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        <title><![CDATA[Zimmer - Hodges Law, PLLC]]></title>
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        <description><![CDATA[Hodges Law's Website]]></description>
        <lastBuildDate>Fri, 27 Mar 2026 20:52:20 GMT</lastBuildDate>
        
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            <item>
                <title><![CDATA[FDA Issues Warning: Increased Risk of Thigh Bone Fractures With Zimmer Biomet CPT Hip System Femoral Stem]]></title>
                <link>https://www.clayhodgeslaw.com/blog/fda-issues-warning-increased-risk-of-thigh-bone-fractures-with-zimmer-biomet-cpt-hip-system-femoral-stem/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/fda-issues-warning-increased-risk-of-thigh-bone-fractures-with-zimmer-biomet-cpt-hip-system-femoral-stem/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Tue, 01 Oct 2024 12:35:46 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[FDA]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                    <category><![CDATA[CPT Femoral Stem]]></category>
                
                    <category><![CDATA[CPT Hip System]]></category>
                
                    <category><![CDATA[CPT recall]]></category>
                
                    <category><![CDATA[FDA warning]]></category>
                
                    <category><![CDATA[Femoral Stem 12/14 Neck Taper]]></category>
                
                    <category><![CDATA[femur breaks]]></category>
                
                    <category><![CDATA[Zimmer Biomet]]></category>
                
                
                
                <description><![CDATA[<p>Zimmer Biomet initiated a voluntary recall of the Zimmer CPT Hip System to provide updated instructions on the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.</p>
]]></description>
                <content:encoded><![CDATA[
<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/01/iStock_000022783055_XXXLarge.jpg"><img decoding="async" alt="Zimmer Biomet CPT Hip System" src="/static/2016/01/iStock_000022783055_XXXLarge-200x300.jpg" style="width:200px;height:300px" /></a></figure>
</div>

<p>Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being <a href="/tag/metallosis/">metallosis</a>. But there’s also another potential risk where the femur (thigh bone) could break.</p>


<p>The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, <a href="/tag/artificial-hip-surgery/">artificial hip revision surgery</a> may be needed.</p>


<p>The U.S. Food and Drug Administration (FDA) recently issued a <a href="https://www.fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety" rel="noopener noreferrer" target="_blank">safety communication</a> alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.</p>


<p><em><strong>Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper Fracture Risks</strong></em></p>


<p>Just to make things clear, practically all medical treatments come with some risks. So the question isn’t about whether there’s a risk, but the level of risk and whether a patient is properly told those risks so they can make an informed decision.</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2014/01/unnamed.jpg"><img decoding="async" alt="Zimmer Biomet CPT Hip System and femur fractures" src="/static/2014/01/unnamed-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>That being said, the primary issue here isn’t that there’s a bone fracture risk if you receive the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (Zimmer CPT Hip System). This is because most artificial hips have some risk of the thigh bone breaking after the surgery. The primary issue is instead whether you’re properly told about the risk of fracturing your femur should you receive this particular artificial hip, and whether this particular artificial hip carries a heightened risk of bone fracture.</p>


<p>The FDA cites a <a href="https://www.gov.uk/drug-device-alerts/cpt-hip-system-femoral-stem-12-slash-14-neck-taper-increased-risk-of-postoperative-periprosthetic-femoral-fracture-dsi-slash-2024-slash-007#fn:1" rel="noopener noreferrer" target="_blank">UK study</a> that found that the Zimmer CPT Hip System had a risk of thigh bone fracture that was roughly 1.4%. This doesn’t sound like much, but it’s <em><strong>almost double the fracture rates of comparable artificial hip products</strong></em>. These other artificial hips had a fracture risk that ranged between 0.6% and 1.0%.</p>


<p>Based on this information, Zimmer Biomet initiated a <em><strong>voluntary recall</strong></em> of the Zimmer CPT Hip System to provide updated instructions that would include the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.</p>


<p><em><strong>How Do I Know if I Received an Affected Artificial Hip from Zimmer Biomet?</strong></em></p>


<p>The best way is to ask your doctor or other health care professional. If you’re curious about the specific models, you can find an affected product list in the FDA’s safety communication or on <a href="https://www.zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/hip/ZFA%202024-00121%20Surgeon%20Notice_September%202024%20Follow-up.pdf" rel="noopener noreferrer" target="_blank">Zimmer Biomet’s website</a> (it’ll be on Attachment 2).</p>


<p><em><strong>What Should I Do If I Received an Affected Artificial Hip?</strong></em></p>


