Current Updates on the DePuy ASR Hip Recall

The DePuy ASR metal-on-metal hip implant was approved in 2005 by the FDA, but soon thereafter both DePuy and the FDA began receiving reports of adverse health events. Some believe that the much less rigorous 510(k) approval process which allows manufacturers to skip clinical trials could be at least partially responsible for the adverse health effects in the thousands of ASR recipients. Following a flurry of complaints, DePuy voluntarily recalled the ASR on August 26, 2010. At present there are approximately 4000 DePuy ASR lawsuits consolidated into an MDL in Ohio as well as a smaller mini-state consolidation in Chicago with approximately 600 plaintiffs and another in California containing 1500 or so plaintiffs. Since California is experiencing so many financial problems, the plaintiffs and their attorneys are expected to face problems in getting a trial setting.

The MDL, or multi-district litigation system is meant to streamline the litigation process, taking advantage of the fact that there are similar allegations from all plaintiffs made against the defendants—in this case DePuy and Johnson and Johnson. The first trial regarding the ASR was scheduled to begin in state court in Las Vegas in mid-December although it has been rumored the case settled prior to trial. Should this be true, it would be a positive precedent for all other ASR lawsuits to follow. The metal-on-metal design came about due to its ability to last significantly longer than the metal-on-ceramic or metal-on-plastic hip implants. Unfortunately, the metal-on-metal design allowed the cobalt and chromium ball and cup to shave off microscopic metal ions into the body, entering the surrounding tissues or even the bloodstream. The FDA recently held a two-day panel to discuss the safety of the metal hip implant. 

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.”

Statute of Limitations and the Likelihood of Reimbursements by Broadspire

Broadspire is one of the foremost third-party risk management administrators to large insurance companies and employers. Broadspire has been retained by DePuy to engage in damage control regarding the ASR hip implant claims.  It is likely that few people who have suffered medical harm because of a metal-on-metal hip implant truly understand the lengths such companies will go to in order to save their client as much money as possible. Broadspire is under orders by Johnson and Johnson and DePuy to downplay the public outcry regarding the ASR hip implant recall to the fullest extent possible. One of the avenues Broadspire will use for this specific purpose is to gain as much knowledge about patients as possible through the use of claimant data.

Will Benefits Be Discontinued?

If you or a loved one has suffered an adverse medical event which is directly related to a metal-on-metal hip implant then one look at Broadspire’s website should give you an idea of the true nature of this company and the depths they will go to in order to benefit their client.  Privileged medical records are being used for the benefit of Johnson and Johnson and DePuy via an entire panel of medical professionals at their beck and call. Many of those victims of the hip implant currently rely on the reimbursement benefits being offered through Broadspire which covers their co-pays and deductibles. The question on everyone’s minds now is whether those benefits will continue after the statute of limitations runs out in August, 2012.

U.S. Drug Watchdog Urges Pinnacle Hip Implant Recipients to Come Forward

Over 130,000 Americans received a DePuy Pinnacle metal-on-metal hip implant between the years of 2005 and 2010. Although its counterpart, the DePuy ASR XL hip replacement system was recalled in 2009, the Pinnacle, while employing the same construction methods and materials, has not been recalled. Because of the recall of the ASR, there is mounting concern that the Pinnacle may also expose recipients to the dangers of metallosis or metal toxicity. The U.S. Drug Watchdog has stated their goal of reaching each and every one of the recipients of the Pinnacle implant to ensure none who have suffered harm are left behind.

Although only about a thousand people have come forward to date, the U.S. Drug Watchdog believes those numbers will grow rapidly, reaching well over 100,000. When the victims are properly identified they will then be provided access to the most knowledgeable attorneys who possess a thorough background in the intricacies of the metal hip implant. The objective of the U.S. Drug Watchdog is to ensure every person who had their health harmed because of a metal-on-metal hip implant receives appropriate compensation for failure of the implant.

Why DePuy Hip Recall Wont Be a Class Action Lawsuit.

By Independent Staff Writer

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.

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.

Many patients who received a DePuy hip implant have suffered heavy metal poisoning. But what does that really mean?

By Independent Staff Writer

As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.

Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.

One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.

For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.

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. 

Too many ASR XL Acetabular Systems causing problems in first three years.

By Independent Staff Writer

In 2003, DePuy released the ASRTM XL Acetabular System, a hip implant that was touted to last up to 20 years with a stronger, more durable metal-on-metal design. Approximately 93,000 people around the world weighed the risks of surgery against their current level of pain and discomfort and chose to receive a hip implant that they believed would give them 15 to 20 years of pain-free movement.

DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule. 

With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%

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 major flaw, as we've said in other articles about the problems with the XL Acetabular System, is the engineering. The two pieces of the implant rub together as the patient moves, releasing microscopic particles of chromium and cobalt into the bloodstream. Some patients experience pain when this happens; others have no idea of the damage being done to the bone and tissue surrounding the hip implant. Some patients and doctors have reported a loosening of the joints in the hip implant, fracturing of the surrounding bone, and full-out dislocation. 

Every hip implant releases small particles of the device's materials into the bloodstream, but the quantities are so small that the body can release them from the bloodstream as waste. In the ASR XL Acetabular System, the quantities being released are sometimes so great that the body can't get rid of them efficiently, causing metallosis.

Much of the pain and problems behind the DePuy ASR total hip implant were caused by metallosis. But what does that really mean?

By Taylor Lindstrom

Johnson & Johnson has announced that its subsidiary company DePuy issued a voluntarily recall of their ASR hip implant due to a number of patients who required a second hip replacement procedure, called a revision surgery." 

