Miss the Filing Deadline for Your DePuy ASR Hip Case? There May Still Be Hope

Despite the fact that the August, 2010 recall of the DePuy ASR metal-on-metal hip implant caused a significant stir among the medical community, thousands of recipients of the metal implant remained unaware of recall and subsequent warnings. Due to the initial FDA notice which was issued July 17, 2010 and the recall of the implant on August 24, 2010, all those who live in a state which operates under a two-year statute of limitations may have already lost their right to file suit against DePuy and Johnson and Johnson. Over half of the states do operate under that two year SOL, while others extend that time limit to three, four, six or even ten years. A handful of states have a one-year statute of limitations.  If you are the recipient of a DePuy metal hip implant it’s important that you determine your state’s statute of limitations for defective medical products even if you are currently having no problems with your implant.

Although DePuy originally set their metal implant’s failure rate at approximately 5%, they increased that number to 12% at the time of the 2010 recall. Independent studies place the likelihood of a DePuy ASR implant failure much higher—50% at five years following implant surgery and 80% at eight years following implant surgery. Statistically speaking, even those patients who have not yet experienced failure of their hip implant or adverse health effects from metal toxicity will do so in the very near future. It is extremely important that all DePuy ASR implant recipients at least be aware of their options prior to the date the statute of limitations will run.

First Three DePuy Cases settled by Johnson & Johnson for over $600,000

The DePuy metal-on-metal hip implant, approved by the FDA a mere seven years ago—has been inundated with over 8,000 lawsuits claiming the implant is inherently defective and can lead to costly and painful revision surgery as well as a myriad of other serious health issues. DePuy initially claimed the failure rate of the ASR metal hip implant to be between 4-5%. When DePuy voluntarily recalled the implant in 2010, they upgraded the failure rate to approximately 12% within the first five years. Studies independent of DePuy or Johnson & Johnson place the failure rate of the ASR metal implant at 50% within six years and 80% within eight years. These staggering numbers almost guarantee that this particular metal-on-metal hip implant will fail at some point in the majority of recipients.

Nearly a hundred thousand ASR devices were implanted worldwide prior to the recall with nearly forty thousand in the United States alone. The propensity of the implant to loosen and detach as well as the thousands of reports regarding adverse health effects from high levels of chromium and cobalt have led to over 6,000 lawsuits filed in federal court an another 2,000 filed at the state level in Maryland, California, Nevada and other states. Johnson & Johnson recently settled three Nevada cases for $600,000—an amount considered to be at the low end of the expected $200,000-$500,000 to settle each case.

“ASR” type Chromium and Cobalt Poisoning also being seen in Pinnacle Hip Implant Recipients

The DePuy ASR metal-on-metal hip implant has repeatedly made the news following a voluntary recall on August 26, 2010. While DePuy’s Pinnacle metal hip implant has not suffered under the recall stigma, many feel that it offers the same risks to implant recipients as the ASR. And, in fact, many attorneys are constantly asked by their clients about the differences between the ASR and the Pinnacle. The primary distinction between the two metal hip devices lies in the fact that the Pinnacle uses an insert liner between the acetabular cup and the femoral head while the ASR does not. It has been theorized that the ASR cup was too shallow for the head, leading to the ball hitting the edge of the cup and metal shavings to shear off into the body, also know as edge-loading.

While the Pinnacle’s cup was designed to give greater depth and allow the femoral head to move more freely within the socket, in some cases it still has been know to cause metallosis in implant recipients when the cobalt and chromium ions migrate around the body. Metal poisoning can cause a wide variety of adverse medical events. Many ASR recipients have had cardiovascular, renal, neurological and thyroid issues although studies done in the 70’s do not definitively tie these metals to cancer. Unfortunately, due to the lack of comprehensive studies on safe levels of cobalt and chromium in the body and the effects of toxic levels, nobody really knows just how dangerous these metals can be should they migrate to the bloodstream. The metal shards can also lodge into the surrounding tissues causing degeneration and destruction.

