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.

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.

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.

New Data From Britain About DePuy ASR Acetabular Hip Replacement Devices

By Independent Staff Writer 

Is Johnson & Johnson Telling the Truth About the Failure Rate?
Johnson & Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson & Johnson started using the device in the United States in 2005 and based its failure rate on five years of research.  However, England has a hip registry dating back well before 2005.
This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson & Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.
Here are the real facts:

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.

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. 

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. 

Choosing a good lawyer isn't as difficult as you might imagine; it's just a matter of asking the right questions.

By Independent Staff Writer

With so many lawyers out there, how should you go about finding a good one? How can you tell a strong lawyer from a weak one? You need solid legal advice, and you want the right attorney. Do not, we repeat, DO NOT just open the phone book, close your eyes, and point to a name. Here are some guideposts to help you. 

A good lawyer is ethical.

You're probably laughing right now. Can the words "ethics" and "lawyer" exist in the same sentence? Actually, it is possible, and you should absolutely insist on it. But how can you tell if a lawyer is ethical? There are some pretty good indicators.

What types of cases does he take?
Lawyers have a choice about which cases they take. Look at her winning cases as well as the losing ones. No lawyer wants to lose a case, but an ethical lawyer will often be willing to take a case because it is the right thing to do and fight to the very end.
Look at whether the lawyer actually tries the cases he takes in court or whether he just gathers cases for others. Ask the attorney when he last went to trial. Ask him how often his cases settle and how often his cases make it to a jury.
Be sure that the lawyer specializes in your type of case. You really don't want a tax attorney to represent you in your personal injury case. An ethical attorney will only take cases in her area of expertise.

What types of clients does he represent?
Does he represent big corporations or everyday people? Does he fight for the underdog? Does he hold wrongdoers accountable for their behavior?

Is he honest?

DePuy Orthopedics, Inc_ ASR Hip Implants Linked to MetallosisHow

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP

HOUSTON—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, which is used for total hip replacements, and the DePuy ASR™ Hip Resurfacing system, which is used in a newer kind of bone-conserving procedure. To date, more than 93,000 of the devices have been implanted worldwide.

DePuy said that it was issuing the recall after new data from a British joint replacement registry showed about 1 in 8, or around 12 percent, of those who received the implants needed corrective procedures, called revision surgeries, within five years. Typically, the devices are supposed to last 15 years before requiring any corrective revision. 

DePuy’s hip replacement system—a metal-on-metal implant—has been linked to metal poisoning or 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 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. 

Metal-on-metal devices gained popularity in recent years among orthopedic surgeons and patients who believed they would be more durable than those made of other materials, such as ceramics. But it soon became apparent that many of the devices were deteriorating quickly, shedding metallic debris that was readily absorbed into the bloodstream. 

The New York Times reported in March that it was "not clear whether some makers’ devices are more prone to the debris problem than others. But some experts argue that some manufacturers, in a rush to meet the demand for metal-on-metal devices, marketed some poorly designed implants and that some doctors fail to properly implant even well-designed ones."

But it appears that DePuy’s ASR devices are more prone to debris problems than other brands. The first lawsuit filed in the United States against DePuy over the defective ASR hip implants was in March 2009—almost 18 months before the device was recalled. In fact, the Food & Drug Administration (FDA) had received over 500 complaints about the devices through the years leading up to the recall, but no action was taken as a result. 

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. 

The surgeon recommended a DePuy hip implant to his patient thinking the device was fully tested by the FDA for safety. He was wrong.

By Taylor Lindstrom

A 30-year-old man needs a hip replacement. His surgeon recommends a DePuy ASR XL Acetabular system because its metal-on-metal design is more durable and allows for a more active life. Following the doctor's recommendations, the young man gets the DePuy hip implant.

Then the hip implant fails. The young man is in extraordinary pain. His revision surgery reveals dead tissue and deteriorated bone, making it extremely difficult for his new implant to take hold. He takes a blood test that reveals extremely elevated levels of cobalt and chromium. He is now hypersensitive to metal and the surgeon warns him he may contract early-onset osteolysis.

The young man blames the surgeon for recommending the ASR XL Acetabular system in the first place? But the surgeon isn't the culprit in this scenario; he made the best recommendation he could for his patient. The surgeon is simply another victim of the real culprit: an FDA approval loophole called "substantial equivalence." 

A surgeon has countless medical devices to choose from. In the world of hip implants, he's looking at numerous options. The surgeon naturally wants to give his patients the best implant possible for their situation, so he chooses only FDA-approved devices that have been rigorously tested for safety.

Or so he thinks. 

Does an FDA Endorsement Guarantee Hip Implants' Safety?

The FDA has two processes for approving a new medical device: the premarket approval process,, and the premarket notification approval process. Similar as their names are, there is a world of difference between those two processes.

In the case of the patients who received an ASR XL Acetabular system, it may have been the difference between an improved quality of life with a working hip implant - or a drastically reduced quality of life with a faulty one. 

