The American medical devices and pharmaceutical giant Johnson & Johnson and its orthopedic and neurosurgery unit DePuy Orthopaedics have reportedly agreed to settle $120 million to resolve false marketing claims on its hip-implant devices by several state prosecutors.
According to sources familiar with the matter, 46 U.S. state attorney generals, including New York Attorney General Letitia James, alleged that J&J’s subsidiary DePuy used “unfair & deceptive” promotional practices for its Pinnacle Ultamet and ASR XL hip-implant devices and made misleading claims on the longevity of the implants.
Doctors and their patients need to have exact information about medical devices and implants to ensure that patients are receiving proper healthcare, Letitia James revealed in a statement. She further claimed that companies should never be permitted to mislead the consumers, particularly when there are serious health concerns involved.
It has been reported that patients needed to frequently undergo a revision surgery even before DePuy’s advertised span for over five years.
DePuy said that the settlement does not involves any misconduct or admission of liability on the part of companies and it will remain committed in meeting the present and upcoming needs of patients and surgeons.
If reliable reports are to be believed, according to Letitia James, the New York Attorney General, DePuy is said to maintain a post-market surveillance program and is required to update procedures to track complaints pertaining to the hip implants, as a part of the settlement.
Sources cite that patients with failures in hip implant device also reported allergic reactions, groin pain, tissue necrosis, and build-up of metal ions in their blood.
As reported by Reuters, in 2010, DePuy announced a voluntary recall of nearly 93,000 ASR XL, saying that about 12% of them failed within 5 years. The company has since then settled thousands of lawsuits from hip-implant patients who had to have the ASR XL removed.
Similar lawsuits have also been filled against J&J and DePuy outside U.S., including Ireland, Australia, Italy, United Kingdom, Canada, and Italy.