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.