The New York Times has reported that in the litigation surrounding the DePuy ASR, evidence that the hip-replacement’s manufacturer conducted internals studies which identified numerous testing flaws during the products development has surfaced. It was reported that DePuy Orthopedics, a Johnson & Johnson subsidiary, had failed to publicize an internal engineering report that found that not only had the manufacturer failed to assess the risks of the device, but also that DePuy used inadequate standards and controls when it conducted safety tests.
The DePuy ASR, or Articular Surface Replacement, was a very popular hip-replacement device that was approved through The U.S. Food and Drug Administration’s “fast-track” approval process because it bore a close relation to DePuy’s other hip replacement device, the DePuy Pinnacle. However, after being implanted in nearly 100,000 patients in the seven years that it was on the market, reports that the device was defective arose after an increasing amount of patients complained of metal debris loosening and infecting the surrounding tissue, the device breaking inside the patient, and bone fracturing around the device. In response to increased pressure from the FDA, doctors prescribing the ASR, and from professional medical publications, the DePuy ASR was recalled in 2010. Then, the FDA mandated that DePuy engage in a post-recall investigation of its device.
The resulting internal report concluded that DePuy knew it had engaged in incorrect and inadequate standards when it was testing the device and preparing it for the market was in response to this recall. The 2010 internal report, which was never publicized by DePuy and which was conducted after failing to respond to such requests for an investigation in both 2008 and 2009, shows that the company acknowledged that the controls and procedures it was using during the testing phase were both insufficient and incorrect to properly understand how the device would function in the approximately 100,000 that would eventually have it installed.
Attorney Paul d’Oliveira stated that “it is a shame that Johnson and Johnson, as well as a lot of other big corporations, continue to put people before profits. There is no other reason why Johnson and Johnson would have continued to market this hip implant. We see way too much of this corporate malfeasance and something has to be done to stop it. The problem is our politicians on both sides of the aisle are bribed with campaign contributions from corporate America to simply look the other way. If our Founding Fathers were alive today, I wonder what they would think. Thomas Jefferson said “The tree of liberty must be nourished from time to time by the blood of tyrants and patriots. It is a natural manure.” I understand this quote the more I see how innocent people continue to be harmed by the wealthy in this country. At some point it has got to stop. Our present government wont be the ones to do it.”
This report, which was entered into evidence in the first DePuy ASR case to go to trial, will likely have a significant impact on the remaining litigation. Consolidated lawsuits from claims around the nation stating that the defective medical device resulted in metal pieces breaking and wearing off and infecting the patient will capitalize off this evidence which shows that the manufacturer admits that the problem was ill-prepared to hit the U.S. market. Claims that the defective device also caused side effects such as severe joint pain, bone and hip fractures, tissue damage, and various infections have all been cited in the mass litigation surrounding the Johnson & Johnson subsidiary.
If you or a loved one has been injured by the DePuy ASR hip replacement, you may be entitled to compensation. Working with the leading DePuy attorneys and defective medical device attorneys handling these cases today, the attorneys at d’Oliveira & Associates will work to ensure that you are offered the legal representation you deserve in your DePuy ASR claim and/or lawsuit.
Please contact the law offices of d’Oliveira & Associates at 1-800-992-6878 or fill out a free contact form for a free legal consultation.