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DePuy Hip Recall

The DePuy Hip Recall: What is it all about?

In late August of 2010, DePuy Orthopedics, Inc., a long time orthopedic products manufacturer and subsidiary of health care products and pharmaceuticals giant, Johnson & Johnson, issued a voluntary recall of its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System. The issuance of this recall was tantamount to an admission by DePuy that it had produced and sold hip replacement products with substandard failure rates, with as many as twelve percent (12%) of patients requiring “revision” surgery to repair problems associated with these devices – in other words, the devices were removed and replaced.

Absent the aforementioned recall, there are 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 smaller patients with osteoporosis. Three years later, DePuy completely withdrew the ASR hip from selected markets, claiming poor sales as the reason behind its decision. Despite these apparent acknowledgements of serious issues with its ASR implants, DePuy kept its products in remaining markets until issuing its worldwide recall in 2010.

David Floyd, DePuy Orthopedics president at the time of the recall, issued the following statement:

“We regret that this recall will be concerning for patients, their family members and surgeons. We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.”

DePuy, through other lines of communication, further expressed its commitment to cover reasonable and customary costs of monitoring, testing, and treatment services, up to and including “revision” surgery associated with the recalled device if necessary.

The DePuy Hip Recall: What is the way forward?

If you are a hip implant recipient whose procedure was performed after July 2003, there is a possibility that you may carry the defective ASR device. To see if this is the case, you are urged to consult with your treating physician immediately. Your doctor should have access to the records that are relevant to this determination. In the event that you were implanted with the recalled device, he or she should also be able to make a clinical assessment as to whether or not your hip implant device is functioning properly, or if you are a candidate for “revision” surgery.

It is important to maintain records and copies of any and all medical bills associated with these types of physician visits, tests, and/or procedures so that you can provide documentation to DePuy Orthopedics of any monies for which you are entitled to reimbursement.

It is also important to speak with an attorney if you have any questions pertaining to potential litigation against DePuy for any injuries you may have suffered as the result of this defective device.

Sullo & Sullo, LLP can provide a free consultation and evaluation of your case.

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The Recent Articles and Publications

 
February 01, 2012
Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip repla
Full Story
February 01, 2012
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to
Full Story
February 01, 2012
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision s
Full Story
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