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J&J Knew of Flawed DePuy ASR Hip Design
Internal documents disclosed in trial revealed that J&J knew several years before the device was recalled that the ASR’s defective design caused it to shed large quantities of metal debris.
Even more disturbing is the trial testimony and internal J&J documents revealing that the DePuy unit failed it own safety standards for the ASR hip cup in which a metal ball atop a femur rotates. The ASR produced 16 times more chromium and cobalt debris in the body than another DePuy product. Records indicate that J&J executives discussed redesigning the ASR to correct the design flaw but never did so. (Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County) J&J recalled 93,000 ASR hips in 2010 after estimating a 12% failure rate within five years. However, an internal analysis conducted by J&J shortly after it recalled its troubled ASR hip device estimated that closer to 37 percent of the devices would fail with the first five years.
The videotaped testimony of the Magnus Flett, who led a DePuy design and testing team, conceded that DePuy terminated efforts to redesign the ASR cup due to financial and business reasons. DePuy never advised surgeons that the ASR failed at a rate eight times that of the DePuy Pinnacle indicating that information “was not clinically relevant.” Flett also testified that a proposal to study the performance of the ASR against the Pinnacle, “seemed like suicide to me,” because “it will prove that one is better that the other and they are both our products and that means that one will be worse.” Flett divulged that DePuy stopped selling them in 2009, as “we didn’t see the sales of the product continuing the way we wanted, so we took it off the market.”
According to the New York Times, other documents unsealed last week showed a 2011 internal analysis by J&J indicated that the recalled hip implants are likely to fail in nearly 40% of patients within the first five years. Furthermore, the company received clinical data in 2008 showing “extreme” levels of metal ions in patients who received the ASR device compared to patients who received other implants. Attorney David Ennis of Ennis & Ennis, P.A. states that although late, “it is good that these documents are finally being made public. The public needs to be aware that it cannot rely solely on the information provided by manufacturers as they are not always forthcoming with accurate information regarding the safety of their products.” Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received a DePuy or other metal-on-metal hip device by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form