|. By Gordon Gibb|
Lawyers and Settlements.com
The announcement was a victory of sorts for health advocates critical of the 510(k) process that cleared the way for all-metal and metal-on-ceramic hip replacement products to appear on the market without intensive clinical trials. The 510(k) “loophole,” for lack of a better word, is a guideline employed by the US Food and Drug Administration (FDA) that allows new products onto the market provided they are substantially similar to existing products. The idea of the 510(k) was to bring promising products to market more quickly in order to benefit consumers - and to save manufacturers from the expense of redundant testing.
However, with some new-age hip and knee replacements, the idea has backfired. DePuy Orthopaedics decided in 2010 to recall its problematic ASR metal-on-metal hip replacement products, and is currently facing in excess of 10,000 lawsuits, according to the New York Times (5/17/13). In addition, 3,300 DePuy Pinnacle lawsuits are on the books.
When the FDA, in January, ordered all manufacturers of metal-on-metal hip replacements - including DePuy Pinnacle hip - to undertake post-market testing of any product approved under the 510(k) program, DePuy decided to cut its losses and discontinue the Pinnacle rather than sink additional funds into costly post-market clinical trials. DePuy also noted that demand for all-metal devices had been steadily waning in the face of high failure rates.
The manufacturer of DePuy Pinnacle was also to discontinue this month a metal component that was heretofore available for use with the Complete ceramic hip implant.
While it may be a victory for health advocates critical of the 510(k) program and the metal-on-metal devices in general, it doesn’t help the thousands of patients who have received the Pinnacle hip replacement and who may be in need of revision surgery. At one time, according to the New York Times, one in three hip replacement procedures in the US utilized the metal-on-metal design.
The latter, at one time hailed as a breakthrough in artificial hips, was soon reduced to a scourge, with high failure rates and increasingly dire health issues for patients negatively impacted when metal surfaces began to wear and break down, causing tissue and muscular issues and risking metal toxicity in the blood. Patients were requiring revision procedures and began launching DePuy Pinnacle hip lawsuits. According to The Star-Ledger of Newark, New Jersey (5/19/13), market share of metal-on-metal components dropped from a 20 percent share in 2007 to less than two percent in 2012.
In 2010, when DePuy issued the ASR recall, it reiterated the safety and effectiveness of its DePuy Pinnacle hip replacement system. That changed in May of this year, when DePuy decided to pull the plug. However, that decision is not based on safety or effectiveness, and is not a DePuy Pinnacle recall, said a DePuy spokesperson in comments made to Bloomberg News (5/19/13), regardless of how it appears.
“We won’t have any metal-on-metal or ceramic-on-metal hips any longer,” said Mindy Tinsley, a spokeswoman for J&J’s DePuy unit, in a telephone interview with Bloomberg. “We’ve seen, for example, a 90 percent decline in metal-on-metal sales industry wide in the US and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.”
As for the thousands of patients currently fitted with metal-on-metal Pinnacle hip replacement, their only recourse is to hope their DePuy Pinnacle hip defies the early failure trend. Failing that is the expectation of additional DePuy Pinnacle hip replacement lawsuits on the horizon.