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.

For DePuy plaintiffs - and our legal team - Ohio is the place to be.

By Independent Staff Writer
Two weeks ago, the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today, the Panel announced that the litigation will take place in the Northern District of Ohio.

Complaints about the DePuy ASR hip implants have been reported throughout the United States, which prompted a hearing to consolidate the cases into multidistrict litigation. Counsel for DePuy Orthopaedics, Inc. did not object to doing so. The Multidistrict Litigation (MDL) Panel determined that the DePuy cases qualified for consolidation and created DePuy Mulitdistrict Litigation.

There were many different courts in the running for the federal district in which the pretrial proceedings would take place, including Kentucky, Indiana, New Jersey, Ohio, and Florida. Counsel for DePuy and several Plaintiffs' lawyers who represent people harmed by the DePuy devices submitted arguments to the Panel as to which court they felt was most appropriate for these cases.

As we've explained in previous articles, consolidating a case conserves resources for the attorneys as well as the judiciary, and bringing individual lawsuits for each case can make the costs so prohibitive as to present an obstacle to getting a fair settlement for the plaintiffs. The fact that DePuy Multidistrict Litigation has been formed creates a more efficient way for our legal team to pursue claims for our clients and ensures we are better able to give them the individual attention they need.

The ASR Acetabular System falls far short of other total hip replacement systems. Here's how.

By Independent Staff Writer

In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life.

In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.

What a Hip Implant is Up Against

Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).

As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.

These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.

For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.

When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.

As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. 

Could the DePuy ASR™ XL Acetabular System recall have been avoided? Looks like it.

By Independent Staff Writer

In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.

But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.

How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States? 

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.

The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market. 

Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word.

Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.

The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.

Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.

Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market. 

The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.

Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product's safety and effectiveness without strong clinical data?

If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might've been avoided. Tens of thousands of patients might've been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first. 

Hip Replacement Implant Complaints on the Rise

Hip Replacement Implant Complaints on the RiseBy Holly Soehnge

Hip replacement is a common orthopedic surgical procedure performed to relieve pain and restore mobility to a damaged hip joint, typically for patients with arthritis or a hip injury.  Diseased or damaged portions of the hip ball and socket joint are replaced by prostheses made of metal, ceramic, plastic, or combinations of these materials.  Metal-on-metal (MoM) hip replacement implants use ball and socket components that are both made of cobalt or chromium metal, or titanium.  The ball fits into and glides against the surface of the socket to imitate the function of the hip joint.

 Hip replacement surgery is mostly successful, and hip implants are made to last 15 or more years before replacement is required.  There are risks of several complications that can occur, however; as with any type of surgery.  Complications that can occur include infection, dislocation of the ball implant from the socket, and implant loosening or other wear and tear over time requiring another hip replacement surgery.

 In contrast to the pain relief and durability characteristic of hip replacement treatments, recently there has been a remarkable surge in complaints of early failures of metal-on-metal hip replacements within a few years of surgery.  Some patients have experienced severe ongoing pain, swelling, and difficulty walking.  Others have suffered damage or death to the soft tissue surrounding the hip joint.  Many of these implant failures require the patient to undergo painful and expensive revision surgery.

Metal-on-metal hip implants wear over time, resulting in deposits of metal debris in the tissues surrounding the hip joint.  A chiseling effect known as edge-loading can occur when the ball of the implant presses on the socket edge as a result of poor implant design or faulty surgical technique.  Large amounts of metal debris are deposited in the tissues as a result, which can lead to high levels of cobalt and chromium ions in the patient’s bloodstream, possibly leading to metal poisoning.  Studies to date have not shown a greater risk of cancer or other adverse effects from the metal ions, although additional data from ongoing studies is needed before the long-term effects are known.