<p>If you don’t have any unexpected problems walking, or pain around your hip, then you’re probably fine as long as you maintain the follow-up schedule with your doctor. The FDA doesn’t recommend surgery to remove the artificial hip if you aren’t experiencing any problems with it. However, it’s still a good idea to talk to your doctor to know if you have an affected device and confirm that there’s nothing additional you need to do or avoid doing.</p>


<p>If you’re having problems with your Zimmer CPT Hip System, then you should contact your doctor as soon as you can. They can review your situation and recommend your next course of action. You may also want to report your issue to <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home" rel="noopener noreferrer" target="_blank">MedWatch</a>, which is administered by the FDA.</p>


<p>If you received a hip replacement surgery that used the Zimmer CPT Hip System and aren’t having any issues with it, that’s good news. But if you’re in pain, have trouble walking, or suffered a broken femur where the artificial hip was installed, <em><strong>legal action might be a possibility</strong></em>. If you want to learn more, call me at (919) 830-5602 or <a href="/lawyers/clay-hodges/">contact me</a> online. In the meantime, you can talk to your doctor if you have any questions or concerns. Good luck.</p>


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            <item>
                <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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            <item>
                <title><![CDATA[Zimmer NexGen Knee Lawsuits: Now the Good News]]></title>
                <link>https://www.clayhodgeslaw.com/blog/zimmer-nexgen-knee-lawsuits-now-the-good-news/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/zimmer-nexgen-knee-lawsuits-now-the-good-news/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Fri, 11 Nov 2016 18:49:34 GMT</pubDate>
                
                    <category><![CDATA[Multidistrict Litigation]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                    <category><![CDATA[bellwether case]]></category>
                
                    <category><![CDATA[causation]]></category>
                
                    <category><![CDATA[judge]]></category>
                
                    <category><![CDATA[knee]]></category>
                
                    <category><![CDATA[MDL]]></category>
                
                    <category><![CDATA[NexGen]]></category>
                
                    <category><![CDATA[order]]></category>
                
                    <category><![CDATA[Surgery]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                
                <description><![CDATA[<p>Without question, the Zimmer NexGen Knee MDL is not going all that well for plaintiffs lately. The first bellwether trial ended in a defense verdict in favor of Zimmer. Then Judge Rebecca Pallmeyer issued a Lone Pine Order which imposed a heavier burden on plaintiffs to avoid dismissal of their cases. That Order requires each&hellip;</p>
]]></description>
                <content:encoded><![CDATA[<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2016/11/iStock_16259902_LARGE.jpg"><img decoding="async" src="/static/2016/11/iStock_16259902_LARGE-300x200.jpg" alt="Zimmer NexGen Knee Replacement Surgery" style="width:300px;height:200px"/></a></figure>
</div>


<p>Without question, the Zimmer NexGen Knee MDL is not going all that well for plaintiffs lately. The first bellwether trial ended in a defense verdict in favor of Zimmer. Then Judge Rebecca Pallmeyer issued a <em>Lone Pine Order </em>which imposed a heavier burden on plaintiffs to avoid dismissal of their cases. That Order requires each plaintiff to file an Expert Declarations form establishing that the case meets all the latest requirements to warrant its continued place in the litigation. These requirements include a showing of (1) evidence of loosening of the artificial knee, (2) evidence of knee flexion of 120 degrees, (3) other detailed designations of injury and product failure. You can <a href="/blog/zimmer-nexgen-knee-lawsuits-lone-pine-order-requires-loosening-evidence/">read more about the <em>Lone Pine Order </em>here</a>.</p>



<p>Then, on October 21, 2016, Judge Pallmeyer ruled that the second bellwether case did not warrant a jury trial. In her Order, she granted summary judgment for Zimmer. You can <a href="/blog/zimmer-nexgen-knee-judge-boots-second-bellwether-case-before-trial/">read about that court decision here</a>, but in a nutshell, Judge Pallmeyer simply rejected the validity of the plaintiff’s key expert witness. She concluded that Dr. Joseph Fetto failed to refer to scientific literature or to “give any explanation for why the implant design, and asymmetric loading generally, causes . . . loosening.” (Order, p. 12) She wrote at length about the reasons why Dr. Fetto’s testimony is unreliable, ultimately concluding that Dr. Fetto has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) Without a reliable expert witness, a plaintiff cannot win a product liability case.</p>



<p>The Judge’s Order was a sledgehammer, but . . .</p>



<p><em><strong>It’s Not All Bad News</strong></em></p>



<p>It’s quite awful to select a bellwether case, prepare it for trial, and then, days before jury selection, the judge grants summary judgment on all claims in favor of defendants. After years of litigation, the plaintiff, who was clearly injured, was out of court without compensation. Still, there is reason to believe that future cases may have different results. Judge Pallmeyer admitted as much in the last section of her 43-page order, titled “<em><strong>Potential Differences Between Joas’s Case and Others in the MDL</strong></em>.” Let’s examine a few keys statements in the part of her Order (the italicized statements below were written by Judge Pallmeyer):</p>



