Tuesday, June 26, 2012

Inventory Clear-Out Responsible for the Sale of Defective DePuy Hip Implants?

Even after the FDA raised concerns regarding the safety of the DePuy ASR hip implants in 2009, Johnson & Johnson forged ahead with the sale of implants in their inventory prior to finally discontinuing the devices. The DePuy ASR XL hip replacement system was approved through the 510(k) FDA process in 2005—a process requiring no human testing. In 2007 DePuy filed a Premarket Approval Application for the hip resurfacing version of the implant device, a clearance which requires more strenuous and time-consuming testing. DePuy received a letter of non-approvable in response to the PMA in August of 2009.

A newspaper report in February of this year stated a J & J executive admitted in an internal email that the approval was denied due to the prematurely high failure rate, constituting a clear safety issue. The President of DePuy, however, called the subsequent removal of the device from the overseas market nothing more than a business decision. The internal email was written a full year before the company agreed to recall both DePuy ASR hip implant systems. The New York Times obtained the FDA’s non-approvable letter through the Freedom of Information Act and reports that the FDA told DePuy at the time they rejected the PMA that blood tests of patients with the metal-on-metal hip implant showed abnormally high concentrations of metal ions.

The metal ions—comprised of cobalt and chromium—which shave off from the metal parts of the implant can potentially enter the bloodstream causing kidney, liver and bladder disease. Changes to cells which are considered precursors to cancer have been noted in as many as 20% of patients with the metal-on-metal hip replacement systems. The metal shavings have also been tied to tissue damage and necrosis, metallosis and tumors. Despite the evidence supporting the high failure rate as well as potential safety risks, it is estimated that over 93,000 patients received the defective hip replacement systems across the globe prior to the recall in August of 2010. Many believe DePuy was doing nothing more than cleaning out their inventory prior to an inevitable recall.

At this point all DePuy ASR hip replacement systems have been recalled—if you have suffered adverse health issues following your metal-on-metal hip replacement system you may qualify for compensation from DePuy.

Author: Sullo & Sullo Attorneys

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