Tag: recall

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.

Was a DePuy Sales Rep Watching You Sleep?

If you have been following our series of DePuy hip recall posts, we hope they have been informative, interesting, and educational. Our previous DePuy hip recall posts have provided information about the actual implant that has been recalled, about signs and symptoms that patients can expect if their implant is fails; and about the bad faith settlement practices of Johnson & Johnson and DePuy claims adjusters. However, this particular post is unique because today we discuss a topic that most DePuy hip recall patients have never considered. Was a DePuy sales representative watching you while you had your implant surgery performed?

Sales Reps Guiding Surgeons Through Procedures

new jersey philadelphia depuy hip recall lawyers shocking sales repRecently, the prestigious Washington Post reported on a fairly widespread yet rarely discussed practice of medical device sales representatives to lurk in operating rooms, without patient knowledge or approval, and guide surgeons in the surgical procedure. According to the Washington Post, this practice of sales rep “assistance” is common among medical device companies including Johnson & Johnson, Stryker, Zimmer, and DePuy.

Unfortunately for most DePuy hip replacement patients, there really is no way to learn whether or not one of DePuy’s sales reps was actually in the operating room. Why? Because most current hospital policies do not require a sales rep to be identified in the patient’s medical chart. They also don’t require consent from the patient, and have not prohibited photography. There have been reports that sales reps have taken pictures of their company’s implant as its being implanted into the patient! These photographs are taken without first advising the patient that a sales representative will even be present.

Imagine that! A DePuy sales representative is allowed to walk into a sterile operating room and observe a patient having surgery, and the patient would never be the wiser.

Frankly, this widespread practice is kind of creepy. As New Jersey and Philadelphia DePuy hip recall lawyers, we urge that legislation be drafted which specifically requires that any medical sales representative obtain permission from a patient before they attend their surgery. If a surgeon is not comfortable performing a hip implant surgery without having a sales representative present, perhaps that surgeon should not perform the surgery in the first place.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

If you are the recipient of a DePuy hip replacement and are experiencing increasing pain and reduced functionality, 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.

DePuy owes you compensation for pain, suffering, and monies paid for any additional treatments associated with the correction of your hip replacement. Make sure you get the help of an attorney in earning this compensation.

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.

As New Jersey and Philadelphia DePuy hip recall lawyers, we are frequently asked whether or not DePuy hip recall patients can trust their orthopaedic surgeons to give them honest, fair, and impartial advice regarding the recall. After all, this orthopaedic surgeon was the one who initially recommended the patient receive the DePuy product in the first place. However, while a small percentage of orthopaedic surgeons may have initially been offered financial incentives by DePuy and Johnson & Johnson to utilize the implant that has since been recalled, many surgeons likely chose the implant based on DePuy’s marketing of the benefits of its product. Also, while some orthopaedic surgeons may have accepted honorarium or speaking engagements money from the Johnson & Johnson subsidiary in the past, now that the implant has been recalled, it is unlikely that any orthopaedic surgeon would jeopardize his or her career by accepting further monetary compensation to promote a recalled product.

Seek a Second Opinion

new jersey philadelphia depuy hip recall lawyers defend orthopaedic surgeonsAs New Jersey and Philadelphia DePuy hip recall lawyers, we are telling our clients that they should give their own orthopaedic surgeon the benefit of the doubt and listen to what the surgeon has to say about their options. Of course, we are also recommending that all patients get a second, independent medical opinion from another orthopaedic surgeon regarding the nature and extent of their current condition, whether or not they have osteolysis, and whether the patient should obtain blood tests to determine the presence of metallic debris. This second opinion should also cover what type of implant will be utilized during the second surgery.

While all DePuy replacement recipients should follow their orthopaedic surgeon’s medical advice, most DePuy hip recall lawyers are recommending that any doctor that insists on using a DePuy implant be looked upon with skepticism. The bottom line: final choice of which hip implant (and which orthopaedic surgeon) always belongs to the patient.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

If you are the recipient of a defective DePuy 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. The defective product attorneys at the Mininno Law Office are prepared to earn you the full and fair compensation that you need and deserve. Don’t be fooled by DePuy insurance claims adjusters who claim to be on your side. Seek out an attorney to fight for your rights.

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: ASR XL Hip Implant

As a Depuy hip recall lawfirm, we have previously posted information regarding the Depuy Orthopaedics recall of the DePuy ASR XL hip implant. As a Depuy hip recall lawyer, I have been asked many times, “What’s the big deal with this hip recall? Don’t all hip implants eventually fail?” The easy answer about hip implants is Yes.