<p>more
<em><strong>Other Cases Should Fare Better</strong></em>
<em>Although the first bellwether case in this MDL proceeded to trial, this second one terminates at the summary judgment stage. There are a number of significant differences, however, between Joas’s case and Batty that explain the different outcomes in the two cases, and differences between Joas’s case and future bellwether cases are likely to allow those cases, like Batty, to go before a jury as well. </em></p>



<p>First, Batty was the plaintiff in the first bellwether case; Joas was the plaintiff in the second bellwether case. Both plaintiffs lost their cases, but Batty survived summary judgment and was granted a jury trial. The statement above is a clear signal from the judge overseeing the Zimmer NexGen MDL that she expects other cases will have better evidence of causation between the injuries and the failure of the artificial knee components than did Joas. Because other cases appear stronger than the second bellwether case, Judge Pallmeyer expects future cases to survive summary judgment and reach a jury. This is good news.</p>



<p><em><strong>Strong Expert Witness Necessary to Establish Causation of Injury</strong></em>
</p>


<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/11/surgery-1049534_1920.jpg"><img decoding="async" src="/static/2016/11/surgery-1049534_1920-210x300.jpg" alt="Knee Replacement Surgeon" style="width:210px;height:300px"/></a></figure>
</div>


<p>Unlike this case, the specific causation theory in Batty did not rely on a differential etiology. Instead, there was significant radiographic evidence that appeared to link Ms. Batty’s injury with the plaintiffs’ general causation theories. Proving causation via differential etiology in a case like this may be difficult because of the many possible causes of aseptic loosening that would have to be ruled out. But a properly applied differential etiology, with consistent standards for ruling causes in and out, may well provide an adequate specific causation opinion.</p>



<p>Differential etiology tries to establish a particular medical condition (or disease) from several other conditions that present similar clinical features. Doctors use differential etiology to diagnose one disease or condition from another. Judge notes here that differential diagnosis is not the strongest approach to proving causation in the knee failure litigation, although it may work with “consistent standards for ruling causes in and out.”</p>



<p><em><strong>Wisconsin Design Defect Law Was Challenging</strong></em>
<em>This case also differs from Batty, and possibly from other cases, in that Wisconsin law requires a proposed safer alternative design as an element of a design defect claim. In states where there is no such requirement, a design defect case may be easier to make.</em></p>



<p>In federal court, the law of the state where the case is originally filed governs the case. Wisconsin law was applied in the second bellwether case, because that is where the case was originally filed. Wisconsin law has an added element to establish a “design defect” of a medical device. Essentially, the plaintiff must show that an alternative design would have been safer. This is a higher burden of proof for design defect claims than many other states have.</p>



<p><em><strong>Femoral Loosening Easier to Establish</strong></em>
<em>Also unlike in Batty, only Joas’s tibial implant exhibited loosening. A causal link between the implant’s design and femoral loosening, as in Batty, may be easier to establish. </em></p>



<p>If your case involves medical evidence of tibial loosening only, you may have trouble proving your case, as did Mr. Joas in the second bellwether case. The judge signals here that she is looking for cases which include evidence of femoral loosening.</p>



<p><em><strong>Implant Surgeon Must Read the Product Package Inserts</strong></em>
<em>And finally, unlike in this case, there was evidence in Batty that the plaintiff’s implanting surgeon had read the device’s package insert and had relied upon information from Zimmer in selecting the device and warning his patients. Under such circumstances, a failure-to-warn claim becomes much more tenable.</em></p>



<p>This statement sets out the obvious threshold for winning a “failure to warn” claim. In a failure to warn claim, the plaintiff argues that the manufacturer knew about the dangers posed by the product, had a duty to warn patients about those dangers, and were negligent about their duty in such a manner that the patient was hurt by the product.</p>



<p>In the second bellwether case, the plaintiff’s expert admitted he did not read the package insert for the Zimmer NexGen knee components. The defendants reasonably argued that they did all they could do: they drafted an insert with warnings about the device, but the implanting surgeon (the “learned intermediary”) failed to read the warnings. This is a key reason Mr. Joas lost his failure to warn claim.</p>



