Is Joining the DePuy ASR Class Action Lawsuit still an Option for Recalled DePuy ASR Hip Implant Recipients With No Pain?

Andrew Sullo, Class Action Lead Counsel & Managing Partner at Sullo & Sullo is working hard to ensure that every single recipient of the DePuy ASR metal-on-metal hip implant is fully aware of both the recall on August 26, 2010 and the upcoming statute of limitations expiration for those who reside in states which implement the two-year statute. There are over 40,000 people who have received an ASR implant in the United States. The ASR was approved by theFDA in 2005 and began being widely used by surgeons who believed the metal-on-metal design would last much longer than the metal-on-ceramic or metal-on-polyethylene models.

Unfortunately, adverse health reports began pouring in with over 17,000 such reports received by the FDA regarding these all metal hip implants. Of those thousands of recipients, there are only approximately 6,000 who have joined into the MDL lawsuits against DePuy. While this might cause some to wonder if the risks of the ASR have been exaggerated, there are other factors involved. First of all, many recipients may not have heard the device was recalled or may truly have no idea what type of implant was used in their surgery. Second, many recipients of the ASR and other hip implant devices are senior citizens who may believe the symptoms they are experiencing are related to advancing age rather than attributing them to the ASR implant.

Finally, many of those who have not come forward to take part in the lawsuits state they are not having any problems with the ASR at present, so why would they sue the company? This is very flawed logic in this particular instance. Although the failure rate of the ASR was originally stated by DePuy to be in the 12-13% range—still much higher than the average of .5-5% failure rates—experts in the field have estimated that by six years following the initial surgery nearly 50% of the ASR hip implants will have failed and by eight years following the surgery a staggering 80% will have failed. When you look at those numbers you can see that it is highly likely that at least half of those thousands of people who have not joined into the lawsuit will suffer a hip failure. In fact, Andrew Sullo notes that “More than 50% of our ASR hip recipient docket has already received revisions.”

Problems with the DePuy Pinnacle Hip Implant: Current Reports

As of this date the Pinnacle metal-on-metal hip implant device manufactured by DePuy has not followed in the recall footsteps of DePuy’s other hip implant, the ASR. While Johnson and Johnson and DePuy vigorously deny that the Pinnacle has any problems—and, in fact, call it the best metal-on-metal hip implant on the market today—many recipients of the device feel it has some of the same flaws as the ASR. Both the Pinnacle and the ASR are manufactured by Johnson and Johnson’s subsidiary company, DePuy. The Pinnacle made its debut in 2002 as the predecessor of the ASR which followed in 2005. The ASR is strictly a metal-on-metal hip implant device while the Pinnacle name includes metal-on-ceramic and metal on polyethylene models as well.

Nearly 150,000 Pinnacle all-metal hip replacements have been implanted compared to 93,000 ASR’s worldwide—approximately half of those in the United States alone. Both the Pinnacle and the ASR all-metal hip implants were approved under the controversial 510(k) FDA approval process. This particular process allows the majority of medical devices to get to market quickly by showing they are substantially comparable to a device which has already gained approval. The process also allows a product to get to market without expensive clinical trials however in some cases the approval process has been predicated on a device which is no longer marketed—even due to poor performance.

Chromium and Cobalt Poisoning: What are the Long Term Side Effects of Metallosis?

It is likely that the recipients of a metal-on-metal hip implant have heard about the possible consequences from the metal shavings which can be released into the body when the metal cup and ball rub against one another during normal activities. Tiny ions of cobalt and chromium shear off when the two surfaces meet and those ions can lodge in the surrounding tissues or can end up in the bloodstream. As more and more metal hip implant patients are realizing the seriousness of metal toxicity, blood testing for elevated levels of metals is increasing. In many cases patients have been found to have levels of cobalt and chromium in their bloodstream which are as much as a hundred times normal levels. 

