Tag: asr xl acetabular

DePuy Hip Recall Due to FDA Loophole?

As DePuy hip recall attorneys, we have heard many disturbing reports which place the blame for the DePuy hip recall squarely at the doorstep of the United States .

FDA “Approves” Implants by Default

Although most hip implant patients assumed that their hip replacement manufacturer (e.g., DePuy, Zimmer, Johnson & Johnson, Stryker, etc.) received approval from the FDA for their device, this assumption is not entirely accurate. new jersey philadelphia medical malpractice lawyers careless FDA approvalFor years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.

Ironically, although DePuy claimed its ASR XL Acetabular or Resurfacing implants were “substantially equivalent” to other hip implants, DePuy was not required to make its product out of the same metals as already existing marketed hip implants. As such, reports have shown that the FDA never considered the effects of the chromium and cobalt metals used in DePuy’s hip implants. As a result, consumer advocates have argued that the FDA allowed DePuy to use – without any FDA testing- potentially hazardous metals in a medical device without proper oversight.

DePuy Hip Recall Attorneys in New Jersey and Philadelphia

The DePuy hip recall shows the potential danger in this process. What is the lesson? All potential hip implant patients should specifically ask whether their hip implant device has received formal FDA approval or was approved through the FDA 510(k) loophole. As a New Jersey and Philadelphia DePuy hip recall lawyer, we strongly encourage and current recipients of a DePuy hip replacement to contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you need and deserve.

DePuy Hip Recall: What About the FDA?

As New Jersey and Pennsylvania Depuy hip recall attorneys, we have been posting various bits of information regarding the Depuy hip recall and its effect on recipients of the implant. We hope these posts have been helpful to not only patients who have experienced implant failure, but to all Depuy hip recall patients, regardless of whether or not they have experienced pain or symptoms associated with the DePuy hip implant failure.

Did the FDA Have Anything to Do With the Recall?

Recently a Depuy hip implant patient asked us, “What does the federal government have to say about the Depuy hip implant recall?” As many know, medical devices, such as artificial hips, prosthesis, knee joint replacements, and other implants, are supposed to be regulated by the Food and Drug administration (FDA). According to its website, the FDA is charged with responsibility for:

“protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

new jersey philadelphia depuy hip recall attorneys examine fda approach Despite this responsibility, the FDA has not done much regarding the recall since July 17, 2010, the date they posted information on specific recalled devices. The recall contained DePuy technical data that listed all of the various sized component parts of the DePuy ASR hip replacement system. As for the reason for the recall, the FDA quoted Depuy, stating that the recall was caused by “notification to clinicians of new revision rate data/information regarding use of the device.” What does that mean? It means that DePuy and the FDA were receiving complaints that the hip implant was failing at an alarming rate, causing the necessity for revision surgeries to rise to a new and unacceptable level. These complaints started coming in shortly after DePuy was granted approval to market their device in the United States in 2003.

DePuy Hip Recall Attorneys in New Jersey and Philadelphia

Unfortunately, the FDA has not provided any additional information to patients about what to do next. In fact, the FDA website refers all inquiries back to Depuy’s home office in Indiana. As New Jersey Depuy hip recall attorneys, we urge the FDA to be more diligent in its reporting of consumer complaints regarding medical devices. The device was approved for use in 2003, and was on the market for 7 years before it was finally recalled. Had the complaints been investigated sooner, perhaps surgeons and potential Depuy hip implant patients would have thought twice about using this defective hip replacement product.

If you are the recipient of a DePuy ASR XL Acetabular hip implant system, or an ASR XL Hip Resurfacing System, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia. Our defective product attorneys are skilled in earning full and fair compensation for victims of negligent and defective manufacturing.