Attorneys of Sullo & Sullo Seeing DePuy Hip Implant Lawsuits Increasing

While many other firms have seen a drop in the number of metal hip implant clients, Sullo and Sullo attorneys have actually seen those numbers climb. Andrew Sullo, Class Action Lead Counsel & Managing Partner notes that “Although many firms have noticed a slowdown in the number of clients hiring them for DePuy ASR and Pinnacle lawsuits, our firm has not. I believe that is because we are constantly offering our clients new and updated information. Our job is to inform all metal-on-metal hip recipients that even though their hip may not have failed yet, it could and after August 26^th they may lose rights to recover compensation from Johnson and Johnson.”

With the statute of limitations coming up soon on the ASR metal-on-metal hip implant lawsuits, Sullo & Sullo is experiencing an increase in the ASR recipients who are coming forward and asking to be a part of the lawsuit. Many clients in the lawsuit have experienced adverse health effects as a direct result of having an ASR all metal hip implant put into their body.  On the other hand, many have experienced little or no pain with their ASR hip implant but have elected to join the lawsuit that they can be financial protected at a point in the future should their ASR device fail. Through no fault of their own, these people have become victims of a heavily flawed system which allows harmful medical devices to be sold to the public. The ASR was approved in 2005 by the FDA under the controversial 510(k) process which allows medical devices to essentially ride in on the coattails of other medical devices which have come before them. In some cases approval is granted based on a device which has actually been discontinued because of the number of problems associated with it.

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 ASRmetal-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 the FDA 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. 

Johnson & Johnson Hip Implant Settlement: Filing Deadlines are Approaching Fast

Many recipients of the ASR metal-on-metal hip implant are unaware of a crucial date which is fast approaching. The ASR was approved by the FDA in 2005 then labored under a flurry of adverse reports regarding early failure rates. Finally, on August 26, 2010, DePuy recalled the ASR, citing failure rates of around 12-13%--as opposed to their initial reports of 4-5% failure rates. What this means is that among the 26 states which operate under the two year statute of limitations, there is less than a month left to join in the multi-district lawsuits against DePuy. Of the more than 40,000 recipients of the ASR in the U.S. alone, only about 6,000 of those have joined in as plaintiffs in the DePuy suit. This means there are over 35,000 ASR recipients out there who have yet to come forward.

There may be several reasons for this including the fact that many of these people may be unaware of the recall. Others may be elderly recipients of the metal ASR and are simply chalking their negative health symptoms up to the aging process. It is believed, however that a large number of those who have not joined in the lawsuit have not done so because they are not yet experiencing problems, therefore believe they have no rights under the current lawsuit. It’s important that this group of people be aware that the actual failure rate of the ASR has been estimated at 50% at six years and 80% at eight years. Considering the ASR metal-on-metal implant has only been on the market since 2005 you can see that the likelihood of thousands more recipients having serious problems from the device is huge.

Metal-on-Metal Hip Implants Tied to Metallosis?

Corrosion, serious tissue reactions and metallosis are all possible side effects for recipients of the metal-on-metal hip implant. The safety of these devices has come under serious question with many recipients requiring revision surgery to remove the harmful devices. The DePuy ASR was recalled in 2010 due to studies showing it corroded much more quickly than other types of implants, most notably those made of ceramic and plastic. Once corrosion occurs in the metal hip implant the tissues surrounding the implant can become inflamed or soft tissue masses, lesions and necrosis can occur. The femoral heads as well as the acetabular cup of the DePuy hip implants are constructed of cobalt and chromium. The past few years have seen serious concerns regarding the metal chromium and cobalt particles which shave off when the femoral head and acetabular cup rub against one another during any activity. Once the levels of corrosion reach the unsafe stage the implant will likely have to be removed during a revision surgery.

Journal of Anthroplasty Study

A recent study in the Anthroplasty Journal compared the levels of corrosion on the femoral heads of the metal hip implants with those constructed of metal-on-polyethylene which implements a synthetic liner between the metal cup and femoral head. This liner acts as a buffer between the two metal pieces meaning there is less chance of the small metal ions slivering off and causing metallosis or metal toxicity in the bloodstream. The metal ions in the bloodstream can lead to kidney and liver disease or certain types of cancer, while the metal shards which lodge in surrounding tissues can lead to serious inflammation, tumors and even bone loss.