<p>So if you are a plaintiff, I see grounds for optimism in this Order. The Zimmer NexGen MDL is far from over.</p>
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                <title><![CDATA[Zimmer NexGen Knee: Judge Boots Second Bellwether Case Before Trial]]></title>
                <link>https://www.clayhodgeslaw.com/blog/zimmer-nexgen-knee-judge-boots-second-bellwether-case-before-trial/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/zimmer-nexgen-knee-judge-boots-second-bellwether-case-before-trial/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Wed, 26 Oct 2016 16:31:47 GMT</pubDate>
                
                    <category><![CDATA[Multidistrict Litigation]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                    <category><![CDATA[artificial knee]]></category>
                
                    <category><![CDATA[bellwether]]></category>
                
                    <category><![CDATA[Judge Pallmeyer]]></category>
                
                    <category><![CDATA[MDL]]></category>
                
                    <category><![CDATA[NexGen]]></category>
                
                    <category><![CDATA[order]]></category>
                
                    <category><![CDATA[Trial]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                
                <description><![CDATA[<p>October 2016 was set to be an important month for thousands of people injured by the Zimmer NexGen artificial knee. The second “bellwether” trial was scheduled. Bellwether trials involve representative cases that are used to educate the defendants and the plaintiffs on what certain juries thinks may be proper results for these kinds of cases.&hellip;</p>
]]></description>
                <content:encoded><![CDATA[
<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/10/iStock_16264743_LARGE.jpg"><img decoding="async" alt="Artificial Knee Components" src="/static/2016/10/iStock_16264743_LARGE-254x300.jpg" style="width:254px;height:300px" /></a></figure>
</div>

<p>October 2016 was set to be an important month for thousands of people injured by the Zimmer NexGen artificial knee. The second “bellwether” trial was scheduled. Bellwether trials involve representative cases that are used to educate the defendants and the plaintiffs on what certain juries thinks may be proper results for these kinds of cases. After several bellwether trials, both sides often come together and work out a global settlement based in large part on results from these bellwether trials.</p>


<p>Unfortunately for the plaintiffs in the Zimmer NexGen MDL, the latest bellwether case never reached the jury. On October 21, 2016, Judge Rebecca Pallmeyer, the federal judge overseeing the Zimmer NexGen MDL, granted summary judgment for Zimmer and the other defendants. Which means the case is over.</p>


<p><em><strong>Summary Judgment</strong></em></p>


<p>Summary judgment is a final judgment entered by the judge prior to trial. Essentially, the judge determines that no material factual issues remain in dispute and that one side is entitled to judgment “as a matter of law.” For the most part, summary judgment is a defensive tool, and defense lawyers will file a motion for summary judgment and will argue to the court that even taking the facts in a light most favorable to the plaintiff, the defendant is still entitled to judgment without the need for a jury trial.</p>


<p>This is exactly what happened last week on the eve of the second bellwether trial in the Zimmer NexGen MDL. In a 43-page Order, Judge Pallmeyer held that the plaintiffs failed to present adequate evidence that the design of the Zimmer NexGen knee caused the plaintiff’s alleged injury, and that the plaintiffs failed to show that the warnings accompanying the medical device were inadequate.</p>


<p>more
<em><strong>Judge Rejects Plaintiffs’ Expert Witness</strong></em></p>


<p>The plaintiff, Theodore Joas, was implanted with the Zimmer NexGen “Flex” knee. He had to undergo revision surgery in 2014 because the NexGen tibial component became loose and caused pain and complications. Mr. Joas and his wife sued Zimmer for several causes of action, but the key claims appear to have been (1) design defect, (2) failure to warn, (3) negligence and (4) punitive damages.</p>


<p>The key decision in the summary judgment order was the judge’s rejection of the plaintiffs’ expert witness. Once the expert witness was excluded as unreliable, the case collapsed.</p>


<p>The plaintiffs offered the testimony of Dr. Joseph Fetto. He testified that the Zimmer NexGen flex knee “puts excessive stress” on the cement and component “and can lead to early failure.” (Order, p. 12)</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2016/10/gavel-1017953_1920.jpg"><img decoding="async" alt="Zimmer NexGen Summary Judgment Order" src="/static/2016/10/gavel-1017953_1920-300x200.jpg" style="width:300px;height:200px" /></a></figure>
</div>

<p>Judge Pallmeyer rejected Dr. Fetto’s expert opinion as not valid. She wrote in her order that Dr. Fetto failed to refer to scientific literature or to “give any explanation for why the implant design, and asymmetric loading generally, causes . . . loosening.” (Order, p. 12) The judge wrote at length about the reasons why Dr. Fetto’s testimony is unreliable, ultimately concluding that Dr. Fetto has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17)</p>


<p>Excluding an expert means the expert cannot testify at trial, that his expert opinions are not sufficiently grounded in science to permit him to present an opinion to a jury. In a product liability case, it is essentially a death sentence for a plaintiff’s case. And it turned out to be for the plaintiff in this case, Mr. Joas.</p>