DePuy Recall Attorney Response to Latest Comment From Reader

As New Jersey and Philadelphia DePuy hip recall attorneys, we recently posted a blog that defended orthopaedic surgeons who had utilized the DePuy hip implant on their patients. Although this post did not totally exonerate orthopaedic surgeons from the DePuy hip recall mess, it did urge patients to give their surgeons the benefit of the doubt. This post drew a very pointed comment by Mr. Juergen Schaberick, who stated-

“As a victim of the DePuy Pinnacle metal-on-metal [hip implant] I like to ask if you would still trust your surgeon when his name pops up on the official DePuy website when searching for a surgeon in your area.”

Not ALL Surgeons Accepted Kick Backs

new jersey philadelphia depuy hip recall lawyers defend orthopaedic surgeonsWe thank Mr. Schaberick for his comment on DePuy and Johnson & Johnson, and we do not completely disagree. However, our own research has shown that not all doctors who show up on the DePuy website have accepted honorarium or other monetary benefits to select the DePuy hip implant for their patients. However, as was pointed out by Mr. Schaberick, many of the orthopaedic surgeons did in fact receive significant monies and benefits from DePuy and Johnson & Johnson in return for selecting the ASR XL Acetabular complete or resurfacing implant systems. Mr. Schaberick is also correct that DePuy and Johnson & Johnson paid millions of dollars over the last several years because of violations of federal anti-kick-back laws.

Most DePuy hip recall lawyers agree that these facts should give patients a good reason to be careful when choosing an orthopaedic surgeon. These facts should also give patients a strong incentive to seek a second, independent medical examination. Although there are a few orthopaedic surgeons who certainly should never be trusted when it comes to DePuy hip implants, we still believe that the majority of orthopaedic surgeons who prescribed the DePuy hip implant for their patients did so because they were fooled by Johnson & Johnson and DePuy’s slick marketing campaign.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

Regardless of your orthopaedist’s reasons for using any of the DePuy hip implants, if you are a DePuy hip recall patient, you are in a very tough situation and have some tough choices. That’s why all DePuy hip recall lawyers are encouraging patients to contact an attorney to learn of all available options when it comes to seeking compensation. Thank you again Mr. Schaberick for your comments. We look forward to future comments from you.

If you or a loved one have suffered the effects of a defective DePuy hip replacement, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia. Don’t be fooled by DePuy claims adjusters. Let the lawyers at the Mininno Law Office earn you full and fair compensation.

DePuy Hip Recall Affects Canada and Elsewhere

As a NJ and PA DePuy hip recall lawfirm, we have posted information about the DePuy hip recall for patients here in the U.S. However, the U.S. is not the only country with pending DePuy hip recall lawsuits.

DePuy Hip Recall Lawyers Busy Everywhere

new jersey philadelphia DePuy hip recall attorneys represent victims everywhereDePuy Orthopaedics, a subsidiary of Johnson & Johnson, marketed its DePuy ASR XL Acetabular Hip Imlplant System and ASR Hip Resurfacing Systems worldwide, and all are included in the recall. In December of 2010, about 1,500 Canadian patients who had DePuy hip replacements filed a DePuy class action lawsuit in the courts in Quebec, Calgary, Alberta, Halifax, Nova Scotia, and Montreal. DePuy hip recall lawyers in Canada are helping these DePuy hip recall claimaints. It is likely that other DePuy hip implant patients in Europe will soon be filing similar class actions as a result of the DePuy hip recall.

It seems that DePuy hip implant patients all over the world are seeking justice against DePuy Orthopaedics and its mega billion dollar parent company, Johnson & Johnson, for this defective hip implant product.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

As a NJ and PA DePuy hip recall lawyer, I encourage all patients worldwide to fight for their legal rights against DePuy and Johnson & Johnson. We will continue to provide DePuy hip recall information and news as it is made available to us. In particular, we are watching very closely the DePuy multi-district litigation which is pending the Northern District of Ohio in front of Judge David A. Katz. Several of these DePuy lawsuits are class actions, and the rest are individual DePuy lawsuit claims that are all being managed by Judge Katz. Keep checking back to our blog for any updates on the DePuy hip implant lawsuit.

