DePuy’s ASR acetabular cup spent just over five years on the American market. In that time, DePuy sold more than 90,000 ASR cups. After hundreds of reports of hip failure and loosening of the ASR cup, warnings from physicians about metal debris, and a growing number of lawsuits, DePuy finally recalled the defective hip replacement device on Aug. 26, 2010.
On the American market, the DePuy ASR cup goes back to March 2004 when DePuy started a process known as 510(k) approval. This type of Food and Drug Administration (FDA) clearance requires a medical device company to show only that its new device is “substantially similar” to other devices already on the market. DePuy claimed that its new ASR acetabular cup was “similar” to its prior cup, the DePuy Pinnacle device.
One crucial distinction between the Pinnacle and the ASR, however, was external fixation. While the Pinnacle was designed to be fastened to the bone with screws, the ASR offered surgeons no means to fasten it to the patient’s bone. Its only means of fixation was for bone to grow into the device.
Based on the representation that the ASR was similar to one of its previous devices, DePuy began marketing and selling the ASR. DePuy and Johnson & Johnson were never required to go through extensive clinical trials or to otherwise prove that the ASR was free of dangerous defects.
The DePuy ASR Hip Implant Cup Failed Long Before Expected And Advertised
When Walkup Melodia filed the first defective DePuy ASR case almost 18 months before the hip implant was recalled, our lawyers discovered that there were already more than 130 reported cases of DePuy ASR cups loosening and requiring revision surgery. Our first action, filed in San Francisco in March 2009, was among the first defective DePuy ASR product liability cases filed in the country.
Since that time, many clients have sought our experience, evaluation and representation. We are personally prosecuting more than 200 claims for patients who received defective DePuy ASR acetabular cups.
If you received a defective hip implant and are experiencing problems, you may qualify for compensation for physical damage, additional surgeries and your pain and suffering.
For a consultation to discuss your case, call us at (415) 981-7210 or contact the Walkup firm online. We handle DePuy ASR hip implant lawsuits in California and nationwide.