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        <title><![CDATA[Metallosis - Hodges Law, PLLC]]></title>
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                <title><![CDATA[Signs Your Artificial Hip May Be Failing (UPDATED 2024)]]></title>
                <link>https://www.clayhodgeslaw.com/blog/signs-your-artificial-hip-may-be-failing/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/signs-your-artificial-hip-may-be-failing/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Fri, 05 Jan 2024 20:01:38 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Health & Wellness]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                    <category><![CDATA[Stryker]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[artificial hip failure]]></category>
                
                    <category><![CDATA[artificial hip surgery]]></category>
                
                    <category><![CDATA[Birmingham]]></category>
                
                    <category><![CDATA[Exactech liners]]></category>
                
                    <category><![CDATA[hip pain]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                    <category><![CDATA[Stryker]]></category>
                
                
                
                <description><![CDATA[<p>Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, artificial hips, particularly “metal-on-metal” hips, have “failed” at a rate much higher than previous artificial hip systems, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2015/07/iStock_000057980522_XXXLarge1.jpg"><img decoding="async" alt="Signs Your Artificial Hip May Be Failing" src="/static/2015/07/iStock_000057980522_XXXLarge1-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, artificial hips, particularly “metal-on-metal” hips, have “failed” at a rate much higher than previous artificial hip systems, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body. As long as the metals held up, all would be well. But it turned out that this intense pressure and movement often caused the metals to grind and deteriorate, and too often releasing metal particles into the surrounding tissue and into the bloodstream. In other artificial hip failures, such as with the <a href="/the-taper-lock-failure-in-the-stryker-lfit-v40-artificial-hip/">Stryker LFIT v40</a>,  femoral heads can malfunction due to a <em><strong>failure in the taper lock</strong></em>. The taper lock is the part of the hip prosthesis that connects the femoral head to the stem. This can cause the neck on the femoral stem to grind down (sometimes referred to as “penciling”) and can even lead to a full disassociation (more on that below).</p>


<p>In still other artificial hip failures, <a href="https://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication" rel="noopener noreferrer" target="_blank">the plastic liner (between the cup and ball) deteriorates and causes the total artificial hip system to fail</a>. Polyethylene liners are very important in an artificial hip because over the years, it will serve as a buffer between the metal cup and also the metal femoral head or ball, so it can protect against excessive grinding of the hip components. But the studies have shown that <a href="/exactech-recall-of-plastic-hip-knee-ankle-joint-replacement-liners/">Exactech hip plastic liners</a> have been breaking down and showing signs of premature wear.</p>


<p>Please note that with any hip replacement surgery, there will be a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the hundreds of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.</p>


<p>For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has <em><strong>failed</strong></em>. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.</p>


<p>Let’s start with the basics:</p>


<p><em><strong>What Is an Artificial Hip Failure?</strong></em>
</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/01/iStock_000022783055_XXXLarge.jpg"><img decoding="async" alt="Watch for Signs of Artificial Hip Failure" src="/static/2016/01/iStock_000022783055_XXXLarge-200x300.jpg" style="width:200px;height:300px" /></a></figure>
</div>

<p>Artificial hips fail in several ways:
</p>


<ol class="wp-block-list">
<li>Pain. This would be pain that lingers after the period of rehabilitation, or which arises months or years after the implant surgery. There is no marker for the precise amount of pain necessary to define a failure. If you are in pain, you need to assume that something is wrong and you need to schedule an examination.</li>
<li>Swelling. The area around your hip replacement <em><strong>should not swell</strong></em> after the period of surgery and rehab is past. Swelling is a sign of a problem.</li>
<li>Metallosis. This is the build up of metal levels in the blood and/or in body tissue. When a metal-on-metal artificial hip cup and ball grind together, tiny shavings can be released into the body, elevating metal levels. A simple blood test can identify metallosis.</li>
<li>Loosening components. This is when a component like the acetabular cup has become loose and shifted or moved. It can hurt (see #1).</li>
<li>Disassociation. In some cases, the femoral head and stem actually separate or break apart. In these cases, the hip and the leg are no longer connected. This can be caused by (for example) <a href="/stryker-lfit-v40-artificial-hip-recall-need-know/">corrosion in the V40 femoral heads</a>.</li>
<li>Inflammation of tissue. This is where the hip area becomes swollen, warm, red, and often painful, as a reaction to the hip failure and/or as a result of infection.</li>
<li>Pseudotumor. This is abnormal tissue growth that occurs as a reaction to metal particles being released near the site of the hip replacement. A pseudotumor is noncancerous. Pseudotumor does not always cause pain or other noticeable symptoms.</li>
<li>Sounds. Other the years, several clients have reported that their hip has begun to make ominous sounds, such as grinding, whistling, popping, or thumping. Your artificial hip should not make noises.</li>
</ol>


<p>
Understand that with most hip failures, <em><strong>several </strong></em>of these conditions may be present, not just one. You may have pain, and swelling, and loosening components. Sometimes you may have all the symptoms.</p>


<p><em><strong>What Might Artificial Hip Failure Feel Like?</strong></em>
</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2017/02/iStock-157188725.jpg"><img decoding="async" alt="Man Suffering From Artificial Hip Failure" src="/static/2017/02/iStock-157188725-300x199.jpg" style="width:300px;height:199px" /></a></figure>
</div>

<ol class="wp-block-list">
<li>Pain. This is nearly always the first <em><strong>red flag</strong></em>. With artificial hip failure, there will likely be unusual pain and discomfort. As doctors like to say, “always listen to your body.” If something doesn’t feel quite right, it may not signal artificial hip failure. But it could.</li>
<li>Popping sounds. I’ve had people tell me that their failing artificial hip actually made noises. The popping sound typically comes from a component that is loose or becoming dislocated. It often occurs with pain.</li>
<li>Swelling or heat coming from the hip area. A sign of infection.</li>
<li>Uncertainty. The hip feels insecure, as if the person’s leg may “give out” while walking or standing. In other cases, the hip feels as if it is <em><strong>locking up</strong></em> on the person.</li>
<li>(Almost) nothing at all. Oddly, with some artificial hip component failures, you may not notice symptoms. This is when an artificial hip failure can be most frustrating; something is wrong, but you can’t detect anything serious. For years, one person I spoke with did not feel abnormal pain, but only some discomfort after walking for long periods on hard surfaces (like asphalt). The blood tests showed slightly elevated metal levels, but not outrageously high numbers. After several years, the pain grew incrementally, and the patient eventually chose revision surgery. The revision surgery revealed a very loose cup, dark metallic fluid, inflamed tissue around the hip, and other problems. Clearly the artificial hip components had failed, and revision surgery was necessary, even overdue. But the individual for years believed everything was “good enough.”</li>
<li>Other sensations. The human body can simply react in all kinds of ways. If the feeling is unpleasant, something may well be wrong.</li>
</ol>


<p>
Despite all this unpleasantness, there is no need to panic. Panic is not good for anyone. But I do believe you must take ownership of your medical care. If something “does not feel quite right,” schedule an appointment with your orthopedic surgeon. Ask questions. Ask for a blood test. Ask more questions. <a href="/blog/four-things-need-believe-artificial-hip-medical-device-failed/">Keep a symptoms journal, which I wrote about here</a>. Stay after it.</p>


<p>And <a href="/lawyers/clay-hodges/">call me if you have legal questions: (919) 830-5602</a>.</p>


<p>No specific client information was used in writing this article. And of course, I am no doctor, and this is not medical advice.</p>


]]></content:encoded>
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            <item>
                <title><![CDATA[Physical Therapist: Problems with Metal-on-Metal Hip Failures (Part 3)]]></title>
                <link>https://www.clayhodgeslaw.com/blog/physical-therapist-problems-with-metal-on-metal-hip-failures-part-3/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/physical-therapist-problems-with-metal-on-metal-hip-failures-part-3/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Thu, 05 Nov 2020 16:39:12 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                    <category><![CDATA[Stryker]]></category>
                
                    <category><![CDATA[Zimmer M/L Taper Hip]]></category>
                
                
                    <category><![CDATA[artificial hips]]></category>
                
                    <category><![CDATA[hip failure]]></category>
                
                    <category><![CDATA[Metal-on-metal]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[MoM]]></category>
                
                    <category><![CDATA[osteolysis]]></category>
                
                    <category><![CDATA[physical therapist]]></category>
                
                
                
                <description><![CDATA[<p>Today I finish my conversation with Physical Therapist Amy Dougherty on specific problems that may arise with metal-on-metal artificial hip failures: Clay: Over the past ten years you have seen a lot of metal-on-metal hip implants. Several years ago an attempt was made to put a metal-on-metal artificial hip together, and that was supposed to&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<p>Today I finish my conversation with Physical Therapist Amy Dougherty on specific problems that may arise with metal-on-metal artificial hip failures:</p>



<p><strong>Clay</strong>: Over the past ten years you have seen a lot of metal-on-metal hip implants. Several years ago an attempt was made to put a metal-on-metal artificial hip together, and that was supposed to last forever, or last a whole lot longer, and it turned out that it was problematic. And I know you have had many patients who have had that [implant]. What did you see out of the metal-on-metal hip implants when they were failing?</p>


<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2020/10/iStock-1194506913.jpg"><img decoding="async" src="/static/2020/10/iStock-1194506913-300x200.jpg" alt="Physical therapist assisting patient after hip replacement surgery." style="width:300px;height:200px"/></a></figure>
</div>


