Articles Posted in Zimmer

Zimmer Biomet CPT Hip SystemArtificial 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 metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

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, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication 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.

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.

Artificial Hip
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:

  • The socket (or acetabular component).

Zimmer NexGen Knee Replacement Surgery

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 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 read more about the Lone Pine Order here.

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 read about that court decision here, 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.

The Judge’s Order was a sledgehammer, but . . .

It’s Not All Bad News

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 “Potential Differences Between Joas’s Case and Others in the MDL.” Let’s examine a few keys statements in the part of her Order (the italicized statements below were written by Judge Pallmeyer):

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Artificial Knee Components

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.

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.

Summary Judgment

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.

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.

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Knee InjuryThe 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.

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: In Re: Zimmer NexGen Knee Implant Products Liability Litigation, No. 2272 (1:11-cv-5468).

Do You Qualify for the Zimmer NexGen MDL?

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 clear evidence of loosening. 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 radiolucent lines, 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.

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Orthopedic surgeon holding X-ray of artificial hip components

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?

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Client Reviews
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I was involved in a case for the faulty hip replacements. Clay Hodges represented me. I can't say enough about how much he has helped me. Clay was able to win multiple settlements on my behalf with most of them being the maximum amount able to be awarded. Matt J.
★★★★★
Clay, thank you sir for making a disheartening experience at least palatable, you and your staff were honest, caring and understanding through the entire process of my wife’s hip replacements, while monetary settlements never make the pain and suffering end, it sometimes is the only way people can fight back to right a wrong. J. V.
★★★★★
We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.
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