DePuy Hip Recall Lawyers Represent Recall Victims

new jersey philadelphia depuy hip recall lawyers asr xl implantAs we have posted previously, all hip recall lawyers will explain that a partial or total hip implant is not a cure for hip pain. However, what makes this Depuy hip recall so unusual is the extraordinarily high failure rate as compared to DePuy’s hip implant competitors. In fact, the medical research which lead to the hip recall has shown that between 12 and 13 percent of Depuy hip implant patients will require a hip replacement revision surgery within five years of receiving the replacement.

Since there were approximately 93,000 Depuy hip implants performed in the last five years, over 12,000 of these patients can expect to have a failure within five years. Unfortunately, there is no way for a Depuy hip implant patient to know whether or not they are one of the 12,000 who will have this five-year failure, or whether their hip implant will last longer.

DePuy Hip Implant Lawyers Scold DePuy for Negligence

There are many reasons for this high failure rate of the Depuy hip implant. As a DePuy him recall lawyer, we have posted information regarding the medical facts which have led to the Depuy hip implant defects which have led to the hip recall. In addition, the Depuy hip recall has also occurred because of the potential of the implant to shed metals (chromium and cobalt) into a hip implant patient’s bloodstream causing a condition called osteolysis.
Again, not all hip replacement patients who have had a Depuy hip implant will have this serious medical condition, but, without sensitive laboratory studies, there is no way to determine whether or not a Depuy hip patient does or does not have such a condition. In a nutshell, while 12 to 13 percent may seem like a low percentage, it is a nightmare for any Depuy hip implant patients who have received a Depuy hip replacement that is now the subject of the DePuy hip recall.

DePuy Hip Recall Lawyers in New Jersey and Philadelphia

If you or a loved one have received a defective hip implant manufactured by DePuy, you may fall into the group of people entitled to compensation from DePuy. If you are experiencing prolonged and excessive pain in your hip joint and you recently had hip replacement surgery, 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 can offer you the legal advice you’ll need to make the next step. Let the Mininno Law Office team earn you the compensation you need and deserve.

DePuy Hip Implants Cause Osteolysis

depuy hip implant recall new jersey philadelphia attorneys osteolysisIn the United States, hip replacement surgery is one of the most common orthopaedic surgeries that occurs each year. In fact, since 1997, there have been approximately 300,000 hip replacement surgeries performed in the United States. Without question, the development of prosthetic hip joint replacements, and the development of cement or “glue” to securely place these implant parts into the human skeleton, has been one of the most major advancements in orthopaedic surgery during the last several decades.

Notwithstanding the numbers, as was detailed on our articles about hip implants, hip replacement surgery is not a cure for hip pain and should only be considered after all other medical treatments have failed. The failure of any manufacturer’s hip implant is something that is inevitable and something all potential hip implant patients should consider.

Why are Hip Implant Failures Almost Always Inevitable?

One of the major reasons for hip implant failure is because of the loosening of the bond (i.e., the cement or glue) which holds hip implant prosthetics to the bone. The loosening of this bond between the hip implant parts and the bone causes an increase in pain and reduces the range of motion for the patient.
In addition, because of the “imperfect fit,” natural friction is increased, as is the wearing down of areas in and around the hip implant. While this wear occurs in all hip implants, DePuy ASR hip implants have been recalled because medical research has shown that the recalled DePuy hip implant has an increased wear rate caused by the friction between the chromium and cobalt metals used in the ASR implant system. The combination of the loosening of the bond between the implant parts and the increased friction wear in the DePuy hip implant patient has been theorized to be the main cause of it’s premature wear and tear.

Finally, the byproduct of the chromium and cobalt friction in the replacment has been shown to result in a greater immune response to the release of these metal particles in the blood system. The immune system response not only attacks the foreign metallic matter in the blood stream, but also attacks the surrounding hip and femur bone, as well as other connective structures. This attack further damages the bond between the DePuy hip implants and the bone. This process, called osteolysis, is one of the most common causes of the accelerated failure of any DePuy hip implant.

NJ and PA DePuy Hip Implant Recall Attorneys

A DePuy hip implant recall lawyer in NJ o PA can answer your questions regarding a DePuy hip implant. If you think you may be the recipent of a recalled product, 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 deserve.

Recently, there has been a lot of news surrounding the recall of the DePuy Orthopaedics defective hip implant system. The product recall occurred after a medical study in Great Britain revealed that this hip implant had up to a 13% failure rate within the first five years of surgery.
And, as if early hip replacement failure and the necessity of additonal surgery wasn’t bad enough, the wear and tear from these defective hip implants is resulting in the flow of metallic debris throughout the bloodstream.

