DePuy ASR Hip Replacement Lawyer - d'Oliveira & Associates

The DePuy ASR Hip Replacement system has been identified as posing serious risks to implant recipients, including hip failure and dispersal of metallic debris in patients’ bodies. We are working with some of the leading DePuy Hip Replacement attorneys in the United States. A claim and/or DePuy ASR Hip Replacement lawsuit can be filed on your behalf and there is no fee until you receive an award or a settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.

Following an earlier warning to physicians about the high failure rate associated with the DePuy ASR hip replacement system, the FDA has instituted a DePuy ASR recall. On July 17, 2010 the FDA indicated that the subsidiary of Johnson and Johnson, DePuy Orthopaedics, notified clinicians of new failure rate information obtained after revision, concerning the DePuy ASR hip replacement system. This physician notification, along with the market withdrawal of DePuy ASR, prompted the FDA to designate DePuy Orthopaedics’ actions as a Class 2 medical implant recall.

Initially DePuy, the company that manufactures the hip replacement system, indicated that the device’s market withdrawal was due to slow sales, rather than due to any safety problems. However, DePuy notified clinicians, on March 6, that the ASR hip implant had been linked to a high failure rate. DePuy identified several patients who received ASR hip replacements and had suffered hip failures soon after. As a result, many patients who experienced hip failures after receiving ASR hip replacements have been required to undergo several additional hip surgeries. Such surgeries may entail, among other things, removal or correction of the implants which have proven defective

The DePuy ASR Hip Replacement Recall Includes:

• 300 Acetabular Implants in cup sizes running from 44 millimeters to 70 millimeters
• 29 models of the ASR 100.

The risk of experiencing problems associated with the device has been identified as the highest in women using devices below 50 millimeters in diameter.

The DePuy ASR emerged in 2005 and is a metal-on-metal hip replacement system. Metal-on-metal hip implants increasingly have been identified as posing various health risks, in that they may disperse metal particles into the body. Such health risks include tissue damage and deterioration, inflammatory reactions, and can lead to bone loss.

Adverse reports concerning DePuy ASR hip implants began to arise in 2007 with approximately 100 patients coming forward to identify problems with the hip replacement system. In 2008, the number of patients reporting adverse events associated with DePuy ASR hip implants rose to over 200 individuals. In 2009, reports of DePuy ASR hip implant problems reached a high of 300.

Studies have shown that approximately 12 to 13 percent of patients that have undergone hip replacement surgery with DePuy ASR devices will need corrective surgery within five years. These individuals who have received metal-on-metal hip implants will have to have this corrective surgery and/or have the defective hip implants replaced because of the dangerous nature of the metal debris. Patients have been advised that they should see their implant surgeons immediately for an evaluation of the DePuy ASR hip replacement system’s performance.

DePuy ASR Hip Replacement Side Effects

In late 2010, a recall was issued for the DePuy ASR Hip Replacement. Initially DePuy Orthopaedics, the company that manufactures the hip replacement system, stated that the device’s recall was due to slow sales, rather than safety problems. However, it has since become known that the recall was due to the overwhelming number of complications resulting from the DePuy ASR Hip Replacement. The hip replacement has been linked to an alarmingly high failure rate.

The ways in which the DePuy ASR Hip Replacement has failed/can fail:

• Components in the implant may loosen
• Above average level of chromium/cobalt in the blood caused by wear of the implant
• Necrosis or soft tissue damage caused by exposure to metal particles from wear of the implant

The symptoms resulting from failure of the hip replacement include:

• Fluid collections and cystic masses around the joint
• Severe pain in implant
• Loosening and lysis/osteolysis
• Problems involving walking, pain, swelling or discomfort in the hip area
• Fracture (bone around the implant breaking)

Data collected shortly before the recall determined that nearly 15% of patients receiving a DePuy Hip Replacement required surgical revision within 5 years of receiving the replacement.

If you have any of the above symptoms and believe that you suffered these because of the DePuy ASR Hip Replacement, you may have a valid lawsuit against the manufacturer.

DePuy ASR Hip Replacement Medical Studies

In 2009, The U.S. Food and Drug Administration denied the approval of the DePuy ASR hip resurfacing device after it was discovered that internal clinical studies at DePuy resulted in high failure and corrective surgery rates. In fact, internal memos from DePuy executives that have been uncovered show that DePuy predicted the FDA would deny approval because of the studies' high failure rates but decided to get it approved anyway.

In fact, the DePuy ASR-XL hip replacement system was approved through the FDA's 501(k) fast track method that allows drugs or devices that are so similar to previously approved products, that the FDA does not undergo a full investigation and rubber-stamps the product as fit for the market. The defective DePuy ASR products began causing severe side effects to the point that the company had to issue a mandatory recall of them amid an increasing amount of lawsuits and while its predecessor, the DePuy Pinnacle Hip Replacement System. This allowed the DePuy ASR to get fast-track approval, which is now the subject of numerous lawsuits for similar problems.