<p><strong>Amy:</strong> Again, the first cardinal sign that I saw was chronic pain, an inability to weight bear normally through that joint. So even after normal hip replacement, the patient should be able to weight bear through it. It should not feel like they collapse on that hip, and so a limp that never resolves or an inability to get away from an assistive device. So, I had a patient in her 50s that could not get off a walker. She was 50. She was playing tennis five days a week before she had her hip replaced. Yes, with the metal-on-metal <em><strong>she suffered metallosis</strong></em> and she had an overt failure of that joint replacement. She was a candidate for this new [metal-on-metal implant], now widely known to be a bad device, because she was so young, active, fit, and healthy. It was supposed to last for longer. It was supposed to allow her to have more function larger range of motion, less risk of dislocation and all of those things. So as we know, that did not really work out so well.</p>



<p><strong>Clay</strong>: Yes.</p>



<p><strong>Amy</strong>: So the folks that had the metal-on-metal problems, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750564/" rel="noopener noreferrer" target="_blank">metallosis was the biggest problem</a> that ended up causing really frankly catastrophic changes in these people’s lives because the metals in the two appliances, they ground on each other and it leaks metal, particularly cobalt. That was a big metal that became known to become systemic and to basically create toxicity in the tissue surrounding the joint.</p>



<p>The metal would basically eat or erode away musculature bone, osteolysis was one of the biggest problems where it caused bone to basically just break down and be eroded away. I was actually in the operating room and saw some revision of a hip that experienced metallosis. And in the revision the musculature that was away from the hip, so when you go in to do a hip replacement, obviously, it is an open field and so you can see all of the connective tissue all the layers of musculature of the capsule of the joint this particular patient.</p>



<p>The <em><strong>capsule of the joint was this</strong> <strong>dingy gray looking color</strong></em>. You knew inherently. You did not have to know anything about science or medicine to know that it is probably not supposed to look like that. And what is astounding was how far away that metal leached into the musculature and so because it is toxic, because it is corrosive, that tissue had to be ripped [out]. It had to be excised. So some people lost part of their musculature and some of it was very important musculature around the hip in regards to stability and mobility restoration in the hip.</p>



<p>So, because the metallosis affected the bone, revision surgeries then became a bit tricky because, so when these folks went in for their first hip replacement, they had this beautiful landscape. They had a bad hip. They had a bad articular surface, but the landscape around it, and by that I mean the bony components that are going to hold that new joint, they were healthy. Otherwise, they would not have been a candidate for a hip replacement. Okay, so they had a healthy landscape to put those two new pieces in the socket. The acetabulum and the femoral head. So, once the metal started breaking down some of the bone, now all of a sudden you have got a landscape. It is not all that great in regards to the how to receive this new joint. So these folks had significantly limited post-op. They had to protect those joints dramatically for long periods of time so that could allow this bone that had really taken a hit to grow into the new prosthesis, which is how you heal a hip replacement. So, it made the post-operative course significantly different than a primary hip replacement where you walk immediately after surgery. I mean, I have seen patients ten days post-op, that are already on a cane and have a pretty decent gait. So–</p>



<p><strong>Clay</strong>: Well, that is kind of horrifying, a revision is one thing but a revision when the whole landscape of the hip and the thigh and the leg and all that area is severely compromised. It makes the revision surgery less likely to be successful. So, that gets me to this question. I know you have seen it quite a bit. Tell me what the rehab might look like and I know it is different for all people. But what might the rehab look like for a person who has to get multiple surgeries on the same hip? I know it is compromising. How would it be compromised?</p>



<p><strong>Amy</strong>: So that same patient when they had the first hip put in, when as soon as they started physical therapy within 24 hours of their surgery. They would be putting weight if they are usually what is called “weight bear,” as tolerated. So basically, we want you putting weight through that new joint. So as much weight as you feel like you can safely place through that leg using a walker, because everybody starts out on a walker, their weight bear is tolerated.</p>


<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2017/02/iStock-157188725.jpg"><img decoding="async" src="/static/2017/02/iStock-157188725-300x199.jpg" alt="Non-weight bearing after artificial hip revision surgery" style="width:300px;height:199px"/></a></figure>
</div>


<p>So, that is in the primary hip replacement that is uncomplicated. In just a plain revision, they can be non-weight-bearing for four to six weeks. So just right out of the gait. They are not putting any weight at all through it for four to six weeks. In the cases where these folks had really substantial metallosis, sometimes that non-weight-bearing was extended 8 to 12 weeks. And now you are talking about being completely non-weight bearing which, by the way, is very difficult to do.</p>



<p><strong>Clay</strong>: Yes.</p>



<p><strong>Amy</strong>: It is really hard if you think about how difficult that is for your upper body and for your contralateral side, for that other leg to be completely off that leg for anywhere from six to twelve weeks. And the reasoning is because that landscape they wanted, the surgeons wanted, every opportunity for that bone to accept that new part for it to heal because bone is live. So it grows into the prosthesis, into the implanted part of the prosthesis.</p>



<p>So they want that bone grow in because over the course of time, <em><strong>that is where the fixation actually lives</strong></em>. That prosthesis becomes incorporated into the bone itself. It great becomes part of that bone. So that is one of the biggest things that occurs postoperatively in those revisions. And so, then you have to think about everything that happens with that revision. So let us say your non-weight-bearing for six weeks, well, if you took your very healthy hip and you got off of your leg for six weeks, <em><strong>you would be astounded at how much strength you lose</strong></em>.</p>



<p><strong>Clay</strong>: All right.</p>



<p><strong>Amy</strong>: It is astounding through the entire extremity. And so there is profound strength loss.</p>



<p><strong>Clay</strong>: So what is your medical opinion about the likelihood that a follow-up surgery or revision surgery will be successful? I mean does the chance for success just drop through the floor once there has been a failure of an artificial hip? Such that you say to yourself “My goodness. This person is going to really struggle,” or is it case by case? And in a lot of cases revision surgery can be fine for a patient.</p>



<p><strong>Amy</strong>: I think that any joint replacement hips included the first one that you get because of that pristine landscape is the best chance you have to have a great outcome. Every time that that surgeon has to go back in, the opportunity for a great success go down.</p>



<p><strong>Clay</strong>: Right.</p>



<p><strong>Amy</strong>: And that is just the way it is. But the problem is that, like for the folks that had these metal-on-metal joints, they did not have an option. I mean, they were in such profound pain. The debility they had to get that hip taken out. And they just basically had to deal with whatever that metal did to the surrounding tissue and they had to try to protect the healing tissue the best they could and understand that their outcomes were going to be less than perfect.</p>



<p><strong>Clay</strong>: Right.</p>



<p><strong>Amy</strong>: Not what they had planned. Not what my fifty year old patient who had every plan of going back to the tennis court because that is why she had a hip replacement, because we know that she can go back to doubles tennis.</p>



<p><strong>Clay</strong>: Right. Did not happen.</p>



<p><strong>Amy</strong>: No, matter of fact, she was just happy frankly at the end of the day after a exhausting very very physically and emotionally challenging rehab process. She is happy to be able to walk and to not feel like she has a nail being driven through her hip every time she way bears.</p>



<p><strong>Clay</strong>: I see.</p>



<p><strong>Amy</strong>: So her measure of success changed dramatically after her revision.</p>



<p><strong>Clay</strong>: I bet. Well, let me try to end on a slightly more upbeat note. Have you seen better outcomes in the last few years since we have learned what we have learned about metal-on-metal hips? And have there been fewer revision surgeries among your patient population?</p>



<p><strong>Amy</strong>: There absolutely have been. As matter of fact, it probably in the last four years, I have had quite a few patients that have not even needed to do anything with me postoperatively. They were strong enough, healthy enough, and had prepared themselves for their surgery enough that they did not even need to do PT. Basically, they just had to protect their hip for a little bit, gradually get their weight back on it. And so, there is no question that the hip surgery that is going on right now, the total hip replacement surgeries, and I am seeing are phenomenally successful. If we look at the whole spectrum of success, I think the last that American Academy of Orthopedic Surgeons was a 95% success rate. I mean that is pretty high success rate for a very dramatically large spectrum of people [aged] 11 to the 90s. So, you know, it inherently has great outcomes. It is just when the outcomes are not great, it is bad.</p>



<p><strong>Clay</strong>: Yes. I have seen it in my work as well. This is what I wanted to talk to you about today. This has been fantastic.</p>



<p><strong>Amy</strong>: Well, I hope I answered your questions adequately, and I am happy to talk with you.</p>



<p><strong>Clay</strong>: Well, thank you so much and who knows, if I have another subject to discuss, maybe we can do this again one day.</p>



<p><strong>Amy</strong>: I would love to do that, Clay.</p>



<p><strong>Clay</strong>: Well, thank you Amy. I really appreciate your time.</p>



<p><strong>Amy</strong>: My pleasure. Have a great night.</p>



<p><strong>Clay</strong>: You too.</p>



<p>Note: You can also listen to this conversation with Amy Dougherty in my <a href="/05-physical-therapist-discusses-hip-replacement-surgery-and-artificial-hip-failures/">podcast</a>. If you want to talk about a possible defective artificial hip case, call me: (919) 830-5602.</p>
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                <title><![CDATA[Zimmer M/L Taper Hip with Kinectiv Technology and VerSys Femoral Head Lawsuits]]></title>
                <link>https://www.clayhodgeslaw.com/blog/zimmer-m-l-taper-hip-with-kinectiv-technology-and-versys-femoral-head-lawsuits/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/zimmer-m-l-taper-hip-with-kinectiv-technology-and-versys-femoral-head-lawsuits/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Tue, 03 Mar 2020 17:05:35 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                    <category><![CDATA[Zimmer M/L Taper Hip]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[femoral head]]></category>
                
                    <category><![CDATA[femoral stem]]></category>
                
                    <category><![CDATA[Hip Litigation]]></category>
                
                    <category><![CDATA[Kinectiv Technology]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[Zimmer M/L Taper]]></category>
                