No mention was made of metallosis in the Johnson & Johnson press release. In fact, Johnson & Johnson didn't mention any of the more significant symptoms patients are suffering after receiving a DePuy ASR XL hip implant. They would prefer that the public believed the revision surgery process is simple and fixes the problem of a faulty hip implant with absolutely no long-term effects. 

We're recommending you get a second opinion - and a blood test.

Metal-on-metal hip replacement bearings like the DuPuy ASR XL Acetabular System total hip replacement were originally reintroduced as an alternative to metal-on-plastic or ceramic hip replacement systems. Metal-on-metal implants (for a hip implant, this is a design that involves both a metal ball and a metal socket) have certain advantages over plastic or ceramic when the design is properly engineered. They last longer, have high resistance to wear and tear, and can withstand more vigorous activity, making metal-on-metal the usual choice for surgeons with younger, more active patients who are going to put more strain on their implants.

However, a poorly engineered metal-on-metal hip resurfacing system has considerable complications, many of them more serious than their ceramic or plastic counterparts. 

The Blue Cross Blue Shield Association Technology Evaluation Center report on metal-on-metal total hip resurfacing notes that metal-on-metal systems have risks of elevated heavy metal ion levels, delayed hypersensitivity to metals, and even carcinogenesis - cancer, to the layman.

All hip replacement systems release tiny particles of the implant's material into the body when the two parts of the hip replacement rub against one another. In metal-on-metal implants, a small amount of friction and metallosis is predictable and part of the considered risks when the surgeon recommends a certain type of hip implant. 

However, when the metal parts are improperly made or installed, the friction releases much more metal into the bloodstream, causing serious metallosis and metal poisoning.

Engineers who have examined the DuPuy ASR hip replacement system noted several design flaws that contributed to increased metallosis and metal poisoning in patients. The implant is shallower than most other hip replacement systems, which made it much more challenging to implant than other systems. DePuy was fully aware of this setback; their instructions to the surgeon recommended a much more precise placement than other implants. 

One engineer we consulted with went on to note that the requirements for placement were so specific that only about 3% surgeons would be able to place the hip implant properly. This is not a comment on the surgeon's skill; the engineer was quick to note that the placement demands would be impossible for all but the most skilled and experienced surgeons, and even then the surgeon would have to be fully informed of the importance of precise placement. 

Depuy Hip Implant Side Effects

 Hip Implants To Blame For Metal Poisoning, Metallosis and Other Long Term Health Effects. 

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DECEMBER 2, 2010 - HOUSTON — If you have undergone hip replacement surgery and are experiencing any amount of pain as a result, you may be in more danger than you realize. Recent findings concerning certain types of metal-on-metal hip implant devices show that they are prone to early system failure and may even cause metal poisoning, or metallosis, which is a reaction to the metal debris that is shed when components of the device rub together. 

On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced it is voluntarily recalling two types of hip implants due to high early failure rates. The recall affects the ASR XL Acetabular System, and the ASR Hip Resurfacing system. To date, more than 93,000 of the devices have been implanted worldwide. 

In the wake of the recall, countless patients have come forward with horrific stories of pain and suffering as the result of receiving a faulty DePuy ASR implant. If you or someone you love has been implanted with one of these devices, you must understand the risks and repercussions if you fail to seek medical help immediately.

Among the problems reported, some of the most common are:

• Swelling or pain in the effected hip or surrounding areas
• Difficulty walking or pain in the hip when doing so
• Grinding or popping noises originating in the hip area
• Inflammation or infection in the affected hip
• Dislocation or improper positioning of the implant

Perhaps the most dangerous side effect of all is metallosis, which, according to the Journal of Bone & Joint Surgery, is “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the devices cause the metal components to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions, blood metal poisoning and bone loss. 

Symptoms of metallosis from metal-on-metal hip replacement devices can include pain, inflammation, tumors and difficulty walking. Specialized blood tests can be used to detect levels of toxic metals in patients experiencing these symptoms. In some cases, patients with DePuy implants have been found with 100 times the normal levels chromium and cobalt in their bodies. 

Chromium and cobalt toxicity has been linked to cancer, and can affect the nervous system, gastrointestinal system, cardiovascular system, blood production, kidneys, liver and reproductive system.

Symptoms of heavy metal toxicity include confusion, pain in muscles and joints, headaches, short-term memory loss, gastrointestinal upsets, food intolerances/allergies, vision problems, chronic fatigue, and others. The symptoms are so numerous that it is difficult to diagnose based on symptoms alone.

The first step in treating metallosis or heavy metal toxicity is to identify the toxic elements and begin the removal process. With the DePuy ASR hip replacement system, this means a painful, costly “revision” surgery, which about 1 in 8, or 12 percent of those who have received the implants have been shown to require within 5 years. Originally, the devices were predicted to last 15 years before requiring any corrective revision. 

For many patients, intravenous Vitamin C and replacement mineral infusions are also recommended to support the body through the metal removal process. Symptoms will often begin to improve within weeks of commencing treatment, but some may linger, indicating residual organ damage. Therapy may last as long as six months to two years. 

Although a full recovery from metallosis is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of heavy metal toxicity for extended periods. Some of the damage, for instance to the liver or brain, may not be fully reversible, and many find that their food intolerances are never completely remedied. Unfortunately for those affected, only time will tell. 

If you or someone you love received a defective DePuy ASR device, it is imperative that you 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 compensated. Call us at 1-800-730-7607 for a free legal consultation today.