Too Little Too Late: DePuy Recall and Withdrawl of its ASR Hip Replacement

Date Added: March 24, 2011

Author: Campbell.Grenier

?

DePuy’s withdrawal from the market and subsequent recall of the defective DePuy ASR hip implant system has since been met with accusations of “too little too late” from the medical community. Evidence has surfaced that DePuy Orthopedics was well aware of problems with its implant and failed to take appropriate precautions to safeguard its consumers when these problems came to light.

In August of 2005 the DePuy ASR hip replacement system was approved for marketing by the FDA by means of a process which does not require extensive testing. In 2007 Dr. Nargol, an orthopedic surgeon out of the UK, began to see his ASR recipients returning with complaints of groin pain. While Dr. Nargol blamed his own surgical technique for the problems, his associate, resident Dr. David Langton, having noticed no such complaints from patients who received a competitor’s hip, began comparative blood testing.

In 2008 data from multiple sources began to suggest problems with the DePuy ASR. Doctors performing surgeries to revise ASR hip systems noticed damage to patients’ surrounding tissue, muscle and bone. Some of these doctors filed complaints with the FDA. In mid-2008 the doctors presented evidence at a medical meeting which showed that recipients of the DePuy ASR had higher levels of metal debris in their bloodstream than recipients of a competing device. They came to the realization that well-positioned cups were failing at a higher rate than expected.

By early 2009 Dr. Nargol and Langton’s studies concluded that the defective design of the cup component of the ASR system was to blame for the device’s early failure. They brought this information to the attention of DePuy officials, expressing concern for patients implanted with and continuing to be implanted with the ASR, as the implications of their data regarding the well-being of this population was startling.

Despite this plea as well as rising evidence from the FDA and Australian registry that the ASR was indeed failing at a higher rate than expected, DePuy stubbornly insisted that its product was comparable to competitor’s devices. Not until late 2009 did DePuy take significant measures to reduce the risks associated with the DePuy ASR.

DePuy still did not admit to the device failing, however, citing declining sales as the reason for the withdrawal of the product rather than patient safety. Dr. Graves, whose registry’s data at this time so strongly suggested the defective nature of the ASR, said he “had to laugh” at the insistence that the purpose for the withdrawal was commercial in nature.

As late as February 2010 DePuy officials were still defending its device, blaming any problems on doctors improperly implanting the devices. When questioned about the withdrawal of its device from the market, DePuy merely cited declining sales and a shift of focus to new technology. Only in March of 2010 did DePuy issue a field safety notice to doctors acknowledging data suggesting increased failure rates associated with the ASR. However, the emphasis was still on doctors ensuring proper placement of the components, rather than acknowledging a design defect. Finally, in August of 2010 DePuy issued a recall of its ASR hip replacement systems.

If you are one of those patients who was implanted with the defective ASR cup, despite the evidence warning DePuy that the device was unsafe, call the office of attorney, Gregg J. Borri today at 1(888) 444-2336.

Gregg J. Borri Law Firm. DePuy Recall – Gregg J. Borri Law Offices specialize in DePuy Recall litigation, call 1-888-444-2336 for a free consultation.

?