April 5, 2012

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. 

Why DePuy Hip Recall Wont Be a Class Action Lawsuit.

By Independent Staff Writer

In a recent article, we explained the difference between bringing an individual lawsuit against DePuy vs. becoming part of a mass action lawsuit. In this article, we're delving into the differences between mass action and class action.
Historically, class action lawsuits are the stuff that give lawyers a bad name. The senior partner at our firm, Andrew Sullo, likes to say that class action lawyers represent people who don't know they've been harmed and don't care.
He's not just speaking metaphorically. It's entirely possible in a class action lawsuit to represent people who have no idea a lawsuit is being conducted in their name. Statistically, it's likely that you yourself have been involved in a class action lawsuit without ever knowing it.
In the case of the DePuy hip recall, it's extremely unlikely that any judge would allow the case to be brought as a class action. Here's why:

Advantages of a Class Action Lawsuit
When a class action lawsuit is filing, it must name one or several plaintiffs on the behalf of a proposed "class" of people. The "class" of people are individuals or business entities who have suffered a common injury or injuries.

The rules vary by state (in Virginia, for example, there are no class action provisions) but in general the idea is that the group is so large that individual lawsuits are impractical, and the claims are so similar that they can be considered by the judge as a single problem that many people have in common.
Class actions have several advantages. As we noted in our article on the advantage of bringing a mass action lawsuit against DePuy, any lawsuit that involves many people working under a single lawyer or collaboration of law firms has distinct financial advantages, since it will cost far more to bring each case individually than it will to bring a group of cases with similar problems. Another oft-cited advantage of class actions is that there is no advantage to plaintiffs who file early as opposed to plaintiffs who file late, and a third advantage is that class action suits have often been used historically to purposely change the behavior of a group of individuals such as physicians or companies.

Of course, all of these advantages only apply to lawsuits that are brought with the plaintiffs' best interests in mind. Unfortunately for our legal system, class action lawsuits have been used repeatedly to benefit unethical lawyers rather than plaintiffs.

The Missing Money
The biggest problem in class action lawsuits is that the plaintiffs often do not receive a share of the money recouped - or the share they receive is so small as to be negligible. Lawyers often take a large share of the awarded compensation while leaving plaintiffs with coupons of little or no value.
Lawyers are required to inform members of the "class" for whom they are filing suit that those individuals are now a part of a class action lawsuit. In theory, this means the people whose names are being used in the class action lawsuit have an opportunity to opt out of being a part of the lawsuit. In practice, most people either do not read such notices, viewing them as junk mail, or do not understand them.
Even if the notices are read and understood, it is extremely unlikely that the individual can do very much to forestall the class action lawsuit unless that person has significant personal funds. It is possible to sue a lawyer who uses your name without your consent in a class action lawsuit, but it would require significant funds and the lawyer often wins such cases, claiming that he brought a suit in the plaintiffs' best interest and had nothing but good intentions.
Meanwhile, the lawyer pockets much of the settlement. For those willing to spend their careers in such shills, it's a process with great rewards and little risks.

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

By Independent Staff Writer
Two weeks ago, the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today, the Panel announced that the litigation will take place in the Northern District of Ohio.

Complaints about the DePuy ASR hip implants have been reported throughout the United States, which prompted a hearing to consolidate the cases into multidistrict litigation. Counsel for DePuy Orthopaedics, Inc. did not object to doing so. The Multidistrict Litigation (MDL) Panel determined that the DePuy cases qualified for consolidation and created DePuy Mulitdistrict Litigation.

There were many different courts in the running for the federal district in which the pretrial proceedings would take place, including Kentucky, Indiana, New Jersey, Ohio, and Florida. Counsel for DePuy and several Plaintiffs' lawyers who represent people harmed by the DePuy devices submitted arguments to the Panel as to which court they felt was most appropriate for these cases.