Current research estimates that 1 to 3 percent of patients could experience an inflammatory reaction to the metal debris, causing chronic pain, damage and death to hip tissues, and bone loss. Women appear to be affected more frequently than men.  A recent Harvard Medical School study looked at the effects of edge-loading from metal hip implants.  The research showed an association between resulting high cobalt and chromium blood levels and patient susceptibility to soft tissue pseudotumors.  Pseudotumors are a rare complication, but nevertheless a very serious problem, causing tissue destruction and the need for revision surgery.  Metal debris complications are a significant safety concern and the focus of ongoing studies.
Concerned for their patients’ safety, most orthopedic surgeons have stopped using metal-on-metal hip implants.  Metal-on-metal hip implants were used in about one third of the 250,000 hip replacements performed in the United States until the past two years, when use of the implants has dropped to only about 5 percent of the market.

The Food and Drug Administration (FDA) has received over 5,000 reports of adverse events in connection with metal-on-metal hip implants since January 2011, according to a study by the New York Times.  In response to the complaints, the FDA is encouraging patients who have received metal-on-metal hip replacements to contact their surgeons immediately if they experience problems, and to participate in safety surveillance studies.  

The FDA has required 21 manufacturers of metal-on-metal hip implants to submit plans to conduct post-marketing surveillance studies to address safety issues related to the implants.  Among these manufacturers are DePuy, a division of Johnson & Johnson, Zimmer Holdings, Wright Medical, and Biomet.  The FDA has until November 2011 to decide whether the proposed plans are adequate to address safety concerns.

 Of the metal-on-metal complaints received by the FDA this year, about 75 percent relate to complications with the DePuy ASR hip replacement systems.  Depuy has attributed the failure of the devices to implant loosening, infection, bone fracture, dislocation, metal debris reactions, and accompanying pain.  Some orthopedic surgery experts have said they believe these devices have a design flaw that makes them difficult to implant properly.  DePuy refuted these statements, but announced last year that it was discontinuing the ASR systems because of declining demand.  

In August 2010, Depuy voluntarily recalled its two ASR systems as a result of new data from the National Joint Registry of England and Wales showing that roughly 1 in 8 ASR patients would experience implant failure within 5 years, an unacceptably high failure rate.  There have been over 90,000 DePuy metal hip implants sold; so that according to the data, over 11,000 patients are likely to experience implant failures that require painful and expensive revision surgery.

The two DePuy systems under recall are the ASR XL Acetabular System, a metal cup and ball replacing the hip joint, and the ASR Hip Resurfacing System, a metal cap that fastens onto the head of the femur.  Only the ASR XL Acetabular System is FDA-approved for use in the US.  Depuy has encouraged surgeons having implanted these devices to request patient evaluations and metal sensitivity testing, since not all patients with metal debris-related tissue damage would necessarily show symptoms.  Depuy has stated that it will cover the costs of patient monitoring and treatment, including revision surgery costs.

DePuy is facing criticism from orthopedic experts that it should have recalled the devices much sooner considering the large number of complaints.  The first of many lawsuits filed against DePuy claims the devices are defective and alleges that DePuy knew about problems with the implants early on, but did nothing to alert patients or surgeons.  

Metal hip implants made by Zimmer Holdings branded “Durom” are also coming under increased scrutiny for potentially causing high blood levels of chromium and cobalt and soft tissue damage from metal debris.  Studies at the University of British Columbia found that patients implanted with a Durom socket implant had 2.6 times or 10 times higher than normal blood levels of chromium and cobalt, respectively.  The researchers recommended that Durom implants no longer be used in standard implants because of the metal ion levels. 
The rise in the incidence of severe medical complications from metal-on-metal hip implants is a rapidly growing concern for patients and orthopedic surgeons.  It is difficult to know the full extent of the problem; the use of the latest metal-on-metal devices is still relatively new, and it is estimated that only one to ten percent of all complications from medical devices are actually reported to the FDA.  More information is needed from ongoing studies to determine to what extent metal debris represents a threat to patient health, and whether implants made by some manufacturers are more or less safe than others.

