Johnson & Johnson Hip Implant Settlement: Filing Deadlines are Approaching Fast

Many recipients of the ASR metal-on-metal hip implant are unaware of a crucial date which is fast approaching. The ASR was approved by the FDA in 2005 then labored under a flurry of adverse reports regarding early failure rates. Finally, on August 26, 2010, DePuy recalled the ASR, citing failure rates of around 12-13%--as opposed to their initial reports of 4-5% failure rates. What this means is that among the 26 states which operate under the two year statute of limitations, there is less than a month left to join in the multi-district lawsuits against DePuy. Of the more than 40,000 recipients of the ASR in the U.S. alone, only about 6,000 of those have joined in as plaintiffs in the DePuy suit. This means there are over 35,000 ASR recipients out there who have yet to come forward.

There may be several reasons for this including the fact that many of these people may be unaware of the recall. Others may be elderly recipients of the metal ASR and are simply chalking their negative health symptoms up to the aging process. It is believed, however that a large number of those who have not joined in the lawsuit have not done so because they are not yet experiencing problems, therefore believe they have no rights under the current lawsuit. It’s important that this group of people be aware that the actual failure rate of the ASR has been estimated at 50% at six years and 80% at eight years. Considering the ASR metal-on-metal implant has only been on the market since 2005 you can see that the likelihood of thousands more recipients having serious problems from the device is huge.

Transvaginal Mesh: Is an FDA Recall on the Horizon?

By Independent Staff Writer

Even though some consumer advocate groups—such as Public Citizen—have called for the FDA to ban the marketing of transvaginal mesh for use in surgeries such as the repair of pelvic organ prolapse and stress urinary incontinence as yet there has been no definitive conclusions reached as to whether the use of mesh should be permanently discontinued. The FDA has made physicians and the public aware of the potential risks involved in using transvaginal mesh including erosion, contraction or shrinkage of the mesh once it has been implanted, however now must decide whether further action is called for in light of the flurry of lawsuits regarding mesh complications.

It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials.  A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.

FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:

• Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.

• Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.

• Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.

• Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.

• Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.

• When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.

• When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.

• As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.

The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.

New Data From Britain About DePuy ASR Acetabular Hip Replacement Devices

By Independent Staff Writer 


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

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

Becoming part of a mass action lawsuit over the DePuy hip implant gives you an edge that going solo can't afford.

By Independent Staff Writer

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.

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

By Independent Staff Writer

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

A good lawyer is ethical.

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

What types of cases does he take?
Lawyers have a choice about which cases they take. Look at her winning cases as well as the losing ones. No lawyer wants to lose a case, but an ethical lawyer will often be willing to take a case because it is the right thing to do and fight to the very end.
Look at whether the lawyer actually tries the cases he takes in court or whether he just gathers cases for others. Ask the attorney when he last went to trial. Ask him how often his cases settle and how often his cases make it to a jury.

Be sure that the lawyer specializes in your type of case. You really don't want a tax attorney to represent you in your personal injury case. An ethical attorney will only take cases in her area of expertise.

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

Is he honest?
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. 

How the ASR XL Acetabular System Causes Bone Deterioration

By Taylor Lindstrom

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When DePuy issued their hip recall, they offered to pay for the revision surgery needed to replace the faulty hip with a new implant. They appear to believe this is the full extent of their responsibility in repairing the damage they've done to thousands of people who had a hip replacement implanted in their bodies.

It's not enough. Because the damage the ASR XL Acetabular system caused doesn't end when the hip is removed. It's only just beginning.

How Your Hips Work

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

A hip is a little bit like oxygen. You don't notice how essential it is until it's gone.

There's a reason you barely notice your hip's contribution to your everyday movements: your body has constructed it more or less perfectly. The hip bone is a portion of your pelvis, and it has a rounded cup-shape in its center into which the top of your femur bone fits, called the acetabulum.

The top of your femur fits smoothly into the acetabulum and rotates when you move, cushioned by synovial fluid that naturally lubricates the hip joint. When you get a hip implant, the idea is to mimic this natural construction of your hip joint as closely as possible, including the range of rotation, the lubrication, and the way the ball (the head) and socket (the acetabulum) fit together.

