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.

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

The DePuy ASRmetal-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. 

Bone deterioration is associated with disease; soon, it may also be linked to the DePuy ASR XL Acetabular System. And for good reason.

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.
When undergoing hip surgery, there are generally two options for a hip implant: cemented and uncemented. Cemented implants, which involve attaching the implant directly to the surrounding bone by means of a specially constructed bone cement, have been used since the 1960s. Uncemented implants were introduced in the 1980s. The ASR XL Acetabular System is an uncemented implant.
The idea behind an uncemented implant is that healthy bone can grow into its surface, thus holding the implant in place by means of the body's own materials instead of a foreign cement. Medical professionals hoped that this design would mean the patient could have a more active life since the concern of gradually wearing away the cement would be eliminated. Cementless total hip replacements are recommended for younger, more active patients and have shown, so far, better results in long-term studies.
Obviously, healthy bone is essential for an uncemented hip implant. Without healthy bone growth, the hip implant will not be secured into the rest of the skeleton and will not function as a replacement for the removed hip.

Evidence is showing that the DePuy ASR XL Acetabular System may cause serious bone deterioration in a number of ways. One of the most significant is osteolysis, which occurs when the body reabsorbs bone as part of an autoimmune response. Osteolysis has been noted as a side effect of many total hip replacement systems; the more debris that is released into the body, the more common osteolysis becomes. Metal-on-metal hip implants were thought to have less likelihood of debris because they are made of harder materials, but the ASR XL Acetabular System's poor design caused significant friction and a great deal of metal debris, raising the risk of osteolysis.

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. 

Women have a disproportionally larger number of problems with hip implant surgery than men do. Especially with the ASR XL Acetabular System.

By Independent Staff Writer

Several news sources, among them the New York Times, have already commented on the mounting data that more women than men are reporting problems with the ASR XL Acetabular System. We'd like to explain exactly why that is.

Problem: Hip Implant Not Designed Ideally for Wider Hip Sockets

Women, as you may have heard, are structured differently anatomically than men. The differences aren't merely on the surface, however; they extend into the skeletal structure and particularly in the pelvis region. Women have wider hips with bigger hip sockets to accommodate the process of giving birth, which means they often have more problems in hip implant surgery because those large hip sockets allow the implant to dislocate more easily.

In the DePuy ASR XL Acetabular System, however, the problems go beyond the norm. One of the reasons is that the hip implant was designed to be extremely shallow, exacerbating the problems women already have with hip implants.

Problem: Women More Likely to Require Hip Implants

Women are more prone to osteopenia, osteoporosis, and often have weaker bones overall than men, particularly as they age. The onset of menopause, and the subsequent drop in estrogen, have been linked to rapid bone deterioration. Because of all of these factors, women are more likely than men overall to require a hip implant because of a hip fracture.

Problem: Small, Shallow Hip Implant

The DePuy ASR XL Acetabular System was designed to give patients a greater range of motion. If you'll recall, the design of the hip implant included two parts: an implant inserted into the femur bone with a rounded top that fit into a cup placed in the hip bone.

In the design of the ASR XL Acetabular System, the cup was made very shallow, which meant that the patient could move their leg in a wider arc before the other part of the implant might dislocate.

Good in theory. And if DePuy had tested their product properly, it might have worked quite well. In real life, it went a little differently.

The shallow hip implants meant that all of the friction caused by everyday movement was focused on a much smaller area. There was more force on a smaller amount of material. The hip implant was under more stress and was more prone to the friction that caused small metal ions to break off into the bloodstream. It was also more likely to break altogether.

Especially in women. Their smaller, shallower hip implants meant there was even more strain on the material. Women who have an ASR XL Acetabular System are reporting problems in greater numbers than men in part because their hip implants are simply breaking down faster. They have the same problems, forced upon a smaller area.

Our consulting doctor offered some sobering statistics for smaller hip implants in general: the risk of a hip revision surgery for a hip implant with a head size of 44 mm is five times that of a hip implant with a head size of 55 mm.