<p>Judge Pallmeyer first granted summary judgment as to all claims the plaintiffs did not defend at the summary judgment hearing. That was the easy part, and plaintiffs would have seen that coming. Then the judge awarded summary judgment as to the design defect, failure to warn, negligent design, and punitive damages claims. She pointed out that because plantiffs designated only Dr. Fetto as an expert witness, and because his testimony was (now) excluded, the plaintiffs were left with no expert to testify that a defect in Mr. Joas’s Zimmer NexGen knee was the cause of his injuries.</p>


<p>Judge Pallmeyer granted summary judgment as to plaintiffs’ failure to warn claim based on the defense of <em><strong>the learned intermediary doctrine</strong></em>, which <a href="/blog/transvaginal-mesh-one-huge-verdict-one-key-court-ruling-2015-part-3/">I write about here</a>. In Mr. Joas’ case, the implant surgeon admitted he <em><strong>did not read the package insert</strong></em> for the Zimmer NexGen flex knee components. Because of the surgeon’s confession that he did not read the product warnings, plaintiffs cannot prove “that an improved warning would have led to a different outcome for Joas’s knee.” (Order, p. 41) Sadly, this makes sense.</p>


<p><em><strong>“The Trial Date is Stricken”</strong></em></p>


<p>Like a slamming door, the last sentence of Judge Pallmeyer’s Order must have been startling to the plaintiffs: “The trial date is stricken.” This of course means that, “in light of what I just wrote, this case does not deserve a jury trial. Case closed.”</p>


<p>So far, the judge in the Zimmer NexGen MDL has not been impressed with the plaintiffs’ arguments. Judge Pallmeyer issued a <em>Lone Pine</em> Order in June, 2016, which <a href="/blog/zimmer-nexgen-knee-lawsuits-lone-pine-order-requires-loosening-evidence/">you can read about here</a>, and which sets out heightened requirements for the plaintiffs in order to reach a trial by jury. The latest summary judgment order, coming as it does in the second bellwether case, is a major setback for the remaining plaintiffs in the NexGen litigation. Still, with almost 6,000 plaintiffs remaining in the MDL, there is reason to believe this product was defectively or negligently designed.</p>


<p><strong><em>Do You Qualify for the Zimmer NexGen MDL?</em></strong>
</p>

<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/07/knee-1406964_1920.jpg"><img decoding="async" alt="Knee X-ray" src="/static/2016/07/knee-1406964_1920-225x300.jpg" style="width:225px;height:300px" /></a></figure>
</div>

<p>The threshold requirements to participate in the MDL are (1) to show implantation of the relevant Zimmer NexGen knee components, and (2) to show through the medical records <strong><em>clear evidence of loosening</em></strong>. Loosening is when the artificial knee components begin to move in the patient’s leg and separate from the bone. A loose artificial knee can cause major complications and eventually require replacement and revision surgery. When a patient complains to a doctor about knee pain after a total knee arthroplasty, the doctor will order an X-ray and look for <strong><em>radiolucent lines</em></strong>, which are spaces between the artificial knee component and the patient’s bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure.</p>


<p>If you have a Zimmer NexGen knee implanted, and it failed, and the failure led to revision surgery, you should find a good product liability attorney to review your case thoroughly and see if it qualifies under the latest guidelines. But as Mr. Joas will tell you: you’ll need a strong expert on causation to overcome Judge Pallmeyer’s critical eye.</p>


<p>Second Bellwether Case Caption: <em>Joas, et al. v. Zimmer Inc.</em>, No. 13-9216 (N.D. Illinois)</p>


<p>Note: Photos for illustration only.</p>


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                <title><![CDATA[Zimmer NexGen Knee Lawsuits: “Lone Pine” Order Requires Loosening Evidence, More]]></title>
                <link>https://www.clayhodgeslaw.com/blog/zimmer-nexgen-knee-lawsuits-lone-pine-order-requires-loosening-evidence/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/zimmer-nexgen-knee-lawsuits-lone-pine-order-requires-loosening-evidence/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Mon, 18 Jul 2016 15:00:12 GMT</pubDate>
                
                    <category><![CDATA[Artificial Knee]]></category>
                
                    <category><![CDATA[Multidistrict Litigation]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                    <category><![CDATA[bellwether trial]]></category>
                
