23.01.2019 04:14:01
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J&J Reaches $120 Mln Settlement With 46 Attorneys General Over Hip Implants
(RTTNews) - The New York Attorney General Letitia James announced that she and 45 other Attorneys General across the country reached a $120 million Consent Judgment with Johnson & Johnson and DePuy Inc. to resolve allegations that the company unlawfully promoted its metal-on-metal hip implant devices, the ASR XL and the Pinnacle Ultamet.
The Attorneys General alleged that DePuy engaged in unfair and deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to the longevity, also known as survivorship, of metal-on-metal hip implants. DePuy advertised that the ASR XL hip implant had a survivorship of 99.2 percent at three years when the National Joint Registry of England and Wales reported a 7 percent revision rate at three years.
The Attorneys General alleged that DePuy promoted the Pinnacle Ultamet as having a survivorship of 99.8 percent and 99.9 percent survivorship at five years when the National Joint Registry of England and Wales reported a 2.2 percent 3-year-revision rate in 2009 increasing to a 4.28 percent 5-year-revision rate in 2012.
Some patients who required hip implant revision surgery to replace a failed ASR XL or Pinnacle Ultamet 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. DePuy discontinued its 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.
Under the settlement New York State will receive $4.66 million.
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