UPDATED July 2, 2014, with comment from DePuy Orthopaedics
The Oregon Justice Dept. today said it wrung a $4 million settlement from Johnson & Johnson (NYSE:JNJ) over its recalled DePuy ASR hip implant, the 1st such settlement of its kind over the metal-on-metal implant.
The Beaver State’s prosecutors said the agreement, in which Johnson & Johnson admitted no wrongdoing, is the 1st government action to resolve allegations that DePuy Orthopaedics "failed to disclose to physicians and patients that its ASR XL ‘metal on metal’ artificial hip devices had an alarming rate of failure," according to a press release.
Some 432 of the devices were sold in Oregon between 2005 and 2010, according to the release, making the settlement worth $9,259 per implant.
"Oregonians in need of a hip replacement deserve to know that the artificial hip they are contemplating in fact has the qualities, and benefits, that a company advertises," Oregon attorney general Ellen Rosenblum said in prepared remarks. "Doctors also need to know that the products they suggest to their patients meet certain standards; and no company should be permitted to exploit that basic tenet. I am proud that Oregon has once again taken the lead on deceptive marketing practices that hurt patients."
"We are fully committed to the appropriate and responsible promotion of all of our products. As the agreement states, this is a settlement of a disputed matter. There is no admission of any legal violation, and DePuy denies any such violation. Resolving this investigation will allow us to continue focusing our full attention on delivering innovative healthcare solutions for patients and their families in Oregon and across the country," Mindy Tinsley, director of worldwide communications for DePuy Orthopaedics, told MassDevice.com via email.
The August 2010 recall of the DePuy ASR devices was "due to the number of patients who required a second hip replacement procedure," according to a company report. An internal review in 2011 found that 37% of DePuy’s ASR hip implants would require revision or replacement in less than 4.6 years.
Johnson & Johnson committed in May to a deal that would see Johnson & Johnson pay out $250,000 each to about 8,000 DePuy ASR patients and set up a $475 million fund to cover extraordinary medical costs associated with the hip implants. Johnson & Johnson would still be on the hook for about 4,000 other lawsuits filed over the DePuy ASR device, which it yanked in 2010 after receiving reports of unusually high failure rates. The deal wouldn’t cover hip-replacement surgeries performed after August 31, 2013.
At an estimated $2.5 billion, the deal is by far the largest medical product liability settlement ever, more than double Sulzer Medica’s $1 billion settlement over its recalled hip implant in 2002. That recall involved roughly 31,000 devices, compared with the recall of about 93,000 DePuy ASR implants.