Many different law firms are suing DePuy Orthopaedics over the faulty ASR XL Acetabular System. In a personal, vulnerable situation like this hip implant case, it can be difficult to assess the situation and make the right legal decision for you. In this article, we'd like to break down the difference between mass action, class action, and solo cases so you can make a well-informed choice for yourself.
"One Riot, One Ranger"
When a single person with a single lawyer brings a case against one organization, our firm's Andrew Sullo likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.
Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.
Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.
"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.
So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?
If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.
And in that situation, the math starts to work against the plaintiffs.
Bluffing Without a Hand
Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.
Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.
Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.
Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.
One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.
In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.
Enter the mass action lawsuit.
The Pocket Ace: Mass Action Lawsuit
Every individual client needs personal attention in a case like this. Everyone has different injuries, different changes to their lifestyle that need to be recompensed, and different problems that need to be addressed.
However, there is a great deal of overlap when it comes to researching the case. All of the plaintiffs in the Company X case were struck by the same vehicle, for example. If 200 different lawyers are working each of the plaintiff's individual cases, each of those lawyers has to do their own research on the driver, the vehicle, and the circumstances that led to the accident.
If one lawyer brings a lawsuit on behalf of all of those 200 plaintiffs, he only has to do that research once. That lowers his costs, which means he can start to compete with Company X in the game of who has the most money to bring to the case.
With a single case, it might cost $200,000 to bring the lawsuit even though the client only recovered $200,000.
With ten cases, it might cost $400,000 to bring the lawsuit, but it's now possible to recover $2 million.
With 100 cases, it might cost $1 million to bring the lawsuit, and the recovery might be $20 million.
The more clients a law firm or a collaborative group of law firms has, the better their position when it comes to bargaining with DePuy about how much money his clients should ultimately get. When the potential recovery is quite high, it's still possible for lawyers to stay in the game even though the company is willing to put in a large amount of money defending the case.
These aren't necessarily the numbers for the DePuy hip recall case. The damages we've seen have been widely varied, but they share a single common denominator: it will be easier to get everyone recompensed properly if everyone bands together in a single mass action suit. The more clients a legal partnership has, the better its position when it comes to bargaining with DePuy about how much money their clients should receive.
New Game: DePuy ASR XL Acetabular System
There are a great many lawyers out there billing themselves as a "hip recall lawyer" or a "faulty hip lawyer." We aren't those things. At Sullo & Sullo, we have a history of bringing mass action lawsuits against major corporations and winning. Usually, when a normal, everyday citizen brings a case against a huge corporation with a lot of money to spend on a lawsuit, he's going to lose.
We tip the scales. We gather together the people who have been harmed and we draw power from those numbers. Our firm's history, bringing and winning lawsuits against Shell Chemical, Prudential Bache, Tenet Healthcare, and National Medical Enterprises, shows that this is the most effective way to win cases when thousands were injured.
No company should get away with causing you serious harm simply because they have deeper pockets. If you have questions about your legal rights in the case against DePuy Orthopaedics, we're here to answer them. More than anything, we want to be sure the thousands of people who were harmed by the ASR XL Acetabular System have the legal and medical information they need to move forward.
Product Defects, Accident and Injury law, Criminal Defense, Traffic Tickets, Family Law at Sullo & Sullo, LLP!
Women have a disproportionally larger number of problems with hip implant surgery than men do. Especially with the ASR XL Acetabular System.
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.
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.
Could the DePuy ASR™ XL Acetabular System recall have been avoided? Looks like it.
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.
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.
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.
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.
Too many ASR XL Acetabular Systems causing problems in first three years.
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.
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.
Choosing a good lawyer isn't as difficult as you might imagine; it's just a matter of asking the right questions.
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.
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.
Much of the pain and problems behind the DePuy ASR total hip implant were caused by metallosis. But what does that really mean?
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.
What's more, even with proper placement, the DePuy ASR hip replacement was made with a poorly designed cup and socket that did not fit together properly. If they had, friction would have been minimal and the metallosis risk would have been akin to other metal-on-metal hip implants. That said, a study by The Journal of Bone and Joint Surgery on metal-on-metal hip implants (not specifically DePuy implants) showed that patients had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times normal. Read more ....
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.
What's more, even with proper placement, the DePuy ASR hip replacement was made with a poorly designed cup and socket that did not fit together properly. If they had, friction would have been minimal and the metallosis risk would have been akin to other metal-on-metal hip implants. That said, a study by The Journal of Bone and Joint Surgery on metal-on-metal hip implants (not specifically DePuy implants) showed that patients had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times normal. Read more ....
The surgeon recommended a DePuy hip implant to his patient thinking the device was fully tested by the FDA for safety. He was wrong.
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.
It's a wonder there haven't been more problems with these hip implants. How many of us would willingly submit to the medical procedures of 40 years ago?
Testing the DePuy Hip Implant Takes a Backdoor to Profits Had thorough clinical testing been done, it would have become clear long before the product went to market that the ASR XL Acetabular system had a revision rate of at least 15% and possibly more, not to mention a much higher rate of metallosis, metal poisoning, bone deterioration, and tissue damage.
Had DuPuy gone through the more rigorous PMA process with the FDA, it's likely the ASR system would never have been sold to the public. But then again, that was probably why DePuy didn't go through the more rigorous process. The 510(k) process and substantial equivalence meant that DePuy could start making profits off their hip implants much more quickly. Why risk losing the profits just because the device can't be proven safe?
While we acknowledge that companies need to make profits, companies who make medical devices such hip implants must be driven by consumer safety above all else. Willingly causing pain and suffering to thousands of people in exchange for a payoff makes DePuy "substantially equivalent" to a hired thug.
It's a harsh comparison - but one that holds up much better under scrutiny than the ASR XL Acetabular System.
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.
It's a wonder there haven't been more problems with these hip implants. How many of us would willingly submit to the medical procedures of 40 years ago?
Testing the DePuy Hip Implant Takes a Backdoor to Profits Had thorough clinical testing been done, it would have become clear long before the product went to market that the ASR XL Acetabular system had a revision rate of at least 15% and possibly more, not to mention a much higher rate of metallosis, metal poisoning, bone deterioration, and tissue damage.
Had DuPuy gone through the more rigorous PMA process with the FDA, it's likely the ASR system would never have been sold to the public. But then again, that was probably why DePuy didn't go through the more rigorous process. The 510(k) process and substantial equivalence meant that DePuy could start making profits off their hip implants much more quickly. Why risk losing the profits just because the device can't be proven safe?
While we acknowledge that companies need to make profits, companies who make medical devices such hip implants must be driven by consumer safety above all else. Willingly causing pain and suffering to thousands of people in exchange for a payoff makes DePuy "substantially equivalent" to a hired thug.
It's a harsh comparison - but one that holds up much better under scrutiny than the ASR XL Acetabular System.
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