Top 10 Things All DePuy ASR Patients Need To Know
As our firm continues to investigate and evaluate the recalled Depuy ASR hip implant device. In our representation we find that our clients are hungry for information regarding the DePuy ASR hip implant recall and the health affects associated with the recalled device. Unfortunately we are finding that many clients are unhappy and often unable to get answers to questions that they have from their surgeon and other trusted sources in order to evaluate their need for monitoring and/or revision surgery. To that end, we have devised the Top 10 Things All DePuy ASR Patients Need To Know to further address many of the common questions we are asked. We sincerely hope this information will help better inform those affected by the DePuy ASR hip implant recall and make everyone aware of both their medical and legal options.
1. Why was the DePuy ASR Hip Implant Recalled?
This recall came after data from a recent study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. The latest Study out ofEnglandshows a failure rate as high as 49% at 6 years. The recall means that patients who have already undergone one surgical procedure to replace a hip may have to undergo a “revision.” That is: a second surgery. But even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that might not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the DePuy ASR XL Acetabular hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.
The DePuy ASR XL Acetabular System first became available in 2005 in theUnited States. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.
At the beginning of 2010 DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2010 the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However at this point they still had not issued a recall of the product. In fact, they adamantly denied there was a recall and claimed any statements referencing a recall were false.
Johnson and Johnson has experienced other recall issues in the past years and DePuy Orthopaedics is barely three years removed from a scandal that involved undisclosed payments to doctors.
2. What kinds of signs or symptoms do I look for if my hip implant is failing?
You may be having pain around your hip, difficulty walking, inflammation or other symptoms. Some patients are experiencing symptoms and medical complications but they do not know it yet. Your physician has the ability to evaluate you to determine if you are at a greater risk of injury or complication. The inflammatory response from the metal sometimes occurs with little or no symptoms until there is harm to the surrounding tissue and loss of bone. An early X-ray is good to look at bone and device placement but without an MRI or blood work to measure the metal ion levels, a patient may not recognize the harms that may be occurring until they develop symptoms. Your orthopedic surgeon can help you with these matters. Call their office to discuss your plan of care and treatment.
3. Why in particular is the level of Cobalt important?
Cobalt is one of the many metals that is found naturally in the body, but as is common with most all metals, levels in excess can become toxic and lead to many harmful and potentially permanent side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the senses. As far as the device goes, excess amounts of cobalt in the bloodstream lead to inflammation which can seriously damage surrounding tissue and bone.
If the Doctor does not independently research studies regarding toxic values of Cobalt, patients will likely not be informed if the level of cobalt present in their blood is actually elevated or even toxic thereby subjecting them to prolonged issues and injuries.
4. Is additional surgery necessary?
That is a question for your physician and the evaluation must be made in the cost benefit analysis of the potential harms of removing the device to that of replacing it all together. Many factors such as ones age, health, weight and other risk factors must be carefully considered. See your orthopedic surgeon to discuss this potential problem and other avenues of medical treatment to see what is best for you and your family. You will find that surgeons that are experienced with the harms from this device may not be the same surgeon that put in the device. You may also want to get a second opinion and ask what components are going to be utilized and if the physician is limited by contract or experience to a certain manufacturer. We have information posted on our website of the Georgia Physicians that we know are doing revision surgery inGeorgia.
5. Are there any risks to having revision surgery?
There are risks to having any type of surgery. This is a very painful and complicated procedure. A second hip surgery is usually longer and more intense than the first and not all patients are candidates for a revision surgery. Only a trained medical doctor can make this determination with you after conducting the requisite blood tests, x-rays, MRIs and other medical examinations.
6. Who is Broadspire and what is their role in the recall?
A Press Release came out on October 8, 2010 detailing that Johnson & Johnson hired Broadspire, a subsidiary of Crawford & Company, to handle DePuy ASR Hip Implant recall lawsuits and related injury claims.
According to reports, Broadspire is the world’s largest insurance and claims adjuster. Broadspire is funded by Depuy to gain access to the medical records of patients affected by DePuy’s recent hip implant recall through medical authorizations. There can be a benefit to the uninsured patient seeking reimbursement for medical expenses or gaining approval to have expensive procedures paid for by the company, but keep in mind that making a claim for out of pocket expenses or medical bills not paid for by insurance is all that Broadspire is really doing based on our findings. If your claim is not filed in a civil action before the expiration of the statute of limitations, you will not be able to pursue a claim for the harms that you have experienced or may experience in the future including but not limited to pain and suffering from the recalled ASR hip implant.
7. What responsibility does my Physician have ?
One common question may patients have here is what responsibility, if any, do the doctors and/or orthopedic surgeons that implanted these ASR Hip Implant devices have in this nationwide ASR hip implant recall. Our firm’s research and findings is clear: NONE in the cases we have seen and reviewed to date. DePuy has failed to convey their findings on the increasing failure rates of DePuy ASR devices to surgeons and made the product that was defective according. The “Cadillac of implants”, as the DePuy ASR implant was commonly referred to by DePuy representatives, was far from that promise and warranty. Doctors and patients alike fell for this sales slogan and failed reality.
8. Should I hire an attorney?
Along with the medical costs from eventual hip replacement revision, a failed hip replacement can cause a lot of other hardships, including effects on the patient’s lifestyle. Too many patients with defective hip replacements struggled through extensive rehabilitation therapy to pursue a more active life after the hip replacement only to have their activities slowly restricted again when the ASR systems began to manifest problems. The representation of our clients is on an individual one on one basis. We are not representing folks in a class action basis nor do we believe it would be in your best interest to be in a class action. Our firm is committed to zealous and effective representation of clients that are affected by this defective device for all harms associated with this recalled device. DePuy claims it will cover “reasonable and customary costs of monitoring and treatment,” but in reality DePuy’s intentions are quite the contrary. DePuy has requested that patients submit all of their bills to private health insurance (including Medicare and employer sponsored – ERISA – health insurance plans), offering only to pay the patient’s out-of-pocket co-pays and deductibles. This is an excellent deal for DePuy, but not justice for the patient or your health insurance carriers who are in essence paying for DePuy’s mistakes.
9. What are examples of harms that are evaluated in a civil suit against DePuy and related entities?
A jury can consider the following list concerning non-economic factors for the DePuy ASR hip replacement recall lawsuit:
1) Any lost wages or loss of earning capacity;
2) The effect the DePuy ASR hip injury had on the individual’s overall mental and physical well-being;
3) The duration and extent of the injury the individual suffered;
4) The mental anguish and pain suffered by the individual;
5) The amount of past or future medical expenses that was caused by the defective DePuy ASR hip replacement implant;
6) The extent of any disfigurement or any scarring that was caused by the defective DePuy ASR hip replacement implant.
10. Should I surrender my defective hip implant to the company?
You should ask an attorney about this question but our position is that you should retain the hip implant hardware in an approved container and solution for optimum results. We have retained a company that works directly with the hospital and surgeon in having the device preserved pursuant to a Court approved protocol and is thereafter retrieved by the our company for any subsequent testing. This is very important decision because the removed hardware will become critical evidence in your claim against DePuy in the days ahead. It is your hardware because you paid for it so do not let anyone tell you anything to the contrary. If you have questions about the retention of your implanted hardware give us a call as we are happy to help.
This entry was posted
on Tuesday, October 11th, 2011 at 12:52 pm and is filed under FDA Alerts Blog, News & Results, News Blog.
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