As we've explained in previous articles, consolidating a case conserves resources for the attorneys as well as the judiciary, and bringing individual lawsuits for each case can make the costs so prohibitive as to present an obstacle to getting a fair settlement for the plaintiffs. The fact that DePuy Multidistrict Litigation has been formed creates a more efficient way for our legal team to pursue claims for our clients and ensures we are better able to give them the individual attention they need.

We've got several good reasons why you shouldn't do anything of the kind.

By Independent Staff Writer

After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery.
In exchange, the company wanted just one minor thing: the hip implant.
On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.
Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you.
The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.

Why Your Hip Implant is Valuable to Your Case
When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.
Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.
If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.

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).
hip1
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. 

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.

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

By Independent Staff Writer


As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.
Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.

One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.
For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.

Could the DePuy ASR™ XL Acetabular System recall have been avoided? Looks like it.

By Independent Staff Writer

In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.
But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.
How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States? 

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.
The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market. 

Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word.
Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.
The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.
Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.
Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market. 

The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.
Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product's safety and effectiveness without strong clinical data?
If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might've been avoided. Tens of thousands of patients might've been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first. 

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

By Independent Staff Writer


In 2003, DePuy released the ASRTM XL Acetabular System, a hip implant that was touted to last up to 20 years with a stronger, more durable metal-on-metal design. Approximately 93,000 people around the world weighed the risks of surgery against their current level of pain and discomfort and chose to receive a hip implant that they believed would give them 15 to 20 years of pain-free movement.
DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule. 

With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%
The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view. 

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

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

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?

How the ASR XL Acetabular System Causes Bone Deterioration...And what it means for your future hip revision surgeries.

By Taylor Lindstrom

When DePuy issued their hip recall, they offered to pay for the revision surgery needed to replace the faulty hip with a new implant. They appear to believe this is the full extent of their responsibility in repairing the damage they've done to thousands of people who had a hip replacement implanted in their bodies.
It's not enough. Because the damage the ASR XL Acetabular system caused doesn't end when the hip is removed. It's only just beginning. 

How Your Hips Work
If this were an after-school special, we'd show you a few clips at this point: Elvis shaking his hips on stage back in the day, or a ballet dancer extending her leg over her head. The after-school special would be missing the point, however - your hips are essential to nearly every movement you make. You use them every time you stand, sit, crouch, or lean over. You use them getting into and out of cars, climbing up the porch steps to your front door, even just standing there. 

A hip is a little bit like oxygen. You don't notice how essential it is until it's gone.
There's a reason you barely notice your hip's contribution to your everyday movements: your body has constructed it more or less perfectly. The hip bone is a portion of your pelvis, and it has a rounded cup-shape in its center into which the top of your femur bone fits, called the acetabulum.
The top of your femur fits smoothly into the acetabulum and rotates when you move, cushioned by synovial fluid that naturally lubricates the hip joint. When you get a hip implant, the idea is to mimic this natural construction of your hip joint as closely as possible, including the range of rotation, the lubrication, and the way the ball (the head) and socket (the acetabulum) fit together.
How a Hip Implant Works
There are two basic ways of affixing the hip implant to the rest of your skeleton. In both, the top of your femur is sawn off and replaced with an artificial new head, while the hip bone itself is shaved down to accommodate a man-made socket. Essentially, the acetabulum is carved out to the shape of the new socket.
The difference lies in how the new femur head and socket are attached to the surrounding bone. In older patients, the most common tactic is to use a bone cement to attach them. In younger patients, however, the surrounding bone is still versatile and capable of regrowth. Since cement has some serious drawbacks, including the risk that it will shrink or crack over time and the fact that it is not especially secure when it comes to withstanding forceful movements like jumping, another procedure has been developed for younger patients. 

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? 

April 4, 2012

DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer

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

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

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

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

April 3, 2012

Reviewing the Safety of Metal-on-Metal Hip Implants

By Independent Staff Writer

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

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

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

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

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