DePuy Hip Implant Litigation
DePuy Hip Recalls
On August 26, 2010, DePuy Orthopaedics, Inc recalled from the market the DePuy ASR Hip Replacement. This hip has resulted in serious problems to a large population of the receiving patients.
The DePuy ASR hip replacements subject to the Depuy Hip recall are both metal on metal replacements. Their model names include: ASR XL Acetabular System and the ASR Hip Resurfacing System. The problem hips have been implanted since 2005 in the United States and since 2001 internationally.
Many of the Depuy ASR patients have and will require a painful revision surgery to remove and replace the ASR hip implant. Preliminary estimate that approximately 10,000 patients may need revision surgery. Based on our work with similar medical product recalls, in addition to our current research, Farrar & Ball believe this figure grossly underestimates the number hip revision surgeries that will be necessary.
Hip revisions are necessary because the ASR device is defectively designed in that the product causes a release of high levels of metal ions into the patient’s blood stream. This metal ion release has been proven to cause tissue damage, pseudotumours, and results in osteolysis. The time frame in which these symptoms occur varies greatly. It may happen shortly after the DePuy ASR hip replacement is implanted into the patient or it may take years to occur. Farrar & Ball currently represents clients with both immediate and long term problems.
DePuy Hip Revision Patient Profile
The FDA requires "Adverse Event Reports" concerning any and all drugs approved by the FDA and placed on the market. The Adverse Event reports involving the DePuy ASR by surgeons performing DePuy hip revision surgeries concern instances of "loosening, pseudotumour and metallosis" metalosis. Surgeons have noted upon revision that the DePuy ASR hip cup was "loose and easy to revise", that the "the cup popped right out" and that "there was no evidence of any bony ingrowth." In most every single case wherein these observations have been made, the surgeon also saw pre-surgical symptoms including, but not limited to "extreme pain when weight bearing. X-rays looked good, and cup was in position."
The Problem Has Existed For Years
Long before the recall of the subject DePuy hip ASR systems, published medical articles detailed specific design problems with the ASR device. Many, hundreds, of Adverse Event Reports in United States confirmed what the studies and medical articles stated. Shortly after these articles came to light, the DePuy ASR hip was withdrawn from the Australian market in December 2009. It was not simultaneously withdrawn from the United States market. Likewise, on May 25, 2010, a Medical Device Alert was issued in the UK for the DePuy Hip. This alert was not simultaneously issued in the United States.
DePuy Wants The Subject Hip For "Testing"
DePuy has issued directives to surgeons meant for the purpose of supposedly assisting the Depuy company concerning the hip recall. Depuy has directed surgeons to "assist" them in getting patients to sign documents which allows DePuy to take possession and keep the explanted hip implant for "testing" purposes. It is imperative that Depuy not be given unfettered access to the hip implant. The implant is the property of the patient and no one else. The explanted device is a valuable piece of evidence and a patient may not be able to prove a product defect case without the explanted hip device. Patients and guardians may not realize what they are doing when they sign the documents. Please realize that your health care insurer is obligated to pay for your revision surgery and testing and it is not necessary for you to sign any documents for DePuy in order to get your revision or testing completed.
Please contact Farrar & Ball with all your questions. Let us help you in this matter.