New York, NYJohnson & Johnson’s (J&J) artificial hip replacement, the Articular Surface Replacement (ASR), was estimated to fail in approximately 40 percent of patients, based on data from its own internal analysis, made public for the first time this week. The document is one of hundreds of internal company documents expected to become public over the coming months, as the first of over 10,000 lawsuits by patients who received a faulty ASR implant gets ready to go to court.
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An article in the New York Times
reports that the J&J analysis was done in 2011, shortly after it recalled the ASR all metal hip implant in 2010. DePuy Orthopaedics withdrew its ASR XL Acetabular hip replacement on August 24, 2010 following approximately 300 complaints from people undergoing hip replacement. The ASR hip replacement is a metal-on-metal device believed to have a design flaw that has resulted in many patients needing follow-up hip revision surgery to replace the device soon after implant.
Based on the results of J&J’s internal analysis, the company estimated that in addition to device failure within five years in nearly half of the recipients, the ASR implant is likely to fail prematurely in thousands more patients over the next few years. This information was not made public until the documents were unsealed in court this week.
The failure of the ASR is one of the largest medical device failures in recent history, and the upcoming trial is widely anticipated to finally make public just what facts the officials of Johnson & Johnson’s DePuy Orthopaedics division were in possession of while hundreds, if not thousands of patients were undergoing costly replacements because their ASR had failed.