                    <category><![CDATA[Zimmer Versys]]></category>
                
                
                
                <description><![CDATA[<p>The human hip is a marvel of bioengineering. It allows for a 360-degree range of motion due to its “ball-in-socket” design. But as we age, this hip joint can sometimes fail. When it does, it may require a total hip replacement. Hip replacements often use a variety of exotic metal alloys or ceramics to recreate&hellip;</p>
]]></description>
                <content:encoded><![CDATA[

<p>The human hip is a marvel of bioengineering. It allows for a 360-degree range of motion due to its “ball-in-socket” design. But as we age, this hip joint can sometimes fail. When it does, it may require a total hip replacement.</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2017/09/iStock-670645196.jpg"><img decoding="async" alt="Artificial Hip" src="/static/2017/09/iStock-670645196-300x300.jpg" style="width:300px;height:300px" /></a></figure>
</div>

<p>Hip replacements often use a variety of exotic metal alloys or ceramics to recreate the ball-in-socket mechanism of the human hip. A total hip replacement will typically consist of four parts:
</p>


<ul class="wp-block-list">
<li>The socket (or acetabular component).</li>
<li>The ball (or femoral head) that goes into the socket.</li>
<li>A liner for the socket that is in direct contact with the ball.</li>
<li>A stem for the ball (also known as a femoral stem) that connects the ball to the thigh bone (femur).</li>
</ul>


<p>
The liner is placed into the socket and the socket is placed into the pelvis. The ball attaches to the stem and the stem attaches to the femur. The result is a total artificial ball-in-socket hip replacement.</p>


<p>Sometimes, these hip replacements don’t work as expected. One such example comes from Zimmer US, Inc. and related companies (which we’ll collectively refer to as “Zimmer”). Many patients have reported problems with a particular set of Zimmer femoral head and stems.</p>


<p><strong>What’s Wrong with Zimmer’s Artificial Hips?</strong></p>


<p>At issue are two femoral stems: the M/L Taper Hip Prosthesis and the M/L Taper Hip Prosthesis with Kinectiv Technology. When either of these components is paired with the Zimmer VerSys Hip System Femoral Head, many artificial hip recipients have reported a variety of problems, such as:
</p>


<ul class="wp-block-list">
<li>Metallosis (elevated metal levels in the body)</li>
<li>Osteolysis (destruction of bone tissue)</li>
<li>Pseudotumor formation</li>
</ul>


<p>
Often, any of these problems require revision surgery, which is surgery to replace the failed implant. It’s believed that many of these hips are failing due to corrosion, trunnionosis and the release of tiny bits of metal at the point where the femoral head connects with the femoral stem.</p>


<p><strong>Have Patients with Failed Zimmer M/L Hip Replacements Taken Legal Action?</strong></p>


<p>Yes. There have been hundreds of plaintiffs who have filed suit against Zimmer alleging defectively designed and manufactured hip components, Zimmer’s failure to warn patients and doctors about the risks of using the hip replacement and that Zimmer did not properly test the artificial hip components.</p>


<p>With so many lawsuits consisting of similar injuries and allegations, along with a single (or small number) of defendants, our court system has a special system in place to consolidate the cases for pre-trial matters. This consolidation is called multi-district litigation, or <a href="/blog/definitions/">MDL</a>.</p>


<p>The purpose of MDL is to handle much of the pre-trial matters, such as discovery, in a single court with a single judge. With a single judge handling these pre-trial matters, the cases can be processed more efficiently, as the judge’s decisions will apply to all cases at the same time.</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2015/08/iStock_000050413018_Double-e1448650656797.jpg"><img decoding="async" alt="Zimmer M/L Taper Hip MDL" src="/static/2015/08/iStock_000050413018_Double-e1448650656797.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>The ultimate goal is to reach a comprehensive settlement that resolves all of the cases fairly. One way to do with is by having several <a href="/blog/definitions/">bellwether trials</a>. These sample cases are supposed to be representative of most of the cases in the MDL. Therefore, how they turn out can serve as a signal of what the plaintiffs and defendants can expect if their respective cases go to trial.</p>


<p>How these bellwether cases turn out will shape how settlement negotiations will go. As you can imagine, the better they go for the plaintiffs, the more negotiating leverage plaintiffs will have during settlement talks.</p>


<p>Right now, the Zimmer lawsuits involving the M/L Taper Hip Prosthesis, the M/L Taper Hip Prosthesis with Kinectiv Technology and the VerSys Hip System Femoral Head are in MDL in the US District Court for the Southern District of New York before Judge Paul A. Crotty.</p>


<p><strong>Zimmer MDL’s Current Status</strong></p>


<p>The Zimmer MDL is in the discovery phase, with the first bellwether trial scheduled for January 25, 2021. But if this date is pushed back, don’t be surprised. It was originally scheduled for September 14, 2020, then pushed back to October 19, 2020 and now has this date in early 2021.</p>


<p>All of this to say, there’s a lot of discovery and pre-trial motions to complete before a single trial takes place. As new developments arise in this case, I’ll post an update in this blog. Until then, there’s a long grind of pre-trial matters to get through.</p>


<p>Call me to discuss further: (919) 830-5602.</p>


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                <title><![CDATA[Should I Automatically Get Revision Surgery If My Artificial Hip is Recalled?]]></title>
                <link>https://www.clayhodgeslaw.com/blog/should-i-automatically-get-revision-surgery-if-my-artificial-hip-is-recalled/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/should-i-automatically-get-revision-surgery-if-my-artificial-hip-is-recalled/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Wed, 04 Dec 2019 20:31:49 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Counseling]]></category>
                
                    <category><![CDATA[Health & Wellness]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[blood tests]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[Recalled artificial hip]]></category>
                
                    <category><![CDATA[revision surgery]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                
                
                <description><![CDATA[<p>I get this question fairly often, and it’s a good one. It usually goes something like this: a person had a total hip replacement several years ago. A few years pass. Then out of the blue the individual receives a letter from the artificial hip manufacturer or from the implanting surgeon explaining that a recall&hellip;</p>
]]></description>
                <content:encoded><![CDATA[<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2019/12/iStock-1130377664.jpg"><img decoding="async" src="/static/2019/12/iStock-1130377664-300x200.jpg" alt="Orthopedic surgeon discussing revision surgery for recalled artificial hip " style="width:300px;height:200px"/></a></figure>
</div>


<p>I get this question fairly often, and it’s a good one. It usually goes something like this: a person had a total hip replacement several years ago. A few years pass. Then out of the blue the individual receives a letter from the artificial hip manufacturer or from the implanting surgeon explaining that a <em><strong>recall</strong></em> has been issued for the artificial hip components implanted. (And these are the lucky patients; many people who receive an artificial hip that was later recalled <em>never </em>get notification from their doctor, the manufacturer, or anyone. They don’t discover they have a defective artificial hip until the pain, <a href="/metallosis-study-serious-health-problems-from-metal-on-metal-artificial-hips/">metallosis</a>, or other injury develops.) If I were in this position, and I received a recalled artificial hip, I would want to know: Should I have the recalled hip removed? And should I have the hip removed immediately?</p>



<p>As with most things in life, the answer is not simple.</p>



<p>I have been a product liability lawyer for many years now, and in that time I have spoken with hundreds of people suffering from defective products. I have heard dozens of variations on a similar narrative. While <em>this is neither medical nor legal advice</em>, here are my suggestions:</p>



<p><em><strong>Don’t panic</strong></em>. Panic never helps, whether you are confronting a decision on revision hip surgery or trying to escape from a bear. (I know, this is easy for me to say.) You do not need to rush out and schedule emergency surgery as soon as get the recall letter. But you should start taking deliberate steps to find answers to your questions and to protect your health, which means first:</p>



<p><em><strong>Take stock of your physical condition</strong></em>. How do you feel? How does the hip function? Do you feel any pain? Any other <a href="/artificial-hip-failure-neurological-problems-first-sign-of-cobalt-poisoning/">symptoms</a>? Can you still exercise, or have you slowly given up many of the physical activities you used to enjoy? What has your doctor said to you in your recent office visits related to the condition of the hip replacement?</p>


<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2015/07/iStock_000057980522_XXXLarge1.jpg"><img decoding="async" src="/static/2015/07/iStock_000057980522_XXXLarge1-300x200.jpg" alt="Orthopedic surgeon examines hip replacement patient" style="width:300px;height:200px"/></a></figure>
</div>


<p>Schedule an appointment with your orthopedic surgeon. You need to meet with your orthopedic surgeon and ask him all the questions you have about the recall and the implanted artificial hip: why was it recalled? what is the defect? how has the defect harmed people? what symptoms can the defect cause? And of course: should I get the revision surgery?</p>



<p><em><strong>Get metals levels checked</strong></em>. As part of this visit with your surgeon, you will want to have him or her order lab work to check your cobalt and chromium levels. Even artificial hips that are not metal-on-metal (MoM) can leach metals into the blood and tissue. It is important to get blood work done to see if you have elevated metal levels.</p>



<p><em><strong>Do your research.</strong></em> Read as much as you can about the recalled artificial hip, starting with <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139519" rel="noopener noreferrer" target="_blank">the FDA website</a> but also working your way to reputable news sources. Find out what is defective about the artificial hip and what problems it is causing when the hip fails.</p>



<p><strong><em>Self-assess. </em></strong>What is your level of anxiety? Are you the kind of person who will suffer with the idea of a recalled product in your body, even in the absence of serious symptoms? Or do you trust your surgeon to give you good advice on revision surgery? If your hip feels good and you have no anxiety, you may be able to hold off on revision surgery. As part of this step, it would also be helpful to discuss revision surgery with your spouse, your family, and even with trusted friends.</p>



