Thursday, February 2, 2012

Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery

Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.

Although DePuy states they did not keep records of those implanted with the artificial hip device, it is estimated there are over 100,000 of the implants worldwide. The FDA received over 400 complaints between 2008 and 2010, when the device was finally recalled. The DePuy hip replacement implements a metal-on-metal hip replacement bearing technique which can cause metal shavings to spread into the body causing inflammation and tissue damage. Early estimates by DePuy puts the number of patients who needed a second hip replacement within five years of the first DePuy implant at between 12 and 13%, although an independent study put the need for a replacement surgery as high as 49% within six years.

DePuy’s hip replacements systems, the ASR XL Acetabular and ASR Hip Resurfacing System were approved under the somewhat lax 510(k) FDA approval process which only requires that manufacturers demonstrate that new devices are substantially equivalent to preexisting devices. DePuy used this process to obtain approval for their metal-on-metal hip replacement devices, claiming their components contained standardized design characteristics.

Finding Out if Your Hip Replacement Was Recalled by DePuy
If you have received a metal-on-metal hip replacement device within the past seven or eight years, you should definitely be checked out to determine whether or not your implant device was manufactured by DePuy, and whether you are suffering any problems as a result. You may be unaware of the specific type of device you received, and therefore should call your doctor or the surgeon who performed the procedure. If you cannot find out whether your metal-on-metal hip replacement is a DePuy hip replacement recall, then try calling the hospital where your operation took place. Remember that even if you are not experiencing pain, swelling or localized discomfort your hip replacement device may still be faulty, leading to painful or dangerous side effects in the future. Your doctor or surgeon should be aware of the DePuy hip replacement recall and call you to schedule a visit however this may or may not happen meaning you must be proactive regarding your health.

Testing for Problems
Once you have an appointment with your doctor, he or she will be aware of whether the implant device you received was one of the two types recalled by DePuy and will likely have blood tests run in order to determine if you have unusual levels of the metals cobalt and chromium in your body. A second blood test may be ordered to confirm the results of the first. Some patients are subject to a cobalt allergy, and may suffer from heavy metal toxicity or heavy metals poisoning from the cobalt in their hip replacement. You may suffer from either cobalt or chromium toxicity, both of which have serious side effects. Your doctor will also conduct further tests to determine whether your hip replacement is working as it was intended to work. These tests may include x-rays which will allow your surgeon to evaluate how the ASR hip system is positioned, whether there has been any significant damage to the surrounding bone, and whether the DePuy ASR hip system has remained attached to the bone. An MRI or ultrasound could be a part of the testing procedure to determine whether your hip device requires replacement.

Who Will Pay for Your Tests?
According to DePuy’s own website regarding the recalled hip implant devices, it is stated that they will work with public and private insurers—including Medicare—to establish a simplified process for addressing financial claims. The company also asks that any person who has established they were implanted with a recalled DePuy hip implant device contact the DePuy ASR help line to initiate a claim. DePuy states they will cover recall-related patient out-of-pocket expenses however it is very important that you discuss the issue thoroughly with a product liability attorney before agreeing to anything with DePuy or signing any paperwork.

Potential Side Effects of a Defective DePuy Hip Implant
Those who have undergone a DePuy hip replacement with one of the known defective devices may have suffered continuing pain in the hip, groin, leg or lower back or may hear an audible crunching or clicking sound which comes directly from the ASR device. Some recipients of the ASR state that they feel their hip is out of place, most particularly when starting a movement such as standing from a seated position or beginning to walk. In fact, any activity which causes the hip to bear weight may cause moderate to severe pain and swelling as well as other DePuy hip recall symptoms directly related to the recalled device.

There may be noticeable declines in the ability to perform physical activities which were once considered normal, and a bone scan may show increased metabolic activity near the location of the hip implant. Just as alarming, as noted above, when the ASR hip devices begin to deteriorate, they leave small metal shavings in the recipient’s bloodstream which can lead to several serious health issues. The body can have an adverse tissue reaction to these chromium and cobalt metal flakes known as an ALVAL (asceptic lymphocyte-dominated vasculitis associated lesion) or can react to the metal by forming pseudotumors.

