(PRWEB) February 20, 2013
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. The New York Times 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. Not only was an internal report entered into evidence, but the jury also viewed a deposition from surgeon who helped design the ASR commenting on its flaws. [Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles)].
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. 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, 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.
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. d’Oliveira and Associates is working with the leading DePuy 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.