Articles Posted in Zimmer NexGen Knee

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Woman with Transvaginal MeshLet’s say you are a woman in your forties, and the mother of three children. After the birth of your third child you began to suffer from pelvic organ prolapse. This condition occurs when an organ like the bladder drops from its normal position and presses against the walls of the vagina. You go to your gynecologist, who recommends implantation of transvaginal mesh (TVM), the net-like plastic product that was marketed and sold as a solution to the problem of pelvic organ prolapse. You have the surgery. Soon you begin to suffer new and different pain and new health problems. You undergo three revision surgeries to remove all the pieces of the mesh. But after the revision surgeries you still suffer from pain and incontinence. You call an attorney, who files a lawsuit against the manufacturer of the TVM product. A few months into the litigation, your attorney explains that you now need an expert witness.

Your attorney is absolutely correct: you will need an expert witness in virtually all product liability cases. And a good one. And fast. If you do not have a qualified expert witness who can make the connection between your injuries and the failed product, then in the eyes of the court you do not have a case.

Your Most Important Witness

Expert witnesses are critical members of the team that is built to win your product liability case. In fact, other than your choice of attorney, the selection of the expert witness will be the most important decision you will make to help you win your case.

Expert Witness in Product Liability Case

Expert witnesses are common in all kinds of litigation. In a simple car crash case, a treating doctor is almost always called to testify about the nature of the plaintiff’s injuries after the crash. In some car crash cases, a second expert witness will be called to explain why a car’s brakes failed, or why the car’s airbag did not deploy. Usually this testimony ends by showing causation, “and if the brakes did not fail, the driver would not have crashed into that oak tree and broken his arm.”

In a product liability case, the expert must be able to show causation, to make the connection between the failure of the product and the injuries the person suffered. If the injured person cannot show this causation through the testimony of a qualified expert witness, she cannot win her case. In the example at the top of this post, the expert will have to be able to testify that the new pains and the new health problems were medically caused by the failure of the mesh and the need for multiple revision surgeries.

But I’m getting ahead of myself.

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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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