New Mexico Office of the Attorney General issued the following announcement on Jan. 22.
Today, Attorney General Hector Balderas announced that he and 45 other Attorneys General reached a $120 million settlement with Johnson & Johnson and DePuy to resolve allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet. Depuy claimed the devices were much more reliable than they actually were. Contrary to DePuy’s claims of reliability, these hip implants were found to fail at rates more than eight times higher than rates advertised.
“Doctors and patients can’t make informed healthcare decisions unless they have accurate information,” said Attorney General Balderas. “Today’s settlement will help ensure that multimillion dollar out-of-state companies like Johnson & Johnson and DePuy are honest and forthcoming about the true risks and benefits that their products present to New Mexicans.”
Some patients who required surgery to replace their failed 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, and DePuy discontinued its sale of the Pinnacle Ultamet in 2013. Thousands of private lawsuits have been filed in courts all over the country against the companies, many of which remain pending.
As part of a formal consent judgment, DePuy has agreed to reform how it markets and promotes
its hip implants, including:
• Basing claims of reliability on scientific information and recent data;
• Creating and maintaining programs to monitor the hip implant market and handle complaints from doctors and consumers, even if those complaints do not rise to the level of a “Medical Device Reportable Event” under FDA regulations;
• Updating and maintaining internal product complaint handling procedures and training complaint reviewers; and
• Performing quarterly reviews of complaints to identify and quickly address trends like higher-than-expected failure rates.
Under the settlement, New Mexico will receive approximately $1.5 million
Original source can be found here.