is available at: https://ag.ny.gov/press-release/attorney-general-james-and-45-attorneys-general-nationwide-reach-120-million