Showing posts with label ASR Acetabular System. Show all posts
Showing posts with label ASR Acetabular System. Show all posts

July 29, 2012

Attorneys of Sullo & Sullo Seeing DePuy Hip Implant Lawsuits Increasing


While many other firms have seen a drop in the number of metal hip implant clients, Sullo and Sullo attorneys have actually seen those numbers climb. Andrew Sullo, Class Action Lead Counsel & Managing Partner notes that “Although many firms have noticed a slowdown in the number of clients hiring them for DePuy ASR and Pinnacle lawsuits, our firm has not. I believe that is because we are constantly offering our clients new and updated information. Our job is to inform all metal-on-metal hip recipients that even though their hip may not have failed yet, it could and after August 26th they may lose rights to recover compensation from Johnson and Johnson.”

With the statute of limitations coming up soon on the ASR metal-on-metal hip implant lawsuits, Sullo & Sullo is experiencing an increase in the ASR recipients who are coming forward and asking to be a part of the lawsuit. Many clients in the lawsuit have experienced adverse health effects as a direct result of having an ASR all metal hip implant put into their body.  On the other hand, many have experienced little or no pain with their ASR hip implant but have elected to join the lawsuit that they can be financial protected at a point in the future should their ASR device fail. Through no fault of their own, these people have become victims of a heavily flawed system which allows harmful medical devices to be sold to the public. The ASR was approved in 2005 by the FDA under the controversial 510(k) process which allows medical devices to essentially ride in on the coattails of other medical devices which have come before them. In some cases approval is granted based on a device which has actually been discontinued because of the number of problems associated with it.

June 22, 2012

U.S. District Judge Expects DePuy MDL to Move Forward


A recent meeting between the Judge chosen to oversee the multi-district litigation in the DePuy Pinnacle hip implant case included attorneys from both sides. The goal of the meeting was to determine the most practical manner of handling the more than 1,000 current DePuy lawsuits. U.S. District Judge Ed Kinkeade—judge for the northern district of Texas—will use the MDL in the interest of expediting and coordinating these consolidated pre-trial proceedings. Unlike many MDL cases, the DePuy case appears to be moving forward with case management procedures expected in the next six weeks to two months.

The initial MDL trials in the DePuy Pinnacle cases are bellwether trials with a purpose of choosing representative cases from those filed to determine how juries will likely react to evidence which is common to all the cases. During a bellwether trial the judge and attorneys are able to gain knowledge which will be helpful in negotiating future DePuy lawsuits. The process dictates that representative attorneys will be chosen to try the DePuy bellwether trials; the knowledge gained from these trials will be extremely helpful in planning strategies and setting precedence for future Pinnacle cases. All attorneys involved in litigating the DePuy Pinnacle metal-on-metal hip implants will be watching the bellwether cases closely as well as the entire MDL.

January 10, 2011

Making of Depuy Hip Recall System

 
How the ASR XL Acetabular System is Constructed 

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In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life.
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against 
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).

As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System.
Conventional Hip Replacement (also called Conventional Hip Arthroplasty)
In a conventional hip replacement, the acetabulum is resurfaced with a new socket, replacing the ring of cartilage as pictured above with an artificial cup made of plastic, ceramic, or metal. The head of the femur is then removed and replaced with a long stem capped with a ball meant to mimic the femur head, as shown below:


In the conventional hip replacement, the plastic cup above is meant to act as the bearing surface, which means that it is the location where the ball and socket contact each other. The liner cushions the point of contact, but it also makes the socket more shallow, which can mean less range of movement and a higher likelihood of dislocation.
The creators of the total hip replacement system hoped to eliminate the problems associated with conventional hip replacement by boldly doing away with a piece of the original design.
Total Hip Replacement
The socket on a conventional hip replacement was technically composed of two pieces: the acetabular cup and the plastic liner, the latter fitting snugly into the former. In a total hip replacement, the design simply eliminated the plastic liner, fitting the femoral head directly into the acetabular cup.
You can see the difference in the image below. The top implant [Fig. 3] is a conventional hip replacement system, with an acetabular cup, a poly (plastic) liner, and a femoral head. The lower implant [Fig. 4] is a total hip replacement system, with only an acetabular cup and femoral head.


This design allowed the femoral head to be much larger, which made it more stable and less likely to dislocate. It also meant, however, that there was no cushion between the two hard surfaces of the acetabular cup and the femoral head.
Many total hip replacement systems are extremely successful, and many surgeons prefer them over the two-piece conventional hip replacement systems, particularly for younger patients who are more active and more likely to dislocate their hip implant by testing the limits of its range of movement.
However, the one-piece system made meticulous design engineering absolutely essential to avoid friction between the acetabular cup and the femoral head.
Which is where DePuy's ASR Acetabular System went wrong.

January 7, 2011

Was Depuy Hip Recall Was Timely

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 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.

http://www.sullolaw.com/ImagesNew/501K_chart.png
(Click above to download our 510K Hierarchy Cart...)
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.
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.
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.