Pope McGlamry is national co-lead counsel for the Wright Conserve Metal-On-Metal Hip Implant Multi-District Litigation (MDL No. 2329) consolidated before The Honorable William S. Duffey, Jr. of the U.S. District Court for the Northern District of Georgia. Wright Medical Technology introduced its Conserve metal-on-metal hip implants to surgeons for distribution in 2006 after obtaining FDA approval through a quickened 510(k) approval process, through which they only had to show substantial similarity to a hip replacement device already on the market. Use of the 510(k) approval process allowed the company to avoid the more rigorous device testing demanded by the alternative Pre-Market Approval process.
The Conserve device consists of a cobalt-chromium femoral head placed within a cobalt-chromium acetabular cup. Because the head and cup components, made of like material but containing no liner, grind together, they often release toxic amounts of metal wear debris into the body. This toxic metal wear debris has caused thousands of Wright implant patients to develop elevated cobalt and chromium ion levels, metallosis, pseudotumors, necrotic tissue and fluid buildup. Many of these patients have ultimately undergone hip revision surgeries to have the Wright Conserve device removed and replaced with a safer implant.
When Wright Medical first marketed and sold the Conserve device in 2006, the company failed to warn implanting surgeons and patients of these hazards, even though they were known to the medical device community at the time. Instead, Wright marketed the device towards younger and more active patients, claiming that the device would preserve bone in younger patients, that it would wear less than metal-on-polyethylene devices previously distributed and that it would last for 15 to 20 years.
Unfortunately, numerous studies have shown that Wright’s marketing claims were false and that the device has had an unusually high early failure rate due to metal ion wear and toxicity. In 2011, the National Joint Registry for England and Wales published an annual report finding an unacceptably high 8.36% revision rate within five years of implantation for the device. That revision rate was second only to that of the DePuy ASR hip device. The DePuy ASR implant was recalled by Johnson & Johnson in 2010 and was the subject of consolidated litigation which ultimately led to a $2.5 billion settlement in 2013 designed to compensate 8,000 patients harmed by that device.
As increasing numbers of patients were injured by metal ion toxicity from the Conserve device and had to undergo hip revision surgery, lawsuits were filed across the nation, leading the Judicial Panel on Multi-District Litigation to consolidate these cases before the Honorable Judge Duffey on February 8, 2012 so that discovery, pre-trial matters and bellwether trials could most efficiently be handled and tried.