If you or a loved one are the recipient of a defective DePuy hip implant, contact the Mininno Law Office for a free case evaluation or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
You will need the help of a good DePuy hip recall lawyer to attain the full and fair compensation you deserve. Let the team at the Mininno Law Office earn you the compensation you deserve.

DePuy Hip Recall Lawyers Fight for Full and Fair Compensation

As a New Jersey and Philadelphia DePuy hip implant recall firm, we have posted information regarding the recent market withdrawal of the DePuy ASR hip implant systems. On its web site, the Johnson & Johnson subsidiary claims that it will cover medical costs for the victims of these defective hip implants. Specifically, it states

“DePuy intends to cover reasonable and customary costs of treatment if you need services associated with the recall of ASR including revision surgery if it is necessary.”

This sounds good, right? But what does this promise really mean?

Depuy Hip Recall Attorneys Clarify Empty Promises

depuy hip recall attonrneys new jersey philadelphia full compensationAs a DePuy recall lawyer, we tell our clients that it means nothing. Why? Because before any claims for compensation are considered, DePuy, who admittedly designed, manufactured, and sold for profit a defective hip implant to 93,000 patients, is requiring those patients to first pay for their medical expenses upfront. That’s right, if your hip implant has failed, and you need treatment or surgery, you first have to send your bills to your own health insurance company and, if you don’t have private insurance, Medicaid or Medicare. DePuy will only then consider a claim for reimbursement for any out of-pocket expenses and deductibles that are not being covered by your health insurance, Medicaid, or Medicare.

Imagine that! DePuy is passing off the cost of its own wrongdoing to working folks whose wages go to fund the Medicaid and Medicare health insurance systems.

DePuy Hip Recall Attorneys against Corporate Wrongdoers

Time and time again, corporate wrongdoers fail to take responsibility and pay fair prices on all of the harm that they cause. As we posted previously, DePuy also refuses to fairly compensate its victims for pain or disability, or for the loss of the activities that many of them enjoyed before their hip implant failed. As defective product attorneys, we will demand that DePuy Orthopaedics make up for all of the harm caused by their wrongdoing. As it stands, DePuy refuses to pay a fair price for harm caused and is trying to push the cost of its harm on to insurance companies and the U.S. taxpayers. As a defective products firm, we can make sure that a DePuy implant victim is properly and fully compensated to the full extent of the law.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

If you are the recipient of a defective DePuy implant, you will need the assistance of a defective products lawyer from the Mininno Law Office. DePuy is trying to pull the wool over the eyes of the victims of their faulty and defective manufacturing. Contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you need and deserve.

DePuy Hip Implant Recall – Johnson & Johnson Knew of Complications

As a New Jersey DePuy Hip Implant recall lawyer, I have been providing potential recall claimants with information about the DePuy hip implant recall. As we have written, in August in 2010, DePuy Orthopaedics, a subsidiary of giant pharmaceutical company Johnson & Johnson, recalled two of its orthopaedic products; the ASR Hip Resurfacing System and the ASR XL Acetabular System.

DePuy ASR Hip Resurafacing System

The ASR Hip Resurfacing System was first introduced worldwide in 2003 and was only approved for use outside of the United States. The ASR hip resurfacing system was a partial hip replacement that involved placing a metal chromium or cobalt cap on the ball of the patient’s existing femur. depuy hip implant recall attorneys in nj and pa Since it was a partial replacement of just the cap, DePuy marketed it as a less invasise hip replacement. The problem with the ASR Hip Resurfacing System system, according to DePuy’s website, is that the independent national joint registry of England and Wales showed a five year failure and revision rate of approximately twelve percent – that’s 1 out of every 8 patients.