Many studies were never concluded because of the abrupt recall of the DePuy ASR resulting from the increasing number of claims and lawsuits against the manufacturer. Many of the lawsuits claimed that the DePuy ASR side effects include severe joint pain, bone and hip fractures, joint and tissue damage, and infections resulting from the increased level of cobalt and the loose pieces of metal that come off from the hip replacement system's use.

As a result of these lawsuits, a federal judge has ordered DePuy to comply with a Section 522 Order that the FDA issued DePuy in 2009. The order requires the company to conduct a post-market study of its devices that have the potential to cause injuries when implanted. The New England Journal of Medicine has called for more stringent requirements on the studies because it believes the lack of harmonization will lead to increased challenges in combating the problems linked to the DePuy hip implants and similar products.

If you have any of the above symptoms and believe that you suffered these because of the DePuy ASR Hip Replacement, you may have a valid lawsuit against the manufacturer.

DePuy ASR Hip Replacement Lawsuits

More than 93,000 patients globally have received the DePuy ASR hip replacement system and the medical device has a one in eight failure rate leaving DePuy Orthopaedics to potentially face thousands of legal claims. Lawsuits against DePuy primarily allege defective design and inadequate warnings. One of the recurring claims being asserted against DePuy is that the corporation was aware of the problems associated with the medical device but failed to adequately warn patients. DePuy faces more than 8,000 lawsuits 6,000 of which have been consolidated. Three DePuy ASR hip replacement system lawsuits have been settled for about $200,000 per claim. Recently, a federal judge ordered DePuy to comply with an FDA order requiring the corporation to conduct additional research on the medical device. DePuy faces legal challenges from both its DePuy ASR hip replacement system and DePuy Pinnacle hip replacement system.

The U.S. Food and Drug Administration (FDA) 510(k) process proves again how dangerous it is. The way the 510(k) process works is that new medical devices, with little to no testing, including no human trials, can obtain FDA approval if it is substantially similar to some previously approved device. This process is how the DePuy ASR Hip Replacement System gained approval.

Within just a few years, the manufacturer of DePuy ASR Hip Replacement, DePuy Orthopaedics, issued a recall for the replacement systems. The first reasons given for the recall were because of low sales. However, it was soon revealed that the true reason for the recall was the severe complications resulting from a very high failure rate of the hip replacement. Close to 100,000 DePuy hip replacements ultimately were recalled.

The DePuy ASR Hip Replacement side effects include:

• Fluid collecting around the hip joint
• Pain in the hip joint
• Loosening of the hip implant
• Swelling causing difficulty walking
• Implant breakage

As a result of these side effects, many lawsuits have now been filed against the manufacturer. The main claim in these DePuy ASR Hip Replacement Lawsuits is that the product was defectively designed.

If you have any of the above symptoms and believe that you suffered these because of the DePuy ASR Hip Replacement, you may have a valid lawsuit against the manufacturer.

In order to prove that you have an injury that should be compensated for by the manufacturer, you must prove either that you did not receive adequate warnings, the device was defective in the condition it was put on the market in, or that this form of the device that you used was in some way defective. The next thing that you have to prove is that the device caused the side effect or disease that you were diagnosed with.

To prove this, people need many different experts and medical opinions. You will need the opinion of your physician and medical experts. There are experts that are brought in to prove that the device is in fact defective. These lawsuits are very time-consuming and detailed but if you have one, you deserve to be compensated for your injuries. Hiring an experienced DePuy ASR Hip Replacement attorney can help you make important personal decisions regarding moving forward with your claim.

DePuy ASR Hip Replacement About Manufacturer

The DePuy ASR hip replacement system is manufactured by the Johnson & Johnson subsidiary, DePuy Orthopaedics. DePuy Orthopaedics was originally founded in Warsaw, Indiana in 1895. DePuy was acquired by Johnson & Johnson in 1998 and now has locations globally. In 2011, DePuy agreed to a merger with Synthes to create the largest orthopedic corporation in the world.

DePuy Orthopaedics Issued Recall of DePuy ASR Hip Replacement System

The DePuy ASR hip replacement system was approved for sale on the market by the FDA in 2005 without clinical trials. In the years following the medical device’s approval, the FDA received hundreds of complaints from patients who had received the device. In early 2010, DePuy stated they were phasing out the medical device due to its declining sales. In March 2010, DePuy acknowledged that approximately twelve percent of patients who had received the DePuy ASR hip replacement system needed revision surgery. In August 2010, DePuy finally issued a recall of the DePuy ASR hip replacement system after years of reported device failure.

Contact the Law Offices of d'Oliveira & Associates

If you believe that you or a loved one has suffered as a result of a DePuy ASR hip replacement system, you may want to speak with a personal injury attorney regarding a potential lawsuit. An injury lawyer familiar with new developments in the investigation of DePuy hip implants may be able to help you make important personal and legal decisions.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.