In 2005, the FDA approved the ASR™ XL Acetabular Cup System for use in traditional hip replacement. The medical device was not required to undergo clinical trials but instead was cleared through a regulatory pathway.
Pharmaceutical giant Johnson & Johnson issued a voluntary recall in August 2010 of its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System. Johnson & Johnson announced the company has set aside $3 billion dollars for ASR hip implant device lawsuits. Is that enough?
There were indications that DePuy had been aware of problems with its hip replacement products for some time. In 2006, DePuy issued warning letters to physicians regarding higher than usual failure rates of its ASR hip implants in more petite patients with osteoporosis. Three years later, DePuy completely withdrew the ASR hip from selected markets, claiming poor sales. Despite acknowledgements of serious issues with ASR implants, DePuy kept products in some markets until issuing its worldwide recall in 2010.
How many thousands of innocent people had hip implants between 2006 and the 2010 worldwide recall?
The failure rate for the ASR cup hip implant system is turning out to be much larger than originally thought and many doctors believe that all of the devices may need to come out. What if all the ASR hip implants can’t be removed? What if people are older and sicker? What if people don’t have health insurance or their Medicare plan doesn’t cover it? What if people don’t have the same support system they had during their first ASR hip implant surgery? What if the next hip implant solution is not effective?
Recently it was noted that more than 5,000 ASR hip implant device lawsuits were filed; 3,159 cases in multi-district litigation in Ohio and 1,500 cases in California. People are still suffering. Trials will begin soon two years after the recall. Do you have an ASR hip system lawsuit?
How can thousands of metal on metal ASR hip devices be implanted in people’s bodies and never be tested? Hip implants have the same FDA classification as condoms. Can you imagine? Nobody has to be hospitalized with anesthesia to remove a condom. Not testing ASR hip implants sounds reminiscent of a greedy Dr. Frankenstein.
How can an industry like medical devices exist without each product and design being tested on the very population that will use the hip device?
If you think you have an ASR hip implant lawsuit, your law firm will examine the following:
- Implant date
- Removal date
- Cause of failure
- Could anything else have caused failure?
- What damages and pain and suffering have you had to endure?