Although slightly elevated levels of these metals are fairly normal for patients with metal-on-metal hip implants, extreme elevations can be very dangerous—and anxiety-producing for the patient. DePuy released a report indicating that concentrations of the metals greater than 7 parts per billion are cause for concern. The Mayo Clinic has set somewhat different reference values, stating that blood serum concentrations of chromium greater than 1ng/mL suggests significant wear of the metal implant while serum concentrations greater than 5.0 ng/mL of cobalt can be considered toxic and also suggest significant wear of the prosthesis. Remember that 1 PPB (part per billion) equals 1.0 ng/mL.

We've got several good reasons why you shouldn't do anything of the kind.

By Independent Staff Writer

After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery.
In exchange, the company wanted just one minor thing: the hip implant.
On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.
Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you.
The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.

Why Your Hip Implant is Valuable to Your Case
When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.
Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.
If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.

How the ASR XL Acetabular System Causes Bone Deterioration...And what it means for your future hip revision surgeries.

By Taylor Lindstrom

When DePuy issued their hip recall, they offered to pay for the revision surgery needed to replace the faulty hip with a new implant. They appear to believe this is the full extent of their responsibility in repairing the damage they've done to thousands of people who had a hip replacement implanted in their bodies.

It's not enough. Because the damage the ASR XL Acetabular system caused doesn't end when the hip is removed. It's only just beginning. 

How Your Hips Work

If this were an after-school special, we'd show you a few clips at this point: Elvis shaking his hips on stage back in the day, or a ballet dancer extending her leg over her head. The after-school special would be missing the point, however - your hips are essential to nearly every movement you make. You use them every time you stand, sit, crouch, or lean over. You use them getting into and out of cars, climbing up the porch steps to your front door, even just standing there. 

A hip is a little bit like oxygen. You don't notice how essential it is until it's gone.

There's a reason you barely notice your hip's contribution to your everyday movements: your body has constructed it more or less perfectly. The hip bone is a portion of your pelvis, and it has a rounded cup-shape in its center into which the top of your femur bone fits, called the acetabulum.

The top of your femur fits smoothly into the acetabulum and rotates when you move, cushioned by synovial fluid that naturally lubricates the hip joint. When you get a hip implant, the idea is to mimic this natural construction of your hip joint as closely as possible, including the range of rotation, the lubrication, and the way the ball (the head) and socket (the acetabulum) fit together.

How a Hip Implant Works

There are two basic ways of affixing the hip implant to the rest of your skeleton. In both, the top of your femur is sawn off and replaced with an artificial new head, while the hip bone itself is shaved down to accommodate a man-made socket. Essentially, the acetabulum is carved out to the shape of the new socket.

The difference lies in how the new femur head and socket are attached to the surrounding bone. In older patients, the most common tactic is to use a bone cement to attach them. In younger patients, however, the surrounding bone is still versatile and capable of regrowth. Since cement has some serious drawbacks, including the risk that it will shrink or crack over time and the fact that it is not especially secure when it comes to withstanding forceful movements like jumping, another procedure has been developed for younger patients. 

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

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.

“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know

“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know

Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.

Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge

Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge

Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.

Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip

Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip

Introduction
The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall. In 2010 it was discovered that the DePuy metal-on-metal hip replacement devices were shedding metal fragments and Johnson & Johnson issued a recall for those particular hip replacements. The metal fragments which were shed into the body were found to cause disabling injuries in some recipients, and the toxicity from the chromium and cobalt debris can cause the surrounding tissues to suffer necrosis or death.

Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients

Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients

Introduction
DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.

New Updates for DePuy Hip Implant Victims

New Updates for DePuy Hip Implant Victims

The DePuy ASR Litigation Status Conference

On January 23, 2012, the DePuy ASR Litigation Status Conference in West Palm Beach, Florida was held before Judge David Katz.  Judge Katz is the United States Federal District Judge assigned by the Multi District Litigation panel of judges to hear all pretrial matters in any DePuy ASR cases filed in federal court. 