What are these metals?

depuy hip implant recall new jersey mininno law officeChromium and Cobalt. These metals are not found in your local vitamin store: Chromium is a chemical element found on the periodic table under atomic number 24. It is used to make stainless steel and all of the shiny parts called “chrome” on automobiles.
While it may look pretty on a “tricked out” automobile, when it circulates in the bloodstream, it has been associated with numerous health problems.

depuy hip implant recall nj and pa attorneys mininno law officeSimilarly, Cobalt is also a chemical element found on the periodic table under atomic number 27. Since ancient times, it has been used as a blue pigment to tint glass, jewelry, and furniture.
However, when it is released into your bloodstream as a result of wear and tear of a defective hip implant, it can also cause serious health problems. It is considered a carcinogen by healthcare professionals. It is definately not a substance that a patient wants circulating through his or her bloodstream.

In selecting these metals, especially with the knowledge of their potential side effects, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, was hoping to create a better hip implant. Instead, the research is starting to show that they have in fact created a defective product which not only results in pain, suffering, and additional surgery, but exposes patients to harmful chemical elements in the bloodstream.

Have a DePuy Implant? NJ and PA DePuy Recall Attorneys

If you have a DePuy Orthopaedics hip implant, you should be aware that these implants have been recalled. You should consult with your family doctor and orthopaedist to determine whether or not you have been exposed to chromium or cobalt metals, and whether you have any symptoms associated with these chemicals.
If you would like more information about the recall, please 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.

Recently, we have been asked if ALL DePuy hip implants are defective. Currently, there is no real answer because it is simply too soon to interperet the data on these defective DePuy hip implants.

new jersey philadelphia depuy orthopaedics lawyers implants recalledWhat is known is that the recall affects the ASR XL Acetabular System, which is used for total hip replacements, as well as the ASR Hip Resurfacing System, which is used in a newer kind of procedure involving bone conservation.
The ASR Hip Resurfacing System has not yet been approved in the United States, but according to Johnson & Johnson, some patients may have gotten these implants through a clinical trial when the company was seeking FDA approval for the hip implants.

Therefore, one of the first things a patient needs to determine is whether or not they have a total DePuy Orthopaedics hip replacement system, or the DePuy ASR hip resurfacing system. A combined total of about 93,000 of the total hip replacement system devices have been implanted worldwide. Presently, the data shows that only 1 in about 8 of these hip replacements have caused patients symptoms, and have required correction.
However, since the symptoms of a defective hip implant may mimic other symptoms, many patients do not yet know whether or not their implant is defective. Many patients are insisting that they get corrective surgery now, before these defective implants cause signs and symptoms, to prevent future problems such as microscopic metal particles in the bloodstream.

So, while the data does not suggest that all DePuy Orthopaedics Hip Implants are defective, it simply is too soon to come to a final conclusion about the number of patients who will have symptoms related to these defective implants.

NJ and PA DePuy Orthopaedics Defective Hip Implant Attorneys

If you have any concerns regarding a DePuy Orthopaedics implant, you should contact your orthopaedic surgeon or family doctor.
If you want to know what your rights are regarding these recalled hip implants, contact the Mininno Law Office. Our NJ and PA DePuy Hip Implant Recall Lawyers are prepared to answer your questions and earn you any and all compensation that you deserve. You may call the Mininno Law Office for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

The recent DePuy Orthapaedics Hip Implant recall should not come as any surprise to most people. Within the last several years, DePuy hip implants, employing a metal on metal function, were used in about 90,000 hip replacements performed in the United States.

click on the image to enlarge:
depuy orthopaedics hip replacement implants recall metal complications

DePuy Orthopaedics Hip Implant Complications

DePuy hip implants mimic our traditional bone structure by creating a ball and socket joint out of metal; specifically, chromium and cobalt. DePuy Orthopaedics hip implant manufacturers believed the elements would be stronger and last longer than conventional hip implant materials.
The problems with the hip implants arise from friction in between the head at the top of the thigh bone and the cup which is placed into the hip socket. These two metals rub together and ultimately cause wear and tear on the materials. Friction on a car tire, results in rubber particles being slowly dispersed on our roadyways. Friction on a metal implant results in metal particles being dispersed inside a human body. These particles and metallic debris can cause signifcant damage to tissue and bone surrounding the hip joint.

Some of these particles even enter the blood stream and can become lodged in other parts of the body. Such patients will have high metal content in their blood streams which can be diagnosed using standard radiological studies that will show the metal dispersed throughout the body.
Unfortunately, orthopaedic surgeons using DePuy hip implants were not alerted of these complications until recently. In the meantime, it appears that nearly 95,000 of these defective hip implants could be in the population today.

NJ and PA DePuy Hip Implant Recall Attorneys

If you have a DePuy Orthopaedics hip implant, do not wait until you are experiencing signs or symptoms of metallic debris in your body. You should immediately consult with your family doctor and orthopaedic surgeon to get properly tested and continue to be tested for any problems associated with this defective implant.
If you wish to know your legal rights, please contact the Mininno Law Office for a free case evaluation. We will be happy to answer any questions you may have. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.