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.

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. 

DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer

In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.  

What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.

DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.

Overview of the Statute of Limitations for Recalled DePuy Implants
If you received a DePuy hip implant and have suffered medical issues as a result, you must be aware of how the legal statute of limitations may affect your right to pursue legal action for the harm done to you. It is urged that potential claimants exercise a measure of urgency in obtaining legal representation for a potential recovery suit. The DePuy hip implant recall occurred in August of 2010, and it is estimated it affected more than 90,000 devices worldwide. In most states—including Texas—personal injury and product liability statute of limitations are only two years, therefore those who reside in a state where a two-year product liability statute exists may only have until August of 2012 to file a DePuy hip implant suit. In order to ensure you preserve your rights, it is a good idea for any hip implant recipient who has experienced painful side effects to seek prompt legal action in the event revision surgery becomes necessary.

Reviewing the Safety of Metal-on-Metal Hip Implants

By Independent Staff Writer

According to a recent BBC Newsnight investigation, literally hundreds upon thousands of patients across the globe may have been exposed to potentially toxic substances following the implantation of metal-on-metal hip implants. Even though it is now believed that the dangers of these hip devices—which appear to have been very poorly regulated at best—was well known and documented for decades, recipients of the devices were nonetheless kept in the dark. The implants which are in question are known as “metal-on-metal,” and are constructed via a head at the top and a lining the head fits into which are made of cobalt-chromium alloy.

The Failure Rate of Metal-on-Metal Hip Implants
These hip implants are used in hip replacements and hip resurfacing, and came into wide-spread use in the 1997. The target group for these metal-on-metal hip replacements was younger, still-active patients who expected the hip replacement to last the rest of their life. Unfortunately, the numbers show that the failure rates among both genders are significantly higher than normal—from 11.8% failure in resurfacing to 13.6% for the total hip replacement as compared to rates of only between 3 and 5% for implants made of other materials.

How Many People Have Hip Implants?
Since 2003, the BBC article reports that over 60,000 patients in England and Wales and over a million in the United States have received the potentially dangerous metal-on-metal hip replacement. The metal ions from the cobalt and chromium hip implants are believed to seep into local tissues causing reactions which can not only destroy muscle and bone but can eventually leave the victim with a permanent disability. The fact that cobalt and chromium can lead to such serious health issues was actually documented in scientific journals over three decades ago.

Was There a Cover-up?
DePuy, a major manufacturer of the metal-on-metal hip implant, released an internal memo in 2005 which stated that in addition to possible changes in immune functioning there was additional concern that the metal debris from the device could be carcinogenic. The memo went on to state that the possibility of distant effects of the device was “worrying,” and that one study indicated a three times higher risk of lymphoma and leukemia ten years following the hip replacement. Despite these very real concerns DePuy continued marketing the device and indicated none of the potential health concerns in their subsequent promotional materials.

A Discussion of the Long-Term Health Effects of the Hip Implant
In 2006 the Medicines and Healthcare Products Regulatory Agency convened a meeting to discuss the long-term health effects of the metal-on-metal hip implant made from cobalt and chromium. An advisory board was appointed, however out of the group’s eight members, two were consultants for DePuy and one was the director of product development for Smith and Nephew—obvious conflicts of interest. In the end the group chose to sidestep the potential dangers of the metal-on-metal hip implants, even refusing to warn women of child-bearing age of the potential dangers despite the fact that metal ions had previously been detected in umbilical cord and placental blood among women with the implant. No alert was put out to either surgeons or patients, and it was not until March of 2011 that the British Orthopedic Association sent out a warning advising that the metal-on-metal hip replacements should be “carefully considered and possibly avoided.”

Defective DePuy ASR Hip Implants Should Consider The ARP Wave

Patients With Defective DePuy ASR Hip Implants Should Consider The ARP Wave

By Andre Sullo

SULLO & SULLO, LLP

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HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.

Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body’s natural recuperative ability.