Judge Katz met with the Executive Committee of the Plaintiffs’ Steering Committee for about an hour privately before he met with all attorneys in open court.  The Plaintiffs’ Steering Committee are the dozen or so lawyers Judge Katz assigned as leaders of all plaintiffs’ lawyers who have filed cases in the ASR litigation. The Plaintiffs’ Steering Committee is responsible for gathering evidence (Johnson and Johnson and others have turned over approximately 18,000,000 documents so far), taking depositions of fact and expert witnesses, legal analysis, submitting briefs to the court, and a variety of other tasks.

Was Depuy Hip Recall Was Timely

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 How Soon Did DePuy Know About the High Failure Rates for the ASR Acetabular System?

Soon enough to save thousands of people from revision surgery and severe medical consequences.   When DePuy issued its recall of the ASR XL Acetabular System and the ASR Hip Resurfacing System, it claimed to be doing so because the revision rates were higher than normal. Surgeons, the company said, needed to be fully informed before making the decision to implant the devices.  Up until this point, the company had consistently blamed the surgeons for implanting the device improperly. The high revision rates were due, DePuy claimed, to surgeons placing the device at the wrong angle.  So it was somewhat surprising that DePuy should suddenly decide to recall a hip implant that it had been planning to "phase out" by the end of 2010 anyway. If the high revision rates were no fault of the company's, surely a recall was unnecessary.  And if a recall was so necessary that the device could not justifiably stay on the market for another nine months, it seems peculiar that DePuy should have waited three years before issuing the recall - considering they had data showing failure rates that were many times the usual for their ASR systems. The ASR hip resurfacing system failed at a 12% rate, over twice the accepted norm of 5%. The ASR XL Acetabular System failed at a 13% rate, topping the average of .5-3% by a hefty margin.  DePuy had the information on those failure rates in 2007. The recall wasn't issued until 2010, and until a month before the recall, the company insisted that its revision rates were equivalent to any other products' on the market.  We believe this timeline proves the company knew otherwise, and allowed the ASR device to stay on the market anyway. We believe they did so for profits: the ASR was an expensive device in both incarnations, and if DePuy had issued a recall in 2007, it would have lost out on several years' worth of device sales.  That said, these are the facts: You can deduce for yourself what DePuy knew, and when, and how despicable it was that they did nothing at all to stop their device from being implanted in thousands upon thousands of people who never suspected what a risk they were really taking. In 2005, the FDA clears the ASR cup for use in traditional hip replacement through the 510(k) approval process. It claims the product is "substantially equivalent" to several other devices already on the market. None of the products to which the ASR product was claimed to be "substantially equivalent" had ever been clinically tested by the FDA. (Click above to download our 510K Hierarchy Cart...) Beginning in 2007, the Australian National Joint Replacement Registry issued seven separate reports to DePuy identifying the problems being reported by surgeons throughout the country with the ASR Hip Resurfacing System, and warning the company of unusually high failure rates. By the beginning of 2008, the U.S. Food and Drug Administration has received approximately 400 complaints about the failure of the ASR XL Acetabular total hip replacement system. In early 2009, DePuy sends a brochure to doctors describing the importance of proper acetabular cup positioning for all hip implants. The brochure did not specifically mention the ASR as a point of concern. In December of 2009, DePuy withdraws the ASR from the Australian market for "commercial reasons" - but does not recall the device. In February of 2010, DePuy officials grant an interview to the New York Times in which they state that the ASR's performance is equal to that of competing devices. In a letter dated March 6, 2010, DePuy issues a formal recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System. In April of 2010, DePuy maintains in the New York Times that the ASR XL Acetabular System is safe, despite the recent recall. On August 26, 2010, Johnson & Johnson announces that DePuy is issuing a worldwide recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System. DePuy clearly attempted to get the device off of the market without having to go through the loss of reputation that accompanies a formal recall. It claimed it was taking the ASR system off the Australian market because of declining sales, rather than declining success rates. It claimed to the New York Times that the device performed at equal levels to other competing hip implants, even when it could not possibly have believed that statement to be true. And most damning at all, even after issuing a recall in the United States in March of 2010, DePuy kept selling the faulty hip implants worldwide for the next five months before extending the recall overseas. To keep selling a device even when the company was fully aware it was risking one in every eight patients' future health is unconscionable. For the sake of every patient who received a hip implant from DePuy, and every surgeon who placed one in good faith that the product would perform well, we would like to see justice done. If you have a DePuy hip implant and would like to join the mass action case against the company, we're here to answer your questions. Give our offices a call at 1-800-730-7607 and we'll have you talking directly to one of our lawyers in short order. It's important to us that you get the personal attention you deserve.