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.

U.S. District Judge Expects DePuy MDL to Move Forward

A recent meeting between the Judge chosen to oversee the multi-district litigation in the DePuy Pinnacle hip implant case included attorneys from both sides. The goal of the meeting was to determine the most practical manner of handling the more than 1,000 current DePuy lawsuits. U.S. District Judge Ed Kinkeade—judge for the northern district of Texas—will use the MDL in the interest of expediting and coordinating these consolidated pre-trial proceedings. Unlike many MDL cases, the DePuy case appears to be moving forward with case management procedures expected in the next six weeks to two months.

The initial MDL trials in the DePuy Pinnacle cases are bellwether trials with a purpose of choosing representative cases from those filed to determine how juries will likely react to evidence which is common to all the cases. During a bellwether trial the judge and attorneys are able to gain knowledge which will be helpful in negotiating future DePuy lawsuits. The process dictates that representative attorneys will be chosen to try the DePuy bellwether trials; the knowledge gained from these trials will be extremely helpful in planning strategies and setting precedence for future Pinnacle cases. All attorneys involved in litigating the DePuy Pinnacle metal-on-metal hip implants will be watching the bellwether cases closely as well as the entire MDL.

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.

Patients With Defective DePuy ASR Hip Implants

By Andrew Sullo SULLO & SULLO, LLP 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.

DePuy offers to remove ASR XL Acetabular System - in exchange for waiving your right to compensation.

By Independent Staff Writer

If you received an ASR XL Acetabular System, your doctor has probably already informed you that DePuy is offering to pay for hip revision surgery.

What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.

They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing. 

Hip Revision Dependent on Loss of Patient Rights

DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."

Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.

Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requested medical information after the revision surgery."

In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.

What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System." 

If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.

The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.

They're lawyers.

What's Wrong With DePuy Having Access to Your Hip Implant Records

To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.

It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.

If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, clinically tested by the FDA, and serious design problems.

In the knee replacement case, DePuy's defense avoided talking about any of these issues.

Instead, they pointed the blame at the patients.

The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.

But mostly, they blamed the patient. 

What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.

They're going to claim that you did. 

Where Is This Form Going to Come From?

DePuy sent copies of their Medical Release Form, also called the Authorization to Use or Disclose Information, to each medical professional who implanted an ASR XL Acetabular System.

The form signs over all medical records, explants and x-rays from the original surgery that implanted the ASR XL Acetabular System, the hip revision surgery, and "all follow up visits and records." Records include "telephone message slips," "copies of lab work," "physical therapy reports," "progress records," and other private medical information. 

This means your surgeon is likely going to be the one who asks you to sign the form, which in turn means you must stay alert. There is a lot of paperwork surrounding any surgery, and it is important that you make sure you don't accidentally sign a form that loses you legal rights.

There are accusations that DePuy has offered the surgeons money for every Medical Release Form they can get signed. They have good reason to offer incentives: all of this information can be used to build a case against you. More importantly, giving DePuy the explant means that your lawyer no longer has access to it and cannot use that evidence to build a solid case against DePuy. 

The surgeon who placed the implant may not be aware that these are DePuy's intentions. In fact, all the communications we have seen between DePuy and the medical professionals who implanted the ASR XL Acetabular System claim that the only reason they want this information is to improve their medical devices. This means your surgeon may have no idea that by encouraging you to sign the form, he or she is also encouraging you to sign away your chance for legal compensation.

Please don't blame your doctor. We certainly don't. They're doing their best to make sure you get the hip revision surgery you need right now. 

We're doing our best to make sure you get everything else you need - including just compensation. 

Have You Already Signed a Medical Release Form for Your DePuy Hip Implant?