The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.

To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.

A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”. 

These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.

If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

Depuy Hip Recall -We are There for You

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

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. To better serve our clients in this case, Moriarty Leyendecker is working in conjunction with The Law Offices of Sullo & Sullo and The Law Offices of Howard L. Nations, the latter of whom was among the lawyers who proposed the Northern District of Ohio as the best venue based on that court's current docket and the speed and efficiency at which they move cases to resolution; the convenience of location for all parties; and the experience of the presiding judge.  The Honourable David A. Katz is highly experienced with a successful MDL track record. Judge Katz is exceptionally well qualified to handle a matter of this size and complexity. Mr. Nations and his legal team were recently before Judge Katz in litigation regarding Ortho Evra Products Liability, a matter which was successfully resolved in the same Ohio court. At Moriarty Leyendecker, we are looking forward to working with Judge Katz and his staff on this important matter, and we are confident that this choice of district is in the best interest of our clients.

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.

Depuy Hip Implant Danger

What is Metallosis? 

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Metallosis occurs when metallic debris builds up in the periprosthetic soft tissues. In the case of the DePuy ASR Acetabular system, the two parts of the hip implant abraded against one another, creating friction and releasing metallic ions of cobalt and chromium into the body. Those microscopic metal ions cause an autoimmune response. The immune system identifies the metal ions as foreign bodies and automatically inflames the area around the debris. The body is essentially trying to "trap" the foreign particles in the inflamed area so that the metal can't spread to the rest of the body. In the case of the DePuy hip implant, it appears that the immune system sends inflammatory cells to the synovial membrane as well, causing synovitis. Synovitis is generally quite painful, since the membrane is too inflamed to allow the joint to rotate properly. Metallosis can be complicated by metal sensitivity, which is essentially an allergic reaction to metal. The normal autoimmune response to foreign matter in the body is to inflame the area and attack the foreign cells. When the body is hypersensitive to a particular substance (like metal), the immune system overreacts and multiplies its efforts to eliminate the foreign body. In the process, normal healthy tissue can get caught in the crossfire as the body mounts an ever-growing campaign against the foreign body. In patients with a DePuy ASR Acetabular System, the immune system is fighting a losing battle, even after its efforts are multiplied through metal sensitivity. Your white blood cells (leukocytes) attack any foreign organism, but they also "tag" and remember the organisms that have attempted to invade before and come up with secretions designed to wipe out those specific invaders. In the ASR hip implant, the device's friction constantly releases new metal ions into the bloodstream, which means the immune system continually receives a message that its efforts are not enough to eliminate the foreign matter.  A simple analogy for the metallosis is a food allergy, which occurs when the body identifies a food as so dangerous to the body that its autoimmune reaction is exaggerated. Essentially, it identifies the food as a poison and reacts strongly so that the brain will realize the food is dangerous and move the body away from it. In extreme allergies, the body's immune response can be so overly strong that it can actually kill the person.  Generally, this sort of over-reaction occurs if the immune system is completely unfamiliar with a foreign body and can find no parallels with other objects it has encountered in the past. It can also occur if the body is over-subjected to the object; for example, it is possible to give yourself an allergy to just about any food if you consume excess amounts for months at a time.  Symptoms of metallosis generally include pain around the site of the implant, pseudotumors (a mass of inflamed cells that resembles a tumor but is in fact merely collected fluid), and a noticeable rash that indicates dying tissue. The damaged and inflamed tissue can also contribute to loosening the implant or causing dislocation, since the tissue that would normally hold the implant in place is weakened.  Women, the small in stature, and the obese are at greater risk for metallosis because their body structure causes more tension on the implant and contributes to the release of the metal ions into the bloodstream.  If you're concerned that you have an ASR XL Acetabular hip implant and would like to speak to someone about getting compensation for your medical problems now and in the future, please give our offices a call at 800-730-7607 or  fill out our online form. We're here to answer any questions you have and advise you of your rights.