Making of Depuy Hip Recall System

How the ASR XL Acetabular System is Constructed  Home | Personal Injury | DePuy Hip Recall | Traffic Tickets | Family Law | Criminal Defense |Get Informed In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life. In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life. What a Hip Implant is Up Against  Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh). As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament. These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket. For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate. When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch. As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Conventional Hip Replacement (also called Conventional Hip Arthroplasty) In a conventional hip replacement, the acetabulum is resurfaced with a new socket, replacing the ring of cartilage as pictured above with an artificial cup made of plastic, ceramic, or metal. The head of the femur is then removed and replaced with a long stem capped with a ball meant to mimic the femur head, as shown below: In the conventional hip replacement, the plastic cup above is meant to act as the bearing surface, which means that it is the location where the ball and socket contact each other. The liner cushions the point of contact, but it also makes the socket more shallow, which can mean less range of movement and a higher likelihood of dislocation. The creators of the total hip replacement system hoped to eliminate the problems associated with conventional hip replacement by boldly doing away with a piece of the original design. Total Hip Replacement The socket on a conventional hip replacement was technically composed of two pieces: the acetabular cup and the plastic liner, the latter fitting snugly into the former. In a total hip replacement, the design simply eliminated the plastic liner, fitting the femoral head directly into the acetabular cup. You can see the difference in the image below. The top implant [Fig. 3] is a conventional hip replacement system, with an acetabular cup, a poly (plastic) liner, and a femoral head. The lower implant [Fig. 4] is a total hip replacement system, with only an acetabular cup and femoral head. This design allowed the femoral head to be much larger, which made it more stable and less likely to dislocate. It also meant, however, that there was no cushion between the two hard surfaces of the acetabular cup and the femoral head. Many total hip replacement systems are extremely successful, and many surgeons prefer them over the two-piece conventional hip replacement systems, particularly for younger patients who are more active and more likely to dislocate their hip implant by testing the limits of its range of movement. However, the one-piece system made meticulous design engineering absolutely essential to avoid friction between the acetabular cup and the femoral head. Which is where DePuy's ASR Acetabular System went wrong.

Depuy Hip Recall Systems Glossary

 

Glossary of Medical Terms Related to the DePuy ASR Acetabular System

 Home | Personal Injury | DePuy Hip Recall | Traffic Tickets | Family Law | Criminal Defense |Get Informed

When you receive a hip implant, your doctor does his or her best to give you all the information you need to make an informed decision. However, it's unlikely that you will ever be as informed as your doctor is on any medical issue, no matter how relevant to your health. All those years of medical school amount to a wealth of knowledge that simply can't be communicated in a few hours.

That said, there are a number of medical terms to which we frequently refer in these articles, and we'd like to make sure you have them available in an easy-to-access location if you need to describe your concerns to your doctor or your legal counsel.

Acetabulum

The acetabulum is more commonly called the hip socket, and it is simply the cup-shaped impression in your pelvis where the top of your femur bone fits. The acetabulum and the head of the femur connect to form the hip joint.  

Acetabular cup

When inserting a hip implant, the acetabulum is kept intact, but is hollowed out to make room for a cup that is inserted into the hip socket to make the other half of the hip joint fit smoothly. This cup is called the acetabular cup.

Articular Surface Replacement (ASR) Hip Resurfacing System

The ASR Hip Resurfacing System is a hip resurfacing system that uses the trademarked ASR 1-piece metal bearing acetabular cup. Unlike the ASR Acetabular System, the ASR Hip Resurfacing System does not replace the head of the patient's femur. Instead, the femoral head is merely "resurfaced" with metal prosthesis that fits into the acetabular cup. It is secured to the patient's femur with a short stem inserted into the top of the femur bone.

This hip resurfacing system was recalled in August of 2010 along with the ASR XL Acetabular System, but it is a separate and unique medical device. The ASR Hip Resurfacing System was never approved for use in the United States, though it was released worldwide. The National Joint Registry of England and Waves reported a 5-year revision rate of approximately 12% for the ASR Hip Resurfacing System.