You may have already signed one of these forms. If you have, please don't panic. There are measures we can take to help you get your medical and legal rights back. For example, we can put out a revocation of authorization to use or disclose your medical information, which compels DePuy to stop asking for new information and to return the information they've already received.

If they don't comply, we can use that refusal to respect your rights in the case against them.

If you have questions about the ASR XL Acetabular System hip recall or you're concerned that you may have already signed a form giving DePuy access to your medical records, give us a call at 1-800-730-7607 or contact us online. We're here to help.

As recall after recall appears in the news, it becomes clear Johnson & Johnson cares more about sales than safety.

By Independent Staff Writer

"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.

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

By Independent Staff Writer


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. 

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. 

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.

Soon enough to save thousands of people from revision surgery and severe medical consequences.

By Independent Staff Writer


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.

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.

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.

 

According to DePuy's website, "the patients who reported problems in the first five years and had revision surgery reported a variety of symptoms." So far, DePuy hasn't listed those symptoms on their website, but the current evidence reveals metal poisoning, bone deterioration, and tissue necrosis, as well as metallosis.

Before any surgery, the surgeon is required to meet with the patient and go over the potential risks. Most people are familiar with the idea of informed consent, which essentially states that patients should understand the facts, implications, and future consequences of any medical decision they're being asked to make.

With hip implant surgery, the potential problems include malignant hyperthermia, infections, respiratory issues, and blood clots that can cause strokes. These are the basic risks for any major surgery; a hip implant patient would've been informed of that fact. The recovery process also has risks, as does refusing to have the surgery. Risks are part of the decision to receive or not receive a hip implant.

However, DePuy never informed the patients who were receiving the ASR XL Acetabular System that their hip implant might have a number of risks above and beyond those of major surgery. DePuy never informed the surgeon performing the procedure that the hip implant's engineering hadn't been tested by the FDA-or that many patients, especially women, had already reported problems only a few years into the life of their hip implant. 

DePuy certainly failed to inform both the surgeons and the patients that their product could mean a revision surgery in less than three years-a fraction of the 15- to 20-year time frame their advertising campaign promised. 

The DePuy ASR XL Acetabular hip replacement system was FDA approved - which might be more cause for worry than relief.

By Lacy Boggs

Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.

It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA. 

The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.

Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health. 

Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.

A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.

The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million. 

The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same?

What, indeed 

The ASR XL Acetabular hip replacement system got its seal of approval from the FDA using the 510(k) process, claiming that its product was substantially equivalent to other hip replacement devices already on the market. The FDA official in charge of approving the device would have gone through a checklist that included the following questions (simplified; the actual document is fairly dense):

• Does the new product treat or solve the same problems as previously approved products?
• Does the new product have the same design, materials, and energy sources as previously approved products?
• Could any new characteristics or combinations of characteristics affect safety or effectiveness?

The first question is easy: there are dozens of hip replacement devices on the market, all designed to help people walk even after their bum hip throws them out of commission. The second question gives us a bit of a hiccup: the ASR XL Acetabular hip replacement system had two parts, a ball and socket

The ball was equivalent to an approved product; the socket was equivalent to an entirely different approved product; and the materials were equivalent to still a third approved product.

Thankfully for DePuy, the FDA had thoughtfully included a caveat that allowed for such an eventuality. Which brings us to question three: could any new characteristics affect safety?

In DePuy's 501(k) application, it declared that the "subject device does not raise any new issues of safety or effectiveness." A brave statement, though one wonders how the company confirmed such a diagnosis without going through any clinical trials. Perhaps if it had, the problem of metallosis would have become evident before the hips were implanted into approximately 93,000 people.   

With such prerequisites for FDA approval, it is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing. 

Which is to say that 90% of claims require no clinical testing whatsoever before being sold to patients.

That's not to say that there is no testing at all. If a mechanical test is available, 510(k) approval process requires that the new product show that it yields similar results to a previously approved product. The DuPuy ASR hip replacement system took a few spins on a robot that went through simulated movements. In a legal suit brought against DePuy for a different hip implant last year, the mechanical test did not include the full range of motion of which a human being is capable.            Read more ....