<p><em><strong>Get revision surgery if you need revision surgery</strong></em>. Once you go through the steps above, you and your surgeon should have a long discussion about the pros and cons of revision surgery. No surgery is low-risk, so you need to make this decision deliberately and carefully. If you have pain, and if you have elevated metal levels, your surgeon will most likely advise revision surgery. On the other hand, if your hip is functioning well, and you have no discernible metal levels, and you otherwise feel fine, you and your surgeon may decide to take a wait-and-see approach. In this case, however, you need to maintain vigilance: schedule periodic metal blood tests, arrange frequent follow-ups with your surgeon, and keep a symptoms journal if they arise.</p>



<p><em><strong>If necessary, seek out a second opinion</strong></em>. It is vital that you trust your surgeon. If you feel you are not getting your surgeon’s full attention or consideration, find another orthopedic surgeon. Ask around for trusted surgeons in your area. Go through the process with the new surgeon. Occasionally some surgeons have reasons for dismissing the importance of recalled medical devices like artificial hips, so they may downplay the importance of removing the recalled artificial hip. (I’ve known at least one surgeon who said high metal levels were not a health risk.) Above all, you should always rely on doctors you trust to make decisions on surgery.</p>



<p>This is not legal or medical advice.</p>
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                <title><![CDATA[UPDATE: Smith & Nephew Birmingham Artificial Hip Lawsuits Advance]]></title>
                <link>https://www.clayhodgeslaw.com/blog/update-smith-nephew-birmingham-artificial-hip-lawsuits-advance/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/update-smith-nephew-birmingham-artificial-hip-lawsuits-advance/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Fri, 11 Jan 2019 16:59:16 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Multidistrict Litigation]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[BHR]]></category>
                
                    <category><![CDATA[Birmingham]]></category>
                
                    <category><![CDATA[chromium]]></category>
                
                    <category><![CDATA[cobalt]]></category>
                
                    <category><![CDATA[MDL 2775]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[R3]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                    <category><![CDATA[THA]]></category>
                
                
                
                <description><![CDATA[<p>I have written about artificial hip litigation on this site more than any other area of product liability law, and for a very good reason: there is a lot to write about. Metal-on-metal hips have gravely injured tens of thousands of people, and new victims are undergoing revision surgeries each week to remove defective hips.&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2017/03/iStock-587512462.jpg"><img decoding="async" alt="Smith & Nephew Birmingham Hip Litigation" src="/static/2017/03/iStock-587512462-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>I have written about artificial hip litigation on this site more than any other area of product liability law, and for a very good reason: there is a lot to write about. Metal-on-metal hips have gravely injured tens of thousands of people, and new victims are undergoing revision surgeries each week to remove defective hips. One current active litigation involves Smith & Nephew “Birmingham” artificial hips. MDL 2775 is the multidistrict litigation court handling hundreds of lawsuits filed against medical device maker <em><strong>Smith & Nephew</strong></em> for these (allegedly) defective artificial hips. There are several artificial hip products involved in MDL 2775:</p>


<p><em><strong>Birmingham Hip Resurfacing System (BHR)</strong></em>. The multidistrict litigation court was first organized to handle these BHR lawsuits. The BHR system is a type of metal-on-metal artificial hip, but in resurfacing procedures the  hip “ball” bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection or “articulation.” As with most metal-on-metal artificial hips, Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and leach into the blood and tissue of the patient, causing all kinds of symptoms and problems, including metallosis.</p>


<p><em><strong>BHR Hip Components Used in Total Hip Arthroplasty (THA)</strong></em>. These hip implants are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and a metal ball component is implanted. MDL 2775 added these Total Hip Arthroplasty (THA) cases to the litigation shortly after the MDL launched.</p>


<p><em><strong>Smith & Nephew R3 Liners. </strong></em>This hip implant consists of a <em><strong>metal liner</strong></em> placed between the femoral head and cup, which creates a metal-on-metal articulation. The R3 has experienced many of the same problems that other metal-on-metal hip implants have caused, including metallosis, pain, and loosening. Smith & Nephew issued a voluntary recall in June of 2012. At the time of the recall, approximately 4,000 R3 liners had been implanted in patients in the United States.</p>


<p>Judge Catherine Blake–who oversees the MDL–has divided the cases into two tracks: the “BHR Track” and the “THA/R3 Track.” For a person injured by the failure of one of these hip implant systems, you will need to verify the exact components implanted and file the proper case under the BHR Track or the THA/R3 Track. (Of course, your attorney is supposed to do all of this work, and you need an attorney for these kinds of cases, as <a href="/handling-your-product-liability-case-without-a-lawyer-good-idea/">I discuss here.</a>)</p>


<p><em><strong>Some Smith & Nephew Cases Dismissed Because They Were Filed Too Late</strong></em>
</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/06/iStock_77982933_LARGE.jpg"><img decoding="async" alt="The Statute of Limitations Can End Your Case" src="/static/2016/06/iStock_77982933_LARGE-300x214.jpg" style="width:300px;height:214px" /></a></figure>
</div>

<p>On November 19, 2018, Judge Blake considered motions to dismiss from Smith & Nephew lawyers, who argued that dozens of cases in the MDL were time-barred. <a href="//">I wrote about statutes of limitations in a prior post</a>, and I’ve referenced it often on this site, but in a nutshell it is one major defense for a company sued by a person injured by a defective product.</p>


<p>Judge Blake denied most of the motions to dismiss in her Order. So that’s the good news. She observed that many of the cases hailed from states with “discovery rules.” The discovery rule clarifies when the clock starts ticking to file a product liability case. It typically means that the clock cannot start ticking against the injured person until the person discovers (or reasonably should have discovered) that he or she was injured by a defective product. As I’ve discussed, determining that moment of “discovery” can be difficult for medical devices.</p>


<p>With regard to Smith & Nephew’s motions to dismiss, Judge Blake dismissed a few cases that were clearly outside the time-limits for bringing a case in that plaintiff’s home state, but kept most of the cases where discovery rules applied or where there was some ambiguity about the passage of time.</p>


<p>As you can imagine, defense attorneys press these statutes of limitation defenses aggressively, so be careful. <em><strong>The takeaway</strong></em>: do not “sleep on your rights.” If you think you have been harmed by a defective product, <a href="/contact-us/">contact an attorney</a> immediately.</p>


<p><em><strong>Smith & Nephew Mediation Scheduled for January 30, 2019</strong></em></p>


<p>Smith & Nephew has not yet made any serious effort to settle these cases, although the company initially expressed some willingness to discuss settlement of the THA/R3 track cases. Judge Blake ordered mediation to be held on January 30, 2019. Smith & Nephew is asking all THA/R3 Track plaintiffs to produce relevant medical records so that the company can properly evaluate each of the THA/R3 cases. If mediation does not lead to a global settlement of these cases, discovery will continue, including depositions to be taken in the coming months.</p>


<p><em><strong>Trial Dates Scheduled</strong></em></p>


<p>The BHR Track cases have trial dates set for March 2020. If THA/R3 mediation is not successful at the end of this month, the plaintiffs’ team will ask Judge Blake for a trial date to be scheduled shortly after the trial for the BHR Track cases.</p>


<p>If you were implanted with a Smith & Nephew artificial hip (of any kind) and are suffering problems, give me a call to discuss further: (919) 830-5602.</p>


<p>Note: All information in this post was distilled from publicly available information and news sources.</p>


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                <title><![CDATA[05: Physical Therapist Discusses Hip Replacement Surgery and Artificial Hip Failures]]></title>
                <link>https://www.clayhodgeslaw.com/blog/05-physical-therapist-discusses-hip-replacement-surgery-and-artificial-hip-failures/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/05-physical-therapist-discusses-hip-replacement-surgery-and-artificial-hip-failures/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Thu, 06 Dec 2018 21:23:54 GMT</pubDate>
                
                    <category><![CDATA[Podcast]]></category>
                
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[physical therapy]]></category>
                
                
                
                <description><![CDATA[<p>{{CODEpodcast}}</p>
<p>Do you have pain that seems irregular after Hip Surgery? Today’s guest will guide us through the expectations of hip surgery, what it is like to go through the surgery, what rehab is like, and what happens to a person when an artificial hip fails inside the body.</p>
]]></description>
                <content:encoded><![CDATA[<template data-third-party="">


    
        


    <iframe src="//html5-player.libsyn.com/embed/episode/id/7825880/height/90/theme/custom/thumbnail/yes/direction/backward/render-playlist/no/custom-color/0f1109/" width="100%" height="90px"></iframe>

    
</template>


<p></p>



<p>Do you have pain that seems irregular after Hip Surgery? Today’s guest will guide us through the expectations of hip surgery, what it is like to go through the surgery, what rehab is like, and what happens to a person when an artificial hip fails inside the body.</p>



<p>Amy Dougherty a physical therapist on the Outer Banks of North Carolina, is the owner of Outer Banks Physical Therapy. She graduated from the University of North Carolina at Chapel Hill, where Clay also attended college and Law School. Loved by her patients, she is an outstanding Physical Therapist and will explain how hip surgery impacts your body and what happens to the body when hip surgery fails.</p>



<p><strong>Show Highlights:</strong>
</p>



<ul class="wp-block-list">
<li>Few reasons a person might need a hip replacement surgery</li>



<li>Arthritis is the most common cause for hip replacement surgery</li>



<li>How soon physical therapy starts after the surgery</li>



<li>Biggest issues that come into play when going home for recovery</li>



<li>What physical therapy might look like when you first arrive</li>



<li>How long exercise at physical therapy tend to last and being able to take them home</li>