For more information on the difference between a total hip replacement and hip resurfacing, please scroll down to Total hip replacement and Hip resurfacing.

Articular Surface Replacement (ASR) XL Acetabular System

The ASR XL Acetabular System is a total hip replacement system that uses the trademarked ASR 1-piece metal bearing acetabular cup, which is placed in the hip socket. This hip implant uses a traditional femoral ball and stem (see conventional hip replacement). The "XL" in the device's name refers to the fact that the sockets are available in larger sizes.

This total hip replacement system was recalled in August of 2010 along with the ASR Hip Resurfacing System, but it is a separate and unique medical device. The ASR XL Acetabular System was sent to market in 2004 and made available worldwide. Currently, it is believed that approximately 93,000 have an ASR XL Acetabular System. The National Joint Registry of England and Wales reported a 5-year revision rate of an estimated 13% of recipients.

Criticisms of the ASR XL Acetabular System include insufficient testing, a lack of clinical testing, a high rate of failure, a delayed recall after problems were reported, poor design and engineering, and medical complications including metallosis, heavy metal poisoning, metal sensitivity, bone deterioration, tissue damage, and hip implant failure. Currently, DePuy has only recommended that recipients of the ASR XL Acetabular System who are experiencing pain or system failure have hip revision surgery.

Femoral component

In a hip implant, there are two parts to the hip joint that need replacing: the acetabular cup and the femoral component. The femoral component is the part of the implant that connects to the patient's femur bone, which runs the length of the thigh.

There are several different types of femoral components: it may be attached with cement or without, and the femoral component may replace part of the patient's femur or simply cap the top of the femur bone with a prosthetic surface and a stem inserted into the bone. 

Femoral head

The top of your femur bone forms a smooth, rounded ball that fits into your acetabulum (also called your hip socket). The part of your femur that fits into the acetabulum is called the femoral head.

In a hip implant, the term for the corresponding replacement is the same. The rounded top of the femoral component which connects to the acetabulum is also called a femoral head.

Hip implant failure

Hip implant failure occurs when a hip implant no longer performs its function properly. Often, hip implant failure requires hip revision surgery (see hip revision, below). The most common causes of hip implant failure are loosening of the hip replacement device, infection, breakage or wear, and damage to the surrounding bone. Hip implant failure may also occur due to poor design and engineering.

Heavy metal poisoning (see metal poisoning, below)

Hip replacement (total and partial)

A hip replacement is any surgical procedure in which the hip joint is replaced by a prosthetic hip implant. There are two parts to the hip joint and therefore two parts to a hip replacement: the acetabular cup and the femoral component. 

Hip replacement (total)

A total hip replacement, also called a total hip arthroplasty, replaces both the acetabulum and the femoral head with prosthetics.

Hip replacement (partial)

A partial hip replacement, commonly referred to as a hemiarthroplasty, generally only replaces the femoral head, though it may in some cases only replace the acetabular cup.

Hip resurfacing

A hip resurfacing system is a total hip replacement system that does not remove a part of the patient's femur to accommodate the femoral component. Instead, the top of the femur is simply capped with a prosthetic replacement and a stem is inserted into the bone.

Hip revision

A hip revision surgery is any surgery after the original hip replacement surgery.

Metallosis

Metallosis is a reaction to the immune system attacking metal objects within the body. In the case of a metal hip implant, the immune system reacts to the amount of metal being released into the bloodstream and concludes that the implant is a foreign body that needs to be attacked and destroyed.

As the immune system attempts to attack the foreign substance, it can over-compensate and kill healthy bone and soft tissue around the area. The surrounding area may also become infected, cutting off blood flow and leading to necrosis.

Metallosis has been linked directly to devices that release metal into the bloodstream via friction. Women, people of small stature, and the obese are more susceptible to metallosis.