                    <category><![CDATA[court order]]></category>
                
                    <category><![CDATA[knee]]></category>
                
                    <category><![CDATA[MDL]]></category>
                
                    <category><![CDATA[NexGen]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                
                <description><![CDATA[<p>The Zimmer NexGen artificial knee has been causing patients much pain and suffering over the past decade. Zimmer first instituted a recall of one group of NexGen components in 2010, and there have been other recalls in the years following. Many patients with the NexGen knees have suffered pain and an inability to maintain normal&hellip;</p>
]]></description>
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<div class="wp-block-image alignright">
<figure class="is-resized"><a href="/static/2016/07/knee-1406964_1920.jpg"><img decoding="async" alt="Knee Injury" src="/static/2016/07/knee-1406964_1920-225x300.jpg" style="width:225px;height:300px" /></a></figure>
</div>

<p>The Zimmer NexGen artificial knee has been causing patients much pain and suffering over the past decade. Zimmer first instituted a recall of one group of NexGen components in 2010, and there have been other recalls in the years following. Many patients with the NexGen knees have suffered pain and an inability to maintain normal physical activity. The lawsuits of course followed.</p>


<p>In August 2011, to handle the growing number of lawsuits over the NexGen knee, a multidistrict litigation (MDL) site was formed in Chicago, Illinois and assigned to federal district court judge Rebecca Pallmeyer. The MDL is titled: <a href="http://www.ilnd.uscourts.gov/mdl-details.aspx?WNesDQBcWakSF/4TSCIYmQ==" rel="noopener noreferrer" target="_blank"><em>In Re: Zimmer NexGen Knee Implant Products Liability </em>Litigation, No. 2272 (1:11-cv-5468)</a>.</p>


<p><strong><em>Do You Qualify for the Zimmer NexGen MDL?</em></strong></p>


<p>The overarching requirement to participate in the MDL is (1) to prove implantation of the Zimmer NexGen knee components (with product stickers from the original surgery), and (2) to show through the medical records <strong><em>clear evidence of loosening</em></strong>. Loosening is when the artificial knee components begin to move in the patient’s leg and separate from the bone. This is not good. Loosening can be very painful. A loose artificial knee will cause major complications and eventually require replacement and revision surgery. When a patient complains to an orthopedic surgeon about knee pain after a total knee arthroplasty, the doctor will order an X-ray. The doctor will look for <strong><em>radiolucent lines</em></strong>, which are spaces between the artificial knee component and the patient’s bone. Essentially, small gaps occur because the medical device is not implanted tightly or securely to the bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure. The spaces often fill with fluid or tissue which can cause additional loosening of the medical device.</p>


<p>more
<strong><em>Zimmer NexGen Knee Was Approved Through the 510(K) Process</em></strong></p>


<p>The Zimmer NexGen artificial knee bypassed the normal premarket testing for new medical products through a process known as “510(k).” I have written about this <a href="/blog/category/510k-process/">“rush to market” procedure</a> on this site. The 510(k) process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 (MDA) of its intent to market a device (like the NexGen knee); the manufacturer must describe the new device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States <em><strong>without rigorous testing</strong></em> as with new medical devices. This is how the Zimmer NexGen Knee reached the market.</p>


<p>Large numbers of people have suffered from pain and required revision surgery to replace the Zimmer NexGen artificial knees. Despite all this suffering, the MDL has moved very slowly. Bellwether cases have been selected, and trial dates assigned, only to be continued or otherwise postponed. For individuals who filed suit against Zimmer years ago (including some of my clients), it has been a frustrating exercise. Over the years, the qualifications in the MDL have narrowed, and the requirements to qualify for potential compensation have gotten more difficult. As a result, many lawsuits have been dismissed from the litigation as not qualifying under the latest criteria.</p>


<p><strong><em>Case Management Order No. 11 (The “Lone Pine” Order)</em></strong>
</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2015/11/iStock000068696003XXXLarge.jpg"><img decoding="async" alt="Zimmer NexGen Knee Injury" src="/static/2015/11/iStock000068696003XXXLarge-300x200.jpg" style="width:300px;height:200px" /></a></figure>
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<p>On June 24, 2016, MDL Judge Rebecca Pallmeyer issued the latest case management order (CMO) which set out the latest requirements to determine if a case has “sufficient merit to proceed to trial.” The new order, which is referred to as a <strong><em>Lone Pine Order</em></strong>, requires each plaintiff to file an <strong><em>Expert Declarations </em></strong>form establishing that the case meets all the latest requirements to warrant its day in court (that is, a trial by jury). These requirements are complex and come from different court orders over several years, but I will try to set them out (in simplified form) here. The plaintiff must:
</p>