How a Hip Implant Works

There are two basic ways of affixing the hip implant to the rest of your skeleton. In both, the top of your femur is sawn off and replaced with an artificial new head; while the hip bone itself is shaved down to accommodate a man-made socket. Essentially, the acetabulum is carved out to the shape of the new socket.

The difference lies in how the new femur head and socket are attached to the surrounding bone. In older patients, the most common tactic is to use a bone cement to attach them. In younger patients, however, the surrounding bone is still versatile and capable of regrowth. Since cement has some serious drawbacks, including the risk that it will shrink or crack over time and the fact that it is not especially secure when it comes to withstanding forceful movements like jumping, another procedure has been developed for younger patients.

The cement-free procedure involves creating an environment that encourages the hip bone to grow onto the implant and hold it into place. To do this, the ASR XL Acetabular system included a cup with a pitted exterior, giving the bone lots of small holes to grow into and secure the implant further.

The small craters and pits give the surrounding bone places to hold onto as it grows around and into the surface of the implant. When this procedure works well, patients can often look forward to extended use of the hip implant for as much as 20 years.

This is more or less what DePuy promised the surgeons who recommended the ASR XL Acetabular System to their patients. 20 years turned out to be a gross overestimate.

How the ASR XL Acetabular System Failed

The ASR XL Acetabular System was a cement-free hip implant. Its design inserted a long stem into the femur bone for increased stability, and featured a socket that had that moon-crated surface which would encourage the hip bone to grow onto it and secure the implant in place.

Unfortunately, the design was deeply flawed. The head and socket did not fit together properly, causing too much friction. There was no room for lubrication to seep into the space between the head and the socket, which meant the patients were in constant pain as the two parts of the hip implant ground together. Even worse, the friction was causing pieces of the implant - tiny metal ions - to rub off and seep into the bloodstream, poisoning the surrounding tissue and bone.

Under circumstances like that, it's no wonder the surrounding bone couldn't grow onto the implant to secure it in place. The bone was under an onslaught of abuse from increased friction and pressure as well as metallosis. Since there wasn't sufficient lubrication around the hip implant, the metal couldn't circulate freely throughout the body - not that this would have been much of an improvement, since the materials the ASR XL Acetabular System are made of include cobalt and chromium.

Since the metal ions couldn't circulate, they stayed put in the hip joint, causing massive bone deterioration, metallosis, metal poisoning, tissue damage and necrosis.

Why You Can't Just Take the Hip Implant Out

The obvious solution to a hip implant that is slowly poisoning you from the inside is to remove it. However, DePuy seems to think the problem ends there - which it doesn't.

As we've explained, you need healthy, living bone to make a hip implant succeed. Once the surgeon removes the ASR XL Acetabular System, there isn't much in the way of healthy bone left.

There are two reasons for this: one is that the hip implant has been slowly poisoning the surrounding bone and discouraging growth. The second reason is much more simple: the hip bone simply hasn't had time to recover from the abuse of the initial surgery. The surgeon shaved away part of the acetabulum to make room for the implant, which is traumatic for the bone. It takes time to recover.

Normally, the hip bone would have 15 or 20 years to recover

With the DePuy hip recall, many patients' hip bones have had as few as two or three years, which simply isn't enough time. When a new device is put in, odds are very good that their bodies will reject the hip implant. That area has suffered a great deal of trauma and the body hasn't had time to forget it - so it will attack, and reject, any new foreign material.

Even a new hip implant - one that works the way it should.

Every hip implant causes more bone trauma and increases the chances that the next 510 will be rejected. Patients with working implants can expect to get a good 15 to 20 years out of their hips before they confront the fact that a new implant may only last half as long.

Those who received the ASR XL Acetabular System? They have to confront it now - along with the myriad side effects of the implant's poor engineering.

Replacing the hip implant isn't enough. We believe DePuy should pay full compensation for problems they've caused. If you received a DePuy hip implant, we'd like to help you. Give us a call at 713-839-9026 or use our contact form to tell us a little about your surgery and any pain you might be in. We'll call you back promptly and help you understand your legal rights in this case.