The premarket notification process is also known as the 510(k) process, and it includes the loophole of "substantial equivalence." The 510(k) process allows a product to go directly to market without full clinical testing if the manufacturer claims the medical device is "substantially equivalent" to another device already on the market.

According to FDA documents, a substantially equivalent product is one that is created for the same intended use as the previously approved products; has the same design, materials and technology; and raises no new concerns about safety or effectiveness.

Substantial equivalence was designed to prevent the 2-3 year waiting period for testing. If one hip implant is so similar to another device that it could be expected to get the same test results, what was the point of testing it?

One might argue "safety," but one would be naive to do so. Medical device companies pushed for the substantial equivalence loophole for an entirely different and far less altrustic reason: profits. Every year spent in testing is a year that hip implant isn't on the market earning money for the company.

A Pyramid Built on Sand

For Johnson & Johnson and its subsidiary DePuy, the priority was on products, not patients. They claimed the ASR XL Acetabular System was "substantially equivalent" to no less than three other devices already on the market that had been tested for safety.

Every part of that statement would prove to be inaccurate.

Companies are allowed to claim that their new product is substantially equivalent to more than one other product. For example, since they have to show that they have the same materials and technology as a previously approved product, a company might show that they used the same materials as one product and the same technology as another.

For the ASR XL Acetabular system's 510(k) application, DePuy cited three different previously approved products saying that the ASR system was "substantially equivalent"-at least in part-to all three.

By this argument, you could get a safety approval from the FDA for a flying car with submarine without ever testing it - after all, it is "substantially equivalent" - at least in part - to an airplane, a car, and a submarine. What on earth would be the point in testing it again when the basic principles have already been proven safe? 

The loophole gets even more absurd: companies are allowed to base their claims of "substantial equivalence" on products that were approved under the same 510(k) process.

One of the devices DuPuy used was approved with one device-that had been approved through another device-that had been approved through a third device-that was approved because it was substantially equivalent to a product grandfathered into the system prior to 1976. 

Essentially, DePuy was claiming that their product was substantially equivalent to hip replacements manufactured before the FDA was ever in place

 

Not a single hip implant in this chain of FDA was ever subjected to clinical trials before it was allowed to go to market. Even if it had been, it seems laughable that a hip implant "substantially equivalent" to a series of pre-1976 implant could ever make it through the FDA. Has technology developed so slowly that the best implants on the market are based on designs from 40 years ago?

Put it into perspective: the ASR XL Acetabular system was marketed to younger people who needed a longer-lasting, more durable hip replacement. That means many of the recipients got a hip implant based on a design older than they were.

Only 10% of applications submitted under the 510(k) process are ever returned with a request for clinical trials. That means that 90% of the Class III hip implants available today were never tested in a clinical setting before being marketed to the public. 

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? 

Depuy Hip Recall Systems Glossary

 

Glossary of Medical Terms Related to the DePuy ASR Acetabular System

 Home | Personal Injury | DePuy Hip Recall | Traffic Tickets | Family Law | Criminal Defense |Get Informed

When you receive a hip implant, your doctor does his or her best to give you all the information you need to make an informed decision. However, it's unlikely that you will ever be as informed as your doctor is on any medical issue, no matter how relevant to your health. All those years of medical school amount to a wealth of knowledge that simply can't be communicated in a few hours.

That said, there are a number of medical terms to which we frequently refer in these articles, and we'd like to make sure you have them available in an easy-to-access location if you need to describe your concerns to your doctor or your legal counsel.

Acetabulum

The acetabulum is more commonly called the hip socket, and it is simply the cup-shaped impression in your pelvis where the top of your femur bone fits. The acetabulum and the head of the femur connect to form the hip joint.  

Acetabular cup

When inserting a hip implant, the acetabulum is kept intact, but is hollowed out to make room for a cup that is inserted into the hip socket to make the other half of the hip joint fit smoothly. This cup is called the acetabular cup.

Articular Surface Replacement (ASR) Hip Resurfacing System

The ASR Hip Resurfacing System is a hip resurfacing system that uses the trademarked ASR 1-piece metal bearing acetabular cup. Unlike the ASR Acetabular System, the ASR Hip Resurfacing System does not replace the head of the patient's femur. Instead, the femoral head is merely "resurfaced" with metal prosthesis that fits into the acetabular cup. It is secured to the patient's femur with a short stem inserted into the top of the femur bone.

This hip resurfacing system was recalled in August of 2010 along with the ASR XL Acetabular System, but it is a separate and unique medical device. The ASR Hip Resurfacing System was never approved for use in the United States, though it was released worldwide. The National Joint Registry of England and Waves reported a 5-year revision rate of approximately 12% for the ASR Hip Resurfacing System.

For more information on the difference between a total hip replacement and hip resurfacing, please scroll down to Total hip replacement and Hip resurfacing.

