Topics and Cases - DePuy
The DePuy ASR Acetabular Cup System was launched in 2005. It was designed and released by Johnson & Johnson’s orthopaedics subsidiary, DePuy. It was intended to be marketed towards younger patients as a more durable option.
Recent studies from the several sources have shown severe negative side effects from using DePuy ASR Hip Replacement Systems, including metal poisoning, metalosis, and early loosening and significant failure rates within only a few years of implantation. Similar issues occurred with DePuy’s other Metal on Metal hip replacement product - the DePuy Pinnacle. Ultimately, DePuy recalled the ASR metal on metal hip in August, 2010.
Facts about DePuy ASR Hip Replacement Systems:
- The system was cleared by the FDA through the 510(k) process, a process which allows a manufacturer to obtain market approval with very little clinical testing of the device if it resembles a product already in use.
- By 2009, DePuy had announced it would be phasing out the ASR hip implant after a year earlier the FDA had received more than 300 reports of problems with the hip implant, most involving premature failure that required revision surgery.
- By March of 2010, DePuy had begun sending letters to doctors recommending that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient.
- In August 2010, DePuy officially recalled the ASR, after 93,000 patients had been fitted with it, citing data that showed 12-13% of those who had received the devices had to undergo revision surgery within five years of receiving it.
- This failure had the potential to cause cobalt and chromium poisoning; a type of metal poisoning that can cause complications such as tumors, brain trouble and heart failure.
Litigation News:
- On December 7, 2010, the U.S. Judicial Panel on Multidistrict Litigation centralized and consolidated the federal DePuy ASR recall litigation before U.S. District Judge David A. Katz in the Northern District of Ohio for pretrial proceedings.
- On January 26, 2011, Judge Katz entered an order in the Multidistrict Litigation naming the leadership counsel for both the plaintiffs and the defendants