Sullo & Sullo LLP

How Soon Did DePuy Know About the High Failure Rates for the ASR Acetabular System?

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

When DePuy issued its recall of the ASR XL Acetabular System and the ASR Hip Resurfacing System, it claimed to be doing so because the revision rates were higher than normal. Surgeons, the company said, needed to be fully informed before making the decision to implant the devices.

Up until this point, the company had consistently blamed the surgeons for implanting the device improperly. The high revision rates were due, DePuy claimed, to surgeons placing the device at the wrong angle.

So it was somewhat surprising that DePuy should suddenly decide to recall a hip implant that it had been planning to "phase out" by the end of 2010 anyway. If the high revision rates were no fault of the company's, surely a recall was unnecessary.

And if a recall was so necessary that the device could not justifiably stay on the market for another nine months, it seems peculiar that DePuy should have waited three years before issuing the recall - considering they had data showing failure rates that were many times the usual for their ASR systems. The ASR hip resurfacing system failed at a 12% rate, over twice the accepted norm of 5%. The ASR XL Acetabular System failed at a 13% rate, topping the average of .5-3% by a hefty margin.

DePuy had the information on those failure rates in 2007. The recall wasn't issued until 2010, and until a month before the recall, the company insisted that its revision rates were equivalent to any other products' on the market.

We believe this timeline proves the company knew otherwise, and allowed the ASR device to stay on the market anyway. We believe they did so for profits: the ASR was an expensive device in both incarnations, and if DePuy had issued a recall in 2007, it would have lost out on several years' worth of device sales.

That said, these are the facts: You can deduce for yourself what DePuy knew, and when, and how despicable it was that they did nothing at all to stop their device from being implanted in thousands upon thousands of people who never suspected what a risk they were really taking.

In 2005, the FDA clears the ASR cup for use in traditional hip replacement through the 510(k) approval process. It claims the product is "substantially equivalent" to several other devices already on the market. None of the products to which the ASR product was claimed to be "substantially equivalent" had ever been clinically tested by the FDA.

Beginning in 2007, the Australian National Joint Replacement Registry issued seven separate reports to DePuy identifying the problems being reported by surgeons throughout the country with the ASR Hip Resurfacing System, and warning the company of unusually high failure rates.

By the beginning of 2008, the U.S. Food and Drug Administration has received approximately 400 complaints about the failure of the ASR XL Acetabular total hip replacement system.

In early 2009, DePuy sends a brochure to doctors describing the importance of proper acetabular cup positioning for all hip implants. The brochure did not specifically mention the ASR as a point of concern.

In December of 2009, DePuy withdraws the ASR from the Australian market for "commercial reasons" - but does not recall the device.

In February of 2010, DePuy officials grant an interview to the New York Times in which they state that the ASR's performance is equal to that of competing devices.

In a letter dated March 6, 2010, DePuy issues a formal recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System.

In April of 2010, DePuy maintains in the New York Times that the ASR XL Acetabular System is safe, despite the recent recall.

On August 26, 2010, Johnson & Johnson announces that DePuy is issuing a worldwide recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System.

DePuy clearly attempted to get the device off of the market without having to go through the loss of reputation that accompanies a formal recall. It claimed it was taking the ASR system off the Australian market because of declining sales, rather than declining success rates. It claimed to the New York Times that the device performed at equal levels to other competing hip implants, even when it could not possibly have believed that statement to be true.

And most damning at all, even after issuing a recall in the United States in March of 2010, DePuy kept selling the faulty hip implants worldwide for the next five months before extending the recall overseas.

To keep selling a device even when the company was fully aware it was risking one in every eight patients' future health is unconscionable. For the sake of every patient who received a hip implant from DePuy, and every surgeon who placed one in good faith that the product would perform well, we would like to see justice done.

If you have a DePuy hip implant and would like to join the mass action case against the company, we're here to answer your questions. Give our offices a call at 1-800-730-7607 and we'll have you talking directly to one of our lawyers in short order. It's important to us that you get the personal attention you deserve.

How do I find a good lawyer?

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? Is she candid about the strengths and weaknesses of your case? A good lawyer will almost never tell her clients that the case is a "slam dunk." Those types of cases are extremely rare. Moreover, is he honest about his own strengths and weaknesses as an attorney? A good lawyer will tell you if he's particularly good in one area, but that he may ask his partner to help out in another area. He knows that two heads are better than one, and he can be honest about it. Is the lawyer truthful about his fees and costs? He should tell you what his services will cost, and there should not be any hidden fees.

What is the lawyer's reputation in the community? Is he known for his honesty, his pro bono work, his strong relationships in the legal and general community? Google the lawyer's name. See what comes up. Look for newspaper articles, websites and blogs. Make sure the attorney is in good standing with the state. Any sort of disciplinary action is a red flag. Ask around the community. Does the lawyer have a good name around town? Have any of your friends or acquaintances had experiences with him? Check his references.

A good lawyer values you as a person.

Does he look you in the eye when he's talking with you? Are you treated as a person or as just some client? Does the lawyer remember personal information about you, including your spouse's or children's names? Do you actually get to meet with him personally, or are you always sent to talk with a secretary? A good lawyer will make time for you and will return your phone calls quickly. Does he show that he understands that you have a unique situation that is quite unlike anyone else's? Has he shown that he respects your time and obligations, or does he talk on and on? Remember, a good lawyer will listen at least as much as he speaks.