Depuy Hip Recall To The Revision Surgery Enough.

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DePuy Wants You to Give Your Defective Hip Implant Back

After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery. In exchange, the company wanted just one minor thing: the hip implant.  On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.  Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you. The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.  Why Your Hip Implant is Valuable to Your Case  When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.  Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.  If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.  The Art of Misdirection   DePuy offered patients a free hip revision surgery as an enticement. For patients who are fearful that their hip implant is faulty and causing problems like metal sensitivity, metallosis, heavy metal poisoning, and bone deterioration, the offer of a no-cost revision is extremely appealing. Worried that the longer they retain the hip implant, the worse off they will be, those patients are likely to sign the consent forms presented to them without reviewing them properly. Even if they do review the forms, it's not likely the full ramifications will become clear until it's too late.  If DePuy lacked sufficient talent to properly design and engineer a functioning implant, they've made up for that shortcoming by perfecting the art of misdirection. Distracting patients with the offer of a free hip revision surgery, DePuy is making the removed hip explants disappear into thin air - or, at the very least, into the hands of their legal defense. It's a clever con, and it is very easy to be taken in by it. Many patients have already signed away their own hip explants to DePuy in exchange for the free hip revision surgery, and have undermined their case by doing so. However, even if you have already signed the consent forms, there are ways to reverse the trick and bring the faulty hip implant out of the shadows and back into the light.  Bad Intentions  It is entirely possible that DePuy intends to use the explants to improve on their current model and produce a better ASR Acetabular System. However, the evidence thus far is not in favor of that story. Leaving aside the fact that DePuy never put the hip implant through clinical trials in the first place, in previous litigation on another implant case, the company's defense team used the explants to try to prove the plaintiff caused the problems himself. In one particularly frightening story recounted to us by an attorney who referred a client to us, a hip explant was "lost" after a revision surgery. The hospital and surgeon's staff insisted that the explant was being held at the hospital after surgery. Another staff member said the explant had been thrown out along with other surgical waste, admitting later that a DePuy representative was present at the hospital on the day of the operation.  We cannot offer irrevocable proof of this story and we have no reason to believe that DePuy representatives are actively attempting to scoop up explants immediately after surgery. However, it is a troubling story and we have no reason to disbelieve the word of the attorney who recounted it. If nothing else, it would seem to indicate that DePuy's motives are not as benign as they claim.  Unless, of course, the representative merely wanted the explant to help the company's engineers improve the design. It must be a great comfort to the patient whose personal property was lost to know that her case was undermined for such a worthy cause.  Don't Sign Your Rights Away  You are entitled to a hip revision surgery without submitting your explant to DePuy. We believe you should be compensated for all medical costs related to the faulty hip implant, which would include the revision surgery.  To put it another way, you can allow them to pay for the surgery now and lose a great deal of future compensation in the future - or you can retain your own explant and receive the compensation you are due, including the cost of the revision, after we have used your explant to make a strong case against DePuy in a mass action lawsuit. If you are asked to sign a document waiving your right to keep your own explant, we strongly advise you not to sign it. If you have already done so, please contact our offices immediately at 1-800-730-7607 or via our online contact form. We may be able to help retrieve the explant or show that DePuy obtained it improperly.