Articular Surface Replacement (ASR) XL Acetabular System

The ASR XL Acetabular System is a total hip replacement system that uses the trademarked ASR 1-piece metal bearing acetabular cup, which is placed in the hip socket. This hip implant uses a traditional femoral ball and stem (see conventional hip replacement). The "XL" in the device's name refers to the fact that the sockets are available in larger sizes.

This total hip replacement system was recalled in August of 2010 along with the ASR Hip Resurfacing System, but it is a separate and unique medical device. The ASR XL Acetabular System was sent to market in 2004 and made available worldwide. Currently, it is believed that approximately 93,000 have an ASR XL Acetabular System. The National Joint Registry of England and Wales reported a 5-year revision rate of an estimated 13% of recipients.

Criticisms of the ASR XL Acetabular System include insufficient testing, a lack of clinical testing, a high rate of failure, a delayed recall after problems were reported, poor design and engineering, and medical complications including metallosis, heavy metal poisoning, metal sensitivity, bone deterioration, tissue damage, and hip implant failure. Currently, DePuy has only recommended that recipients of the ASR XL Acetabular System who are experiencing pain or system failure have hip revision surgery.

Femoral component

In a hip implant, there are two parts to the hip joint that need replacing: the acetabular cup and the femoral component. The femoral component is the part of the implant that connects to the patient's femur bone, which runs the length of the thigh.

There are several different types of femoral components: it may be attached with cement or without, and the femoral component may replace part of the patient's femur or simply cap the top of the femur bone with a prosthetic surface and a stem inserted into the bone. 

Femoral head

The top of your femur bone forms a smooth, rounded ball that fits into your acetabulum (also called your hip socket). The part of your femur that fits into the acetabulum is called the femoral head.

In a hip implant, the term for the corresponding replacement is the same. The rounded top of the femoral component which connects to the acetabulum is also called a femoral head.

Hip implant failure

Hip implant failure occurs when a hip implant no longer performs its function properly. Often, hip implant failure requires hip revision surgery (see hip revision, below). The most common causes of hip implant failure are loosening of the hip replacement device, infection, breakage or wear, and damage to the surrounding bone. Hip implant failure may also occur due to poor design and engineering.

Heavy metal poisoning (see metal poisoning, below)

Hip replacement (total and partial)

A hip replacement is any surgical procedure in which the hip joint is replaced by a prosthetic hip implant. There are two parts to the hip joint and therefore two parts to a hip replacement: the acetabular cup and the femoral component. 

Hip replacement (total)

A total hip replacement, also called a total hip arthroplasty, replaces both the acetabulum and the femoral head with prosthetics.

Hip replacement (partial)

A partial hip replacement, commonly referred to as a hemiarthroplasty, generally only replaces the femoral head, though it may in some cases only replace the acetabular cup.

Hip resurfacing

A hip resurfacing system is a total hip replacement system that does not remove a part of the patient's femur to accommodate the femoral component. Instead, the top of the femur is simply capped with a prosthetic replacement and a stem is inserted into the bone.

Hip revision

A hip revision surgery is any surgery after the original hip replacement surgery.

Metallosis

Metallosis is a reaction to the immune system attacking metal objects within the body. In the case of a metal hip implant, the immune system reacts to the amount of metal being released into the bloodstream and concludes that the implant is a foreign body that needs to be attacked and destroyed.

As the immune system attempts to attack the foreign substance, it can over-compensate and kill healthy bone and soft tissue around the area. The surrounding area may also become infected, cutting off blood flow and leading to necrosis.

Metallosis has been linked directly to devices that release metal into the bloodstream via friction. Women, people of small stature, and the obese are more susceptible to metallosis.

Metal poisoning

Also referred to as heavy metal poisoning, metal poisoning is the build-up of metals in the soft tissues of the body. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the heavy metals associated with the ASR XL Acetabular System are chromium and cobalt.

Metal poisoning causes nausea, vomiting, diarrhea, stomach pain, headaches, metallic taste in the mouth, and in extreme cases the loss of cognitive, motor, or language function. Chromium and cobalt have also been linked to increased cancer risk.

Metal sensitivity

Metal sensitivity can be viewed as an allergic reaction to metals. Metal sensitivity affects approximately 10-15% of the population, and as with other allergies, it can develop over time if the patient is over-exposed to certain metals. The most common reactions include hives, eczema, redness and itching; however, in patients who have received metal implants, the metal sensitivity may also cause pseudotumors (see pseudotumors).

Necrosis

Necrosis is the premature death of living cells and tissue. Usually, necrosis occurs as a result of infection, toxins, or trauma to the area. 

Pseudotumors

A pseudotumor is essentially an enlargement that resembles a mass of abnormal cells, but is in fact an inflammation. In the case of the DePuy ASR Acetabular System, doctors who have found pseudotumors in their patients have found that they are filled with fluid. 

If you have any questions about the ASR XL Acetabular System or the impending lawsuit against DePuy, please do give us a call at 800-730-7607 or contact us via our online form. We're here to help.