The blood test administered by your physician should determine whether you have heightened levels of metal shavings in the blood surrounding your hip replacement. Because it can take several years for problems with these metal particles to arise, it’s important that you continue to be monitored for problems through periodic blood tests. This is true even in the absence of pain, swelling or localized discomfort. In the most extreme cases, the DePuy ASR hip implant can completely fail. This can happen when the implant loosens from the bone, dislocates itself or when the bone around the hip implant fractures.

Corrective Procedures for a DePuy Recalled Hip Device
Just as the initial hip replacement surgery was painful, revision surgery will be equally if not more painful for those whose DePuy implant has failed. There are a number of potentially serious complications which can result from this invasive revision surgery including anesthesia issues, moderate to severe levels of infection, pulmonary embolisms and even deep venous thrombosis. In many cases dislocation occurs following a hip revision surgery due to the weakened tissues which surround the affected bone and implant device. The bones are likely in a much more fragile state than they were during the first surgery because of bone deterioration and possible metal shavings in the bloodstream.

One study found that the long-term risk of dislocation for revision hip replacements was as high as seven percent. It is generally understood that a hip revision surgery has an even less favorable outcome potential than the original hip implant surgery. Many of those who undergo a revision surgery will require a longer hospital stay as well as a longer recovery period and may need assistive devices such as canes and walkers for a considerable length of time following the surgery. Those who undergo hip revision surgery may end up with a smaller range of motion than was seen with the first surgery and long-term discomfort could be substantially higher. It is believed that a second hip implant may last only eight to ten years, while the first implants generally last for fifteen—assuming they are not one of the recalled devices which have caused health problems.

Legal Ramifications of the DePuy Hip Replacement Device
The metal-on-metal hip replacements comprise roughly one-third of the 250,000 hip replacement devices used annually in these procedures. One Cornell-based doctor estimates that tens of thousands of people will eventually have to undergo revision surgery procedures to remove the defective hip implant. As of October, 2010, over 3,500 people had filed product liability suits against DePuy, and another 560 are suing the company regarding the non-cemented version of the Pinnacle Hip Replacement System. Naturally, those who have been forced to undergo revision surgery will want DePuy to pay for these surgeries through a replacement settlement or court judgment, and insurers will want to be reimbursed for subsequent procedures.

This means that money received from a recall reimbursement could end up going right back to your insurance company. Medicare is attempting to seek reimbursement from DePuy for any procedures they have paid for or will pay for which occurred because of the hip device recall. Recipients of the recalled DePuy hip implants should be aware that a lawsuit could result in plaintiff damages for full medical expenses, lost wages, costs for transportation, reimbursement for pain and suffering and possibly even punitive damages. These recovery amounts could be considerably more than what recipients will obtain from DePuy’s own recall reimbursement process.

How Will I Choose an Attorney for My DePuy Hip Implant Product Liability Case?
Before contacting DePuy Orthopedics, you should consult a qualified hip replacement attorney who is skilled in product liability. Because DePuy has not been particularly forthcoming regarding their defective products, it would be unwise for those who have received a DePuy hip replacement device to trust that they will be taken care of. Evidence shows that DePuy and Johnson and Johnson were well aware of the problems associated with the metal-on-metal hip implants for a significant period of time before they initiated their voluntary recall of the devices. For this reason alone, a DePuy hip replacement lawsuit could be your best choice.

A DePuy lawsuit brought by a qualified product liability attorney can ensure you recover medical costs such as hospital bills, physical therapy and supplemental doctors’ visits as well as paying the costs for hiring a caregiver. Your attorney will work hard to recover these medical expenses as well as travel expenses, loss of income, scarring and disfigurement and pain and suffering—items DePuy definitely does not want to be responsible for. You may be able to receive compensation for damaged relationships, loss of satisfaction in your life, loss of independence and mobility as well as the psychological effects and chronic pain you have undergone as a direct result of the DePuy hip implant device. Ask plenty of questions before you settle on the attorney for your hip replacement lawsuit to ensure you find the most experienced attorney who will fight hard for your rights. Time, tenacity and diligence are traits you will definitely want in your chosen DePuy recall product liability lawyers.

Author: Sullo & Sullo Attorneys

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