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DePuy ASR Hip Replacement Implant Recall Lawsuit
Over recent years, a number of medical devices have been found to be defective. Frequently, these devices were put onto the market before being fully investigated in regard to patient safety. One device, the ASR XL, a hip replacement implant manufactured by the DePuy Orthopaedics, Inc., was found to cause a number of medical issues in patients who received the device. DePuy issued a recall of the product in 2010 after a significant number of failures of the implant were reported to the U.S. Food & Drug Administration.
The Problem of Defective Medical Devices
Patients undergoing joint replacement surgery have the expectation that the implant devices they receive have been thoroughly tested and approved by overseeing agencies. However, many products go through an abbreviated process and are put on the market even when the quality or long-term functionality of the product are in question. The medical implant manufacturing industry, in particular, invests significant amounts of money into the research and development of new devices that help to restore function for patients around the world and work hard to get these products on the market as quickly as possible.
Problems With FDA Approval of Devices
In many cases, new orthopedic products received FDA approval without the thorough safety testing that the agency generally requires. All that was needed for approval was proof that the new device was similar to previously approved devices. However, evidence that new these new products are, in fact, similar to previous models is often sketchy. This process only required filing of supporting documents and the payment of a fee. This effort to streamline the process to get new medical devices on the market faster has resulted in a number of problems that caused patients additional pain, injury and medical treatment. The failure of these devices has led to a number of lawsuits filed against the manufacturer.
The DePuy Hip ASR XL Implant
In the late 1990s and early 2000s, medical device companies began manufacturing a new type of hip replacement implant. This type of implant was expected to be superior to previous models, which used high-tech plastic parts and were subject to eventual loosening and wear. The new implant featured a metal-on-metal design that was expected to last much longer than previous designs. In this design, a metal cup fits into the acetabulum, the concave hip bone in the pelvis. A metal ball that is connected by a metal stem into the femur then fits into this one-piece constructed cup to simulate the normal construction of the human hip. Although the basic design followed a number of other models of hip implants, the metal-on-metal construction proved to a significant change that caused new problems for patients who received the device.
Not long after the ASR XL device was introduced to the market, reports of medical problems began. A number of patients experienced a variety of problems with the device, including:
· Loosening of the implanted device
· Early failure of the device, requiring revision surgery
· Chronic pain
· Allergic reactions to the metal
· High levels of chromium and cobalt in the bloodstreams from tiny chips that break off from the device, causing metal poisoning
· Growth of pseudotumors at the site of the device
The failure rate for these devices at five years was found to be as high as 13 percent. In August of 2010, with growing evidence that many patients were having problems with their product, DePuy issued a voluntary recall of an estimated 93,000 ASR XL implants around the world. However, it is not clear how many implants were replaced, nor how many people are still unaware of the defective implant they received.
Additional Medical Treatment
The medical issues caused by the defective hip implant often required additional medical treatment, including diagnostic procedures, medications and treatments. These medical expenses added to the burden of physical pain and inconvenience. Continued reports of patient problems came to the attention of the FDA as early as 2008. By 2010, DePuy acknowledged problems with the implant and issued a recall of the product.
DePuy Hip Implant Lawsuits
Thousands of people who suffered injuries and additional medical costs because of the effects of the DePuy ASR XL hip implant filed suit against the manufacturer. These suits cite “grievous injury” by patients who received the implant. In November of 2013, Johnson & Johnson, the parent company of DePuy Orthopaedics, agreed to pay $4 billion dollars in a settlement to these patients. The settlement was uncapped, meaning that the company may have to pay additional amounts for future patients who must undergo revision surgery because of the defective implant.
What Patients Can Do
If you have received a hip replacement implant, ask your orthopedic surgeon about the type of implant used. Discuss any medical problems you are having with the physician to determine if further treatment is necessary. Research the FDA information about the DePuy hip implant on the agency site. Stay alert to any changes in your physical health and see a physician immediately to determine the source of the problem. Keep all medical bills available for review if it becomes necessary in the future.
Legal Remedies For Those Injured By DePuy Hip Implants
If you feel you have experienced further injury from use of the implant, talk to an attorney who specializes in defective medical devices to determine if you should file suit against the manufacturer. These specialized attorneys can walk you through the steps of filing your lawsuit, submitting supporting documents and other matters regarding the successful filing of defective medical device cases.