Johnson & Johnson (NYSE:JNJ) subsidiary DePuy has reached a $120 million settlement deal with 46 U.S. Attorneys General in a case alleging that the company illegally promoted its Pinnacle Ultamet and ASR XL metal-on-metal hip implants, according to a recent posting from New York AG Letitia James.
The New Brunswick, N.J.-based company faced allegations that it made misleading claims related to the longevity, or survivorship, of its metal-on-metal hip implants, according to the release.
Despite the National Joint Registry of England and Wales reporting a 7% revision rate at three years, DePuy advertised that its ASR XL hip implant had a survivorship of 99.2% over the same period. The company also reported a 99.8% and 99.9% survivorship rate at three and five years for its Pinnacle Ultamet, respectively, while the same national registry reported a 2.2% and approximately 4.3% revision rate at three and five years, according to the release.
The ASR XL was recalled in 2010, while DePuy discontinued its Pinnacle Ultamet hip implant in 2013, according to the release.
In addition to allegations of providing misleading data on longevity and efficacy of the hip implants, DePuy also faced claims that patients who required revision surgery experienced persistent groin pain, allergic reactions, tissue necrosis and the build-up of metal ions in the blood, according to the NY AG’s release.
As part of the company’s Consent Judgement, DePuy “agreed to reform how it markets and promotes its hip implants,” according to the release.
DePuy agreed to six new requirements related to its marketing of hip implants: basing survivorship, stability and dislocation data on scientific information and the most recent registry dataset for any such device; maintaining a post market surveillance program and complaint handling program; updating and maintaining internal product complaint handling operating procedures, including training complaint reviewers; updating and maintaining a system for tracking and analyzing product complaints that don’t meet the definition of Medical Device Reportable Events; maintaining a quality assurance program including audit procedures for those non-MDRE complaints; performing quarterly reviews of complaints and investigating subgroups with high incidence rates of adverse events to identify causes and alter promotional practices appropriately.
“Doctors and their patients need to have accurate and up to date information to ensure that patients are receiving appropriate healthcare. Companies should never be allowed to freely mislead the public, especially when there are health concerns involved. This settlement serves as an important message that deceptive and false medical practices will never be tolerated,” AG James said in a press release.
New York AG Letitia James said that New York will receive approximately $4.7 million of the settlement.
The investigation was led by Texas and South Carolina and joined by New York, 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, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington, and Wisconsin.
Earlier this month, India’s Supreme Court reportedly approved a compensation plan for patients there who were implanted with a since-recalled metal-on-metal hip made by Johnson & Johnson.
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