<li>Sports that Amy would discourage after a hip replacement surgery</li>



<li>Symptoms Amy notices if the hip surgery has failed</li>



<li>There should be little to no pain after a hip surgery and the rehab </li>



<li>Metallosis – description and what happens when you have it</li>



<li>Rehab for a person who has multiple surgeries on the same hip</li>



<li>Amy’s medical opinion if a follow-up surgery would be successful </li>



<li>Better outcomes after learning of metal on metal hips, and fewer revision surgeries</li>
</ul>



<p>
<strong>Resources:</strong></p>



<p>Call Attorney Clay Hodges (919) 830-5602</p>



<p><a href="https://itunes.apple.com/us/podcast/failed-hips-and-harmful-drugs/id1418154129?mt=2" rel="noopener noreferrer" target="_blank">Subscribe to Failed Hips and Harmful Drugs Podcast</a></p>



<p>Outer Banks Physical Therapy <a href="http://obxpt.com/our-team/" rel="noopener noreferrer" target="_blank">Website</a></p>
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                <title><![CDATA[Dr. Steven Tower Is Trying to Save the World from Chrome Cobalt Artificial Hips]]></title>
                <link>https://www.clayhodgeslaw.com/blog/dr-steven-tower-is-trying-to-save-the-world-from-chrome-cobalt-artificial-hips/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/dr-steven-tower-is-trying-to-save-the-world-from-chrome-cobalt-artificial-hips/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Tue, 16 Oct 2018 16:11:31 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Depuy ASR]]></category>
                
                    <category><![CDATA[Health & Wellness]]></category>
                
                
                    <category><![CDATA[ACE]]></category>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[chromium]]></category>
                
                    <category><![CDATA[cobalt]]></category>
                
                    <category><![CDATA[metal-on-metal hips]]></category>
                
                    <category><![CDATA[metal-on-plastic hips]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[neurological symptoms]]></category>
                
                    <category><![CDATA[Steven Tower]]></category>
                
                
                
                <description><![CDATA[<p>If you have any interest in artificial hips, you need to follow the work of Dr. Steven Tower. An orthopedic surgeon in Anchorage Alaska, Dr. Tower has built a one-man research laboratory studying the horrifying health effects of chrome and cobalt hip components. While hip manufacturers have been slow to produce meaningful studies on the&hellip;</p>
]]></description>
                <content:encoded><![CDATA[

<p>If you have any interest in artificial hips, you need to follow the work of <em><strong>Dr. Steven Tower</strong></em>. An orthopedic surgeon in Anchorage Alaska, Dr. Tower has built a one-man research laboratory studying the horrifying health effects of chrome and cobalt hip components. While hip manufacturers have been slow to produce meaningful studies on the ill-effects of metallosis on the human body, Dr. Tower decided to study his own patients. What he discovered could save lives.</p>


<p><em><strong>Dr. Tower’s Backstory</strong></em>
</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2016/05/surgery-688380_1920.jpg"><img decoding="async" alt="Orthopedic Surgeon Steven Tower" src="/static/2016/05/surgery-688380_1920-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>Steven Tower’s story is remarkable. He is featured in the Netflix medical device documentary <a href="/the-bleeding-edge-you-must-watch-this-film/"><em>The Bleeding Edge</em></a>. Dr. Tower is an avid cyclist and needed a hip replacement several years ago. He chose the DePuy ASR metal-on-metal artificial hip because it was marketed to “exceptionally active individuals.” Several months after his hip replacement surgery, however, Dr. Tower noticed a tremor in his hand. His ears started ringing, his thinking became confused and he began repeating himself when he spoke. One night while attending a medical conference Dr. Tower had a mental breakdown and trashed his hotel room. He wrote all over the walls with sharpies and pens, and wrote on the hotel mirrors with soap. When he returned home he measured the metal levels in his blood, and the test results revealed 100 times the normal amount of cobalt that should be in his body. Dr. Tower soon arranged to have his metal hip components removed in a revision surgery. Within a month his thinking cleared and his other symptoms mostly disappeared. He was relieved, but also intrigued.</p>


<p><em><strong>Dr. Tower’s Chrome Cobalt Hip Study</strong></em>
</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/08/iStock_89156129_XLARGE.jpg"><img decoding="async" alt="Cobalt poisoning is a serious risk for metal artificial hips." src="/static/2016/08/iStock_89156129_XLARGE-300x210.jpg" style="width:300px;height:210px" /></a></figure>
</div>

<p>The metal-poisoning ordeal stayed with Dr. Tower, so he decided to study the symptoms of his orthopedic patients. In March 2015 he started a screening program to measure cobalt levels in the blood of patients who received an artificial hip with <em>any</em> chrome-cobalt component. Astonishingly, Dr. Tower discovered that over half of his patients with a chrome-cobalt hip part had measurable cobalt in their urine. A quarter of those patients had a metal-on-metal (“MoM”) artificial hip, but most had the metal-on-plastic hips, which are thought to be safer. Steven Tower didn’t buy it.</p>


<p>Ominously, Dr. Tower discovered that 81% of his patients with cobalt presence in the urine suffered from “Arthroplastic Cobalt Encephalopathy” or “ACE,” which is a collection of troubling mental symptoms he believes are caused by elevated metal levels in the blood and tissue. <a href="/artificial-hip-failure-neurological-problems-first-sign-of-cobalt-poisoning/">You can read more about Steven Tower’s discovery that high metal levels in the blood can cause serious neurological problems here</a>.</p>


<p>Among other things, Dr. Tower’s study concluded:
</p>


<ul class="wp-block-list">
<li>One million Americans could be at extreme risk for ACE from metal-on-metal artificial hips. The good news is that MoM hips are no longer actively marketed and sold; the bad news is that many individuals still have MoM hips in their bodies.</li>
<li>Five to ten million individuals could be at some risk for ACE from metal-on-plastic hips. Few surgeons and fewer manufacturers are studying the health effects of metal-on-plastic hips.</li>
<li>One million people could be at risk for ACE from shoulder replacements. Shoulder replacement surgeries use chrome-cobalt implants.</li>
</ul>


<p>
<em><strong>Dr. Tower’s Recommendations for Hip Replacement Surgery</strong></em></p>


<p>If you read nothing else, read this: Steven Tower does not recommend any patient consent to hip replacement surgery involving components containing “any chrome-cobalt hip part.” This means that patients should never receive a MoM artificial hip, where the femoral head articulates with a metal acetabular cup or a metal liner. But Dr. Tower goes further than rejecting the M0M hip. He also believes that a hip replacement with <em><strong>any </strong></em>chrome-cobalt component should be avoided. Dr. Tower’s study on his patients indicates that many hip replacements using any chrome-cobalt part can increase metal levels in the blood and cause significant negative symptoms. This means that even if your orthopedic surgeon suggests a metal-on-plastic hip system, and the metal component is made from chrome-cobalt (and most of them are), you should avoid it.</p>


<p>Instead, Dr. Tower recommends a cemented stainless steel stem with a stainless steel head or a ceramic head along with a polyethylene (plastic) socket. For revision surgeries Dr. Tower recommends a Titanium stem with a ceramic head “articulating” with a polyethylene socket. In his work as an orthopedic surgeon, Dr. Tower does not implant artificial hips with any chrome cobalt components because “proven safe alternatives exist.”</p>


<p>Please note: I am not a doctor and this is not medical advice. This article represents my understanding of Steven Tower’s artificial hip study and recommendations. Dr. Tower has not affirmed the accuracy of this article, and if any mistake is made it is mine alone. As always, if you have medical questions about your hip, talk to your doctor. If you have legal questions, call me (919.830.5602).</p>


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                <title><![CDATA[Neurological Problems May Be First Sign of Metallosis From Artificial Hips]]></title>
                <link>https://www.clayhodgeslaw.com/blog/artificial-hip-failure-neurological-problems-first-sign-of-cobalt-poisoning/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/artificial-hip-failure-neurological-problems-first-sign-of-cobalt-poisoning/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Fri, 01 Dec 2017 21:25:12 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Depuy ASR]]></category>
                
                    <category><![CDATA[Depuy Pinnacle]]></category>
                
                    <category><![CDATA[Health & Wellness]]></category>
                
                
                    <category><![CDATA[artificial hips]]></category>
                
                    <category><![CDATA[chromium]]></category>
                
                    <category><![CDATA[cobalt]]></category>
                
                    <category><![CDATA[encephalopathy]]></category>
                
                    <category><![CDATA[Metal-on-metal]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[neurological symptoms]]></category>
                
                
                
                <description><![CDATA[<p>For many years my clients with failing artificial hips have asked me about the health effects of high cobalt and chromium levels in the body. These questions usually arise after clients get blood work done and the test reveals abnormally high metal levels. If you are reading this article, you probably already know that cobalt&hellip;</p>
]]></description>
                <content:encoded><![CDATA[

<p>For many years my clients with failing artificial hips have asked me about the health effects of high cobalt and chromium levels in the body. These questions usually arise after clients get blood work done and the test reveals abnormally high metal levels. If you are reading this article, you probably already know that cobalt and chromium are two metals used in the construction of most metal-on-metal (MoM) artificial hip systems. In fact, cobalt and chromium are used to make artificial hips that are not metal-on-metal but instead use polyethylene liners, or ceramic heads, or other non-metal components. When metal components grind together, as they naturally do when a MoM artificial hip is implanted in a person, very small metal particles can be released into the tissue and the bloodstream. I wrote about the health effects of <em><strong>metallosis</strong></em> on the body over a year ago. <a href="/blog/metallosis-study-serious-health-problems-from-metal-on-metal-artificial-hips/">You can check out that article here</a>.</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/08/iStock_89156129_XLARGE.jpg"><img decoding="async" alt="Cobalt poisoning from artificial hip implants" src="/static/2016/08/iStock_89156129_XLARGE-300x210.jpg" style="width:300px;height:210px" /></a></figure>
</div>