DePuy ASR hip replacement recall

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Cobalt and Chromium Blood Toxicity in Hip Replacement Patients Chromium Poisoning and Cobalt Poisoning in the DePuy ASR hip replacement recall 

By Attorney Andrew Sullo
SULLO & SULLO, LLP

 

DECEMBER 15, 2010 - HOUSTON — DePuy hip replacement recall by DePuy Orthopedics, Inc.’s metal-on-metal hip replacement system sent shockwaves through the international medical community. Given the fact that these devices have gained great popularity in recent years among orthopedic surgeons and patients alike, reports that the ASR XL Acetabular System and ASR Hip Resurfacing System were prone to early failure were met with great fear and unease. 

Since the DePuy hip replacement recall, many of the 93,000 people worldwide who received an ASR hip implant have been scrambling to find answers to pressing health-related questions, especially as stories of blood toxicity, metallosis, chromium poisoning, cobalt poisoning, and other metal poisoning issues in patients have reached the public. And while countless studies have confirmed the consequences of metal wear debris from faulty orthopaedics, many people are still left with grave concerns regarding the the DePuy hip replacement recall. 

To date, the most widely researched side effect of DePuy’s defective hip replacement devices is the aforementioned metallosis, which the Journal of Bone & Joint Surgery describes as “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the recalled DePuy ASR hip replacement system cause the metal components such as chromium and cobalt to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions and bone loss. 

Of particular interest are the remarkably high concentrations of cobalt and chromium that have been found in patients with metal-on-metal hip resurfacings. In some cases, patients with recalled hip replacement implants have been found with 100 times the normal levels chromium and cobalt in their bodies. 

The potential adverse effects of systemic cobalt and chromium ion elevation are the subject of ongoing investigation. While their individual implications on the body are somewhat understood, their combined effects are not. Doctors are struggling with patients’ questions because they simply do not have the answers. But based on existing research we do have some insight into the long-term ramifications of blood toxicity, chromium poisoning, cobalt poisoning and metallosis and sadly, it is not promising for DePuy patients.

Research relating to the hip replacement recall – Metallosis, Chromium Poisoning & Cobalt Poisoning

As early as 2003, researchers at the Municipality of Vienna Gersthof Orthopaedic Hospital in Austria found that patients with metal-on-metal total hip replacements had higher cobalt and chromium levels than those in a control group. Their findings, published in the Journal of Orthopaedic Research, showed cobalt concentrations up to 50 times higher and chromium concentrations up to 100 times higher, and called for the careful monitoring of patients to ensure that any local or systemic complications are detected early on.

In 2006, a study published in the British Volume of the Journal of Bone and Joint Surgery found a correlation between metal ions from hip resurfacing and reduced T-cell counts. Researchers discovered that elevated cobalt and chromium levels in patients with metal-on-metal hip resurfacings were associated with statistically significant decreases in the level of CD8+ cells (T-cytotoxic/suppressor cells).

In the same publication in 2007, a review by researchers from University of Bristol in Bristol, UK, demonstrated the long-term effects of metal-on-metal arthroplasty. The team compiled data describing the release, dissemination, uptake, biological activity and potential toxicity of chromium and cobalt debrispotential harmful effects on immunity, reproduction, kidney function, development, the nervous system and carcinogenisis. released from alloys currently used in modern orhopaedics, which included a list of

 

Doctors from ANCA Medical Center in Ghent, Belgium, released a study in 2008 showing a direct correlation between inclination of the acetabular component and metal ion levels in hip implant patients. Their research found that there were significantly higher levels of metal ions in patients with steeply-inclined components, and that high concentrations of chromium and cobalt are toxic; are known to interfere with a number of biological functions; can result in fluid or mass formation with subsequent destruction of soft tissues; and can result in bone resorption leading to loosening of he implant or fracture of the femoral neck.

Finally, hip replacement patients with metal-on-metal implants have been shown to pass chromium and cobalt ions to their infants during pregnancy, according to research presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Data showed that there is a correlation between whole blood metal ion levels in the mother and her infant at the time of delivery, which proves that the placenta is not a complete barrier to the transport of these harmful substances. 

The known risks of failure of DePuy ASR hip implants are clear, and evidence of their dangerous, long-term health consequences is substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before it is too late. 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 DePuy hip is part of one of the biggest hip replacement recalls in history. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 for a free legal consultation today.

