The following is a press release from the Massachusetts Attorney General’s ofice submitted to SOURCE.
BOSTON _ Massachusetts Attorney General Maura Healey has joined a coalition of 46 attorneys general in a $120 million settlement with Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. over allegations that the company endangered consumers by falsely advertising and misrepresenting the durability of its hip implantation devices.
According to the complaint, filed today, January 22, with a consent judgment in Suffolk Superior Court, Attorney General Healey alleges that DePuy violated the state’s consumer protection law by misrepresenting the durability of its ASR XL and Pinnacle Ultamet hip implant devices, as well as the stability, fit, and rate of wear of the ASR XL.
Under the terms of the consent judgment, which remains subject to court approval, Massachusetts is slated to receive $2,379,774.
“Surgeons and patients need all the facts when deciding on major medical procedures,” said AG Healey. “This settlement with Johnson & Johnson sends a strong message of accountability to the medical device industry.”
Some patients who required hip implant revision surgery to replace a failed ASR XL or Pinnacle Ultamet experienced persistent groin pain, allergic reactions, or tissue necrosis, as well as a build-up of metal ions in the blood.
The ASR XL was the subject of a recall in 2010. DePuy discontinued the 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, including:
- Basing its claims of wear, durability, and stability of its hip implant devices on scientific information and the most recent dataset available from a registry.
- Updating and maintaining internal product complaint handling operating procedures including training of complaint reviewers.
- Disclosing DePuy’s role as a sponsor of a study referenced in any marketing materials.
- Tracking and analyzing product complaints including complaints that do not rise to a level of a federally required Medical Device Reportable Event.
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. Also participating in the settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Dakota, Oklahoma, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.
The case was handled by Assistant Attorney General Michael Wong of AG Healey’s Health Care Division.