Has the hip replacement that was meant to provide you with better mobility and freedom from pain become a curse? Are you one of the thousands of individuals that have had a hip replacement since 2003 and continue to have symptoms or have already needed additional hip surgeries? If the ASR System by DePuy was used, then you may be entitled to compensation. Call the Law Firm of Roger "Rocky" Walton now at (817) 429-4299 or toll-free at (888) 762-5988 to discuss the details of your case. We are experienced at handling all types of defective medical device cases in Arlington, Dallas, Fort Worth and Mansfield, Texas.
On August 24, 2010, years after the FDA began receiving complaints, DePuy Orthopaedics, a division of Johnson and Johnson, issued a worldwide recall for the ASR XL Acetabular System and the ASR Hip Resurfacing System due to the defective design and manufacturing. Evidence of the problem has been mounting since 2001 that the implants were defective within 5 years of patients’ surgery.
The cup has a tendency not to affix to the bone as it was intended. This results in a “loose cup” that must be revised, or removed and replaced. This recall affects 93,000 individuals who have had hip replacements since 2003 using the ASR systems. Designed to last 15 years or more, the ASR is failing worldwide after just a few years. This recall means additional testing and monitoring is needed to ensure your hip implant is functioning well. Some individuals will need additional costly and painful surgery.
The systems did not go through the intensive testing for approval by the FDA. In fact, the DePuy Hip Resurfacing System was only approved for use outside the United States and is now having a significant failure rate.
Unlike prescription drugs which must be proven safe and effective through clinical trials before their approval from the FDA, medical devices can be introduced to the market without the intensive testing if they resemble a device already available for use. It was this loophole that allowed DePuy to market the devices without proper safety testing. While the DePuy ASR hip implant resembled hip systems already available in the United States, one of the ASR implants key component, the cup of the implant intended to replace the hip socket, was a new model that has never received approval from the FDA.
In recent past, many medical devices have been offered for use by manufacturers. Many of them have not been able to fulfill their promises made in their advertising. The DePuy ASR Hip Resurfacing System is a glaring example of these failed products.
The recalled DePuy ASR XL Acetabular System consists of three components: 1) the femoral stem which is inserted inside the femur; 2) the femoral head (or ball) connected to the stem; and 3) then the system fits inside the acetabulum. The ASR Hip Resurfacing System consists of two components: 1) a cap which is placed over the natural femoral head; and 2) the acetabulum is replaced with the one piece cup, intended to preserve more of the actual bone. Each of the metal systems is used to replace a worn or weakened part of the hip, which consists of a socket at the outer edge of the pelvis and a rounded bone atop the thigh bone that fits into the socket like a ball. Total hip replacement involves replacing both parts at one time.
The ASR is included in a category of devices know as metal-on-metal. The ASR device can lead to excessive pressure on the edge of the cup causing extensive wear and tear which in turn, can cause loosening of the prosthesis and release of large amounts of ionic metal particles of cobalt and chromium into the tissue and circulatory system. The metal particles are known to cause severe inflammation damaging muscle and soft tissues, as well as exposing patients to high levels of chromium and cobalt. Chromium and cobalt are found in the healthy body in small amounts and are required for healthy function, however; the amounts released as a result of the metal-on-metal grinding joint are toxic to the tissues of the hip. Excessive amounts of cobalt (cobaltism) can cause irritability, ringing in the ears, hearing loss, headaches, loss of coordination, cognitive decline, and depression. The condition may also lead to blindness, convulsions, nerve damage and disease of the heart muscle. In addition to the neurological and cardiac problems, cobaltism can also cause tissue damage that can complicate future revision surgeries intended to replace the damaged metal implant.
Many of the problems can occur even without the total failure of the device. There is diagnostic testing available to determine if you have a significant amount of metal particles building up in your body and if those particles are harming you. This testing is not invasive and your surgeon can help you get it done. The testing may include x-rays of your hip and blood work to determine metal levels in your body.
Depuy is defending the claims by saying that the device failed at least partly because it was not properly placed. This lays blame on the surgeon. In litigation, the Depuy lawyers will probably name the surgeon as a “responsible third party” which will likely cause the surgeon to be added as a defendant to share responsibility in paying the damages. However, the design of the ASR system has made proper placement virtually impossible because of the ASR cup, which is shallower than similar devices, making the implant very difficult at best to position at the proper angle. The cup, which resembles a small hollow ball cut in half, must be positioned in the hip at just the proper angle in order to function properly.
A total hip replacement is a surgical procedure that replaces diseased parts of the hip joint with a new artificial prosthesis. The surgery was designed to improve both mobility and eliminate the discomfort of painful joint. Hip pain limits your ability to enjoy activities that give you pleasure. Our hip joints are made as a continuously mobile unit which totally controls movement. Diseased hip joints will not permit easy movement, and thus, can become a hindrance even with day to day activities.
The typical hip replacement without complications should last 15-25 years. Unfortunately, there are individuals that have undergone hip replacement surgeries in recent years who are now having continued pain and medical issues creating a need for a second revision within just a few years. Recovery from the revision surgeries is often as difficult, or more, than the recovery from the initial surgery.
The highest rate for failure has been found in individuals with small statures, typically women and individuals with weakened bones. Hundreds of individuals have had to undergo additional hip revision surgery in the United States alone due to the DePuy ASR hip replacement’s defective design.
