DePuy Receives Warning Letter From FDA
DePuy Orthopaedics, a division of Johnson & Johnson, is in hot water again with the U.S. Food and Drug Administration as claims continue to grow from a previous recall.
In December, the company received a warning letter from the government agency over artificial knee and hip replacement implants being manufactured in Warsaw, Indiana, without approval. DePuy argued that the implants are custom devices and not subject to FDA inspection, but the agency disagreed and ordered the company to halt sales. In addition, the FDA said poor quality-control issues at the plant led to additional violations.
This regulatory action is just the latest for DePuy, which was forced to recall 93,000 ASR metal hip implants in August 2010. The devices included in the recall are the ASR XL Acetabular System, a socket used in total hip replacement surgeries, and the ASR Hip Resurfacing System, a partial hip replacement used to preserve the bone. Together, the devices created excessive friction, releasing metal fragments into patients’ blood.
DePuy recalled the devices after researchers found 13 percent of patients would need a second corrective surgery within five years. Some reports suggest that more women will be affected than men in the recall. The ASR metal hip implants were used between 2005 and mid-2010.
Do you suspect you or a loved one might be affected? Symptoms of ASR hip implant failure include pain or swelling of the hip area, difficulty standing or walking, lack of flexibility and general discomfort.
More than 3,500 lawsuits have been filed over the ASR hip replacement implants in the United States.
In response, Johnson & Johnson has taken some unusual steps to manage the crisis. It hired a third party, Broadspire Services, Inc., to manage reimbursement claims, which some say is a way for the company to limit payments and get access to patients’ medical records that could be used against them in court.
Perhaps most offensive is that Broadspire’s doctors — not the patients’ own physicians — determine whether a replacement surgery is necessary. Broadshire doctors cannot dictate treatment, but they can decide whether the company will pay for the second operation, which essentially makes the decision for those who cannot pay.
After the ASR recall, the FDA has received numerous complaints about the DePuy Pinnacle hip replacement system, which was the predecessor to the ASR hip replacement system. Because of the similar, defective design associated with metal-on-metal components, many patients have had revision surgeries. No recall has been issued so far, but a multidistrict litigation (MDL) has been established in Texas for those filing lawsuits.
