How Did the DePuy Hip Get on the Market?
The DePuy ASR hip replacement, which DePuy Orthopaedics recalled several months ago following disclosures that it frequently failed and required painful and costly revision surgery, is already the basis of numerous lawsuits against DePuy and its corporate parent, Johnson & Johnson.
As litigation against DePuy escalates, many people are asking how the DePuy hip – which DePuy said would last longer than less well-designed artificial hips – ever got onto the market in the first place. It is a story of regulatory failures and a corporate conglomerate with billions of dollars in annual sales that, for far too long, ignored the apparent dangers its product caused.
The DePuy Hip: A Closer Look
When people refer to the “recalled DePuy hip,” they generally mean one or both of two hip replacement products sold by DePuy Orthopaedics: the ASR XL Acetabular system, used in total hip replacements, and the ASR Hip Resurfacing System, used in partial hip replacements (also referred to as “hip resurfacings”). In 2003, DePuy Orthopaedics began selling the resurfacing implant outside the U.S., and it began clinical testing to be able to sell that implant, which involved a new “resurfacing” procedure, in the U.S.
While DePuy was continuing that process, the FDA authorized it to begin to sell the ASR XL Acetabular system in the U.S. This was permitted under the law because of a loophole that allows a company to market a product it claims is “substantially equivalent” to another product that the FDA had previously approved. Signficantly, the DePuy ASR XL hip did not go through the rigorous FDA testing process. As the director of the Public Citizen’s Health Research Group, Dr. Sidney M. Wolfe, recently observed to The New York Times, that means that manufacturers of products such as the DePuy hip “are basically testing these devices in an uncontrolled way on a large number of people.”
And in this case, the human testing appears to have had tragic results. The common part of both versions of the DePuy hip was the “cup.” As thousands and thousands of people who were implanted with the DePuy hip now know, that is the part of the DePuy hip that appears to be defective.
In late 2007, DePuy finally sent the data from the clinical trials to the FDA for the hip resurfacing implant, but never actually received FDA approval to sell it in the U.S. DePuy continued to sell the ASR XL Acetabular implant until last August, when it recalled both hip products.
DePuy ASR Hip Replacement Lawsuit
If you or a loved one has experienced any problems as a result of a DePuy ASR hip replacement product, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact one of our lawyers today for a free and confidential DePuy ASR hip replacement lawsuit evaluation.