Trust your gut.

It all really comes down to trusting yourself. Ask yourself: Do I like the guy? How does he treat his office staff? Do I trust this guy? Does it feel like he's trying to sell me the Brooklyn Bridge? If you don't like how you feel at that first meeting, chances are that it's not going to get any better. Listen to that little voice inside - odds are, you're exactly right.

How do I know if Sullo & Sullo is right for me?

Please browse our site and give us a call. We'd like to answer any questions you may have. Give your gut a chance to test our ethics and people skills.

Hip Implant Risks May Include Premature Failure.

In 2003, DePuy released the ASRTM XL Acetabular System, a hip implant that was touted to last up to 20 years with a stronger, more durable metal-on-metal design. Approximately 93,000 people around the world weighed the risks of surgery against their current level of pain and discomfort and chose to receive a hip implant that they believed would give them 15 to 20 years of pain-free movement.

DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule.

With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.

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

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

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

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

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

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

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

The hip implants recall issued by DePuy was voluntary-but it was too little too late. According to their website, "DePuy intends to cover reasonable and customary costs of testing and treatment associated with the ASR recall, including revision surgery if it is necessary... This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis."

"Out-of-pocket costs" means everything that's not covered by the insurance company-and insurance companies haven't exactly developed a reputation for being forthcoming with treatments that keep the patient's health at the forefront of considering factors. They're more likely to choose the least costly option, which means that many of these patients will find themselves in a lawsuit over what is and is not a necessary medical procedure.

This is the last thing any of these patients with failing hip implants needs. They needed a hip implant-not costly procedures and legal battles to make sure they get the care they need to replace the damage that was done. They also need full compensation for all their losses and damages, not just out-of-pocket costs.

Every patient who undergoes major surgery takes a risk. Those who received a DePuy ASR XL Acetabular System weren't merely asked to take a risk, however-they're being asked to take the fall.

If you received an ASR XL Acetabular System, we're here to answer your questions and let you know how we can help. Give us a call at 1-800-730-7607.

FDA Approval Process Changes: Too Little, Too Late.

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 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.

Critics have long argued that companies use the 510(k) process is a loophole that allows companies to get around the more arduous premarket approval process otherwise required by the FDA. While it's true that the 510(k) process saves companies a lot of time and money, the cost is merely passed on to the patients, who pay with their money, pain, and quality of life.

We can only hope that the proposed reforms to the current process take effect soon and prevent more tragedy from prematurely approved devices like the DePuy ASRTM XL Acetabular System.

If you think you have a DePuy hip implant and would like to know more about this case, give our offices a call at 1-800-730-7607. We have people standing by to answer your questions and explain how we can help.

DePuy Asks Hip Implant Patients to Sign Away Their Legal Rights

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 requiested medical information after the revision surgery."

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

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

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

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

They're lawyers.

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

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

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

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

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

Instead, they pointed the blame at the patients.

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

But mostly, they blamed the patient.

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

They're going to claim that you did.

Where Is This Form Going to Come From?

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

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

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

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

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

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

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

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

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

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

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

What is Heavy Metal Poisoning?

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.

Chromium and cobalt have also both been linked to cancer. One study recommended that human beings should not have more than 1 part per million of cobalt or chromium in the bloodstream many patients with the ASR XL Acetabular System have exceeded 7 parts per million.

The standard treatment for metal poisoning is chelation therapy; however, this process does not reverse any neurological damage done.

It is essential, if you have a DePuy ASR XL Acetabular System, to get tested for heavy metal poisoning, particularly your cobalt and chromium levels. If you have any questions or would like some help understanding your legal rights, please do give our offices a call at 1-800-677-7095 or simply fill out our online contact form.

Why Women Are Affected More Than Men by the DePuy Hip Recall

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.

Problem: Bone Deterioration Exacerbated in Women's Hip Implants

Because women are more prone to bone deterioration in general and have less bone density than men, the problems caused by the ASR XL Acetabular System are multiplied. We've explained the problem of bone deterioration at length, but here's the issue in a nutshell:

For a non-cemented hip implant like the ASR XL Acetabular System to work properly, the surrounding hip bone needs to be healthy and growing. DePuy's hip implant design caused an inordinate number of metal ions to be released into the bloodstream, causing problems with metallosis, heavy metal poisoning, and metal sensitivity - all of which adversely affect the bone.

One reason why women may be reporting problems with their hip implants sooner than men is because they have less bone to sacrifice to the effects of the metal ions floating in their bloodstream. The symptoms become painful more quickly, and more women are going to their doctor with concerns about the hip implant.

Handicapped with less dense, weaker bones, women now face the additional problem of attempting a hip revision with severely damaged hip bones from the previous DePuy hip implant.

It is already more difficult for a woman to have a successful hip replacement surgery than a man. DePuy's ASR XL Acetabular System made it even more difficult - not to say dangerous.

If you have any questions about your hip replacement surgery or your options moving forward, we'd like to help. Give us a call at 800-730-7607 or fill out our online form and we'll explain your legal options and try to answer any of your questions about the DePuy hip implant and how it's affecting your health.