Depuy Hip Implants
DePuy ASR Hip Replacement Recall
In the past few years, Johnson and Johnson – one of the largest pharmaceutical and medical device manufacturers in the world – has been forced to recall 11 drugs and medical devices. The most recent recall involved 29 models of a prosthetic hip implant, the DePuy ASR XL Acetabular System, which were recalled by the FDA in August, 2010 because of evidence of high failure rate. Failed implants cause pain to patients and often necessitate additional surgeries. If you are experiencing pain or have had to undergo surgery for a hip implant, contact one of our skilled Florida DePuy hip replacement lawyers.
Johnson and Johnson’s ASR XL Acetabular System is a metal-on-metal (MoM) implant; both the “ball” and “socket” of the artificial hip are made of chromium or cobalt. Each year, a quarter of a million Americans undergo hip replacement or hip resurfacing surgery with MoM devices. There are about two dozen manufacturers of MoM implants. An estimated 100,000 patients received DePuy ASR MoM devices before its recall was ordered.
Johnson and Johnson informed the public that its DePuy ASR implants were being “discontinued” due to low sales and declining demand. Nothing was further from the truth. Demand for hip replacements was rising, and a year after the recall DePuy secured FDA approval for a ceramic-on-metal total artificial hip system.
Your Defective Medical Device Lawyers explain what really happened:
- Hip replacement systems consist of ball and socket components. The socket portion is implanted into the outer edge of a pelvis. The ball portion sits atop the femur (thigh bone) and is affixed to a stem that is inserted into the femur. When both of these components are made of metal, and especially if they do not fit properly, they rub against each other awkwardly. This abnormal wear causes microscopic metallic particles to break away from the devices and travel to other parts of the body, sometimes entering the patient’s blood stream.
- When patients react adversely to these metal shavings, called “metallic debris” a condition known as metallosis occurs. Metallosis can cause pain, swelling, and difficulty walking. While these symptoms are considered normal for patients who recently have received a hip replacement, they also can signal a problem if they persist or worsen over time.
- According to DePuy’s website, prolonged complaints of these symptoms may be a sign of loosening of the hardware (the implant does not stay attached to the bone in the correct position), or dislocation (the two parts of the implant are no longer aligned).
- In April 2010, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued an alert to the UK medical community about soft tissue necrosis (“tissue death”) in some patients with metal-on-metal hip devices. Drawing upon adverse events reported to the National Joint Registry of England and Wales, MHRA reported failure rates of 13% for the DePuy ASR XL Acetabular System and 12% for the ASR Hip Resurfacing System. These rates are alarmingly high – about twice the industry average for similar devices. Approximately one in eight patients implanted with ASR products will require corrective surgery within five years after the initial implant.
- In August 2010, the FDA initiated a Class 2 voluntary recall of DePuy’s ASR XL Acetabular System – a recall that affected an estimated 93,000 patients worldwide.
Products subject to Class 2 recalls have a lower probability of causing serious injuries or death than Class 1 recalls, but nonetheless have the possibility of causing irreversible damages. The FDA defines a Class 2 recall as one issued in “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Many patients who were implanted with the DePuy ASR XL system would argue with the FDA’s recall classification, finding the prospect of “serious adverse health consequences” not so remote. They continue to experience pain, swelling and difficulty walking due to inflammation, tissue damage, bone loss, and other complications.
Patients with a DePuy ASR XL system implant may also suffer from metallosis, which can lead to tissue necrosis and to osteolysis, in which the bone becomes almost porous and the implanted hip device can loosen. The FDA’s website on metal-on-metal hip replacements cites more serious findings; high levels of metal ions in a patient’s system can cause neurological and cardiac disorders.
In May 2011, the FDA issued a surveillance order requiring all manufacturers of metal-on-metal hip replacement devices, including DePuy, to design and implement testing of patients who had been implanted with these devices. The order stressed that physicians should follow up with their patients to check for symptoms of metal poisoning, and that patients with symptoms should undergo blood tests to measure the level of metallic ions in their systems. Patients who suffer from elevated metallic levels in their body will likely have to undergo revision surgery for removal of the implant.
Many patients with DePuy ASR XL artificial Metal on Metal hips do not realize that this device was approved by the FDA without any requirements for evidence on its safety or efficacy. A controversial approval method called 510k allows medical devices to be approved without clinical trials or tests on humans if the device is substantially similar to other devices already approved and in the market.
In July 2011, a well-respected scientific group, the Institute of Medicine, made public a report proposing a tougher approval process for a broad range of medical devices in the United States. The report mentioned hip implant devices specifically, suggesting that scrutiny up front could have prevented thousands of failures that cause numerous injuries. A New York Times article discussing the Institute of Medicine recommendations notes that metal-on-metal artificial hips such as the DePuy ASR XL were tested and appeared to work well on mechanical simulators – but “failed disastrously when implanted in humans.”
Thousands of patients who received DePuy implants have sued DePuy and Johnson and Johnson. At the federal level, these cases have been consolidated before Judge David A. Katz in Toledo, Ohio. There are also cases filed in state courts. Searcy Denney Scarola Barnhart & Shipley filed the first case in Florida state court, and the firm has also filed cases in the federal proceedings.
Florida DePuy Hip Replacement Lawyers’ Advice
If you have an implanted metal-on-metal DePuy ASR XL hip device, you may be confused and worried. You may have received a letter notifying you of the recall. Many patients are having their implants removed, or are being closely monitored by their doctors for signs of elevated heavy metal in their systems.
If you have not already consulted with your physician and/or surgeon, you should do so immediately both for evaluation of your device and to see if enhanced monitoring is appropriate. For most recipients of DePuy metal-on-metal hip implants, the thought of going through another surgery is enough to put it off unless symptoms appear – and that is understandable.
DePuy has a company website that contains good information for patients with ASR hip implants. A word of caution DePuy has hired a company called Broadspire to contact recipients of the ASR hip implant and offer medical expenses to cover removal of the device. Patients should remember that Broadspire is working for Depuy and Johnson and Johnson, and that its job is to protect the interests of the device manufacturers, not the patients. It is not advisable to release medical records or other personal health information to Broadspire without first obtaining the advice of a pharmaceutical litigation attorney. The experienced Florida DePuy Hip Replacement Lawyers at our firm will review your case and help you determine the best courses of action available to you.
As with side effects and complications of any pharmaceutical drug or medical device, you should remain alert to obvious symptoms or any other changes in your health that could signal metal poisoning or failure of your DePuy ASR XL hip device. Look for credible sources of information about metal-on-metal device failure and make regular visits to your physician.
Watch one of our clients tell her real life story of the suffering she has been forced to endure as a result of injuries she suffered from defects in Stryker’s Rejuvenate Hip Implant.