<p>Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many <em><strong>neurological</strong> <strong>problems</strong> </em>he has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.</p>


<p><em><strong>What is Arthroplasty Cobalt Encephalopathy (ACE)?</strong></em></p>


<p>ACE is meant to identify a brain disease or associated neurological symptoms caused by elevated levels of cobalt from a metal artificial hip. Cobalt poisoning is a common problem in patients with artificial hips. The neurological symptoms that occur with cobalt metal poisoning include:
</p>


<ul class="wp-block-list">
<li>tremors</li>
<li>memory problems</li>
<li>fatigue</li>
<li>weakness or imbalance</li>
<li>mood alterations</li>
<li>sleep issues</li>
<li>pain</li>
<li>weight loss</li>
<li>executive dysfunction</li>
<li>blindness</li>
<li>other symptoms</li>
</ul>


<p>
Dr. Tower did a post-surgical study of his patients with artificial hips containing at least one component made from chromium/cobalt. He discovered that 57 were cobalt positive, meaning the cobalt urine test revealed 1 part per billion (ppb) or higher. Of the 57 patients with a cobalt positive test, 28 had symptoms consistent with Arthroplasty Cobalt Encephalopathy.</p>


<p>One issue Dr. Tower discovered was that ACE could occur with lower readings of cobalt in the body. It has generally been accepted that cobalt readings below 4 ppb was not cause for concern, and some surgeons would not order further testing until the cobalt readings exceeded 7 ppb or even 10 ppb. Dr. Tower found that patients could have serious neurological issues caused by cobalt with readings of 1 ppb.</p>


<p>Among the patients who were diagnosed with ACE, the median length of time for onset of neurological symptoms was around seven years. ACE symptoms usually occurred one year before hip symptoms (pain, weakness, clicking, loosening, etc.) occurred.</p>


<p><em><strong>Are Neurological Problems From Metallosis Limited to Metal-on-Metal Artificial Hips?</strong></em>
</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2017/12/iStock-670645322.jpg"><img decoding="async" alt="Metal on plastic artificial hip can cause metallosis" src="/static/2017/12/iStock-670645322-300x300.jpg" style="width:300px;height:300px" /></a></figure>
</div>

<p>Unfortunately, no. As recently as five years ago, the medical community mostly believed that metallosis derived from metal-on-metal artificial hips. This would include products such as the DePuy ASR hip and the Zimmer Durom hip (and several other metal-on-metal hip products, about which <a href="/blog/category/artificial-hip/">I have written often on this website</a>). But Dr. Tower has observed neurological problems in several patients with metal-on-plastic hips, or hips utilizing a ceramic ball with a metal cup. In fact, if any part of an artificial hip contains chrome or cobalt materials, the patient is at risk for higher metal levels in the blood and neurological symptoms as a result. He notes that the onset of symptoms with metal on plastic or ceramic occurs more slowly, but the symptoms themselves can be just as severe.</p>


<p>This finding, if true, could be a game changer. The medical community has (slowly) accepted that MoM hips were a health problem and have moved away from their use. But now a thoughtful surgeon is saying, “Hold up. We are finding cobalt poisoning in too many patients with metal-on-plastic and metal-on-ceramic hips. The risk to the patient occurs with any artificial hip containing a cobalt component.” Conventional wisdom has been that eliminating the metal on metal contact should eliminate the risk of metallosis, but Dr. Tower at least does not accept this thinking.</p>


<p>In his discussion Dr. Tower noted that after nine of his patients had <em><strong>revision surgeries</strong></em>, seven patients no longer showed signs of being cobalt-positive, and five of those seven improved neurologically. That’s a promising sign.</p>


<p><em><strong>The Takeaway</strong></em></p>


<p>Does this settle the questions regarding artificial hip implants and metallosis? Of course not. But we need to start looking much more closely at the things we put into our bodies, whether it’s a Twinkie, a sleeping pill, or a metal artificial hip. Also, it is well past time for medical device companies to <em><strong>slow down</strong></em> and return to more extensive testing of new medical products. Too often the pursuit of a blockbuster medical device or new prescription drug clouds a corporate board’s better judgment. And clouded judgment hurts people.</p>


<p>Remember I am not a doctor and this is not medical advice. I am a product liability lawyer with many clients who were injured by artificial hips containing cobalt and chromium.</p>


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                <title><![CDATA[Metal-on-Metal Artificial Hip Victim Recounts Her Harrowing Ordeal]]></title>
                <link>https://www.clayhodgeslaw.com/blog/metal-artificial-hip-victim-recounts-harrowing-ordeal/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/metal-artificial-hip-victim-recounts-harrowing-ordeal/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Mon, 16 Oct 2017 11:37:19 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Depuy ASR]]></category>
                
                    <category><![CDATA[Depuy Pinnacle]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Depuy]]></category>
                
                    <category><![CDATA[Metal-on-metal]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[narrative]]></category>
                
                    <category><![CDATA[recall]]></category>
                
                    <category><![CDATA[revision surgery]]></category>
                
                    <category><![CDATA[Smith & Nephew]]></category>
                
                
                
                <description><![CDATA[<p>Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2017/10/iStock-672865916.jpg"><img decoding="async" alt="Woman waiting for Depuy ASR revision surgery" src="/static/2017/10/iStock-672865916-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of <em><strong>individuals</strong></em> uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.</p>


<p>In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:</p>


<p><strong>Part 1</strong></p>


<p>I have been home in North Carolina from my two month sabbatical in Costa Rica for almost four months now. The memories of my time there, the simple routines, new friendships and the feeling that I would return home and make significant changes in my life after “re-entry” have faded into the urgency of daily demands from work, family, relationships and most urgently: my body. Any time I am away from home I look forward to the pile of mail waiting for me when I return, most of it is junk, I know, but I still get excited by post that is addressed to me personally. Now after two months away from home my stack of mail was significant and I settled into the comfort of my screened in porch in anticipation of what I had missed.</p>


<p>After separating the junk from the catalogs, the catalogs from the bills, the personal emerged and that is where I started. What was waiting for me on that September afternoon among the pile of letters that were a combination of known and unknown, was a curious letter from Duke Diagnostic Clinic. I read it twice to make sure that what I was reading was true and then with an unsettling feeling growing in the pit of my stomach, I looked for my husband John [not his real name]. “John, you are never going to believe what I am reading here in this letter from Duke University. It seems that the artificial hip I received four years ago has been recalled.”</p>


<p>The letter went on to say that only a small percentage of recipients would have complications, but I didn’t need to read any further to know that these were going to be my complications–my life–starting now. Since then I have been traveling the two hundred plus miles back and forth to Durham, the home of Duke University and the Duke medical complex to find that every test that I have taken indicates my device has not only failed, but has been poisoning my blood, damaging surrounding tissue, and quite possibly–we will not know for certain until the surgeons are inside–infecting me.</p>


<p>In the past I spoke of bold action and, with trust, falling into the arms of the universe. Now, faced with major surgery in four days and all of the unanswered questions surrounding this endeavor, I feel like I am falling, but I’m not sure where.</p>


<p>Today was my last day at work before embarking on a two month medical leave to have my left hip re-replaced due to a device “recall.” I left work feeling almost completely satisfied that I could face the impending circumstances with almost no work-related stress or unfinished business. I just have to let it go. I’m finding that I am letting go of a lot of things these days. I will no longer be able to run after my bionic-titanium parts are replaced with more fragile parts. Ceramic, plastic and metal will probably not invoke words from my surgeon like the words after my first hip replacement: “Do whatever you want as long as it does not cause you pain.” Not that pain has ever stopped me before. No pain, no gain, right?</p>


<p>I will miss running though, and I’ll have to face other limitations head-on as they come. Since I am returning home from the hospital mere days before Christmas, I am letting that go too. My family, my husband, and our two children have been trying to create a family holiday experience as far from the consumer, commercial version as we can, spending our time making gifts, cooking food, playing games and music–and if we are not on a traveling adventure–staying home and just having fun. Two years ago our kids, they are twenty six and twenty one now, squirreled away and wrapped random objects from our home so when we woke on Christmas morning, John and I really thought Santa had come. The gifts were spilling out from under the tree, until I looked closer at the bicycle with the big red ribbon tied around it, noticing the rust and dirty tires–who’s bike was that?</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2017/01/iStock-615736330.jpg"><img decoding="async" alt="Woman preparing for Depuy ASR revision surgery" src="/static/2017/01/iStock-615736330-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>In the days leading up to this week I have amassed a stack of books to read while recovering. I have selected various tomes for friends and family as gifts this season and that is all I am doing. Cooking, traveling, creating, taking care of family and friends, I’m letting it go. The first time I had total hip replacement surgery was four years and four months ago. John and I are amazed that we have almost no recollection of what happened the first time I had surgery. We are trying to put the pieces together in order to prepare ourselves this time around, but we have hardly any memory of the experience. This time I have the full support and care of a loving man–my husband of almost twenty seven years. And it’s funny because this second surgery, this “do-over” is like another chance to make all my stories right, to let go of those stories and parts that “no longer serve me,” as one of my wise friends noted.</p>


<p>And so here it is, another chance to let go, another chance to continue creating my story.</p>


<p>Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.</p>


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                <title><![CDATA[Depuy Knew About Metal-on-Metal Hip Risks Decades Ago: Documents]]></title>
                <link>https://www.clayhodgeslaw.com/blog/depuy-knew-about-metal-on-metal-hip-risks-long-ago-documents/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/depuy-knew-about-metal-on-metal-hip-risks-long-ago-documents/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Wed, 26 Apr 2017 14:48:56 GMT</pubDate>
                
