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 Hip Recall Lawyers Scoff at DePuy’s “Generous” Offer

As a DePuy hip recall lawfirm, we have been watching the DePuy website to see whether they are really interested in paying full and fair compensation to anyone who was harmed by one of the ASR hip implant systems that were recalled. DePuy has made many public statements proclaiming that they were concerned and looking out for the best interests of their hip implant patients. However, these public statements are inconsistent with DePuy’s hip implant claims policy.

DePuy Hip Recall Lawyers Want You to be Compensated

depuy hip recall lawyers new jersey philadelphia scoff generous offerIn the Johnson & Johnson subsidary’s first press release, which was sent out on August 26, 2010, they boasted that they would cover “reasonable and customary costs of monitoring and treatment for services.” This was their first “offer” of compensation. This vague statement really meant nothing. DePuy refused to even acknowledge whether or not they would cover lost wages, medical expenses, or any other of the typical compensatory damages that defective product makers are required to pay to makeup for the harm they cause to their patients. In this case, if you are one of the 93,000 DePuy ASR hip implant patients and your hip implant has failed, or you are concerned about metal poisoning your system, you will likely need a second hip implant surgery.

As a DePuy hip recall lawyer, I make sure to let my clients know that hip implant surgery will dramatically affect how they are able to live their lives while recuperating from surgery. In addition, there is not any medical way to determine what long-term effects may occur to patients from having a second hip implant surgery, or from the release of the DePuy chromium and cobalt metals into their bloodstream.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

DePuy hip recall lawyers believe that DePuy’s “offer” is unfair. We will continue to urge all potential DePuy hip recall clients that they are entitled to full and fair compensation. After all, they did not cause their own harm – DePuy did. Why should the cost of DePuy’s defective product be placed on the victims?

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.
Let the team at the Mininno Law Office earn you the full and fair compensation that DePuy is trying to evade.

DePuy Hip Implant Recall: What Should DePuy Pay For?

As a New Jersey DePuy hip replacement recall attorney, I am often asked why it would be unfair for DePuy to pay only for out of pocket medical costs and wage loss, and not to pay for other compensatory damages such as pain, suffering and loss of enjoyment. Many believe that the Johnson & Johnson subsidiary did not intentionally design, manufacture, market, and sell a defective hip implant. The argument goes that since the company did not act intentionally, it should not have to pay full compensatory damages. This argument is one that is made in all types of case, not just defective product cases involving medical devices. As a trial lawyer, I hear this argument every day in the courtroom. It’s also something that has been debated by civilization for nearly thousands of years; what should be done when people with excessive money, power, and influence, break the rules of society and end up hurting other people? What should our civil justice system do to make sure that corporations pay for the harm the cause?

DePuy Hip Implant Recall; Who Pays?

In the first legal code, the Code of Hammurabi, the authors were very much concerned about restitution for breaking the rules and hurting someone. That code is similar to the Old Testament code, an eye for an eye, a tooth for a tooth. In fact, some civilizations today still use that code for their civil justice system. depuy hip implant recall attorneys New Jersey PhiladelphiaJust last year, an Iranian court sentenced someone to the surgical removal of their eye after their actions caused the loss of another man’s eye. That “eye for an eye” justice system is still very much a part of “civil justice” in some parts of the world.

Here, in the United States, we would never consider that justice. But what are injured parties allowed to ask for here in the United States? What we’re allowed to ask for is that a jury require a corporation like DePuy to pay a fair price on all of the harm that was caused by manufacturing, marketing and selling a defective hip implant. In some instances, it’s easy to figure out what that fair price should be. Wage loss and medical bills, things that DePuy has already “generously” offered, are things that any court or jury would find them liable for. However, what about the other things – intangibles such as pain, suffering and other compensatory damages. Our system of civil justice requires that corporations like DePuy pay for these intangible damages.

DePuy Hip Implant Recall – Intangible Damages

If a DePuy hip implant causes someone to have to undergo years of physical pain in the hip joint, then our law requires that DePuy pay damages to make up for those years of physical pain. After all, it is the company’s defective hip implant that caused that pain, just like it caused medical bills and wage losses. In addition, if one of DePuy’s hip implant patients must undergo another surgery to remove a defective hip implant and reimplant a nondefective hip implant, DePuy must pay for the pain, suffering, and the time lost in preparation of and recovery from that surgery. Again, this is because our civil justice system requires corporations to pay for the full amount of the harm they cause, not just part of the harm they cause. Ironically, in its recall notice and claims forms, the Johnson & Johnson sunsidiary does not accept full responsibility for its own defective hip implant. They are looking to pay for only part of the harm they caused, not the full extent of the harm caused. That’s why it is important for anyone with a recalled hip implant to contact an attorney to seek full damages for all harm caused.

DePuy Hip Implant Recall Attorneys in New Jersey and Philadelphia

If you or a loved one received a defective implant and are now unsure of what to do, contact the Mininno Law Office for a free case evaluation. Our DePuy hip implant recall lawyers want to earn you fair compensation for damages caused by the defective design of DePuy’s ASR XL Acetabular Hip Implant System. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the Mininno Law Office team work to 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.

Defective DePuy Hip Implants: Signs and Symptoms

DePuy Orthopaedics has recently recalled it’s defective ASR Hip Implant System, however, not every DePuy hip implant has failed. If you are a recipient of the DePuy hip replacement, you should look for any of the following signs and symptoms:

  1. Hip Pain (with or without activity) – All patients who have had hip replacement surgery will experience some pain at first. However, the symptoms are supposed to improve and, eventually, go away. If your symptoms have gone away and have now returned, or never did go away at all, it may be a sign of a defective hip implant.
  2. Hip Swelling – Swelling is normal in the immediate post operative period following a hip replacement. However, if you have a new onset of hip swelling following a DePuy hip implant, this may be another sign that the metal components are wearing out and causing the swelling.
  3. Problems Walking – Finally, some patients who have been discovered to have received defective hip replacements complain of problems walking. This problem is usually caused by the body’s reactions to the metallic particles which have worn away from the DePuy hip implant. This may be one of the most serious signs or symptoms, because this could mean that the metal particles have caused damage to the muscles, tissue, bones, and nerves surrounding the hip joint.

click on the image to enlarge:
depuy hip implants replacements recall defective

Depuy Recall Attorneys at the Mininno Law Office

If you are experiencing any of the above signs or symptoms, please contact the Mininno Law Office for more information and a free case evaluation.
In fact, even if you have not yet experienced the symptoms and want more information about what you should do if you have a DePuy hip replacement, call for a free consultation at (856) 833-0600 in New Jersey and (215) 567-2380 in Philadelphia.