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.

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 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.

J&J Recalls Depuy Hip Implant

Who Is Johnson & Johnson? 

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"No more tears." "The #1 choice of hospitals." "Everything in life should be this pure." Johnson & Johnson's slogans over the years have assured consumers, particularly mothers, that their products are - above all else - safe. However, a recent, seemingly endless stream of recalls suggests otherwise. Children's Tylenol, Motrin Infant Drops, and Children's Benadryl are among the many medications recalled this year for manufacturing and labeling issues. Those products join recalls of Acuvue contact lenses, the allergy medication Zyrtec, and the ASR hip implant, which was sold to approximately 93,000 adults needing hip replacement surgery. A consistent pattern emerges: the company recalls products only as a last resort, and its quality controls seem to allow an inordinate number of dangerous products to reach the market - and enter the bodies of consumers. J&J may once have cared that its products were safe. Now, it appears the company only cares if they're sold. The company consistently sells products long after it is fully aware that the products present a danger to the public. And the FDA is helping.  Silent Recalls   In a report by ABC News,  an inventory company employee named Lynn Walther tells reporters that J&J hired him to quietly purchase specific lots of Motrin IB. His instructions stated that he should, "simply act like a regular customer while making these purchases. There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out." Johnson & Johnson's Head of Consumer Affairs, Colleen Goggins, stated that the company had nothing to do with the buy-back, and that she didn't "believe there was any intent to mislead or hide anything." It's difficult to believe the now-retired Goggins, considering J&J has a long history of "phantom" or "silent" recalls. In 2007, the Australia joint registry sent seven separate reports to the company identifying specific problems with the ASR device and detailing the high failure rate.  The device was withdrawn for "commercial reasons" in December of 2009 and only officially recalled in March of 2010. Meanwhile, thousands of people received an implant that may cause permanent tissue and bone damage or require a revision, which could mean they will be unable to have a successful future implant. Other recalls show a similar pattern of attempting to minimize the amount of product recalled - or avoid a recall altogether. Where one might hope that a company would issue a recall as rapidly as possible after being informed of problems, J&J's usual response is to "wait and see", followed by an attempt to remove the product by some other means than a recall. If it does recall the product, the company issues the smallest recall possible, expanding by minute degrees to keep products on the shelves as long as possible. Hundreds of wrongful death claims were issued over the Duragesic pain-killing patch. The jury determined that J&J was aware of the defects in the Duragestic patches, but neglected to inform doctors and consumers. the company recalled the patch that administered a 75mg/hour dose in 2004 - and waited until 2008 to recall the same patch that administered a 25mg/hour dose. In Japan, J&J expanded a recall of its Acuvue TruEye lenses five times, from the initial 100,000 boxes to half a million.  The expanded recall was only announced in Japan. At the time of the recall notice, J&J rather cavalierly noted that the recall represented less than 1% of all contact lenses made by the company worldwide. This fact is surely a great comfort to the 500,000 people who put acidic lenses in their eyes. We're surprised a similar statement was not made about the Duragesic pain-killing patches; surely the hundreds of people who died represented only a small - negligible, really - fraction of the product consumed worldwide. When it comes to consumer safety, though, Johnson & Johnson would almost always prefer to look at the numbers than the people. Fine Print in Invisible Ink Johnson & Johnson has been reprimanded, and occasionally sued, repeatedly over the last ten years for not giving their customers adequate warning about the risks of their products. Many jokes are made about reading the fine print - but the fine print can be rather difficult to read if the warnings simply aren't put on the labels at all. The antibiotic Levaquin is associated with tendon ruptures, particularly in older patients. The company did not warn doctors before changing its label, which meant doctors with previous lots of the medication (or ones who do not read new labels in every new lot) were unaware of the problem. The label change, plaintiffs say, remains inadequate. The ASR hip implant may have similarly inadequate warning problems. The company's literature on the ASR implant states that it must be placed at precisely a 45-degree angle, rather than the usual range of between a 30-45 degree angle. Though it has yet to be proven that the company did not make sufficient efforts to inform doctors of the dangerous results of placing the implant incorrectly, our sources indicate that surgeons were largely unaware that this particular implant was so sensitive to proper placement. The company  recalled 12 million bottles of Mylanta and 85,000 of Alterna Gel  due to insufficient labeling as well: no mention is made of the presence of alcohol in the products from flavoring agents. The company also recalled 9.3 million bottles of Tylenol cold treatments for the same reason, including 40 types of J&J medication specifically made and marketed as being for children. There's Something in the Water The range of foreign matter found in J&J products encompasses everything from the aforementioned alcohol to  metal and wood particles to  glass shavings. Perhaps most disturbing, however, is the  bacteria found at the Johnson & Johnson plant that produced the now-recalled children's medicines. It's called Burkholderia cepacia, and while it produces little risk to healthy people, it can cause serious infections in those with weakened immune systems. Such as, say, sick children whose concerned mothers gave them Children's Tylenol to combat fever. The bacteria was found during an investigation by the FDA of the facilities operated by McNeil Consumer Healthcare, a unit of Johnson & Johnson that manufactures many popular medications for the company. J&J executives had previously said that the recall problems were limited to a single plant in Fort Washington, PA, that was shut down for an overhaul. However, the FDA's principal deputy commissioner states that  all of the facilities operated by McNeil Consumer Healthcare have deficiencies that could affect the qualtiy of the products being sold. "The company had an inadequate quality system," Dr. Joshua M. Sharfstein said. It's a mild rebuke for a serious problem. Johnson & Johnson's quality control system has allowed multiple dangerous products to get to market over the last 10 years - some of which have caused permanent physical damage or even death. But then, the FDA has never been all that inclined to look closely at Johnson & Johnson's proceedings. Getting Cozy with the FDA  The House Committee on Oversight and Government Reform recently investigated the "phantom" recall of Motrin as well as individual manufacturing issues that led to the recall. They found that the FDA had visited the McNeil plants multiple times and characterized the relationship between J&J and the FDA as " too cozy." This isn't the first time that we at Moriarty Leyendecker noted that the  FDA seems to be doing an inadequate job of ensuring quality controls are met on Johnson & Johnson products that they endorse. The FDA approved the ASR medical devices too - without asking the manufacturers to put the product through clinical testing and without seeming to notice that of the multiple devices to which the J&J company DePuy claimed the ASR was "substantially equivalent", not a one had ever actually been clinically tested by the FDA. The FDA also claimed that it was unaware J&J was re-purchasing defective Motrin without informing consumers - a claim that was later refuted in a report by ABC News. In emails obtained by ABC, the company's employees  appear to be in cahoots with FDA officials who agreed to allow the company to buy back their product instead of issuing a formal recall Cozy, indeed. Cutting Corners Where it Counts In November,  J&J announced that it intended to cut 8,000 jobs globally. It also decided to give its chief executive, William C. Weldon, an 11% increase on his salary. His new paycheck? $25.6 million. Weldon is currently the worldwide chairman of Johnson & Johnson and is currently testifying to Congress about the recent medication recalls. Of the 8,000 employees cut by Johnson & Johnson, no mention is made of their official job titles. However, we'd like to propose that Weldon's salary might be better spent in hiring some of those employees back - to manage quality control. Perhaps then Johnson & Johnson might be able to keep dangerously faulty products like the ASR hip implant from reaching the market. Of course, such a proposal precludes the assumption that J&J executives care more about the safety of real people than about lining their own pockets - and there isn't much evidence to support that theory.