Some medical professionals refer to it as one of the worst recalls in United States history. Unfortunately, there are thousands of victims that would agree. The truth is, Johnson & Johnson and DePuy Orthopaedics let down people who were depending on their hip implant to help them lead a normal life.
DePuy first released their ASR Acetabular System in 2005. The following year, the FDA began receiving reports about high failure rates and metallosis symptoms. Nevertheless, DePuy was still able to manufacture and market these faulty devices. Between 2006 and 2010 a total of 887 people blamed their DePuy hip implant as the source of numerous adverse reactions. During this same period of time, while thousands suffered, DePuy gathered profits totaling $19.4 billion.
People who received these implants were told that the implant had a life expectancy of at least 13 to 15 years. However, nearly 13% of people fitted with the device will need revision surgery within 5 years.
Patients in the United States weren’t the only ones who were exposed to this massive hip replacement recall. DePuy had to recall its ASR Hip Resurfacing System in several overseas markets after a report by the UK National Joint Registry. In Australia, 5,500 patients complained about toxic levels of cobalt and chromium in their blood streams. Alarmingly, DePuy kept the device available in the United States even after it had been pulled from overseas markets.
So, how did this catastrophe happen? Through a small loophole in the FDA medical device approval process. Although the ASR hip implant was classified as a level three device and subjected to a premarket review, it was similar to a device already on the market. Because of this, it was approved under code 510(k). This procedure qualified the defective hip implant for premarket notification without any extensive testing. This is a faster and cheaper route for manufacturers, but patients have paid a high price.
There are approximately 2,000 hip implant lawsuits in the U.S. alone, and that number is rising. These lawsuits will only help solve part of the problem. The other necessary action is a federal reevaluation of the 510(k) process.
If you’re a victim, or want to support a recovery process, join the American Joint Recovery Registry (AJRR) to raise awareness about these failed devices. You can also contact a DePuy hip recall attorney at Parker McDonald Law for more information on your legal options.
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