DePuy ASR XL Acetabular System

Similarly, the same publication showed a five-year revision rate of 13%for the ASR XL Acetabular System which was widely available here in the United States. The ASR XL Acetabular System was the more traditional total hip socket replacement. depuy hip implant recall attorneys in nj and pa

DePuy Hip Implant Patients Suffer Complications

According to DePuy, there are approximately 93,000 patients who have received one of the recalled hip ASR hip implant systems. Given the shockingly large number of patients who have potentially defective hip implants, there have been patients who have already experienced medical problems. As a result, there already have been several lawsuits filed by patients who have had pain, swelling, and damage to surrounding structures and tissues. These lawsuits claim that DePuy’s billion dollar parent company, Johnson & Johnson, knew for years that many of the 93,000 patients with these defective implants required corrective surgery more frequently than the traditional implants. More lawsuits are pending as additional information becomes known about what executives at DePuy Orthopaedics and Johnson & Johnson knew about this product defect. Ironically, these very same DePuy Orthopaedic ASR hip system continue to be listed on the Johnson & Johnson website, listing their subsidiary as a maker of “innovative implants and technologies for the treatment of joint and spine conditions can get you back to an active, pain-free daily routine.”

Similarly, Johnson and Johnson’s website further states that promotes DePuy and states “your doctor can use a product from DePuy to help build an ankle, elbow, hand/finger, hip, knee or wrist as well as arthroscopy products for shoulders, and put you on the road to recovery everyday.” Finally, the Johnson & Johnson website lists recalled hip implant under “sports medicine and trauma” wherein it states “enjoy an active life again with products for the surgical treatment of knees, as well as soft tissue and shoulder repair.”

DePuy Hip Implant Recall Attorneys in NJ and PA

As a New Jersey and Philadelphia DePuy hip recall lawyer, we have fielded many questions about these potentially defective devices. Although some 93,000 patients now have a potentially defective hip implant that has been the subject of a recall and litigation, Johnson & Johnson continues to promote their subsidiary as a trusted hip implant maker for patients. It is no wonder that patients who have trusted and relied upon Johnson & Johnson to manufacture a safe and longstanding hip implant are seeking recourse in the courts. Contact the Mininno Law Office for a free case evaluation, or call for a free consultation at 856-833-0600 in New Jersey, or 215-567-2380 in Philadelphia.

DePuy Defective Hip Implants; How Were They Approved?

A common question among consumers who suddenly find themselves affected by a product recall is, “What is the process for FDA approval?” As a DePuy Hip Implant Recall attorney, I hear the question quite often. Surprisingly, the process is rather simple for products such as hip, knee, and shoulder replacements and parts.

DePuy Hip Implant Approval Process

depuy hip implant recall attorneys in new jersey and philadelphiaAccording to the FDA, DePuy’s first step towards FDA approval is the successfull completion of a number of clinical testing procedures set up by the FDA. However, in this instance, DePuy was able to avoid FDA scrutiny and it’s screening process by using a legal ‘back door,” which allowed it to circumvent the normal approval channels. This legal backdoor is known as a “510(k),” which permits pharmaceutical companies like DePuy (a subsidiary of Johnson & Johnson), to avoid the normal screening process by claiming that their hip implants would be a “substantial equivalent” to other implant devices that have already been approved by the FDA. By claiming that their product was the “substantial equivalent,” DePuy was able to gain quick approval by the FDA to market and sell it’s ASR XL Acetabular hip implant system within the United States.

Unfortunately, the United States does not have an effective hip implant registry system to determine what the failure rates were for DePuy ASR hip implants and other substantially equivalent implants. This data had to come from the United Kingdom and Australia. Those hip implant registries demonstrated their ability to prevent patient harm. In both the United Kingdom and Australia, the registries were so successful in revealing data that showed the early and unacceptable failure rate of the DePuy hip implant system, DePuy phased out the hip implants long before the American recall. Now, given the debacle over the DePuy hip implant recall, the United States and the FDA are considering creating their own registry for implants, so that potential defects and patient harms can be identified sooner rather than later.

DePuy Hip Implant Recall Attorneys in New Jersey and Philadelphia

By cutting corners and dodging red tape, DePuy was able to skirt their responsibilities to their consumers. Had those implants been properly tested and assessed by the FDA, approval would have been halted and kinks worked out before patients could be harmed. If you or a loved one have been affected by a defective DePut hip implant, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you deserve.