<ul class="wp-block-list">
<li>File a Plaintiff Fact Sheet (which details the key facts of the case);</li>
<li>Show Evidence of Loosening of the Zimmer NexGen knee;</li>
<li>Submit Evidence of Knee Flexion of 120 Degrees or Greater;</li>
<li>Identify the Case as Track One or Track Two (Track Two is essentially a case where the requirements of Track One have not been met);</li>
<li>Designate Whether the Plaintiff Intends to Pursue Certain Specific Claims, Such as:
<ul>
<li>Femoral loosening resulting from high flexion activities;</li>
<li>Loosening of tibial component;</li>
<li>Tibial loosening of MIS tibial component with a drop down stem.</li>
</ul>
</li>
</ul>


<p>
I know, I know, what the heck does all this mean? It is highly technical, and an orthopedic surgeon or a competent medical device attorney is often necessary to make sense of these directives. For now, let me say that this case management order presents a new challenge for the plaintiffs involved in the litigation. These requirements are precise and rigorous and designed to weed out cases which do not have medical records clearly showing evidence of artificial knee loosening, along with injury and pain for the patient. Undoubtedly, this Lone Pine Order will cause some of the cases to be abandoned. But if you have a Zimmer NexGen knee implanted, and it failed, and the failure led to revision surgery, you should find a good product liability attorney to review your case thoroughly and see if it qualifies under the latest guidelines. But do not delay.</p>


<p>The first bellwether trial in the Zimmer NexGen MDL is scheduled for October 2016. Let’s hope it does not get postponed (again).</p>


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                <title><![CDATA[Failed Artificial Hips:  What Cases Are Still Active in 2016?]]></title>
                <link>https://www.clayhodgeslaw.com/blog/failed-artificial-hips-cases-still-active-2016/</link>
                <guid isPermaLink="true">https://www.clayhodgeslaw.com/blog/failed-artificial-hips-cases-still-active-2016/</guid>
                <dc:creator><![CDATA[Clay Hodges]]></dc:creator>
                <pubDate>Wed, 27 Jan 2016 21:34:16 GMT</pubDate>
                
                    <category><![CDATA[Artificial Hip]]></category>
                
                    <category><![CDATA[Depuy ASR]]></category>
                
                    <category><![CDATA[Depuy Pinnacle]]></category>
                
                    <category><![CDATA[Stryker]]></category>
                
                    <category><![CDATA[Zimmer]]></category>
                
                
                
                
                <description><![CDATA[<p>Artificial hips have been failing for years now. The effort in the last two decades to build and market a metal-on-metal hip that might last the patient’s lifetime has not been a success. The manufacturers were too quick to move the new metal hips to market, and using the flawed 510(k) fast-track process, they did&hellip;</p>
]]></description>
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<figure class="is-resized"><a href="/static/2016/01/iStock_000022783055_XXXLarge.jpg"><img decoding="async" alt="Orthopedic surgeon holding X-ray of artificial hip components" src="/static/2016/01/iStock_000022783055_XXXLarge-200x300.jpg" style="width:200px;height:300px" /></a></figure>
</div>

<p>Artificial hips have been failing for years now.  The effort in the last two decades to build and market a metal-on-metal hip that might last the patient’s lifetime has not been a success.  The manufacturers were too quick to move the new metal hips to market, and using the flawed 510(k) fast-track process, they did not test the devices sufficiently to understand the risks.  As a result, thousands of people suffered through hip replacement surgery failure and had to undergo revision surgery, just months or a few years after the original surgery.  Because of these hip failures, thousands of lawsuits have been filed.  The litigation continues for many people, and will continue for years.  Still, because most of the failed medical hip products were recalled or taken off the market years ago, the litigation is plainly winding down with several of these artificial hip devices.  So what’s still going on?  And what does this mean for you?</p>


<p>more
<strong><u>Depuy ASR </u></strong></p>


<p>This was a big one, and I have written about it extensively on this website.  Two settlement agreements have been reached in the multidistrict litigation (MDL), several cases have been tried to juries, and thousands of lawsuits have been settled.  Of course there is still time to bring a lawsuit against Depuy for the failure of the Depuy ASR hip system, but the window is closing.  Two key facts are required:  (1) did you have the Depuy ASR hip implanted in your body? and (2) are you having problems with your hip?  If you answered yes to both, you need to get answers to your medical questions and legal questions immediately.  Keep in mind that your state’s statute of limitation, which sets a limit on the time you can file a claim, is always a critical issue for an injured person.  Don’t wait.</p>