DePuy ASR Hip Implants Risk

Cobalt Poisoning: DePuy ASR Hip Implants Are a Serious Risk 

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A person with 1 microgram of cobalt in their bloodstream has nothing to worry about.  Someone whose blood contains more than 25 micrograms has cobalt poisoning. And a patient whose blood contains more than 100 micrograms? Probably has a DePuy ASR hip implant. As more and more patients who received DePuy ASR Acetabular hip replacement systems ask their doctors for blood tests, the numbers of people who have extraordinarily high levels of cobalt in their bloodstreams become staggering. Several of our own clients have received the worrying news that their cobalt levels are far above normal, and at least one doctor has published a case study of two DePuy hip implant recipients who have cobalt levels that are 100 to 500 times normal. How Much Cobalt Is Normal?  If you go to a doctor and get a blood test, the amount of metal (including cobalt) in your bloodstream will be calculated in micrograms per deciliter. A healthy person has approximately 0.019 micrograms per deciliter - about one microgram for their entire body. The metal in your bloodstream only presents in very, very small amounts; someone with normal cobalt levels could gather all the cobalt in their system together and come up with an amount smaller than a grain of sand. Even at highly toxic levels, the actual amount of cobalt looks very, very tiny. 0.5 micrograms per deciliter of cobalt is considered toxic. That's about five grains of sand in a giant bucket of water. Seems small - but those tiny grains of metal can throw the entire chemistry of your body wildly out of order. In Britain, there are regulations for keeping close observations on patients who have metal-on-metal bearings in any hip implants, including the ASR hip implants. At cobalt levels of 0.7 micrograms per deciliter, patients must be kept under observations. Symptoms at those levels include hip pain, dying tissue, and pseudotumors - masses under the skin. Generally doctors recommend revision if a patient with a hip implant has a cobalt concentration of 1.9 micrograms/deciliter or above. Revision isn't suggested until cobalt concentrations are one hundred times the mean average - even though levels are considered toxic at twenty-five times the average. One patient with severe cobalt poisoning had levels of 6.6 micrograms/deciliter. That's nearly three hundred and fifty times the mean average. The dangers of cobalt levels so high were quite apparent: in addition to hip pain, the patient showed declining cognitive function, was losing control of his senses like hearing and sight, suffered from seizures, heart failure, and multiple other problems. The amount of cobalt that patient had in his blood was still small enough that it wouldn't have filled a teaspoon. But the damage was great enough to threaten his life. What is Cobalt Poisoning? Cobalt is one of the many metals that is found naturally in the body, but as with all other metals, in excess amounts it becomes toxic and leads to many harmful and potentially permanent side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the senses. It can cause neuropathy, seizures, blindness, headaches, and liver damage. Cobalt has also been linked to cancer. For DePuy hip implant recipients, it can also mean that future hip revisions have a lower chance of success. Excess amounts of cobalt in the bloodstream lead to metal sensitivity and metallosis, which can seriously damage surrounding tissue and make a second implant less likely to succeed. Doctors Unaware of Risk  For many patients with DePuy ASR hip implants, the symptoms of cobalt poisoning either go unnoticed initially or are chalked up to other pain and problems related to the hip implant failure. For example, a patient might have deteriorating mental function, mood disorders, or vertigo -  but if the patient is also in a great deal of pain because the hip implant is failing, it is very possible that he might assume the other symptoms are related to his pain and will go away if he has a revision surgery. Meanwhile, doctors who are fully aware that DePuy ASR XL Acetabular System is failing at inordinate rates may recommend a revision surgery to solve problems of pain and inflammation. Those doctors may not know that the friction of the hip implant is releasing excess amounts of metal ions into the bloodstream and causing potential problems with far more long-reaching effects. A patient could walk out of surgery with heavy metal poisoning - and not be aware until the symptoms become extreme enough to return to the hospital. What Should You Do?  If you have a DePuy ASR Acetabular hip implant and are concerned about cobalt poisoning, see your doctor as soon as possible to discuss your options and express your concerns. Our medical crib sheet for DePuy ASR hip implant patients can give you some guidance on questions you may want to ask your doctor and tests you may wish to request. If you'd like some advice on any legal case you may have against DePuy because of the danger this implant may present to your current and future health, we're here to answer any questions you may have. Call our offices at 1-800-677-7095 or use our online contact form, and we'll do everything in our power to get you the answers you need.