Officials for DePuy estimate that about one-third of approximately 93,000 patients worldwide who received some version of the implant were here in the United States. Both versions of the ASR shared a common element, a so-called cup, the part of the joint that replaces the hip socket, which in its design has proven faulty.
If you or a loved one is experiencing any of the following symptoms:
Continuing hip, groin, leg or low back pain;
Clicking or crunching sounds;
A feeling or sensation that your hip is not in place, especially when standing up or beginning to walk;
Marked decline in ability to do physical activities
You are encouraged to contact your surgeon for additional testing and to determine if in fact you have the ASR implants.
If you received an ASR hip implant after 2003 and are experiencing any of the symptoms, you may qualify for compensation for additional medical treatment, disfigurement, pain and discomfort, as well as compensation for loss of income.
It is important that you do not contact DePuy Orthopaedics or that you do not sign any medical release authorizations, even if requested by your physician, without first consulting with an experienced litigation attorney. You do not want to risk the chance of evidence being destroyed. If you have a defective DePuy hip replacement implant removed, you will need to keep the device as evidence for your future lawsuit. Let the hospital and your doctor know in writing that you want the device kept for you. Also, do not allow a DePuy representative to video or photograph any medical treatment or surgery without first seeking advice from your attorney.
DePuy has announced they will reimburse individuals for reasonable medical expenses, but only if they will sign medical release forms giving the company access to their personal and otherwise private medical records. This reimbursement only covers out of pocket expenses that are not paid by your health insurance. There is no compensation for pain and suffering, disability, nerve or tissue damage, or any loss of income associated with the defective product. Some individuals who are suffering from their defective hip implants may need to move to different homes or have their homes modified to fit their needs and some may need to be on permanent disability. The out of pocket expenses that DePuy is willing to pay will not cover these types of expenses.
It is anticipated that as many as 11,000 individuals will eventually require painful and disabling hip replacement surgeries to remove the defective DePuy implants and replace them with other units. Let us help you hold DePuy responsible for the damages caused to you by its defective and dangerous product.
In August of 2010, the DePuy ASR XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System were recalled.
Five years after implantation, approximately 1 out of every 8 patients who had received the recalled systems needed to have revision surgery. Some of the revision surgeries were due to metal particles wearing off of the ball and socket components as they rub against each other over time. These microscopic particles may react in a way that causes fluid to collect in the joint and muscles around the joint. This can cause damage to the muscles, bone and nerves around the hip.
Your orthopedic surgeon will most likely have that information in your medical file, but if not, the information will definitely be within your medical records at the hospital or surgery center where your procedure was done.
Yes, even if you are not having noticeable symptoms such as pain, you need to follow up with your surgeon for additional testing such as blood work and diagnostic x-rays. Do not wait until you develop symptoms.
Pain, swelling, audible clicking or crunching sounds in the hip, and difficulty walking are signs that your implant is failing. You should seek medical attention from your surgeon.
Some individuals report discomforts like swelling and problems walking even after the usual healing period from the surgery, or does not go away at all. This may be a sign of problems such as:
Loosening when the implant does not stay properly attached to the bone in the right position; Fracture where the bone around the implant may have broken; and dislocation where the two parts of the implant that move against each other are no longer aligned. Please remember individuals that haven’t experienced signs of hip loosening or failure may still have a valid lawsuit as a result of complications from metal poisoning, a reaction which may occur in some as the metal components wear and release small particles.
Not necessarily. Some patients do not experience problems from the system. However, it is important that you follow up with your surgeon on an annual basis at least for the first five years after your surgery even if you are not experiencing problems to ensure that your hip continues to work well.
No. Not every individual that has the implant has received the recall notice letter.
If you are experiencing pain, difficulty walking, or other symptoms, your surgeon will want to take x-rays of your hip. X-rays will allow the surgeon to evaluate how the ASP Hip System is positioned, if there is any damage to the bone and if the System has remained attached to the bone. A blood test may be ordered. The blood test indicates the level of microscopic metal particles around your hip.
If the blood test indicates high levels of these particles, your surgeon will most likely do a second blood test 3 months later. These levels may be high even if you are not experiencing any symptoms. If the second blood test still indicates a high level of these particles, a MRI or ultrasound will be ordered. If the diagnostic radiology show a reaction to the particles, surgery may be recommended.
It is possible, but unwise to attempt. Litigation for a medical device injury is very complex. DePuy will be offering minimal settlements to individuals. You deserve to have an experienced attorney fighting for the compensation that you deserve.
It is impossible to determine without reviewing your claim thoroughly. Many factors including medical evidence to the extent of your injuries and your current and future losses will be considered. Even then it is difficult to determine a specific amount. Our firm is committed to trying to get the absolute best settlement possible for your claim.
It is best to contact an attorney as soon as possible. Investigation of your claim will require some time. Also, statues of limitations vary from state to state. If your legal deadline expires, your claim may be permanently barred.
Simply call our office. We offer a free consultation without obligation with our legal team. If you choose to have our firm represent you, we will begin working on your case immediately.
The approximate date when you had your hip replacement. The name of the surgeon who performed your surgery. The name of the hospital where the surgery was preformed. A list of symptoms that you are currently experiencing. If you have had a revision surgery, the date and any findings.
The personal injury information offered and contained herein, regarding personal injury statutes and claimants' rights is general in scope. No attorney client relationship with our attorneys is hereby formed nor is the information herein intended as formal legal advice.