                    <category><![CDATA[Depuy ASR]]></category>
                
                    <category><![CDATA[Depuy Pinnacle]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[ASR]]></category>
                
                    <category><![CDATA[Depuy]]></category>
                
                    <category><![CDATA[documents]]></category>
                
                    <category><![CDATA[litigation]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[MoM]]></category>
                
                    <category><![CDATA[Pinnacle]]></category>
                
                    <category><![CDATA[risks]]></category>
                
                
                
                <description><![CDATA[<p>“What did they know and when did they know it?” When something goes wrong with a medical device, this eventually becomes the key question. Unfortunately for Depuy Orthopaedics (Depuy), a lot has gone wrong with its metal-on-metal (MoM) hip implants over the past ten years. And to make matters worse, recently released documents* show Depuy&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<p>“What did they know and when did they know it?” When something goes wrong with a medical device, this eventually becomes the key question. Unfortunately for Depuy Orthopaedics (Depuy), a lot has gone wrong with its metal-on-metal (MoM) hip implants over the past ten years. And to make matters worse, recently released documents* show Depuy knew it would have problems with its MoM hip implants decades ago.</p>



<p><em><strong>Depuy MoM Hip Implants: An Overview</strong></em>
</p>


<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2017/04/iStock-587512462-1.jpg"><img decoding="async" src="/static/2017/04/iStock-587512462-1-300x200.jpg" alt="Hip Replacement document." style="width:300px;height:200px"/></a></figure>
</div>


<p>Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.</p>



<p>One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and <a href="/blog/metallosis-study-serious-health-problems-from-metal-on-metal-artificial-hips/">metallosis</a>.</p>



<p>As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or <a href="/blog/definitions/">MDL</a>. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, <a href="/">which I wrote about here</a>.</p>



<p>Basically, things have not been looking good for Depuy. And they just got worse.</p>



<p>more
<em><strong>The Incriminating Documents</strong></em></p>



<p>The <a href="http://www.telegraph.co.uk/news/2017/04/11/hip-implant-maker-alerted-safety-fears-surgeon-told-borders/" rel="noopener noreferrer" target="_blank">Daily Telegraph</a> recently published a story, based on internal documents recently made available, that show Depuy actually knew it had serious problems with its MoM hip implants for years. The company deliberately took steps to ignore the problems. The released documents include:
</p>



<ul class="wp-block-list">
<li>A <a href="https://www.documentcloud.org/documents/3549260-PLT-00001-END-GAME.html#document/p1" target="_blank" rel="noopener noreferrer">paper written by Graham Isaac, Ph.D.,</a> discussing problems with MoM hip implants.</li>



<li>A <a href="https://www.documentcloud.org/documents/3549256-PLT-00007-IRVING.html" target="_blank" rel="noopener noreferrer">letter from Dr. John F. Irving</a>, MD, to Depuy’s head of US marketing (Paul Berman).</li>



<li>Depuy corporate <a href="https://www.documentcloud.org/documents/3549255-PLT-00048-1995-LITIGATION.html" target="_blank" rel="noopener noreferrer">meeting minutes</a> where Depuy executive met to discuss various topics, including MoM hip implants.</li>



<li><a href="https://www.documentcloud.org/documents/3549250-PLT-01499-NARGOL-CONCERNS.html" target="_blank" rel="noopener noreferrer">Internal Depuy e-mail exchange</a> discussing MoM hip implant problems.</li>



<li>A <a href="https://www.documentcloud.org/documents/3549253-PLT-00178-NORWICH-INVESTIGATION.html" target="_blank" rel="noopener noreferrer">July 2008 paper</a> on the topic of MoM hip implant problems.</li>
</ul>



<p>
These papers are especially incriminating because they show what Depuy knew (or should have known) and when they knew it.</p>



<p><em><strong>What Did Depuy Know?</strong></em>
</p>


<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2017/04/scientist-1332343_1280.jpg"><img decoding="async" src="/static/2017/04/scientist-1332343_1280-300x200.jpg" alt="Two scientists looking through the same microscope." style="width:300px;height:200px"/></a></figure>
</div>


<p>In Dr. Graham Isaac’s paper, he explains how metal wear debris created from MoM hip joints were a serious problem due to poor design and manufacturing of the metal components. However, Dr. Isaac goes on to state that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were still “as unpredictable as ever, working well for a period of time before suffering catastrophic breakdown…accompanied by a release of a large volume of debris.”</p>



<p>Dr. Isaac went on to conclude that metal-on-polyethylene hip implants performed significantly better than MoM implants. He also mentioned that using ceramics can produce hip implants that perform better than MoM hip implants.</p>



<p>In Dr. John Irving’s letter to Paul Berman, he spoke of his data collection which shows that Depuy’s MoM hip implants were dramatically underperforming other types of hip implants. When looking at metal-on-polyethylene hips from the last 10 years, Dr. Irving had a 1.2% failure rate, or eight revisions out of 660 hip implants.</p>



<p>Contrast this with Depuy’s MoM hip implants, where out of 262 implants, 31 required revision surgery. This was an 11.8% failure rate, almost 10<em><strong> </strong></em>times that of the conventional metal-on-polyethylene hip implants.</p>



<p>As if that wasn’t bad enough for Depuy, Dr. Irving complained about Depuy’s “lack of attention and head-in-the-sand response to this problem.” Dr. Irving went on to state that “<em><strong>these products are harming patients</strong></em>,” that he “did not feel Depuy [was] doing enough to understand the extent of the Pinnacle MoM hip disease” and it would be “unethical to continue to market the product.”</p>



<p>And in 2010, when Depuy finally starting taking action with its MoM hip implants, there was an e-mail exchange among Depuy executives and experts acknowledging a “link to a failure pattern of the ASR XI to the Pinnacle with 36 mm heads when used with metal liners” and that “the problem may be widespread” with “evidence of metal on metal and ceramic on metal failings.”</p>



<p>There was also the recognition that when a hip implant failed, it was “sometimes catastrophic.” One of the e-mails ended with the belief that Depuy should “investigate and manage this growing problem.”</p>



<p><em><strong>When Did Depuy Know?</strong></em></p>



<p>So these internal documents go to what Depuy knew, but how long did Depuy know this? Corporate minutes show <em><strong>Depuy most likely knew of the MoM</strong> <strong>risks in 1995</strong></em>, over twenty years ago.<em><strong> </strong></em>One of the meeting’s attendees, Dr. Paul Peters, noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.”</p>



<p>Additional notes from the corporate minutes indicated that Depuy observed the following problems with MoM hip implants:
</p>



<ul class="wp-block-list">
<li>Large volume of metal particles being released from the hip implants</li>



<li>Metal ions being released into the body</li>



<li>Poor wear results</li>



<li>Metal scratches in the components taking the form of peaks and valleys (as opposed to just valleys, which would result in the hip implant lasting longer).</li>
</ul>



<p>
<em><strong>What Does All this Mean?</strong></em></p>



<p>These documents appear to be from discovery in recent litigation concerning the Depuy Pinnacle hip implants, and they may have been used in Depuy Pinnacle bellwether trials. However, it’s somewhat unusual that these have been made public (by sources other than this website). The level of incriminating evidence contained in these documents is also quite unusual. If Depuy had all this information at its disposal more than twenty years ago, the injuries to patients who received the Depuy ASR and Depuy Pinnacle artificial hips in the years since then are particularly horrifying and egregious. I hope such bad publicity will further motivate Depuy to resolve its pending Depuy Pinnacle lawsuits as soon as possible.</p>



<p>*Note: The documents referenced and linked in this post are widely available from other news sources and were released prior to the publication of this article. <em>The Daily Telegraph</em> originally published “End Game” and other documents. I can not and do not verify the authenticity of these documents, nor can I confirm the truth of the statements made in the documents.</p>
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                <title><![CDATA[Depuy Pinnacle Hip: Third Bellwether Trial Underway in Texas]]></title>
                <link>https://www.clayhodgeslaw.com/blog/depuy-pinnacle-hip-third-bellwether-trial-underway-in-texas/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/depuy-pinnacle-hip-third-bellwether-trial-underway-in-texas/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Fri, 07 Oct 2016 20:52:44 GMT</pubDate>
                
                    <category><![CDATA[510(k) Process]]></category>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Depuy Pinnacle]]></category>
                
                    <category><![CDATA[Multidistrict Litigation]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[bellwether trial]]></category>
                
                    <category><![CDATA[Dallas]]></category>
                
                    <category><![CDATA[Depuy Pinnacle]]></category>
                
                    <category><![CDATA[MDL]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[Texas]]></category>
                
                
                
                <description><![CDATA[<p>The latest Depuy Pinnacle Hip bellwether trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/02/iStock_000059387488_Full.jpg"><img decoding="async" alt="Third Depuy Pinnacle Bellwether Trial" src="/static/2016/02/iStock_000059387488_Full-300x197.jpg" style="width:300px;height:197px" /></a></figure>
</div>

<p>The latest Depuy Pinnacle Hip <em><strong>bellwether</strong></em> trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy Pinnacle hip. More about that case in a moment. But this third bellwether trial is critically important to Depuy and Johnson & Johnson (the Depuy Pinnacle manufacturers) who desperately need a court victory after the second bellwether trial. Another large verdict for the plaintiffs will most likely change the fate of any global settlement with the eight thousand plaintiffs who still have cases against Depuy and Johnson & Johnson.</p>


<p><em><strong>Third Depuy Pinnacle Bellwether Trial</strong></em></p>


<p>Judge Kinkeade, the federal judge in Texas overseeing the Depuy Pinnacle multidistrict litigation, selected seven individual cases to be consolidated in the current bellwether trial. The plaintiffs are Marvin Andrews, Kathleen Davis, Sandra Llamas, Rosa Metzler, Judith Rodriguez, Lisa Standerfer, and Michael Weiser. All the plaintiffs are from California. Their cases were transferred to the Depuy Pinnacle MDL in Dallas, Texas.</p>