Metal poisoning

Also referred to as heavy metal poisoning, metal poisoning is the build-up of metals in the soft tissues of the body. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the heavy metals associated with the ASR XL Acetabular System are chromium and cobalt.

Metal poisoning causes nausea, vomiting, diarrhea, stomach pain, headaches, metallic taste in the mouth, and in extreme cases the loss of cognitive, motor, or language function. Chromium and cobalt have also been linked to increased cancer risk.

Metal sensitivity

Metal sensitivity can be viewed as an allergic reaction to metals. Metal sensitivity affects approximately 10-15% of the population, and as with other allergies, it can develop over time if the patient is over-exposed to certain metals. The most common reactions include hives, eczema, redness and itching; however, in patients who have received metal implants, the metal sensitivity may also cause pseudotumors (see pseudotumors).

Necrosis

Necrosis is the premature death of living cells and tissue. Usually, necrosis occurs as a result of infection, toxins, or trauma to the area. 

Pseudotumors

A pseudotumor is essentially an enlargement that resembles a mass of abnormal cells, but is in fact an inflammation. In the case of the DePuy ASR Acetabular System, doctors who have found pseudotumors in their patients have found that they are filled with fluid. 

If you have any questions about the ASR XL Acetabular System or the impending lawsuit against DePuy, please do give us a call at 800-730-7607 or contact us via our online form. We're here to help.

Was Depuy Hip Recall Was Timely

 Home | Personal Injury | DePuy Hip Recall | Traffic Tickets | Family Law | Criminal Defense |Get Informed

 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 and Lawsuit

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Why DePuy Hip Recall Won't Be a Action Lawsuit

