The lawsuits also alleged that DePuy failed to warn patients and doctors of problems with the implant despite already knowing of design glitches with the cup. It further claimed that the manufacturer was negligent in designing, manufacturing and selling the product.
DePuy introduced the ASR hip implant system in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration.
DePuy had discontinued the cup and phased it out last March and notified doctors that the data from the Australian medical device registry showed a “higher-than-expected” failure rate in traditional hip replacements, especially in smaller patients or those with weak bones. The failure rate also prompted J&J and DePuy to initiate a worldwide hip replacement recall August of last year.
Read more about Lawsuits may cost J&J $1B for defective DePuy hip implants here.