On August 24, 2010, DePuy Orthopedics, a Johnson & Johnson company, issued a voluntary hip recall of two of its ASR products. The ASR XL Acetabular System and the ASR Hip Resurfacing System were found to be failing at a higher rate than other types of hip replacements like metal-on-plastic. Metal-on-metal hips have metal balls and metal sockets, which create friction. The friction caused by the rubbing together of these two parts can lead to the shedding of particles of metal into surrounding tissue and even the bloodstream.
A patient with a DePuy hip replacement can have as high as 100 times the normal levels of chromium and cobalt in the bloodstream. When metal particles get into the tissue and bloodstream, it can have a very adverse effect on the body. DePuy patients may experience necrosis and infection of the tissue, along with allergic reaction. High levels of cobalt and chromium in the blood have been linked with heart, kidney, nervous, and liver damage. Moreover, if a patient has a defective DePuy hip, he or she must get a revision surgery. A revision surgery can be costly, painful, and risky.
These risks would not have been necessary if DePuy had been responsible and honest in the beginning. Instead, however, DePuy put its own interests ahead of its patients and perpetuated the growing problem of greed we know all too well of in present day corporate and healthcare settings. The DePuy ASR hip replacement first became available in 2005, but even its origin is suspect. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials.
Throughout the first five years of the ASR’s history, DePuy repeatedly heralded the metal-on-metal hip’s safety. It balked at doctor’s claims that Depuy hip replacements were more defective than other models. It took pressure from the FDA and news converage for DePuy to admit failure. Since 2008, the FDA has received approximately 400 complaints from patients who received a DePuy hip replacement. In March 2010, after several scathing New York Times articles questioned the safety of metal-on-metal hip replacements, J&J acknowledged that ASR products had an above average failure rate. Data showed that approximately 12% of patients who received an ASR device needed hip replacement revision surgery. Still throughout early 2010, DePuy did not issue a recall. It did scale back production of ASRs but said that this was due to lacking sales.
Things changed later in the summer. DePuy has never been a stranger to controversy. It was involved in a scandal concerning the bribery of doctors a few years earlier. This history was further darkened in the middle of the summer. On August 19, 2010, the FDA issued a warning letter to DePuy for marketing strategies used on two of its products, the DePuy Corail AMT Hip Stem and the TruMatch Personalized Solutions System. DePuy decided to avoid a PR nightmare. On August 24, 2010, DePuy issued a voluntary recall of both ASR devices.
However, the recall was issued after 93,000 patients worldwide were given the faulty DePuy hip replacement. Many doctors and experts felt that this was too late, and too many patients were allowed to suffer before DePuy did the right thing. One in eight DePuy hip replacements has failed causing the need for costly revision surgery. This is unacceptable. It is the responsibility of DePuy to take responsibility and pay financial compensation to these victims. The first lawsuit was filed on June 15, 2010. Hundreds of others have followed.
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