<p><strong><u>Depuy Pinnacle</u></strong></p>


<p>Depuy Orthopaedics (and Johnson & Johnson) also marketed and sold an artificial metal-on-metal hip known as the Depuy Pinnacle Hip Replacement System.  I wrote about the basics of the Depuy Pinnacle hip and its litigation <a href="/blog/depuy-pinnacle-artificial-hip-lawsuits-basics/">here</a>.  A key difference between the Pinnacle and the ASR is that Depuy Orthopaedics has not recalled the Pinnacle and has aggressively defended the Pinnacle in litigation, claiming that the device is not harmful and that surgeon error is the cause of the “few” problems associated with the Pinnacle.  The multidistrict litigation (MDL) is situated in Texas, but you can certainly bring a claim in any state if you’ve been hurt by the failure of the Depuy Pinnacle.  Unlike the ASR, the Pinnacle litigation will last longer because no recall has occurred, which means the products have been out in the marketplace longer and thus have the potential to hurt artificial hip patients, even recently.  As of today a second “bellwether” trial is underway in Texas federal court, with Judge Ed Kinkeade presiding (<strong><em>Peterson et al v. Johnson & Johnson Services, Inc. et al </em>3:11-cv-01941</strong>).  I will let you know immediately when the jury reaches a decision in that case.</p>

<div class="wp-block-image alignleft">
<figure class="is-resized"><a href="/static/2016/01/iStock_000016768061_Large.jpg"><img decoding="async" alt="Courtroom" src="/static/2016/01/iStock_000016768061_Large-300x199.jpg" style="width:300px;height:199px" /></a></figure>
</div>

<p>
<strong><u>Zimmer Durom Cup</u></strong></p>


<p>Zimmer Inc. put its Zimmer Durom Acetabular Component (“Durom Cup”) on the market in 2006, so this troublesome artificial hip has been on the market a decade now.  More than 12,000 people had the Zimmer Durom Cup implanted between 2006 and 2008 (including several of my own clients).  People almost immediately began complaining of pain and injuries, and many had to undergo revision surgery.  The allegation is that the metal Durom Cup does not bond with and seal to the hip bone the way an effective acetabular cup is supposed to.  Despite receiving thousands of complaints, Zimmer, Inc. has not permanently removed the Durom Cup from the market, and never issued a recall.  Nevertheless, I have seen little evidence that the Durom Cup is sold or used much these days.</p>


<p>On July 24, 2015, in <strong><em>Kline, et al. v. Zimmer Inc., et al</em></strong>., a California jury awarded Gary Kline $9.2 million dollars for the failure of the Zimmer Durom Cup.  You can read more about that case <a href="/blog/recent-jury-verdicts-artificial-hip-trials-part-2/">here</a>.</p>


<p>The key thing about Zimmer Durom is that the product is mostly gone from the market.  If you had the Zimmer Durom Cup implanted, and medical problems have now occurred, speak to your doctor and a trusted attorney <strong><em>immediately</em></strong>, as your claim may be close to being time-barred by your state’s statute of limitation.  If you don’t file within the time limits of a statute of limitation (often within three years of discovery of the negligence) your claim may well be lost, which means you missed your chance to seek compensation for your injuries against Zimmer Inc.</p>


<p>The MDL is located in New Jersey and is still active.</p>


<p><strong><u>Stryker Rejuvenate and ABG II</u></strong></p>


<p>Stryker Corporation placed two metal-on-metal artificial hips on the market in 2008 and 2009:  the Rejuvenate and the ABG II.  As with most of the metal-on-metal artificial hips, Stryker pushed these products on the market using the 510(k) process.  Stryker Rejuvenate and ABG II began causing problems for patients soon after the first sales occurred, and Stryker eventually received thousands of complaints.  Stryker voluntarily recalled the Rejuvenate and ABG II in July 2012, citing “potential for fretting and corrosion” at the neck of the hip, which may result in “adverse local tissue reactions, as well as possible pain and/or swelling at or around the hip.”  See Stryker Corporation Website.</p>


<p>Because the recall did not occur until July 2012, there is still the possibility that if you had hip replacement surgery between 2008 and 2013, you could possibly have the Stryker Rejuvenate or the ABG II implanted in your body.  If you are not having any pain or discomfort, then most likely you should be fine and need to take no action.  But if you are suffering abnormal pain and discomfort, check with your doctor to make sure you do not have implanted the recalled Stryker Rejuvenate or ABG II.</p>


<p>I will discuss other companies with pending artificial hip lawsuits in a later post.</p>


<p><strong><em>Key Takeaway</em></strong>:  if you received an artificial hip as part of hip replacement surgery in the last ten years, and particularly in the last three to five years, it is important to be attentive to your body and to your hip.  See all your doctors regularly.  Keep a close watch on your hip.  If something feels wrong, schedule an appointment and figure out what it is going on.  It may be a normal result of hip replacement surgery.  But it may be one of the failed hip components listed above.  If so, there is still time to bring a claim and seek compensation.  Good luck.</p>


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