<p>Depuy has attempted several times to postpone the current trial. Judge Kinkeade has denied those motions. After jury selection, both sides made opening statements to the jury earlier this week. One major defense for Depuy seems to be that the surgeons implanted the Pinnacle hip in these plaintiffs incorrectly. In addition, there have already been several skirmishes between the plaintiffs’ attorneys and the defense team.</p>


<p>It is important to note that the current case is being tried under the laws of California. A case is typically governed by the laws of the state in which the plaintiffs originally file suit. A federal court in any state is often asked to consider a case with another state’s laws. The previous bellwether trial was governed by the laws of the state of Texas, which has a statute capping punitive damages. But California has no such statute. If the jury in this present case awards a large punitive damages award for the seven plaintiffs, the award will most likely stand.</p>


<p>So as I said, this is an important case, and a lot is at stake for both sides.</p>


<p><em><strong>The Depuy Pinnacle Hip</strong></em>
</p>

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<figure class="is-resized"><a href="/static/2016/01/iStock_000022783055_XXXLarge.jpg"><img decoding="async" alt="Depuy Pinnacle Artificial Hip" src="/static/2016/01/iStock_000022783055_XXXLarge-200x300.jpg" style="width:200px;height:300px" /></a></figure>
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<p>The Depuy Pinnacle Hip was originally designed to replace your natural bone “ball-and-socket” with artificial ball-and-socket parts. The Depuy Pinnacle system was supposed to provide more range of motion and to be more useful to an active group of patients undergoing hip replacement surgery. The Pinnacle system gave surgeons different options in the materials to be used for the hip replacement: metal-on-metal, or ceramic-on-metal, or other combinations. One of the major complaints against the Pinnacle is that the metal components grind and release metal particles into the body and blood of the patient, often leading to extremely high levels of cobalt and chromium (metallosis). You can read more about metallosis here.</p>


<p>The Depuy Pinnacle Hip was first sold in 2000. Depuy stopped manufacturing and selling the device in 2013.</p>


<p>Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).” This process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 of its intent to market a device (like an artificial hip) and to explain the device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States, which it did for the Depuy ASR and Pinnacle, and which I believe is a significant reason for all the injuries and suffering related to failed medical devices.</p>


<p><em><strong>Second Bellwether Trial Was Remarkable</strong></em>
</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2015/08/iStock000016768061Large-1.jpg"><img decoding="async" alt="Depuy Pinnacle MDL" src="/static/2015/08/iStock000016768061Large-1-300x199.jpg" style="width:300px;height:199px" /></a></figure>
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<p>Depuy needs a win in this third bellwether trial, as the company got walloped in the second bellwether trial. On March 17, 2016 a Dallas-area jury ordered Depuy Orthopaedics and Johnson & Johnson to pay five injured people <strong><em>$502 million dollars</em></strong>, including $360 million in punitive damages.  The jury based this award on several factors, including findings that Depuy hid critical defects in the design of the Depuy Pinnacle artificial hip system and hid these risks from doctors and patients. Remember that a bellwether trial, even with several plaintiffs, is <em><strong>not </strong></em>a class action lawsuit. Rather, because the five individual cases had sufficient similarities, the judge, attorneys, and litigants agreed to try all five cases in one jury trial. The single jury heard all the evidence in these cases, but Judge Ed Kinkeade instructed the jury to consider liability in each individual case, and to award separate damages for each plaintiff. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not warn patients and their doctors of the risks. The jury then awarded $142,000,000.00 in actual damages and $360,000,000.00 in punitive damages. The punitive damages award was later reduced (by operation of a statute capping punitive damages) to $9,646,256.00. To put it another way, the statute stripped $350,000,000.00 from the punitive damages award a jury of twelve individuals, after a 42 day trial, decided was appropriate. So much for the sanctity of the jury.</p>


<p>Even with this staggering reduction in the jury’s money damages award, the second bellwether trial was a huge win for the plaintiffs. Depuy and Johnson & Johnson have appealed, but they must also recognize that juries do not look favorably on rushing a dangerous product to market, particularly when more than eight thousand people are later injured by the device.</p>


<p>Stay tuned.</p>


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                <title><![CDATA[Metallosis: Serious Condition Caused By Metal-on-Metal Artificial Hips]]></title>
                <link>https://www.clayhodgeslaw.com/blog/metallosis-study-serious-health-problems-from-metal-on-metal-artificial-hips/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/metallosis-study-serious-health-problems-from-metal-on-metal-artificial-hips/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Thu, 11 Aug 2016 15:11:22 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Counseling]]></category>
                
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[chromium]]></category>
                
                    <category><![CDATA[cobalt]]></category>
                
                    <category><![CDATA[health problems]]></category>
                
                    <category><![CDATA[Metal-on-metal]]></category>
                
                    <category><![CDATA[Metallosis]]></category>
                
                    <category><![CDATA[study]]></category>
                
                
                
                <description><![CDATA[<p>Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings&hellip;</p>
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<figure class="is-resized"><a href="/static/2016/08/iStock_89156129_XLARGE.jpg"><img decoding="async" alt="Cobalt and Chromium from metal-on-metal hip implants" src="/static/2016/08/iStock_89156129_XLARGE-300x210.jpg" style="width:300px;height:210px" /></a></figure>
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<p>Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings of cobalt, chromium, or other metals. Still, the treating physician would occasionally dismiss the blood work results. At least one doctor told a patient, “no one knows the effects of higher metal levels on the body. We haven’t studied the impact of metallosis sufficiently. It is nothing to be worried about at this point.”</p>


<p>Sadly, this isn’t true. And it’s not the best medical advice. There have been several studies over the years that looked at metallosis in the body derived from metal-on-metal hip components. The first incident of metallosis from MoM hip implants was reported in 1971. Since then, doctors have been reporting the higher incidence of metallosis in patients who received MoM artificial hip implants. Several scholarly studies have been conducted, including a recent one whose results were published this month examining the impact of metallosis on the cells of patients.</p>


<p><strong><em>What Is Metallosis?</em> </strong></p>


<p>Metallosis is a serious medical condition involving the deposit and build-up of metal debris in the soft tissues of the body. Metallosis has been shown to occur when metal components in medical implants rub or scrape against each other. Imagine the metal cup and the metal ball in an artificial hip grinding against each other day after day, for months and years. Very tiny metal shavings can be scraped away and released into the human body. Over time, these tiny shavings can build up alarming metal levels in the blood. It is common in hip replacements but also occurs in other joint replacements.</p>


<p><strong><em>The Latest Study on Metallosis</em></strong>
</p>

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<figure class="is-resized"><a href="/static/2016/08/blood-1291130_1920-1.jpg"><img decoding="async" alt="Metallosis" src="/static/2016/08/blood-1291130_1920-1-200x300.jpg" style="width:200px;height:300px" /></a></figure>
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<p>In the August 2016 edition of <a href="http://www.sciencedirect.com/science/article/pii/S014296121630134X" rel="noopener noreferrer" target="_blank"><strong><em>Biomaterials</em></strong></a>, an international research team looked at the physical impact of metallosis on the body. They studied metal-on-metal hip components made of cobalt and chromium and/or molybdenum alloys (CoCrMo). The study confirmed that use of these hip components can lead to the “release of wear products such as metallic particles and dissociated metal species, raising concerns regarding their safety” for orthopedic surgeons and patients. The study showed that release of these metal particles in the body are capable of producing problems on a cellular level, and can cause “aseptic osteolysis” and other health problems. Osteolysis is the destruction or disappearance of bone tissue.</p>


<p>The study also examined the impact of metallosis on “mesenchymal stromal cells.” These are multi-functional cells that can develop into several different cell types which produce bone, cartilage, muscle or fat. According to the study, metallosis interferes with this cell development and can cause serious problems and “impair osteogenic differentiation of MSCs.” That’s a mouthful, but it’s not good.</p>


<p>Importantly, the study concluded by saying that the continued use of cobalt, chromium, and molybdenum alloys for joint replacement implants “<em><strong>needs critical reconsideration</strong></em>.”</p>


<p>Dr. James Pritchett is an orthopedic surgeon who writes a lot about the onset of metallosis following hip implants. He states that symptoms of metallosis include pain, instability, and increasing noise from the hip. In addition, metallosis may cause some or all of these symptoms: pseudo-tumors, nerve and thyroid problems, brain impairment, heart problems, depression and anxiety, visual impairment, rashes, infection, and implant loosening.</p>


<p><strong><em>The Takeaway</em></strong></p>


<p>The takeaway is that more and more studies are showing that high metal levels in the blood are a bad thing. The recent study in <strong><em>Biomaterials</em></strong> journal points to harmful changes that metal levels can cause to the cells of human tissue, and that use of metal-on-metal components for artificial hips and other joints must be “reconsidered.” I hear that to mean: “discontinued immediately.” In any event, do not accept your physician’s offhand comment that your higher metal levels (even if only slightly higher than normal) are of no concern. Get a second opinion. Metallosis is not a healthy condition. Good luck.</p>


<p>Note: This post does not reference any individual person or client. The information is general and is derived from many circumstances over several years.</p>


<p>For further information, check out the <em><a href="http://www.journals.elsevier.com/biomaterials" rel="noopener noreferrer" target="_blank">Biomaterials</a> </em>website. <em>Biomaterials</em> is an international journal covering the science and clinical application of biomaterials. But be warned: these are people with high levels of very specific knowledge. Pack a medical dictionary.</p>


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