DePuy Orthopeadics has agreed to pay more than $120 million to settle a metal-on-metal hip lawsuit filed by a consortium of 46 state attorneys general.
According to Reuters, the settlement resolves allegations that DePuy engaged in unfair and deceptive practices in the promotion of its ASR XL and Pinnacle Ultamet hip implant devices.
Among other things, the settlement agreement requires DePuy to maintain a post-market surveillance program and update procedures to track complaints over the metal-on-metal hip implants.
“Doctors and their patients need to have accurate and up to date information to ensure that patients are receiving appropriate healthcare,” New York State Attorney General Letitia James said in a statement announcing the agreement. “Companies should never be allowed to freely mislead the public, especially when there are health concerns involved. This settlement serves as an important message that deceptive and false medical practices will never be tolerated.”
DePuy, a division of Johnson & Johnson, did not admit any liability in agreeing to settle the states’ claims.
DePuy’s ASR line of metal-on-metal hips were recalled in August 2010, after data suggested 12% of the devices would fail within 5 years of implantation.
In November 2013, the company announced a $250 billion settlement to resolve 93,000 product liability claims stemming from the DePuy ASR hip recall.
The company also faces more than 10,000 metal-on-metal hip implant lawsuits involving the Pinnacle/Ultamet liner configuration. Most of these claims are pending in a consolidated litigation currently underway in the U.S. District Court, Northern District of Texas.
Since October 2014, the federal litigation has convened four bellwether trials. The first concluded with a verdict in favor of DePuy and Johnson & Johnson. Plaintiffs won the following three trials, with jury awarding plaintiffs verdicts ranging from $247 million to $1 billion. However, the Court reduced the $1 billion verdict to $543 million and cut a $500 million verdict to $151 million.
Last month, the Court reported that DePuy and Johnson & Johnson had agreed to settle more than 3,000 Pinnacle hip lawsuits. According to Bloomberg News, the settlement agreement cost Johnson & Johnson about $413 million, with payouts averaging $150,000 per case.
Additionally, Bloomberg indicated that Johnson & Johnson was in negotiations to resolve the remaining metal-on-metal hip lawsuits involving the Pinnacle/Ultamet combo. Among other things, sources suggested the company wanted to settle the massive litigation ahead of the next bellwether trial.
Metal-on-metal hip replacements include any device in which the femoral head (ball), the femoral stem in the thighbone, and the acetabular component (cup) in the hip bone are all constructed of a chromium/cobalt alloy.
In January 2013, the U.S. Food & Drug Administration warned that toxic ions shed from a metal-on-metal hip replacement can accumulate in surrounding tissue, leading to tissue deterioration, device loosening, and other debilitating complications. The agency also noted that the ions could enter the blood stream, possibly leading to other long-term health problems, including:
In May of that year, DePuy announced it would stop selling metal-on-metal hips, including the Pinnacle/Ultamet combo. However, the company stated that its decision was driven by slowing sales of the devices, rather than safety concerns.