In a recent article, we explained the difference between bringing an individual lawsuit against DePuy vs. becoming part of a mass action lawsuit. In this article, we're delving into the differences between mass action and class action. Historically, class action lawsuits are the stuff that give lawyers a bad name. The senior partner at our firm, Andrew Sullo, likes to say that class action lawyers represent people who don't know they've been harmed and don't care. He's not just speaking metaphorically. It's entirely possible in a class action lawsuit to represent people who have no idea a lawsuit is being conducted in their name. Statistically, it's likely that you yourself have been involved in a class action lawsuit without ever knowing it. In the case of the DePuy hip recall, it's extremely unlikely that any judge would allow the case to be brought as a class action. Here's why: Advantages of a Class Action Lawsuit  When a class action lawsuit is filing, it must name one or several plaintiffs on the behalf of a proposed "class" of people. The "class" of people are individuals or business entities who have suffered a common injury or injuries. The rules vary by state (in Virginia, for example, there are no class action provisions) but in general the idea is that the group is so large that individual lawsuits are impractical, and the claims are so similar that they can be considered by the judge as a single problem that many people have in common. Class actions have several advantages. As we noted in our article on the advantage of bringing a mass action lawsuit against DePuy, any lawsuit that involves many people working under a single lawyer or collaboration of law firms has distinct financial advantages, since it will cost far more to bring each case individually than it will to bring a group of cases with similar problems. Another oft-cited advantage of class actions is that there is no advantage to plaintiffs who file early as opposed to plaintiffs who file late, and a third advantage is that class action suits have often been used historically to purposely change the behavior of a group of individuals such as physicians or companies. Of course, all of these advantages only apply to lawsuits that are brought with the plaintiffs' best interests in mind. Unfortunately for our legal system, class action lawsuits have been used repeatedly to benefit unethical lawyers rather than plaintiffs. The Missing Money  The biggest problem in class action lawsuits is that the plaintiffs often do not receive a share of the money recouped - or the share they receive is so small as to be negligible. Lawyers often take a large share of the awarded compensation while leaving plaintiffs with coupons of little or no value. Lawyers are required to inform members of the "class" for whom they are filing suit that those individuals are now a part of a class action lawsuit. In theory, this means the people whose names are being used in the class action lawsuit have an opportunity to opt out of being a part of the lawsuit. In practice, most people either do not read such notices, viewing them as junk mail, or do not understand them. Even if the notices are read and understood, it is extremely unlikely that the individual can do very much to forestall the class action lawsuit unless that person has significant personal funds. It is possible to sue a lawyer, who uses your name without your consent in a class action lawsuit, but it would require significant funds and the lawyer often wins such cases, claiming that he brought a suit in the plaintiffs' best interest and had nothing but good intentions. Meanwhile, the lawyer pockets much of the settlement. For those willing to spend their careers in such shills, it's a process with great rewards and little risks. Why Can't the DePuy Hip Recall Be Filed as a Class Action Lawsuit?  Lawyers must seek approval to bring a case as a class action lawsuit, and as we've already explained, class actions must include a group of individuals with similar damages. Though all the people who received an ASR XL Acetabular System and a notification of the DePuy hip recall have the same hip implant, the injuries they have suffered are extremely wide and varied. The future consequences, and the damages they are due for pain, suffering, and loss of wages will also vary widely. One person may receive a hip revision that fails as a direct consequence of the faulty ASR Acetabular System he originally received. As a result, he may be completely incapable of doing his former job as a construction worker. That person will have an entirely unique case from someone who had a few minor medical consequences as a direct result of the ASR Acetabular System and whose hip revision was successful. The latter case still has merit and that person should still be compensated, but the evidence, the harm done, and the consequences for which the plaintiff should receive compensation will be very different. In a case where the injuries to the plaintiffs are this varied but it is still to the plaintiffs' disadvantage to bring an individual lawsuit, a mass action lawsuit is best. A mass action suit means that plaintiffs will have all the advantages of a class action suit (lower costs to bring the case, no advantage to early filers, etc.) without the disadvantages of receiving a negligible sum for their grievances. It is extremely unlikely that any judge would allow the DePuy hip recall case to be brought as a class action lawsuit, since it clearly does not fit the parameters for such a suit. Why Mass Actions Don't Dip into Plaintiffs' Pockets In a mass action lawsuit, most lawyers will agree to bring the case on a contingent fee basis, which means that you owe nothing if the case is lost. The lawyer takes the risk of funding the case up front in exchange for a portion of the awarded compensation at the conclusion of the case. This is also true for class actions, with one significant difference: there are limits on the percentage of the compensation a lawyer is permitted to recoup at the conclusion of the case. In most states, the limits are between 30-40% of the total compensation. Though that number may seem high, recall that the lawyer is funding the case throughout the time period it is being brought, which may be years. The lawyer is taking significant risk and asking for no fees until the case is successfully concluded. And, of course, the lawyer earns nothing if the case is lost. In fact, the lawyer is out of pocket if the case is lost, since there is no way to recoup the money already spent on bringing the case in the first place. This gives the lawyer strong incentive to bring the best case possible. In a class action, lawyers often retain the majority of the funds awarded. In a mass action, that number is limited to a reasonable fee and the plaintiffs are assured of proper compensation for their injuries. One More Significant Advantage to Mass Action Lawsuits In a class action, plaintiffs are treated like numbers. In a mass action lawsuit, plaintiffs are treated as individuals. This is both a personal and professional choice for us at Sullo & Sullo. Every plaintiff's story and personal experience is valuable to the case, so it is only logical that we should want to hear every word and learn all about the client's history. We also do it simply because it is important that these stories be heard. Every story we've heard so far from our clients has been heartbreaking. It isn't enough to say "some people got hurt and we settled the case." It's important that your story is heard, and that the compensation you receive is directly tied to your life and your losses. If you'd like your story to be heard and you have questions about your particular situation or about becoming a part of the lawsuit against DePuy, we're here to listen and to give you the best answers we have. Give us a call at 1-800-730-7607 or contact us online. We'll do everything we can to help.